Loading…

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Friday, June 12
 

8:00am EDT

SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.
Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

Explain the major elements of the Japanese regulatory system;Describe the regulatory procedures during development, registration, and post-approval;Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.


Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →


Friday June 12, 2020 8:00am - 11:30am EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial
 
Sunday, June 14
 

9:00am EDT

SC19: #19: Core Labeling
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-064-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

This half day short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, how local labeling changes and regulatory requirements may have an impact on Company Core Data Sheet (CCDS). In addition, it will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments

Learning Objectives

• Discuss the concept and use of CCDS;Analyze with the detailed content of CCDS;Discuss knowledge of core labeling implementation and deviations; Identify options to bridge different local/regional requirements in the CCDS; Examine the potential impact of CCDS on the company, e.g. tracking, deviation management.


Speakers
avatar for Gerrit Nijveldt

Gerrit Nijveldt

EASi
Gerrit Nijveldt is currently Labeling consultant with EASi. Gerrit has more than 20 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   01: ClinSafety-PV, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:00am EDT

SC22: #22: Data Visualization in the Life Sciences
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 02086-0000-20-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response. Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon.
Back to DIA 2020 Short Courses

Who should attend?

This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.


Learning Objectives

Describe the transition from traditional methods of data analysis to visual approaches;Identify life science data using one or more data visualizations;Assess the strengths and limitations of various graphical techniques;Explain the “data story” of numerous clinical research, examples using data visualization techniques.


Speakers
avatar for Kelci Miclaus

Kelci Miclaus

Sr Manager, Advanced Analytics R&D, SAS Institute Inc., JMP Division
Dr. Kelci Miclaus is Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute where she manages the R&D team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics from North Carolina... Read More →
avatar for Richard Zink

Richard Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc
Richard C. Zink is Senior Director of Data Management and Statistics at TARGET PharmaSolutions. He is the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, host of the Biopharmaceutical Section Statistics Podcast, and Associate Editor for the DIA... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   03: Data-Data Standards, Tutorial |   01: ClinSafety-PV, Tutorial |   02: ClinTrials -ClinOps, Tutorial

9:00am EDT

SC24: #24: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.
Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

Define core concepts and main principles of the risk-based monitoring (RBM) methodology; Discuss the use of key tools in the RBM process; Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.


Speakers
avatar for Rodrigo Perez

Rodrigo Perez

CSU Risk-Based Monitoring (RBM) Business Lead, Sanofi
Rodrigo Perez, based in Mexico City, has more than 12 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →
avatar for Samantha Hewlett

Samantha Hewlett

Risk-Based Study Execution Capability Lead, Amgen
Samantha qualified as a pharmacist and has worked in the pharmaceutical industry in varying roles and countries for over 20 years. She moved back to South Africa in 2014 and transitioned in to clinical research where she lead local clinical operations for both GSK and Amgen. She has... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044

9:00am EDT

SC21: #21: Real World Evidence: The Evolving Landscape of Regulators, Data and Integrated Use
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

This short course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December, 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data. Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning Objectives

Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies;Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments;Recognize when RWE based approaches are of sufficient quality to enable decision making.


Speakers
avatar for Brian Bradbury

Brian Bradbury

Executive Director, Head, Data and Analytics, Center for Observational Research, Amgen, Inc.
Brian D. Bradbury is Executive Director in the Center for Observational Research (CfOR) at Amgen, Inc, and an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who use real-world data (RWD) to... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health... Read More →
avatar for Gillis Carrigan

Gillis Carrigan

Director, Center for Observational Research, Amgen
Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number... Read More →
avatar for Matthew Reynolds

Matthew Reynolds

Vice President, Real World Evidence, IQVIA
As a member of the Center for Advanced Evidence Generation in Real-World Solutions at IQVIA, he designs innovative solutions for real-world evidence on effectiveness and safety, reporting to the Chief Scientific Officer. He concentrates on studies that are enriched by combining primary... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial

9:00am EDT

SC25: #25: Regulatory Requirements for IND/NDA Procedures in China
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

Since NMPA becomes ICH regulatory member, Chinese regulatory landscape seems much more harmonious with global standards and practices. Currently, Chinese GCP guidelines published by NMPA have been significantly adopted ICH requirements, which makes it possible directly to utilize global trial data to submit NDA NMPA. NMPA is also enhancing inspective forces on the quality and integrity of clinical trial outcomes, including data from oversea trials. The procedures of IND/NDA review and approval have been greatly reformed, such as 60 days IND silent system and filing site qualification on file instead certificate process etc. Quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA strategies in China. This short course will provide insights into critical considerations impacting IND/NDA practices involving in drugs development in China and upcoming NMPA reformations of regulatory submission review and approval.
Back to DIA 2020 Short Courses

Who should attend?

Regulatory affair professionals, Drug development professionals, Clinical trial management, Monitors, Data management professionals, Clinical operation professionals.

Learning Objectives

Describe basic NMPA regulatory requirements for IND/NDA submission; Discuss how to support simutanous regulatory submissions to FDA/NMPA authorities; Compare the similarity and difference between Chinese GCP and Western GCP; Discuss an overview of the updated Chinese GCP guideline of IND drug trials; Describe utilization of oversea clinical CSR for NMPA submission; Identify updated NMPA requirements of data quality/integrity.


Speakers
avatar for Daniel Liu

Daniel Liu

Chief Science Officer, Beijing Clinical Service Center
Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial

9:00am EDT

SC26: #26: “Has it Happened Already?” Questions of Precedent from which Regulatory Intelligence Can Save You
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-505-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

This intent of this short course is to provide a quick overview and practical insight into locating, analyzing and applying precedent as an aid to making better strategic regulatory decisions. In a rapidly evolving regulatory environment, it is critical for regulatory professionals to employ research skills in locating precedent, determining those that are deemed meaningful and discarding those that are misleading, and developing an understanding of the bigger picture as a critical deliverable in a time of data-driven decision-making.
Back to DIA 2020 Short Courses

Who should attend?

Regulatory affairs, regulatory intelligence and policy professionals, professionals engaged in regulatory research and precedent analysis to support regulatory decision-making.

Learning Objectives

Describe the importance and context of precedent in regulatory strategy; Discuss locating and analyzing precedent from EU and US drug and biologic sources;Identify the impact of precedent for regulatory decision-making.


Speakers
avatar for Linda Bowen

Linda Bowen

Head of Regulatory Policy and Intelligence, Seattle Genetics
Linda joined the BioPharma industry in 1983 and has spent the last 27 years in regulatory strategy, intelligence and policy roles. She is Head of Regulatory Policy and Intelligence at Seattle Genetics and Assistant Professor in the Temple University RAQA graduate program. She attained... Read More →
avatar for João Duarte

João Duarte

Director, Chief of Staff & Regulatory Science, Alexion Pharmaceuticals
João Duarte is currently Chief of Staff and Regulatory Science within the Global Regulatory Affairs team at Alexion Pharmaceuticals. João leads the regulatory intelligence and policy activities globally and supports Senior Management in steering internal activities based on the... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial

9:00am EDT

#e-Posters: Professional and Student e-Posters Gallery
Component Type: Poster Presentation
Level: Basic

Professional and Student e-Posters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2020. Attendees are invited to scroll through and search e-Posters throughout the duration of virtual meeting. e-Posters run continuously during the meeting. There are no formal or LIVE e-Poster presentations during the DIA 2020 virtual meeting.

Chair

Jess Warner


Speakers
MT

Mai Tu

Drug Product Reviewer, OLDP, OPQ, CDER, FDA
Mai Tu is a drug product (CMC) quality assessor. She has been performing quality assessment and research of ANDAs. Her position is in in the Office of Lifecycle Drug Products (OLDP), OPQ. Her expertise is in formulation of multiple dosage forms. She has a Ph.D. in Pharmaceutics, and... Read More →
avatar for Danielle Abatemarco

Danielle Abatemarco

WWPS Innovation & Publications Management, Bristol Myers Squibb
Danielle leads the Publications strategy and execution for World Wide Patient Safety at BMS, where she joined via the acquisition of Celgene. With background in neuroscience and nursing, Danielle is passionate about the value of AI/ML in pharmacovigilance. She recently graduated with... Read More →
RR

Rajeswara Rao Arasada

MACPR Student, The Ohio State University
avatar for Tyler Benning

Tyler Benning

Medical Student, Mayo Clinic
Tyler Benning is a medical student at the Mayo Clinic Alix School of Medicine. He studied political science at St. Olaf College and is interested in the intersections among law, politics, and medicine. He is currently pursuing a Masters degree in Science of Health Care Delivery, and... Read More →
KC

Karen Chan

Pharmacy Student, University of Southern California
Karen Chan is a rising third year pharmacy student at the University of Southern California School of Pharmacy. She was born and raised in Hawai'i then received her bachelor’s degree in Chemistry and Japanese across the country at Bowdoin College. Her current research focuses on... Read More →
MC

May Chan-Liston

Global Risk Management Lead, Hematology and Cell Therapy, BMS
avatar for Lien-Cheng Chang

Lien-Cheng Chang

Section Chief, Division of Medicinal Products, TFDA
Lien-Cheng (Eric) Chang received his PhD degree from the Institute of Biopharmaceutical Sciences at Yang Ming University. Previously, he worked in Taichung Hospital and NTU Hospital in Clinical Pharmacy Services and also served in the former Bureau of Pharmaceutical Affairs for six... Read More →
avatar for She-Chia Chen

She-Chia Chen

ORISE Fellow, Office of Medication Error Prevention & Risk Management, OSE, CDER, FDA
She-Chia (Sage) Chen holds a Bachelor of Science in Pharmacological Chemistry from University of California, San Diego. While studying at Medical University of South Carolina, Sage interned at MUSC adult inpatient pharmacy from 2016- 2018. Sage co-authored an abstract published online... Read More →
SD

Sameen Desai

Senior Director, Pharmacovigilance Innovation, Bristol Myers Squibb
avatar for Arielle Dipasquale

Arielle Dipasquale

PharmD Candidate, Class of 2021, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey
I am a current 4th professional year pharmacy student at the Rutgers Ernest Mario School of Pharmacy. My early involvement with my campus chapter of DIA as well as other industry-driven organizations led me to becoming interested in pursuing a career path as an industry pharmacist... Read More →
SD

Sahith Doppalapudi

Manager, Safety Data Management and Analytics, Bristol Myers Squibb
My name is Sahith Doppalapudi, I have a masters degree in Chemical Engineering from Oklahoma State University, I have been in the pharmaceutical industry for close 10 yrs in varying capacities such as Quality Analyst, Validation lead, Pharmacovigilance Data manager, currently I am... Read More →
avatar for Brian Dow

Brian Dow

Scientist, Dossier Development and Operations, Janssen Research & Development, LLC
BD

Brian Dreyfus

Director, Bristol-Myers Squibb
Solid Tumor Oncology Epidemiology Lead and Safety, Analytics and Reporting Lead at Bristol Myers Squibb.
KE

Kathryn Evans

Research Associate, Analgesic Solutions
Kathryn Evans MS, MPH, uses her background in epidemiology and biostatistics to inform clinical trial research, monitoring, and outcomes analyses. She also manages medical communications and publications.
DF

Daniel Fiebig

Faculty, Rutgers University
avatar for Hannah Glenny

Hannah Glenny

Research Associate, Otsuka Pharmaceutical Development & Commercialization, Inc.
I am a Research Associate in the Clinical Management and Applied Innovation team since 2018 at Otsuka Pharmaceutical. My most recent work includes leading various transformation initiatives to deliver the next generation of clinical research, while driving improved patient outcomes... Read More →
avatar for Cammilla Horta Gomes

Cammilla Horta Gomes

LATAM Regulatory Policy Lead, Roche
Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence... Read More →
AH

Anand Harugeri

Director, Service Operations, Lifecycle Safety, IQVIA
Dr. Anand Harugeri is a Pharmacist. Over the past 18+ years, worked as Clinical Research Scientist for Ranbaxy Research Laboratories, and BioClinical Project Coordinator for Apotex Research Pvt. Ltd. Worked as Senior Research Fellow for an Indian Council of Medical Research. Served... Read More →
RH

Rika Hayashi

Otsuka Pharmaceutical Co., Ltd.
Author belongs to Clinical Development, Otsuka Pharmaceutical Co., Ltd..
avatar for Stephanie Jameison

Stephanie Jameison

Senior Director, Promotion Compliance, Otsuka Pharmaceutical Development & Commercialization, Inc.
Stephanie Hayes Jameison, MBA, is a Senior Director, Promotion Compliance at Otsuka Pharmaceutical Development & Commercialization, Inc., where she provides regulatory oversight and ensures compliance for the company’s marketed products. She also interacts with the FDA as a corporate... Read More →
avatar for Becky Johnson

Becky Johnson

Associate Director, Global Patient & Site Solutions, IQVIA
Becky has 20 years of experience in the biopharmaceutical industry, with a focus on healthcare communications and clinical trial recruitment. In her current role at IQVIA, Becky is accountable for the strategic direction of communication initiatives to support recruiting and engaging... Read More →
EK

Eva Katz

Associate Director, Patient Reported Outcomes, Janssen Research & Development
Eva Katz, PhD, MPH, RD is a member of the PRO team at Janssen Research & Development where she works cross-functionally to develop strategy for development, selection and implementation of Patient-Reported Outcomes (PROs) in clinical trials. Prior to this role, Dr. Katz has 20+ years... Read More →
JK

Jackline Kemboi

Student, African Institute For Mathematical Science (aims)-Rwanda
Being in love with mathematics, Jackline Kemboi took a brave decision to join the field of Applied statistics with computing. Her passion for mathematics enabled her to apply for Cooperative Master’s in mathematical science. She did her final project on Impact of different randomization... Read More →
avatar for Michelle Kissner

Michelle Kissner

Director, Publications Management, Pfizer Inc
Michelle Kissner is an accomplished innovator & leader in medical publications at Pfizer & is responsible for overseeing multiple publication agency partners & operational aspects of cross-functional publication teams to ensure successful development/implementation of comprehensive&scientifically... Read More →
avatar for Rushabh Lagdiwala

Rushabh Lagdiwala

Student, University of the Sciences, Philadelphia College of Pharmacy
Current student at the University of the Sciences, Philadelphia College of Pharmacy working towards a duel degree in Doctor of Pharmacy and MBA in Pharmaceutical and Healthcare Business. Conducted research on the Effect of the Pennsylvania Prescription Drug Monitoring Program on Opioid... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Regulatory Affairs Director, BioPharmaceuticals R&D, Late-stage Development, CRM, AstraZeneca
Dr. Jingyu (Julia) Luan is a Regulatory Affairs Director in AstraZeneca, leading global drug development and regulatory strategies for the treatment of cardiovascular and renal disease. Prior to AstraZeneca, she worked at the FDA for 13 years and held positions with increasing responsibilities... Read More →
avatar for Annie Ly

Annie Ly

Project Assistant, University of Southern California
Annie Ly, M.S. ‘21, is currently pursuing a Master of Science degree in Regulatory Science. Annie completed her Bachelor of Arts in Health and Human Sciences with a minor in English at USC. She has been conducting research in the Department of Regulatory and Quality Sciences within... Read More →
LL

Liyang Lyu

Student, University of Macau
NM

Nag Mani

Data Scientist, Gilead Sciences
I am a Data Scientist working in Gilead Data Science team with research interest in deep learning algorithms and its applications in health domain. I received my Masters in Computer Science from San Jose State University and my research thesis was on the topic of securing deep learning... Read More →
avatar for Jackie Miller-Giles

Jackie Miller-Giles

Clinical Scientist, Covance Inc.
Jackie Miller-Giles is a Senior Clinical Scientist at Covance. She holds a Master of Science from the University of Wisconsin-Madison. She has worked in the industry for 14 years and specializes in the area of clinical pharmacology with emphasizes on impairment studies.
avatar for Alexandra Moutet

Alexandra Moutet

Global Head of Patient Engagement, UCB Biopharma SPRL
Alexandra Moutet joined UCB in January 2017 as Global Head of Patient Engagement, based in Brussels, providing global leadership in patient engagement all across the medicine lifecycle continuum. She was previously Director of Patient Engagement and Care for Western Europe and Canada... Read More →
avatar for Michelle Nguyen

Michelle Nguyen

Doctor of Pharmacy Candidate, Class of 2021, University of Maryland School of Pharmacy
I am a rising 4th year student at the University of Maryland School of Pharmacy, with an interest in the patient-centered healthcare process. During my professional pharmacy program, I have gained experience as an ORISE fellow at the FDA with the Office of Clinical Pharmacology and... Read More →
avatar for Jennifer Nguyen

Jennifer Nguyen

Director, Patient and Health Impact, Pfizer Inc
MN

Mona Nili

PhD Student, West Virgina University
Mona Nili is a PhD Student at West Virginia University. She also has an M.Sc in pharmacy administration, an MBA, and a Pharm.D. Mona’s research focuses on methods for evaluating health outcomes and translating those outcomes into economic evaluations. Her expertise includes analysis... Read More →
avatar for Heejung Noh

Heejung Noh

ORISE Fellow, Office of Medical Policy, CDER, FDA
Heejung Stacey Noh, Pharm.D. ORISE Fellow, Office of Medical Policy, CDER FDA, United States Heejung Stacey Noh is a Real-World Evidence (RWE) ORISE Fellow of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. The primary focus of her research... Read More →
SO

Sarah Ofori

Post-Doctoral Fellow, Rutgers University
Sarah Ofori is post-doctoral fellow within global medical affairs, Inflammation and Immunology at Rutgers Pharmaceutical Industry Fellowship in conjunction with Pfizer Inc. Her current focus is medical dermatology. She completed her Bachelor of Science in Biochemistry at Old Dominion... Read More →
KO

Kim Olsen

Associate Director, Global Regulatory Policy and Intelligence, Global Regulatory, Janssen Research and Development
Kim Olsen is an Associate Director of Regulatory Policy and Intelligence for the Janssen Pharmaceutical Companies of Johnson and Johnson. Her primary responsibilities are providing intelligence to support the regulatory leaders. Kim has spent most of her career at Janssen, most recently... Read More →
BP

Bhavika Parikh

Student, Ernest Mario School of Pharmacy, Rutgers University
My name is Bhavika Parikh and my co-authors, Krishna Rana and Apoorva Vasireddy, are from Rutgers University, Ernest Mario School of Pharmacy. We decided the topic of our research project based off of the relevance of Real World Data and Real World Evidence used recently in pharmaceutical... Read More →
avatar for Shivali Patel

Shivali Patel

Drug Information Resident, GlaxoSmithKline, Duke University Hospital
Shivali Patel is from Rochester, NY and received her Doctor of Pharmacy degree from the Philadelphia College of Pharmacy. Dr. Patel completed her PGY1 Pharmacy Practice Residency at the Massachusetts General Hospital and is currently completing a PGY-2 Drug Information Residency at... Read More →
avatar for Tulika Paul

Tulika Paul

Associate Consultant, IQVIA
Tulika Paul is associated with IQVIA as Associate Consultant. She is a M.Tech-Biotechnology from Amity University, Noida. She is part of the Health Economic and Outcomes Research (HEOR) team of IQVIA, Gurgaon, India. She has experience of more than two years in Database landscaping... Read More →
avatar for Andrei Pikalov

Andrei Pikalov

Head of Global Medical Affairs, Sunovion Pharmaceuticals, Inc.
Andrei Pikalov, MD, PhD is a licensed & Board Certified psychiatrist, Head of Global Medical Affairs at Sunovion Pharmaceuticals Inc., who possesses a unique combination of pharmaceutical industry leadership experience with scientific background and clinical expertise.He holds a medical... Read More →
JQ

Janifer Quick

ORISE Fellow/ Division of Risk Management, Food and Drug Administration
Janifer Quick holds a doctorate in pharmacy, and she is an ORISE Fellow within the Division of Risk Management, Office of Surveillance and Epidemiology at the U.S. Food and Drug Administration. Her current work focuses on researching and evaluating scientific methods related to Risk... Read More →
avatar for Janifer Quick

Janifer Quick

ORISE Fellow, Division of Risk Management, OSE, CDER, FDA
Janifer Quick holds a doctorate in pharmacy, and she is an ORISE Fellow within the Division of Risk Management, Office of Surveillance and Epidemiology at the U.S. Food and Drug Administration. Her current work focuses on researching and evaluating scientific methods related to Risk... Read More →
avatar for Shariva Ranadive

Shariva Ranadive

Pharmacology post graduate student, Lokmanya Tilak Municipal Medical College
Dr Shariva Ranadive is currently post-graduate student at one of premier medical schools in the country. She has interest in both pre-clinical research and clinical research. She is interested in hematopharmacology and is doing clinical research in the same.
avatar for Asif Rasheed

Asif Rasheed

Review Scientist, OLDP, OPQ, CDER, FDA
Dr. Asif Rasheed is a CMC reviewer in Office of Lifecyle Drug Products in the Office of Pharmaceutical Quality (OPQ). Dr. Rasheed joined FDA in 2008 at Center for Veterinary Medicine (CVM) where he reviewed applications for new animal drug for medicated feeds. He moved to OPQ in 2015... Read More →
avatar for Christian Reyes

Christian Reyes

Undergraduate Research Associate, USC Department of Regulatory Science
Christian Reyes is currently a third-year undergraduate student at the University of Southern California pursuing a degree in Pharmacology and Drug Development at the USC School of Pharmacy. In addition, he is also completing a Master of Science degree in Regulatory Science at the... Read More →
avatar for Boris Reznichenko

Boris Reznichenko

Associate Director, Regulatory Operations, Otsuka Pharmaceutical Development & Commercialization, Inc.
Boris Reznichenko is currently Associate Director, Regulatory Operations in the Global Regulatory Affairs team at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). In this role, he is leading global regulatory publishing activities. Prior to joining OPDC in 2013... Read More →
KR

Kelly Roland

Associate Director, Otsuka Pharmaceutical Development and Commercialization
Kelly Roland is a member of the Applied Innovation team at Otsuka. Kelly drives both innovative ideas and process improvement activities across all levels of the Otsuka portfolio. With an undergraduate degree in Psychology and a Masters in Innovation, Kelly has participated in and... Read More →
avatar for Heather Romero

Heather Romero

Clinical Scientist, WCG – Analgesic Solutions
Heather Romero, PhD is a Clinical Scientist and neuropsychologist at Analgesic Solutions, a WIRB-Copernicus Group company. I provide Clinical Outcome Assessment (COA) scientific expertise for clinical trials and collaborate with other industry leaders to shape COA policy and standards... Read More →
ER

Elke Roschmann

Senior Director, IQVIA R&D Solutions Gmbh
Dr. Roschmann is a Senior Scientific Strategy Lead in the IQVIA Strategic Drug Development group. She leads cross-functional IQVIA/Sponsor teams delivering strategic design and development activities, bringing a combination of program leadership, drug development expertise, clinical... Read More →
avatar for Rachana Salvi

Rachana Salvi

Post Graduate Student, Seth GS Medical College & KEM Hospital
Dr Rachana Salvi is post graduate student of Pharmacology at one of the premier institutes in India. She is passionate about drug development in Pharmacology and her areas of interests include neuro-pharmacology, reproductive pharmacology and pharmacovigilance. She is well acquainted... Read More →
SA

Sadiq Ali Sayed

Medical Student, National Pirogov Memorial Medical University, Vinnytsya
The next presenter is Sadiq Ali Sayed, a second-year medical student from National Pirogov Memorial Medical University, Vinnytsya in Ukraine. Ukraine has a population of about 42 million making it the 32nd most populous country in the world. It is well known for its food, culture... Read More →
avatar for Philip Schneider

Philip Schneider

Chair, Advisory Board, Alliance for Safe Biologic Medicines
Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →
AS

Anjali Sharma

Sr Director, Business Capabilities and Innovation, Worldwide Patient Safety, Bristol-Myers Squibb
Anjali Shah, PharmD has 15 years experience in the biopharmaceutical industry in a variety of therapeutic, operational and leadership roles across Medical Affairs and Patient Safety. Inspired by the opportunity to unlock the potential of PV practices and professionals, Anjali is currently... Read More →
MS

Meiyu Shen

Expert Mathematical Statistician, Office of Translational Sciences, CDER, FDA
A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D... Read More →
avatar for Sapthagirishwaran Thennal Sivaramakrishnan

Sapthagirishwaran Thennal Sivaramakrishnan

Gilead Sciences Inc
Sapthagirishwaran Thennal Sivaramakrishnan is a Data Scientist at Gilead Sciences Inc. He holds a Masters in Business Analytics from University of Michigan-Dearborn. He is currently applying the concepts of data science and machine learning on large volumes healthcare data (EMR/Claims... Read More →
avatar for Jeffrey Smith

Jeffrey Smith

Senior Director, Head, Patient Advocacy, Wave Life Sciences
Jeff leads Wave’s efforts to support and collaborate with advocacy organizations, individuals, and families affected by severe genetic illnesses. Jeff has more than 18 years of experience in the biopharmaceutical industry and is passionate about making a positive and sustainable... Read More →
avatar for Ramana Sonty

Ramana Sonty

Director, Global Medical Organization, Johnson & Johnson
Dr. Sonty is a Strategy Leader in the Global Medical Organization of Janssen R&D. He is currently leading efforts to transform the Safety Organization, including implementing advances in Data Sciences, Visualization & Analytics and Automation. Previously he helped launch Janssen’s... Read More →
US

Uttara Soumyanarayanan

Associate II, Centre of Regulatory Excellence, Duke-Nus Medical School
YO

Yoselin Ordonez Suarez

Clinical Trials Fellow, Veterans Affairs Cooperative Studies Program
Yoselin Ordonez is currently a post-doctoral fellow in clinical trials with the Veterans Affairs Cooperative Studies Program. She holds a Bachelor of Science in Biochemistry, Master of Science in Pharmaceutical Sciences and Pharm.D from the University of New Mexico. Yoselin is currently... Read More →
avatar for Marina Suvakov

Marina Suvakov

Director, GPV, Otsuka
A PV professional with over 12 years’ experience ranging from start up’s to big pharma. I graduated with a degree in Medical Biochemistry and have a Masters in Pharmaceutical Sciences. I have spent time working in Switzerland, the USA and the UK and am passionate about the work... Read More →
NT

Niki Tetarenko

Sr Manager, PV Innovation, Bristol-Myers Squibb
Niki works within the Business Capabilities & Innovation Function of World Wide Patient Safety at Bristol-Myers Squibb. Niki has been working within the Safety Operations space of Pharmacovigilance for almost 10 years, with broad experience ranging from contracts to quality & compliance... Read More →
avatar for David Thompson

David Thompson

Senior Vice President, Real World and Late Phase, Syneos Health
David Thompson, PhD is a health economist with 25+ years of experience in HEOR consulting and real-world research design. He currently holds the position of Senior Vice President for Real-World & Late Phase Research at Syneos Health, where he provides RWE design solutions to study... Read More →
avatar for Kousalya Vaddempudi

Kousalya Vaddempudi

Sr. Manager, Regulatory Operations, Otsuka Pharmaceuticals
Kousalya Vaddempudi Otsuka Pharmaceutical Development and Commercialization Inc. Kousalya Vaddempudi is a Sr. Manager for Lifecycle Management and Regulatory Obligations in Global Regulatory Operations at Otsuka Pharmaceuticas Development & Commercialization (OPDC). She has experience... Read More →
avatar for Riddhi Virparia

Riddhi Virparia

Postdoctoral Fellow, University of North Carolina, GlaxoSmithKline
Riddhi Virparia is currently a post-doctoral fellow in regulatory affairs in a joint program with the University of North Carolina and GlaxoSmithKline. She primarily works within the oncology therapeutic group and is interested in global regulatory strategy. She received her Doctor... Read More →
avatar for Jess Warner

Jess Warner

Project Manager, DIA
DIA Project Manager
avatar for Christine Wells

Christine Wells

Senior Statistical Scientist, Roche Products Ltd
I have been a statistician in the Pharmaceutical Industry for 18 years now and have worked for Roche Products for the past 11 years. During this time I have been involved in many Clinical Studies and many Regulatory submissions. However, in the past three years I have diversified... Read More →
avatar for Andrew Wilson

Andrew Wilson

Scientific lead, Parexel
I lead the pharmacoepidemiology & statistics initiatives within Real World Data Services at PAREXEL. To be part of the real world evidence movement, it is essential we embrace the data generation process, and keep data context as all-important. Real world data typically comes from... Read More →
avatar for Karen Woolley

Karen Woolley

Global Lead, Patient Partnerships, Envision Pharma Group
Professor Karen Woolley is the Global Lead for Patient Partnerships at Envision Pharma Group. She is an adjunct Professor at two universities, serves on the Editorial Board for the Research Integrity and Peer Review journal, and has held government-appointed board positions at 5 hospitals... Read More →
avatar for Xiaomo Xiong

Xiaomo Xiong

PhD Candidate, University of South Carolina
Xiaomo Xiong is currently a PhD student majoring in pharmacoeconomics under the supervision of Dr. Kevin Lu at the School of Pharmacy, University of South Carolina. Xiaomo has got a bachelor\\'s degree in economics and a master\\'s degree in pharmacoeconomics at China Pharmaceutical... Read More →
JX

Jin Xu

Chemical Engineer, OLDP, OPQ, CDER, FDA
avatar for Tony Yuan

Tony Yuan

PhD Candidate, The University of Sydney
Senior Associate, Regulatory Affairs at Phebra Pty Ltd. Tony Yuan has submitted his PhD thesis in the area of optimizing written medicine information for prescription medicines (AUS, EU & USA perspective). His experience in the pharmaceutical industry is predominately within regulatory... Read More →
avatar for Zhuo Zhang

Zhuo Zhang

Doctoral Candidate, University of Macau
Zhuo Zhang is now a doctoral candidate under the supervision of Prof. Ying Bian at the institute of Chinese Medical Sciences, University of Macau. Before that, she got a master’s degree from Shandong University in 2018. Her research interests mainly include health management and... Read More →
avatar for Junliang Zhang

Junliang Zhang

Student, University of Macau
XZ

Xiangmin Zhang

Statistician, OB, OTS, CDER, FDA
Xiangmin Zhang is a statistician at the US FDA’s Center of Drug Evaluation and Research (CDER). She reviews drug applications for neurology products and medical imaging products. She earned her PhD in Statistics from the University of Iowa.
avatar for Enav Zusman

Enav Zusman

PharmD Student, University of British Columbia


Sunday June 14, 2020 9:00am - Thursday June 18, 2020 5:00pm EDT
TBD Virtual Event Horsham, PA 19044

11:00am EDT

#0000 OR1: DIA 2020 Virtual Meeting Orientation
Component Type: Session
Level: Basic

Are you new to the DIA VirtualGlobal Annual Meeting? Then join us to learn how to navigate this incredible learning and networking experience. Let us help you with maximizing the value of your time at DIA 2020.

Chair

Meredith Kaganovskiy

Speaker

Panelist
Paul Wong



Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA
PW

Paul Wong

Associate Director, Meeting Operations, DIA


Sunday June 14, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#0001 L: Student and Emerging Professionals Forum
Component Type: Forum
Level: Basic

The Student and Emerging Professionals Forum will kick off “Student Day at DIA”! This forum will introduce students and young/new/emerging professionals to the Drug Information Association (DIA) and its relationship to the global pharmaceutical, device, and therapeutic industries. Participants will hear from leading industry professionals about “What’s Hot and Not: Emerging Careers and Trends in Pharma” as part of a panel discussion where they will have an opportunity to ask questions and discuss the challenges of working in translational research/academia, industry and government.

Chair

Nancy Pire Smerkanich, DrSc, MS

Speaker

Panelist
Vada A. Perkins, DrSc, MS, MSc

Panelist
Nadina Jose, MD



Speakers
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →
avatar for Nadina Jose

Nadina Jose

Assistant Professor, School of Health Professions, MS Clinical Research Program, Rutgers, The State University of New Jersey
Rejoined academia on Oct 2016 and is currently Assistant Professor at Rutgers University, Department of Health Informatics, Biopharma Education Initiative, School of Health Professions MS in Clinical Research Management. Dr. Jose is the Founder and President of Anidan Group Pte. Ltd... Read More →
avatar for Vada A. Perkins

Vada A. Perkins

Executive Director, Regulatory Policy and Intelligence, Bayer Pharmaceuticals
Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Intelligence, Head Regulatory Intelligence- Vada A. Perkins, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory... Read More →


Sunday June 14, 2020 12:30pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Forum

1:00pm EDT

#0000 OR2: DIA 2020 Virtual Meeting Orientation
Are you new to the DIA Virtual Global Annual Meeting? Then join us to learn how to navigate this incredible learning and networking experience. Let us help you with maximizing the value of your time

Sunday June 14, 2020 1:00pm - 2:00pm EDT

1:00pm EDT

#0000 OR2: DIA 2020 Virtual Meeting Orientation
Component Type: Session

Are you new to the DIA VirtualGlobal Annual Meeting? Then join us to learn how to navigate this incredible learning and networking experience. Let us help you with maximizing the value of your time at DIA 2020.

Chair

Meredith Kaganovskiy

Speaker

Panelist
Paul Wong



Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA
PW

Paul Wong

Associate Director, Meeting Operations, DIA


Sunday June 14, 2020 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044

1:30pm EDT

#0002 L: Student and Young Professionals Resume Workshop
Component Type: Forum
Level: Basic

This interactive session will introduce students and young/new/emerging professionals to the fundamentals of resume/CV writing skills. Participants will be able to understand the difference between a resume and a curriculum vitae. The session will also discuss components of an effective document; action verbs, value-added bullet points, and transferable knowledge, skills and abilities (KSA). Common mistakes and information to not include on the documents due to legal considerations and self-protection from identity theft will also be discussed. Bring a copy of your resume to share during a peer-review exercise!

To access this hadle, please click here:


Learning Objectives

Evaluate and review their resume/CV for components of an effective document; Discuss the fundamentals of resume/CV writing; Identify common mistakes within resume/Cv documents

Chair

Kristen Felthousen, MS


Speakers
avatar for Kristen Felthousen

Kristen Felthousen

Program Administrator, Department of Regulatory and Quality Sciences, University of Southern California School of Pharmacy
Kristen Felthousen has more than 15 years of experience in HR, higher education, teaching, training and development. She earned her MS in HR Development from Rochester Institute of Technology. For the past 13 years, she has focused on career, professional and leadership development... Read More →


Sunday June 14, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Forum
  • Featured Topics Student Programming
  • Tags Forum

1:30pm EDT

SC28: #28: Leadership: How to Organize and Lead People in a Work Group
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-507-L04-P; CME 3.25; IACET 3.25; PDU 3.25 PMI 21660GS56K; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.
Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and want to learn how to exert influence on group behavior. This course will also benefit individuals to whom project managers report.


Learning Objectives

Identify the different types of work group structures and be able to predict the quality of work the group will produce;Identify ways to correct dysfunctional group dynamics;Create and maintain cooperation among team members, including cross-functional teams.


Speakers
avatar for Michael Laddin

Michael Laddin

Managing Partner, ResultsMatter
avatar for Michael Laddin

Michael Laddin

Managing Partner, ResultsMatter
Mike Laddin is the principal and owner of ResultsMatter. ResultsMatter provides leadership development workshops, strategic consulting, and executive coaching and management team assessments to clients worldwide. The premise of ResultsMatter’s work is that management is a science... Read More →


Sunday June 14, 2020 1:30pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044

1:30pm EDT

SC33: #33: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management.
The instructors will take you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented, will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections.
Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for professionals within sponsor, CRO, and regulatory agency organizations interested in research and development, clinical research, and/or clinical quality assurance

Learning Objectives

Describe the risk process;Design a comprehensive quality strategy to manage risk throughout the drug lifecycle;Establish Quality Tolerance Limits and Issue Management;Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.


Speakers
avatar for Tim Grey

Tim Grey

Senior Director,R&D Quality Systems, AbbVie, Inc.
Tim Grey joined AbbVie in December 2013. He is currently Senior Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team which includes Quality Systems, Documentation Management, training, QKM, QRM, CAPA, Qualification and Validation... Read More →
avatar for Victoria Burk

Victoria Burk

Senior Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the Sr. Director R&D Quality Assurance Clinical QA Program Management, Combination Products and Medical Devices and the Comprehensive Quality Strategy at AbbVie. She leads teams responsible for Clinical QA across all stages of development and Combination Product/Medical... Read More →


Sunday June 14, 2020 1:30pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   08: R-D Quality-Compliance, Tutorial |   02: ClinTrials -ClinOps, Tutorial
  • FEATURED TOPICS ICH
  • Featured Topics ICH
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:30pm EDT

SC34: #34: Preparing for a US FDA Advisory Committee Meeting
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

Preregistration required. Already registered? Log in to DIA's My Account>My Events.

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:
  • What an advisory committee is
  • How an advisory committee is structured
  • Critical factors for advisory committee preparation
  • How to design the most applicable preparation program for your team
  • Top ten "best practices" and "must avoids"

Back to DIA 2020 Short Courses

Who should attend?

This short course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

Identify the critical success factors in preparing for an advisory committee meeting; Outline those factors that are most applicable to your team;Design the most effective preparation strategy for your team(s).


Speakers
avatar for Lisa Peluso

Lisa Peluso

Principal Consultant, Strategic Communications, PharmApprove, a Member of the NDA Group
Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals... Read More →
avatar for Kaia Agarwal

Kaia Agarwal

Strategic Lead, PharmApprove, A Member of the NDA Group
Kaia Agarwal is an independent regulatory consultant working with PharmApprove, with over 30 years of global leadership experience in the pharmaceutical and biotechnology industry, with strategic regulatory expertise across CMC and Clinical Development. Kaia has extensive experience... Read More →


Sunday June 14, 2020 1:30pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial

2:30pm EDT

#0003 SL: The Five Steps to Establish Yourself as an Influencer and Improve Your Professional Communications
Component Type: Workshop
Level: Basic

Today’s professionals have more options than ever to easily create content and promote themselves to external audiences. But developing the best strategy can be difficult for those unfamiliar with the process. Where is your audience? How do people in clinical research consume their news? And how much time needs to be invested to be successful? We will show attendees how to create a streamlined, efficient thought leadership program to break out and share their stories differently than the competition. Topics covered will include how to authentically promote yourself and your knowledge through: • Social media and the best types of content for each platform • Media relations and the news cycle • Speaking opportunities and conferences (even through exhibition booths) • Self publishing and organically-created content

Learning Objectives

Create and execute a thought leadership strategy; Promote yourself and your brand through social media, news publications, and through your company; Create content and share your viewpoints and expertise in a way that resonates with audiences.

Chair

Leigh Anne Minnier


Speakers
avatar for Leigh Anne Minnier

Leigh Anne Minnier

Communications Manager, TransCelerate BioPharma Inc.
Leigh Anne is the Communications Manager at TransCelerate Biopharma, Inc. In this role, she is responsible for all corporate communications, public relations, and marketing efforts on behalf of the company. This includes creating and executing public relations campaigns; maintaining... Read More →


Sunday June 14, 2020 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044

4:00pm EDT

#0004 SL: Student Self-Awareness Workshop
Component Type: Forum
Level: Basic

Do you know what your strengths and weaknesses are and how to articulate them? Are you aware of how you communicate and interact with others? This workshop will help you answer those questions and frame your “soft” skills through self-awareness.

To access this hadle, please click here:


Learning Objectives

Identify why self-awareness is critical and how it relates to both our professional and personal lives; Recognize your own qualities and personal attributes and how to manage them; Identify your own strengths and weaknesses; Assess strategies to build self-awareness.

Chair

David Onks, MS


Speakers
avatar for David Onks

David Onks

Founder and Chief Executive Officer, Sparked Professional Coaching
Founder and CEO of Sparked, LLC, an Executive and Leadership Coaching practice based in Raleigh, NC that helps people who are experiencing or desire a pivot point in their career. His global leadership experiences over 23 years of change in GlaxoSmithkline enable an empathetic yet... Read More →


Sunday June 14, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Forum
  • Featured Topics Student Programming
  • Tags Forum
 
Monday, June 15
 

8:00am EDT

#100 SL: DIA Global Annual Meeting – Opening DIAmond and Plenary Session
Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-20-525-L04-P; CME 1.50; IACET 1.50; RN 1.50

We are excited to welcome you to the DIA 2020 Virtual Global Annual Meeting
Join us for the Global Annual Meeting Welcome Remarks, Keynote Address, and Opening DIAmond Session!

Keynote Address: Confessions of a "Human Subject" - Can We Put the Humanity in Scientific Study?
When Mary Elizabeth Williams was diagnosed with metastatic cancer and trying to get into an odds-defying clinical trial, a clinician at her hospital casually introduced her to his research fellows as "the tumor." Science is advancing, but what good is it if patients feel alienated? Journalist and author Williams will discuss why the treatment plan process must understand the emotional and logistical needs of the patient, and how humanity is an essential element of successful healthcare outcomes.


DIAmond Session:

In this thought-provoking session, top leaders will discuss how the COVID-19 crisis is shaping the future of drug development. They will look back on the world’s response to the pandemic and what that has revealed about our preparedness to manage a crisis of this proportion. How will learnings be applied in the post-COVID environment? The panel will discuss forward-looking efforts being implemented and how collaboration and innovative thinking will be crucial to our ability to better prepare for “the next time.”


Learning Objectives

Discuss why treatment plans must address the emotional and logistical needs of the patient in advancing science; Identify how forward-looking efforts are shaping the future of drug development as a result of the COVID-19 crisis; Evaluate how collaborative and innovative thinking can better prepare for next pandemic.

Chair

Barbara Lopez Kunz, MSc

Speaker

Honorary Chair
Michelle Rohrer, PhD

Keynote Address
Maryelizabeth Williams

DIAmond Session: Emerging from the COVID-19 Crisis: Innovation Will Not Be Optional
Elizabeth Garner, MD, MPH

Panelist
Dalvir Gill, PhD

Panelist
Michelle Rohrer, PhD

Panelist
Rod MacKenzie, PhD

Panelist
Christopher P. Austin, MD

Panelist
Doris Rouse, PhD



Speakers
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive, DIA
Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s... Read More →
avatar for Michelle Rohrer

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Roche Genentech
Michelle Rohrer, PhD is Global Head of Product Development Regulatory and Policy, as well as the ad interim Global Head of Medical Affairs for Roche Genentech. Michelle has worked at the company for 27 years, starting as a post-doctoral fellow. She has worked as a clinical scientist... Read More →
avatar for Maryelizabeth Williams

Maryelizabeth Williams

Writer, Speaker, Consultant, maryelizabethwilliams.net
Mary Elizabeth Williams is a journalist and author. In 2011, facing metastatic melanoma, she became one of the first people in the world in an innovative immunotherapy clinical trial -- and twelve weeks later showed a complete response. She chronicled her experience in the nonfiction... Read More →
avatar for Elizabeth Garner

Elizabeth Garner

Chief Medical Officer, ObsEva SA
Elizabeth Garner, MD, MPH completed her medical training at Harvard Medical School and Harvard School of Public Health.
avatar for Christopher Austin

Christopher Austin

Director, National Center for Advancing Translational Sciences, National Institutes of Health (NIH)
Christopher P. Austin has served as director of the NCATS since 2012. Prior to this role, he was NCATS’ scientific director, focusing on translating basic science discoveries into new treatments and technologies to improve the efficiency of therapeutic/diagnostic development. He... Read More →
avatar for Dalvir Gill

Dalvir Gill

Chief Executive Officer, TransCelerate BioPharma Inc.
Dalvir Gill has more than 25 years of drug development & leadership experience. Prior to his appointment as CEO of TransCelerate, he was the President of a major international CRO. Dr. Gill earned his BSc from the University of Hertfordshire and his PhD from the Royal Free Hospital... Read More →
avatar for Rod Mackenzie

Rod Mackenzie

Executive Vice President, Chief Development Officer, Pfizer Inc
Chief Development Officer and Executive Vice President for Pfizer. Rod leads the Global Product Development organization and is responsible for the clinical development of Pfizer’s pipeline of innovative medicines, as well as regulatory affairs in support of Pfizer’s R&D portfolio... Read More →
avatar for Doris Rouse

Doris Rouse

Vice President, Global Health Technologies, RTI International
Doris Rouse, PhD, manages the coordination of diverse disciplines to address major global health needs. Dr. Rouse’s research interests include development of new drugs and drug therapies to combat antibiotic resistance and antimicrobial resistant strains of bacteria. She leads a... Read More →


Monday June 15, 2020 8:00am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044
  00: Plenary, Forum |   20: DIAmond, Forum

8:00am EDT

Professional and Student e-Posters Gallery

Professional and Student e-Posters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2020. Attendees are invited to scroll through and search e-Posters throughout the duration of virtual meeting. e-Posters run continuously during the meeting. There are no formal or LIVE e-Poster presentations during the DIA 2020 virtual meeting.

Monday June 15, 2020 8:00am - 5:00pm EDT
e-Poster Gallery

10:15am EDT

#101 SL-CH: Challenges in Advanced Therapy Development: A New Community
Component Type: Workshop
Level: Intermediate

Advanced therapies face very unique challenges at every stage of development and beyond marketing. DIA is launching a new Advanced Therapy Community to facilitate cross-functional discussion of every aspect of advanced therapy development.

Learning Objectives

Identify the complexity and challenges of advanced therapy development from the preclinical conception throughout clinical development through development and post-approval cost and monitoring implications; Discuss the benefit of joining the new Advanced Therapy Community and attending the monthly online meetings.

Chair

Kirsten Messmer, PhD, RAC

Speaker

Facilitator
Richard Dennett, DrSc



Speakers
avatar for Kirsten Messmer

Kirsten Messmer

Principal Regulatory Affairs Specialist, PPD
Kirsten Messmer, PhD, RAC, is a Principal Regulatory Affairs Specialist in the Regulatory Intelligence Solutions team at PPD which provides regulatory intelligence to clients and departments within PPD to support drug development and clinical research. Prior to joining PPD she completed... Read More →
avatar for Richard Dennett

Richard Dennett

Senior Director Regulatory Affairs CMC, PPD
Richard Dennett heads the Regulatory Affairs CMC activities at PPD and provides expertise, technical guidance & leadership for global CMC regulatory strategy. He additionally chairs PPD’s Advanced Therapy Forum. Richard has held several strategic product development roles including... Read More →


Monday June 15, 2020 10:15am - 10:45am EDT
TBD Virtual Event Horsham, PA 19044

10:15am EDT

#102 SL-IT: Advanced Clinical Innovation Theater: Future Forward Trends for Overcoming the Talent Shortage in Clinical Research while Diminishing Risk
Component Type: Session

It is no secret that the industry has a shortage of seasoned clinical research talent that oftentimes lack the skillset required to maintain quality and compliance sponsors require. Confounding the talent shortage dilemma are not only increased pipelines and rising competition, but also that some roles are being displaced due to COVID-19 related adjustments to reduce organizational risk. In this presentation, you will learn: • Current trends affecting industry talent, such as increasing competition, the impact of COVID-19, and the need to consider alternative models in outsourced clinical research • Predictions on how the industry will respond to needs which require more flexibility and a need for scalability quickly up or down, to reduce risk and burden • Innovative programs being used in the industry to engage emerging talent like CRAs • Which outsourcing and recruitment delivery model is right for you to help balance risk, maintain timelines and compliance, drive innovation and retain knowledge capital through better employee retention: Contingent staffing, Functional Service Provider (FSP) and/or full-service CRO.

Chair

Stacey Arrambide, MS

Speaker

Panelist
Steve Matas



Speakers
avatar for Stacey Arrambide

Stacey Arrambide

Senior Vice President, Functional Service Solutions, Advanced Clinical
"Stacey Arrambide, M.S., Senior Vice President, FSP and Managed Staffing, has over 21 years of global statistical and data management experience across a broad range of therapeutic areas. Stacey oversees strategic growth and operational delivery of FSP and managed staffing services... Read More →
avatar for Steve Matas

Steve Matas

Vice President, Strategic Solutions, Advanced Clinical
"Steve has over 20 years of strategic staffing experience across the information technology and life sciences industries. Mr. Matas is responsible for leading the staffing efforts across the company, including recruitment, sales, and operations. Prior to joining Advanced Clinical... Read More →


Monday June 15, 2020 10:15am - 10:45am EDT
TBD Virtual Event Horsham, PA 19044

10:15am EDT

#103 SL-IT: Veeva Innovation Theater: Annual Industry Report - Trends, Insights, and Strategies to Modernize Clinical Operations
Component Type: Session

Hear new results from the Veeva 2020 Unified Clinical Operations survey. By gathering the experiences and opinions of more than 450 clinical operations professionals from around the globe, the goal of the annual research is to understand the challenges and advances in today’s clinical operating model. Topics include tracking the industry's progress towards: 1. Streamlining clinical systems and processes 2. Aligning stakeholders throughout study execution 3. Reducing complexity to improve trial performance

Chair

Christopher McSpiritt


Speakers
avatar for Christopher McSpiritt

Christopher McSpiritt

Senior Director, Vault Clinical, Veeva Systems
Chris is part of the Clinical Operations Suite. He works with clients and prospects to understand their pain points and to align software solutions with their desired future state. Prior Chris worked for 8 years at a Life Sciences consulting firm where he helped organizations define... Read More →


Monday June 15, 2020 10:15am - 10:45am EDT
TBD Virtual Event Horsham, PA 19044

10:15am EDT

#104 SL-IT: ArisGlobal Innovation Theater: Leveraging Automation in PV
Component Type: Session

A look at how organizations are approaching and implementing automation. This session will discuss the types of automation currently being leveraged as part of the PV process , challenges presented by the changes in technology including validation, and advancements on the horizon. The scenarios presented will all be delivered based on a today’s landscape and experiences from actual implementations.

Chair

Emmanuel Belabe


Speakers
avatar for Emmanuel Belabe

Emmanuel Belabe

Associate Vice President, Safety, ArisGlobal
Emmanuel Belabe is currently a member of ArisGlobal’s Product Management Group but has been with ArisGlobal in various roles. Better known as Manny, he has worked in the Healthcare\Life Sciences industry for 18 years with the last 14 being with ArisGlobal. Manny is one of ArisGlobal’s... Read More →


Monday June 15, 2020 10:15am - 10:45am EDT
TBD Virtual Event Horsham, PA 19044

11:00am EDT

#105 SL: To Shape the Future of Patient Labeling Across Regions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session we will discuss ongoing initiatives in the field of electronic labeling and look ahead to their potential impact on the future of digital health, with a particular focus on patient product information in the US, EU, Japan, and Asia. This session will also discuss how different approaches to electronic labeling may converge across regions, driving a new patient-centric focus to product information.

Learning Objectives

Discuss how emerging trends for electronic labeling are impacting risk communication across the US, EU, Japan and Asia; Describe the challenges of provision of patient product information in the future; Discuss approaches to improving health literacy and adherence to patient labeling; Discuss the possibility of convergence of electronic labeling standards to drive patient centricity across regions.

Chair

Rie Matsui, RPh

Speaker

PMDA’s Updates for Electronic Labeling Initiative and Patient-Centric Labeling in Japan
Junko Sato, PhD

Electronic Product Information (ePI) in the EU: Key Principles and Beyond
Elizabeth Scanlan, PhD, MSc

Electronic Labeling in the US / Canada and A Global eLabeling Vision
Khyati Roberts, RPh

Dynamic Landscape in Asia for Electronic Labeling and Patient Labeling
Rie Matsui, RPh



Speakers
avatar for Junko Sato

Junko Sato

Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She... Read More →
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer R&D
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group(ILG), Global Regulatory Affairs, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer. The Asia Labeling Hub has created various... Read More →
avatar for Elizabeth Scanlan

Elizabeth Scanlan

Scientific Communication Officer, Stakeholders and Communication Division, European Medicines Agency
Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is a Scientific Communication Officer, with a focus on communication of information on safe and effective use of medicines to patients and healthcare professionals. Prior to joining EMA, she worked in communication... Read More →


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   09: Regulatory, Session

11:00am EDT

#106 SL: Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-528-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present on an innovative tech-enabled clinical trial model that leverages electronic health record data and technology to streamline clinical development. A panel of experts will provide their perspective on digital clinical trials.

Learning Objectives

Discuss a new integrated digital model for clinical research, including digital clinical trial designs, eSource data collection and management, partnership models, and regulatory implications; Describe best practices for digital clinical trial partnerships and conduct.

Chair

Lauren Neighbours, PhD, RAC

Speaker

Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model
Jeffry G. James, CPA, MBA

Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model
Stephanie Abbott, PhD



Speakers
avatar for Jeffry James

Jeffry James

Chief Executive Officer, Wilmington Health and Innovo Research
Jeff James is currently the CEO of Wilmington Health in Wilmington, NC. Wilmington Health is a multispecialty group practice with 161 providers covering 37 specialties in 22 locations. He is responsible for the strategic vision and its deployment as well as all financial and operational... Read More →
avatar for Lauren Neighbours

Lauren Neighbours

Vice President, Regulatory Affairs and Program Management, Optum
Lauren Neighbours, PhD, RAC oversees the regulatory strategy, compliance, and program management for the Optum Digital Research Network. Lauren has over 15 years of research experience within industry, government, and academia. Lauren led multidisciplinary development programs from... Read More →
SA

Stephanie Abbott

Director of Research, Western Washington Medical Group


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

11:00am EDT

#107 L: Patients First! How FDA is Making Patients a Priority
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore/discuss Agency-wide patient engagement programs/initiatives that provide patient stakeholders opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review. Join the DIA Patient Engagement Community for a follow up round table discussion (session #112 L-RT) on Monday, June 15, 12:30PM - 1:30PM.

Learning Objectives

Describe components established focused on making patients a priority; Describe avenues for patient stakeholders to engage with the agency; Review key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss value added from patient stakeholder participation.

Chair

Andrea Furia-Helms, MPH

Speaker

Panelist
Diane Maloney, JD

Panelist
Michelle Tarver, MD, PhD

Panelist
Sadhna Khatri, PharmD, MEd, MPH, MSc

Panelist
Philip Posner, PhD



Speakers
avatar for Andrea Furia-Helms

Andrea Furia-Helms

Director, Patient Affairs Staff, OC, FDA
Andrea Furia-Helms is the Director of the Patient Affairs Staff in the Office of the Commissioner at FDA. She works closely with the medical product centers and other offices to coordinate cross-cutting patient engagement activities and ensure patients, caregivers, and advocates have... Read More →
DM

Diane Maloney

Associate Director for Policy, CBER, FDA
Diane Maloney, J.D., is the Associate Director for Policy, Office of the Director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). She oversees regulation and policy development for CBER as well as the Center’s participation on cross-cutting... Read More →
avatar for Sadhna Khatri

Sadhna Khatri

Regulatory Officer, PASES, OCD, CDER, FDA
CDR Sadhna Khatri, PharmD, MPH, is a regulatory officer in Professional Affairs and Stakeholder Engagement (PASE) in the Office of the Center Director in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She is the Supervisor of the PASE Engagement... Read More →
avatar for Philip Posner

Philip Posner

Retired Academic, Patient Representative
Dr. Posner is a patient with MS and Atrial Fibrillation He has been involved in research and teaching at several major institutions. He has served as a patient representative for the FDA and P.C.O.R.I. He also volunteers with the National Capitol MS Society through various programs... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, PSE, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Her program interacts with digital health... Read More →


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Session

11:00am EDT

#108 SL: Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-642-L04-P; CME 1.00; IACET 1.00; RN 1.00

At the time of drug approval, information on optimal use of the drug may not be available for the entire range of patients who might need the drug. This includes certain ‘special populations’ who may be unstudied or understudied at the time of approval, for e.g., pediatrics, pregnant or lactating women, patients with compromised kidney or liver function, etc. This session will discuss opportunities for leveraging real-world data (RWD) to generate real-world evidence (RWE) to help personalize treatment for these special populations. The speakers will also highlight how clinical pharmacology-relevant (e.g., pharmacokinetic, pharmacodynamic, and pharmacogenomic) RWD can generate RWE to promote therapeutic individualization and supplement clinical trial and modelling and simulation data in special populations to make drug development and approval decisions. Case examples will be used to illustrate the key concepts.

Learning Objectives

Describe the potential role for RWD and RWE in promoting therapeutic individualization in unstudied/understudied special patient subpopulations (e.g. pediatrics, compromised kidney/liver function); Discuss the opportunities and challenges in leveraging clinical pharmacology-relevant RWD to generate RWE.

Chair

Anuradha Ramamoorthy, PhD

Speaker

Real World Evidence of Male Breast Cancer Patients Treated With Palbociclib in Combination With Endocrine Therapy: Extension of Indication
Keith D. Wilner, PhD

Leveraging Real World Data to Support the Development of Precision Medicines
Frederick Joseph Derosier, DO

Using Real World Data to Support Drug Development in Pediatric Patients: C.E.R.A. Case Study
Pascal Chanu, PharmD

Use of Real World Data to Advance the Mission of Clinical Pharmacology
Qi Liu, PhD



Speakers
KW

Keith Wilner

Executive Director, Oncology, Global Product Development, Pfizer Inc
Dr. Wilner received his Ph.D. in pharmacology from the University of Texas Health Science Center at Houston. He joined Pfizer in 1986. Dr. Wilner’s past experiences at Pfizer included overseeing the early development of new drugs in Inflammation, CNS, CV, Metabolism, and Infectious... Read More →
avatar for Pascal Chanu

Pascal Chanu

Modeling and Simulation Expert, Genentech, A Member of the Roche Group
Pascal Chanu has a Pharm.D., he started modeling with drug monitoring during hospital residency. He joined Roche Modeling & Simulation (M&S) group in 2003 as a postdoc and grew professionally up to Disease Area M&S expert. He moved to consultancy working for Pharsight (now Certara... Read More →
QL

Qi Liu

Senior Science Advisor, Office of Clinical Pharmacology, OTS, CDER, FDA
Dr. Qi Liu is a Senior Science Advisor in the Office of Clinical Pharmacology (OCP), FDA. At FDA, Qi contributed to the review of over 200 NDA/sNDA, 20 BLA/sBLA, and numerous IND. Qi co-authored about 40 manuscripts and presented on many topics at Advisory Committee meetings and scientific... Read More →
AR

Anuradha Ramamoorthy

Policy Lead, OCP, OTS, CDER, FDA
Anuradha Ramamoorthy, Ph.D. is a Policy Lead at the Office of Clinical Pharmacology (OCP), Food and Drug Administration (FDA). She received her Ph.D. in Medical and Molecular Genetics from Indiana University and was a postdoctoral fellow at the NIH and FDA. In her current role, she... Read More →
avatar for Frederick Derosier

Frederick Derosier

Executive Director, Rare Diseases, Covance
Dr. Frederick Derosier, D.O., joined Covance Inc. as an Executive Medical director for Rare Diseases in 2017 and has over 10 years of private practice experience (internal medicine) and nearly 19 years of clinical development experience, primarily in neurosciences and rare diseases... Read More →


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session
  • Featured Topics Real World Evidence,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

11:00am EDT

#109 L: International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-541-L04-P; CME 1.00; IACET 1.00; RN 1.00

The introduction of innovation into healthcare systems requires decision making based on an increasingly complex and diverse evidence. This international panel of regulators and HTAs will discuss perspectives for “universal clinical evidence”.

Learning Objectives

Contrast principles for different types of decision making to facilitate introduction of innovative medicines;Translate evidence requirements for different types of decision making(regulatory, HTA, payers and reimbursement); Apply the understanding of multi-dimensional decisions on universal evidence generation plan value versus.

Chair

Michael Berntgen, PhD

Speaker

Perspectives From a Regulator
Michael Berntgen, PhD

Planning for Evidence for HTA
Michelle Mujoomdar, PhD

Panelist
Guido Rasi, MD

Panelist
Pierre Sabourin, MBA

Panelist
Peter W. Marks, MD, PhD

Panelist
Niklas Hedberg, MPharm



Speakers
avatar for Michael Berntgen

Michael Berntgen

Head of Scientific Evidence Generation Department, European Medicines Agency
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification... Read More →
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV
Niklas Hedberg, MSc, is Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden. He is also Chair of the EUnetHTA Executive Board, TLV’s lead partner in EUnetHTA, and has led EUnetHTA WP3 – Evaluation since 2016. Mr. Hedberg has broad experience in... Read More →
avatar for Michelle Mujoomdar

Michelle Mujoomdar

Director, Scientific Affairs, Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH)
Dr. Michelle Mujoomdar has held several leadership roles since joining CADTH in 2008. In 2013, Michelle joined CADTH’s Evidence Standards team as Director, Scientific Affairs where she has accountability for the quality of CADTH’s work. In this role, she also has oversight for... Read More →
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Pierre Sabourin

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... Read More →


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   12: Value-Access, Forum

11:00am EDT

#110 L: Outcomes as a Pathway to Value and Pharma, Payer, Provider Collaboration
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-611-L04-P; CME 1.00; IACET 1.00; RN 1.00

A focus on value is driving efforts to improve outcomes and reduce costs. This session explores the use of real world data to predict treatment benefit, response and cost and the use of measurable outcomes for supporting contracting and clinical decisions.

Learning Objectives

Describe standardized outcomes measurement practices and initiatives and their importance to getting to a partnered solution; Discuss how predictive analytics are being applied to real-world data to measure and predict outcomes; Identify opportunities for using real world and outcomes data for supporting formulary, access, and clinical decision making.

Chair

Richard Gliklich, DrMed, MD

Speaker

Developing and Leveraging Harmonized Outcome Measures in Depression
Elise Berliner, PhD

Patient-Reported Outcomes, Experience, Quality, and Value-Based Payment
Rachel Dupre Brodie



Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions... Read More →
avatar for Rachel Brodie

Rachel Brodie

Senior Director, Measurement and Accountability, Pacific Business Group on Health
Rachel Brodie works with prominent purchaser, payer, provider and consumer stakeholder organizations to advance the quality of health care and put performance information to use for payment and decision-making. She provides strategic leadership to manage and lead the methodological... Read More →


Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session

12:00pm EDT

#601 NL: Networking Lounge: Real World Evidence
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Real World Evidence
  • Tags Session

12:00pm EDT

#602 NL: Networking Lounge: COVID-19
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics COVID 19 - Pandemic
  • Tags Session

12:00pm EDT

#603 NL: Networking Lounge: Patient Focused
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Patient Focused
  • Tags Session

12:00pm EDT

#604 NL: Networking Lounge: Emerging Professionals and Students
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Student Programming
  • Tags Session

12:00pm EDT

#605 NL: Networking Lounge: Advanced Therapies
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Advanced Therapeutics
  • Tags Session

12:00pm EDT

#607 NL: Networking Lounge: Digital Technology and Artifical Intelligence
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Digital Technology
  • Tags Session

12:00pm EDT

#608 NL: Networking Lounge: Data Science
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Data Science
  • Tags Session

12:00pm EDT

#608.1 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Monday June 15, 2020 12:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Innovative Trial Design
  • Tags Session

12:30pm EDT

#111 SL-CH: Collecting Meaningful Patient Experience Data
Component Type: Workshop
Level: Intermediate

This discussion will demonstrate how patient advocacy groups can be leveraged for critical information beyond protocol design and for capturing meaningful experience data from standard clinical practice.

Learning Objectives

Review and discuss how to work with advocacy groups to facilitate the collection of meaningful patient experience data and clinical validation; Identify the type of information that can be learned from advocacy groups that can influence collaboration and optimization to address unmet needs, especially in rare disease patient populations.

Chair

Shazia Ahmad

Speaker

Facilitator
Kristen Wheeden, MBA

Facilitator
Kristin Anthony, MS



Speakers
avatar for Shazia Ahmad

Shazia Ahmad

Director, Patient & Physicians Services, UBC
Shazia Ahmad serves as a director on UBC’s Patient and Physician Services team. She brings to this role 20 years of experience in the healthcare industry. Shazia provides oversight and strategy on patient recruitment and retention as well as site feasibility and recruitment for... Read More →
avatar for Kristin Anthony

Kristin Anthony

President, PTEN Hamartoma Tumor Syndrome Foundation
Kristin Anthony, is the President of the PTEN Hamartoma Tumor Syndrome Foundation. Kristin is a non-profit leader with extensive management, marketing and healthcare experience. Rare disease and hereditary cancer advocate and speaker.
avatar for Kristen Wheeden

Kristen Wheeden

Executive Director, American Porphyria Foundation
Kristen Wheeden is the Executive Director of the American Porphyria Foundation (APF). The APF is a patient advocacy group that serves the porphyria community. The organization is dedicated to the health and well-being of all individuals affected by Porphyria.


Monday June 15, 2020 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#113 SL-IT: Google Innovation Theater: Enabling Insights and Collaboration Across the Lifesciences Enterprise with Google Cloud and Accenture
Component Type: Session

Life Sciences industry leaders are looking for a new approach to better access, manage and analyze the volumes of information that is critical to the development of life-changing drugs and therapies. In this session hear from leaders across Google Cloud and Accenture Life Sciences and learn how they are solving these challenges together with the INTENT Platform.

Chair

Shweta Maniar

Speaker

Google Innovation Theater: Enabling Insights and Collaboration Across the Lifesciences Enterprise with Google Cloud and Accenture
Michael Stapleton, PhD



Speakers
avatar for Shweta Maniar

Shweta Maniar

Life Science and Medical Device Strategy Lead, Google Cloud
Shweta is the strategy and market leader responsible for Healthcare and Life Sciences. Shweta has quickly risen through the ranks as a well-known innovator, game-changer, and relationship ambassador. With 18+ years’ experience in clinical research, Healthcare and Bio Tech, she has... Read More →
avatar for Michael Stapleton

Michael Stapleton

Managing Director and INTIENT Strategy Lead, Accenture
Michael is responsible for the business service strategy, with specific focus on the INTIENT platform. Prior to joining Accenture, Michael held the position of VP & CIO, R&D IT at Merck, where he had global responsibility for all IT and informatics in support of Merck Research Laboratories... Read More →


Monday June 15, 2020 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#115 SL-IT: IQVIA Innovation Theater: COVID-19 Disruption Provides a Pivotal Opportunity to Accelerate Patient Engagement Innovation
Component Type: Session

A critical driver to patient recruitment challenges is the ongoing evolution of the clinical trial landscape, and as we look to recover from COVID1-19, the acceleration of that evolution is exponentially higher. Innovation is needed to minimize friction for investigators, reduce site burdens, and drive productivity to safely recruit and retain the right patients. An innovative, holistic digital approach to recruitment can influence every aspect of trial design and transform patient recruitment in this new complex landscape.

Chair

Erica Prowisor


Speakers
avatar for Erica Prowiser

Erica Prowiser

Global Head of Recruitment and Retention, IQVIA
In her current role, Erica leads efforts to leverage IQVIA’s CORE data, technology, direct-to-patient, and direct-to-site capabilities to optimize recruitment and retention strategies for the purpose of consistently and transparently delivering patients on time and on budget. A... Read More →
avatar for Erica Prowisor

Erica Prowisor

Global Head of Recruitment and Retention, IQVIA
In her current role, Erica leads efforts to leverage IQVIA’s CORE data, technology, direct-to-patient, and direct-to-site capabilities to optimize recruitment and retention strategies for the purpose of consistently and transparently delivering patients on time and on budget. A... Read More →


Monday June 15, 2020 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#116 SL-IT: Parexel Innovation Theater: The Future is Now: The Rise and Rise of Decentralized Clinical Trials During the COVID Pandemic and Beyond
Component Type: Session

A rapid increase in interest, adoption, and acceptance of decentralized clinical trials (DCT) is underway as central to maintaining research activity during the COVID-19 pandemic. And, with the duration of the global crisis unknown, it looks like DCTs are here to stay. During this session, we’ll explore the practicalities of managing the swift transition of ongoing trials to a DCT approach and how to plan for success for new trials too. #nogoingback

Chair

Rosamund Round, MS


Speakers
avatar for Rosamund Round

Rosamund Round

Vice President, Patient Innovation Center, Parexel
Roz leads Parexel’s Patient Innovation Center, dedicated to improving patient access to and experiences in clinical trials. Focused particularly on the reduction of geographical, financial and practical barriers to study participation, she is excited by the industry shift towards... Read More →


Monday June 15, 2020 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#112 L-RT: Round Table Discussion: Patients First! How FDA is Making Patients a Priority
Component Type: Forum

Join DIA Patient Engagement Community for a round table discussion tied to session #107 L: Patients First! How FDA is Making Patients a Priority (Monday, June 15, 11:00AM-12:00PM). Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message that the meeting has been locked by the host.To include special guest from the session: Phil Posner.

Chair

Mary Murray, MBA, MPH


Speakers
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →


Monday June 15, 2020 12:30pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

1:00pm EDT

#117 SL-IT: Syneos Health Innovation Theater: Patient Engagement: Driving Better Care and Outcomes
Component Type: Session

Patient engagement is critical to solving the most complex health care challenges – from navigating a lifesaving clinical trial to managing a chronic disease. Yet engagement is often ineffective with 30% of individuals failing to pick up medicines. This presentation will cover patient engagement solutions – from diagnosis to disease management – to significantly improve access to timely information, address patient concerns, and most importantly positively impact patient outcomes.

Chair

Tim Raducha-Grace

Speaker

Panelist
Kathleen Starr, PhD



Speakers
avatar for Tim Raducha-Grace

Tim Raducha-Grace

Senior Vice President, Partnerships, Syneos Health
Tim has deep experience driving growth through unique partnerships across the healthcare sector. Most recently, Tim led clinical market performance and clinical partnerships for Bright Health, a technology enabled health insurance start up, as they expanded from 1 to 25 markets. He... Read More →
KS

Kathleen Starr

Managing Director, Behavioral Insights, Syneos Health


Monday June 15, 2020 1:00pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

1:00pm EDT

#118 SL-IT: WCG Innovation Theater: A Tale of Two Eras: Interpreting Clinical Operations Data Pre- and Post- COVID-19
Component Type: Session

How valuable is clinical operations data collected prior to the COVID-19 pandemic? Suzanne Caruso from WCG explores and interprets how benchmarks and baselines set in the era before COVID will require rapid translation to meet our current and future state.

Chair

Suzanne Caruso


Speakers
avatar for Suzanne Caruso

Suzanne Caruso

Vice President, Clinical Solutions, WCG
Suzanne Caruso serves as the Vice President of Clinical Solutions for WCG. In this role, Suzanne oversees WCG's robust suite of transformational solutions and manages the growth, development, and operational strategy relating to these services. She uses her unique expertise to design... Read More →
avatar for Ryan Moog

Ryan Moog

Director of Research, Cerner Corporation


Monday June 15, 2020 1:00pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

1:00pm EDT

#118.1 SL-IT: UBC Innovation Theater: Unlocking the Evidence-Generating Potential of the EMR
Component Type: Session

We have only just begun to scratch the surface of the potential that the electronic medical record (EMR) can bring to bear to support research and evidence generation in the realm of drug development. Even today we spend a significant amount of our time and research budgets manually harvesting data that resides in digital formats. In this discussion, we will examine several practical applications of real word data from EMRs to support research use cases.

Chair

Aaron Berger, PMP


Speakers
avatar for Aaron Berger

Aaron Berger

Senior Director, Real World Evidence, UBC
Mr. Berger joined the UBC team in 2003 and has since served in a range of diverse roles leveraging global capabilities in the execution of peri and post marketing product development programs and Real World Evidence generation. In this role, Mr. Berger supports the development of... Read More →


Monday June 15, 2020 1:00pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

1:30pm EDT

#119 L: How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should you Measure to Gain Insights?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

An industry consortium has been developing a set of metrics to measure the process of centralized and site monitoring. The forum will provide insights into the approach, the progress, and plans to obtain further industry feedback.

Learning Objectives

Describe methodologies for developing metrics to monitor the processes related to centralized, remote and site monitoring; Discuss some of the challenges of developing metrics to monitor risk-based processes.

Chair

Linda B. Sullivan, MBA

Speaker

Panelist
Charles Lawrence Liss, MS

Panelist
Barbara Alexandra Novak

Panelist
Joe Kunakorn, MS

Panelist
Jacqueline Gough, MS



Speakers
avatar for Linda Sullivan

Linda Sullivan

Executive Director, Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →
avatar for Barbara Novak

Barbara Novak

Systems and Process Management Lead, Clinical Operations- NA/EU, Kyowa Kirin Pharmaceutical Development, Inc.
Barbara Novak – Systems and Process Management Lead, Clinical Operations KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT Barbara has twenty five plus years of Clinical Research and Development experience and has worked at Kyowa Kirin for the past ten years. In her role, she is the North... Read More →
avatar for Charles Liss

Charles Liss

Associate Director, Global Biostatistics, CSL Behring
Mr. Liss has a MS degree in Statistics from Virginia Tech and nearly 40 years of experience in the pharmaceutical industry as a biostatistician. He has worked in a broad range of therapeutic areas including neuroscience, vaccines and cardiovascular. His research interests include... Read More →
avatar for Joe Kunakorn

Joe Kunakorn

Associate Director, Oncology Risk Management, Janssen Research & Development, LLC
Joe has 20+ years of experience in the Biopharma industry as a quality professional with expertise in auditing, QMS, GCPs, GMPs, and medical devices. In his current role with Janssen Research & Development, LLC, Joe leads the clinical quality oversight, risk management, and inspection... Read More →
JG

Jacqueline Gough

Director, Central Monitoring and Data Surveillance, Astellas
Jackie Gough is the Director for Central Monitoring and Data Surveillance at Astellas. Previously she led the RBM team at Lilly. Jackie began her career as a statistician – first in the academic world, then at a CRO and for the last 17 years on the sponsor side. She has been a member... Read More →
avatar for Linda Sullivan

Linda Sullivan

Executive Director, WCG Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

1:30pm EDT

#120 L: The Changing Role of the Data Professional
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-554-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will review the current positions that exist within the province of data management and clinical research, how specific tools, technologies, and regulations are changing the landscape, and what the future state is likely to involve from a more inclusive biometrics perspective.

Learning Objectives

Discuss the current state of data management-related roles and how newer roles within clinical research will impact it; Explain how modern technological advances have not only spurred development within data management, but also expanded the functional area overall.

Chair

Michelle Hoiseth

Speaker

Integration Versus Disruption: Discussion on Making New Technologies Work in Clinical Research
Michelle Hoiseth

The Evolution of Clinical Data Management to Clinical Data Science
Catherine Celingant, MA



Speakers
avatar for Michelle Hoiseth

Michelle Hoiseth

Senior Vice President and Chief Data Officer, Parexel
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently leads PAREXEL’s... Read More →
avatar for Catherine Celingant

Catherine Celingant

Oncology Therapeutic Area Lead, Data Monitoring and Management (DMM), Pfizer Inc
Catherine has over 25 years of experience in Data Management, Clinical Informatics, and Medical Operations. Prior to joining Pfizer, Catherine worked at Millennium: The Takeda Oncology Company, where she successively led the Clinical Data Management and Clinical Systems, Medical Systems... Read More →


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session

1:30pm EDT

#121 SL: Non-Profit Organizations Role in Accelerating Preclinical Compound Testing to Fuel the Rare Disease Clinical Pipeline
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-681-L04-P; CME 1.00; IACET 1.00; RN 1.00

A panel will review examples of preclinical drug screening platforms and consortia organized by non-profit organizations. Experts will present their experience and describe the challenges encountered, solutions found, and best practices defined.

Learning Objectives

Discuss how rare disease non-profit organizations accelerate drug development; Develop consensus with industry, academia and patients; Identify unmet needs, optimize translational methods, criteria for compound selection, addressing gaps, ensuring quality, reproducibility, robustness and interpretation of data; Discuss challenges and solutions to transparency, data sharing and sustainability.

Chair

Daniela Brunner, PhD

Speaker

Panelist
Dean Aguiar, PhD

Panelist
Salvatore La Rosa, PhD

Panelist
Dominique Pichard, MD



Speakers
avatar for Daniela Brunner

Daniela Brunner

Founder/CIO, Science Forward/PsychoGenics
Daniela Brunner, PhD is the Chief Innovation Officer of PsychoGenics inc. and founder of ScienceForward, which is focused on the development of digital health technology and treatments for rare disorders and underserved populations. She is part of the Business Advisory Board of the... Read More →
avatar for Salvatore La Rosa

Salvatore La Rosa

Chief Scientific Officer, Children's Tumor Foundation
Salvatore La Rosa, PhD, serves as the Chief Scientific Officer at the Children’s Tumor Foundation (CTF) and he is responsible for the implementation of the Foundation’s business strategy into research projects. He manages the foundation’s research activities, providing scientific... Read More →
avatar for Dominique Pichard

Dominique Pichard

Chief Science Officer, Rettsyndrome.org
Dominique Pichard, MD is the Chief Science Officer at the International Rett Syndrome Foundation (IRSF). In this role, she is responsible for the research program that includes funding of basic, translational, clinical, and neurohabilitation research, the Scout program to accelerate... Read More →
avatar for Dean Aguiar

Dean Aguiar

Director, Preclinical Research, Tuberous Sclerosis Alliance
Dean Aguiar, PhD is the Director for Preclinical Research at the Tuberous Sclerosis Alliance, where he is responsible for leading the Tuberous Sclerosis Complex Preclinical Consortium, a private-public partnership developed to stimulate collaboration and innovation to find a cure... Read More →


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Forum

1:30pm EDT

#122 L: ICH 30th Anniversary Series: Harmonizing Global Requirements for Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-645-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of ICH efficacy topics instrumental to the harmonization of pharmaceutical development standards and an introduction to the new and revised topics that are currently underway. We will also discuss how ICH Guidelines apply now more than ever, in the time of a global pandemic. Additionally, an overview will be presented of ICH's GCP Renovation plan to provide updated guidance to address the increasing diversity of study types and data sources that support regulatory and other health policy decisions.

Learning Objectives

Discuss the role of ICH efficacy topics in harmonizing standards for more efficient pharmaceutical development and registration; Understand how ICH Guidelines help support drug development in the time of a global pandemic; Explain current ICH Guidelines being revised, new Guidelines being developed, and their anticipated impact to pharmaceutical development.

Chair

Amanda Marie Roache, MS

Speaker

Revision of ICH E6 Good Clinical Practices
M. Khair ElZarrad, PhD, MPH

Revision of ICH E8 General Consideration for Clinical Studies
Joanne Palmisano, MD, FACP

ICH E11A Pediatric Extrapolation
Lynne Yao, MD



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Deputy Director, Office of Medical Policy, CDER, FDA
Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads... Read More →
avatar for Joanne Palmisano

Joanne Palmisano

Vice President, Head Global Regulatory Strategy, Vertex Pharmaceuticals, Inc.
Joanne Palmisano, MD, FACP, FRAPS Dr. Palmisano is a global regulatory leader with extensive biopharmaceutical drug development expertise in small molecule and biologics in multiple therapeutic areas. As Vice President Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Session

1:30pm EDT

#123 L: Is Your App a Drug, a Device, or Something Else Entirely?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present and examine FDA’s regulation of “apps” and discuss what is required to bring these types of digital health technologies to market. A panel of experts will discuss their experience working with the FDA in this evolving area.

Learning Objectives

Discuss FDA’s current landscape regarding the regulation of mobile digital health solutions (or “apps); Describe best practices when working with the agency to bring such solutions to market; Explain how to differentiate between those products that may be considered a device, a drug, or a “digital therapeutic”.

Chair

Ernest S. Voyard, JR, JD

Speaker

FDA Perspective
Kristina Lauritsen, PhD

Industry Perspective
Yuri Maricich, MD, MBA

Industry Perspective
Vernessa Pollard, JD



Speakers
avatar for Ernest Voyard

Ernest Voyard

Associate Director, Global Regulatory Policy and Intelligence, Janssen Research & Development, LLC
Ernest is an associate director of Regulatory Policy and Intelligence for The Janssen Pharmaceutical Companies of Johnson and Johnson. There he focuses on public policy issues related to the development of drugs and biologic products. Ernest has spent most of his career working on... Read More →
avatar for Yuri Maricich

Yuri Maricich

Chief Medical Officer and Head of Development, Pear Therapeutics
Dr. Maricich leads the Clinical/Regulatory/Quality group at Pear Therapeutics as the Chief Medical Officer and Head of Development. He leads and manages the development programs from Discovery/TPP stage, thru Translational, Clinical Development, Regulatory submission and review as... Read More →
avatar for Vernessa Pollard

Vernessa Pollard

Partner, Chair FDA Pratice, McDermott Will & Emery LLP
Vernessa T. Pollard provides strategic business and regulatory advice to FDA-regulated companies on complex issues related to the development, manufacture, marketing, post-market safety and compliance for FDA-regulated products, including medical devices and digital health technology... Read More →
KL

Kristina Lauritsen

Combination Products Regulatory Policy Advisor, OEP, CDER, FDA
Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including... Read More →


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

1:30pm EDT

#124 SL: Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-544-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA at multiple levels, from the Commissioner to CBER Director to reviewers, has identified manufacturing as the most crucial issue in gene therapy. The panel will focus on innovation in this area and how the pioneers hope to overcome capacity limits

Learning Objectives

Describe the current state of gene therapy manufacturing; Analyze the challenges associated with manufacturing of gene therapies; Identify potential solutions to issues related to gene therapy manufacturing.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Peter W. Marks, MD, PhD

Panelist
Karen Walker

Panelist
Mike Paglia



Speakers
avatar for Nancy Myers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Karen Walker

Karen Walker

Senior Advisor, Cell and Gene Manufacturing, Genentech, A Member of the Roche Group
Karen Walker is a Sr. Advisor, Cell and Gene Therapy Manufacturing at Roche/Genentech. She brings 30+ years’ experience in the Biopharmaceutical industry, holding positions in Technical Development, Technical operations, Regulatory Affairs and Quality, including the role of VP and... Read More →
MP

Mike Paglia

Senior Vice President, CMC Operations, ElevateBio
Michael has over 16 years of experience building, leading and motivating process development and manufacturing teams to support clinical programs from early development to late stage clinical trials.


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Forum |   09: Regulatory, Forum

2:30pm EDT

#125 SL-IT: Covance Innovation Theater: Driving Patient-Centric Trials: Moving Beyond the Hype
Component Type: Session

Decentralized trials (DCT) are a hot topic to help solve clinical trial challenges. However, making DCT a reality requires a holistic shift in trial design and execution. Integrated systems, processes and tools are needed to support this transition. Effective implementation is contingent on understanding the evolution of the traditional delivery continuum. Come learn how choosing the right delivery strategy gets you beyond the hype to executing successful patient-centric decentralized trials.

Chair

Bola Oyegunwa, PhD, MBA, MS


Speakers
avatar for Bola Oyegunwa

Bola Oyegunwa

Vice President, Head of Virtual Trials, Covance, Inc.
Dr. Bola Oyegunwa is the Vice President and Head of Virtual trials at Covance. Bola is an industry thought leader in developing and implementing virtual trial solutions. Bola has led the implementation of innovative technology-enabled hybrid and virtual trials solutions for leading... Read More →


Monday June 15, 2020 2:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044

2:30pm EDT

#126 SL-IT: SAS Innovation Theater: The Role of Augmented Clinical Trials in the Response to COVID-19 and Beyond
Component Type: Session

The COVID-19 pandemic is accelerating adoption of new technology and advanced analytics to mitigate delays in clinical research. Virtual and hybrid trial designs are ideal for improving patient enrollment and retention by reducing or eliminating the need for site visits. Approaches like direct-to-patient drug supply, remote patient monitoring, telemedicine, modeling for missing data, and more integrated and personalized patient communication can keep clinical research moving forward despite slowdowns to traditional site-based research caused by stay-at-home orders and social distancing. In addition, augmented trial methodologies lead to increased trial outcomes, enable real-time decisions around safety and help prevent risks of supply shortage. Machine learning and AI, supported by the Internet of Medical Things, enable this innovation in trial design by keeping researchers connected to patients and their data.

Chair

Jim Box, MBA, MS

Speaker

Panelist
Matt Becker



Speakers
avatar for Matt Becker

Matt Becker

Advisory Industry Consultant, SAS Institute Inc
Becker has been a Principal Industry Consultant at SAS since 2013. Prior to joining SAS, he had been using SAS in the life sciences industry since 1988. He focused on clinical programming, data management and visualizations. Becker presented numerous papers and won best paper awards... Read More →
avatar for Jim Box

Jim Box

Principal Data Scientist, SAS Institute Inc
Box provides strategic insights across the life sciences industry, with a focus on optimizing the execution of clinical trials. He spent 18 years in the CRO industry, holding leadership roles in statistics, statistical programming, data management and information technology. Throughout... Read More →


Monday June 15, 2020 2:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  18: InnovTheater, Session

2:30pm EDT

#127 SL-IT: IQVIA Innovation Theater 2: Digital Patient Orchestration, An Examination of the Patient Journey
Component Type: Session

The healthcare and life science industry is undergoing a tremendous shift in research, care, and therapeutic models. Patients are more informed and have much more say about their treatment and expect a better experience today. From Molecule to Market, a patient-centric experience starts with the human centered design of cloud applications that map to the patient journey. Stakeholders want to understand patient experience, and factor it into their assessment of treatments. Orchestrated Clinical Trials are about understanding and responding to the Patient Voice and intelligently orchestrating their experience through SaaS-based applications that provide the ability to gain understanding of the trial from digital eConsent and continue through study close and re-engagement.

Chair

MaryAnne Rizk, PhD

Speaker

Panelist
Jean Paty, PhD, MS



Speakers
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Science, IQVIA
Jean Paty is a leader in effective strategies and practices of capturing patient experience data for use in clinical development and commercial success of new and existing medical products. Jean has been published extensively in the areas of Clinical Outcome Assessments (COA) and... Read More →
avatar for MaryAnne Rizk

MaryAnne Rizk

Senior Vice President, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →


Monday June 15, 2020 2:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044

3:00pm EDT

#128 SL-IT: Appian Innovation Theater - Bayer: Shaping the Future to Meet Our Needs – A Digital Transformation
Component Type: Session

Clinical Development is a constantly changing environment with new regulations, new processes, and new tools being regularly implemented. There is rising industry pressure to increase R&D productivity and remain competitive in this ever changing environment. Because of this, the way of working is constantly changing and there is an opportunity to better leverage our workforce and expertise. This is Envision…Shaping the Future to Our Needs: Envision is a workflow automation enabling platform for Clinical Operations and focuses on seamless work across data, including reports, and documents independent of systems and infrastructure. It also allows stakeholders to leverage the power and simplicity of digitization to bring the data to the users (rather than users having to find the data). With this, organizations are able to optimize time spent by minimizing repetitive, non-value-added tasks, freeing end users to focus on what’s most important.

Chair

Patricia Letwink, MBA

Speaker

Panelist
Evi Cohen, MBA, MS



Speakers
avatar for Patricia Letwink

Patricia Letwink

Strategic Initiatives, Communications and Change Management, Bayer U.S. LLC
Patricia is an executive in the Pharma Clinical Development business with over 20 years of experience leading enterprise-wide teams to successful delivery of complex, multi-faceted products and services in the Pharmaceutical and Pharmacy Benefit Management industries. She currently... Read More →
avatar for Evi Cohen

Evi Cohen

Vice President, Global Life Sciences & Healthcare, Appian
Experienced pharmaceutical executive with extensive background in developing global business portfolios with emphasis on new products, technologies and IP. Skilled innovation management professional with experience managing global business process transformations and cross-functional... Read More →


Monday June 15, 2020 3:00pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044

3:30pm EDT

#129 SL: The Rare Disease Clinical Outcome Assessment Consortium: Aiming to Fulfill Unmet Drug Development Endpoint Measurement Needs
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-636-L04-P; CME 1.00; IACET 1.00; RN 1.00

Appropriate endpoint selection for rare disease trials is challenging. The Rare Disease Clinical Outcome Assessment (COA) Consortium’s aim is the creation of a resource of publicly available COAs deemed fit-for-purpose as trial endpoint measures.

Learning Objectives

Explain a definition of “rare disease” and describe the global burden of rare diseases and the challenges to drug development; Describe the unmet need that the Rare Disease Clinical Outcome Assessment Consortium is intended to address. •Discuss why a pre-competitive, multi-stakeholder collaboration is the optimal setting for achieving its aim of creating a database of publicly available COAs.

Chair

Lindsey Murray, PhD, MPH

Speaker

Panelist
Michelle Campbell, PhD

Panelist
Stephen Joel Coons, PhD

Panelist
Vanessa Boulanger, MSc

Panelist
Dylan Trundell, MSc



Speakers
avatar for Lindsey Murray

Lindsey Murray

Associate Director, PRO Consortium, Critical Path Institute
Lindsey Murray, PhD, is the Associate Director for Rare Diseases at the Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium. Dr. Murray has more than 13 years of experience in clinical and health outcomes research, specializing in quantifying the patient’s... Read More →
avatar for Vanessa Boulanger

Vanessa Boulanger

Director of Research Programs, National Organization for Rare Disorders (NORD)
Vanessa Boulanger is the Director of Research at the National Organization for Rare Disorders (NORD). In this role, Vanessa oversees the management, growth, and implementation of NORD’s research and scientific activities. In 2018, Vanessa was appointed as a member of the Patient-Centered... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, DNP, OND, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →
avatar for Stephen Joel Coons

Stephen Joel Coons

Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical... Read More →
DT

Dylan Trundell

Senior Principal PCOR Scientist, Roche Products Ltd.
Dylan Trundell is a health outcomes researcher with 10+ years experience. He has led the development of clinical trial measurement strategies, including the development of novel COAs, across several disease areas, including multiple rare diseases.


Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

3:30pm EDT

#130 L: Virtual Clinical Trials
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-576-L04-P; CME 1.00; IACET 1.00; RN 1.00

The term decentralized trial is not something new. However, it is becoming more mainstream as patients are more willing to participate in a clinical trial when there is less patient burden. By removing barriers of trial participation, patients are more likely to be compliant, more likely to be retained, and more likely to complete the trial. Key lessons learned will be discussed as well as pitfalls to avoid in the future. What went well, what was more challenging than expected, where were the surprises.

Learning Objectives

Discuss key lessons learned about decentralized trials; Describe pitfalls to avoid.

Chair

Nechama Katan, MA, MS

Speaker

Building Connections and Building Blocks for eSource: eCOA and ePRO are the Building Blocks to Decentralized Trials
Alison Holland

A Case Study in Applying Risk-Based Monitoring Analytics to a Fully Virtual Trial
Nechama Katan, MA, MS



Speakers
avatar for Nechama Katan

Nechama Katan

Associate Director, RBM, Pfizer Inc
Nechama Katan, is a “Data Wizard with Personality.” Nechama has been the technical lead for the RBM team at Pfizer and is working on understanding the best ways to upskill SMEs so that they can drive Data Science Discussions. She helps organizations access and use their data to... Read More →
avatar for Alison Holland

Alison Holland

Head of Decentralized Trials, Medable
Alison (Ali) Holland is Head of Decentralized and Remote trials at Medable and is chartered to design and expand the end-to-end capabilities needed to partially or fully virtualize clinical studies, building on the commitment to reduce clinical trial times by 50%. Ali has over 20... Read More →


Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   02: ClinTrials -ClinOps, Session

3:30pm EDT

#131 L: Engaging Patients to Support the Modernization of ClinicalTrials.gov
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-661-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present findings from patient engagement efforts on needs for ClinicalTrials.gov modernization and discuss priorities. A panel of experts will provide interpretation of the priorities for modernization and include audience engagement.

Learning Objectives

Identify the phases ClinicalTrials.gov modernization efforts entail and describe users evolving needs; Describe the regulatory and policy obligations and goals for the ClinicalTrials.gov program;Identify what is most important for you or your organization as a user of ClinicalTrials.gov.

Chair

Rebecca Williams, PharmD, MPH

Speaker

Panelist
Catina O'Leary, PhD

Panelist
Christine M. Crandall, MS

Panelist
Deborah E. Collyar

Panelist
T.J. Sharpe, PMP



Speakers
avatar for Rebecca Williams

Rebecca Williams

Acting Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH
Rebecca Williams, PharmD, MPH, is Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Assistant Director for over a decade. She is responsible for technical, scientific, policy, regulatory... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →
avatar for Christine Crandall

Christine Crandall

Head of Clinical Project Management, GlaxoSmithKline
Christine Meyer Crandall is the Head of Clinical Project Management at GSK with over 20 years of experience in project management and clinical operations. She is responsible for a team focused on the delivery of robust, quality data to optimize trial scenario planning and improve... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media (HLM)
Catina O’Leary, PhD, LMSW, is President & CEO of Health Literacy Media (HLM), a nonprofit health communications company located in Saint Louis, Missouri and working around the world. HLM provides training for health care providers in clear verbal and written health communication... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in his Patient #1 Blog.  He was diagnosed in August 2012 with metastatic melanoma, weeks after his second child was born. He has undergone six surgeries and four immunotherapy treatments over two different... Read More →


Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum

3:30pm EDT

#132 SL: Benchmarking and Identifying Opportunities to Improve Intentional Dose Non-Adherence in Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-561-L04-P; CME 1.00; IACET 1.00; RN 1.00

The results of a groundbreaking study quantifying intentional dose non-adherence are presented followed by a discussion among a panel of clinical and regulatory professionals on the implications of the findings.

Learning Objectives

Quantify intentional dose non-adherence rates in clinical trials; Identify factors associated with, and predictive of intentional non-adherence; Discuss policies and solutions to address and reduce intentional non-adherence.

Chair

Kenneth A. Getz, MBA

Speaker

Quantifying the Magnitude of Intentional Dose Non Adherence
Kenneth A. Getz, MBA

Accounting For and Managing Dose Non-Adherence in Clinical Trials
Marlen Rattiner, MA



Speakers
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
MR

Marlen Rattiner

Vice President, Product Management, AiCure


Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum

3:30pm EDT

#133 L: FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-542-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA will present an overview of considerations on benefit-risk assessment across the drug development lifecycle and solicit input from session attendees.

Learning Objectives

Explain FDA’s approach to benefit-risk assessment throughout the lifecycle of drug development; Identify important milestones along the drug development lifecycle for communication between FDA and stakeholders on key considerations for regulatory benefit-risk assessment; Describe how early planning should be considered to collect data that may inform benefit-risk assessment.

Chair

Graham Thompson

Speaker

Key Considerations and Patient Experience
Kerry Jo Lee, MD

Benefit-Risk Planning and Statistical Considerations
Gregory Levin, PhD

Post Market Benefit-Risk Considerations
Judith Zander, DrMed, MD

Additional Analysis to Inform Benefit-Risk Assessment
Hong Yang, PhD



Speakers
GL

Gregory Levin

Deputy Director, DBIII, OB, OTS, CDER, FDA
Greg Levin is a supervisory mathematical statistician at the Center for Drug Evaluation and Research within FDA. He joined FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped regulate products across a wide range of therapeutic... Read More →
avatar for Judith Zander

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA
Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA).She oversees the Divisions of Pharmacovigilance 1 and... Read More →
avatar for Kerry Jo Lee

Kerry Jo Lee

Clinical Advisor, Office of New Drug Policy, CDER, FDA
Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →
GT

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Team (DSAT) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and supporting... Read More →
avatar for Hong Yang

Hong Yang

Biologist, Office of Biostatistics and Epidemiology, CBER, FDA
Dr. Hong Yang is a senior regulatory scientist in the Office of Biostatistics and Epidemiology, CBER, FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products. She has been devoted in regulatory review, as well... Read More →


Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

3:30pm EDT

#134 L: Should a COVID-19 Vaccination be Legally Mandated and Can HTA Inform That Decision?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-569-L04-P; CME 1.00; IACET 1.00; RN 1.00

Health Technology Assessment (HTA) is defined as a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of an intervention or health technology. In anticipation of COVID-19 vaccine, a panel composed of the relevant stakeholders will have an open dialogue about the role of HTA in informing public health policy-making, with particular focus on vaccination, and enforcing such policies at an individual country and global levels. Potential learnings from previous pandemics, such as H1N1, will be reviewed. Ethical and economic challenges will be debated to offer a consensus position that takes into account societal benefits, economic, logistical and legal considerations.

Learning Objectives

Debate the ethical, logistical, and legal implications if a mandated vaccine program were to be instituted and what would inform such a decision; Discuss the role and opportunity of HTA to inform and recommend a decision.

Chair

Richard Hiraiwa Stanford, PharmD, MS

Speaker

Panelist
Richard Hiraiwa Stanford, PharmD, MS

Panelist
Phil Ball, PhD

Panelist
Andrew H. Briggs, PhD, MSc



Speakers
avatar for Phil Ball

Phil Ball

Health Policy, Biopharmaceutical Development Strategy, Independent Consultant
Phil Ball has over twenty years of international experience spanning from pharmaceutical product development to health policy. Most recently he was Executive Director, U.S. Value Policy and Strategy, at Allergan. In this role he led U.S. HEOR- and value-related policy and legislative... Read More →
avatar for Andrew Briggs

Andrew Briggs

Professor of Health Economics, London School of Hygiene and Tropical Medicine (LSHTM)
avatar for Richard Stanford

Richard Stanford

Vice President, Strategic Consulting, AESARA
Dr. Stanford is VP of Strategic Consulting Solutions at AESARA, a digital-forward market access agency that designs innovative solutions that enable transformative market access. In addition, he is an Adjunct Assistant Professor at UNC Eshelman School of Pharmacy. Prior to joining... Read More →


Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Forum
  • LEVEL Intermediate
  • FEATURED TOPICS HTA
  • Featured Topics HTA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum
 
Tuesday, June 16
 

8:00am EDT

#201 L: Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will highlight progress to date in identifying metrics to assess patient involvement in drug development and drug safety, and the current challenges to, and benefits of, achieving a more patient-centric culture within the pharmaceutical industry. Perspectives on this topic will be provided by representatives from IMI-PARADIGM, industry, the patient advocacy sector, and the US FDA. Join the DIA Patient Engagement Community for a follow up round table discussion (session #216 L-RT) on Tuesday, June 16, 10:45AM - 11:30AM.

Learning Objectives

Discuss how to use a framework to guide selection of appropriate patient-centricity metrics for use within a pharmaceutical company; Describe the types of metrics that have been developed to date to measure patient involvement in drug development, including drug safety; Identify key challenges to implementing patient-centricity metrics within a pharmaceutical company and identify specific strategies to overcome those barriers.

Chair

Mariette Boerstoel-Streefland, MD, MBA, MS

Speaker

FDA Update
Robyn Bent, MS, RN

Industry Update
Katherine Capperella

Policy Update
Elisabeth Oehrlein, PhD, MS

What Frameworks and Metrics Exist for Measuring Patient-Centricity in Drug Development and Drug Safety
Tjerk Jan Schuitmaker, PhD, MSc



Speakers
avatar for Katherine Capperella

Katherine Capperella

Global Patient Engagement Leader, Janssen Pharmaceutical Companies of Johnson & Johnson
As global head of Patient Engagement, Katherine leads a cross-functional team responsible for developing and driving patient engagement strategy and measuring progress over time. She is focused on leading Janssen to incorporate direct patient voice early and throughout the entire... Read More →
avatar for Mariette Boerstoel-Streefland

Mariette Boerstoel-Streefland

Senior Vice President Global Drug Safety, Alexion Pharmaceuticals, Inc.
Mariette Boerstoel-Streefland, MD, MBA, MS(epi) is SVP, Head of Global Safety at Alexion Pharmaceuticals, Inc, a world leader in rare diseases. Prior to her current role, Mariette was SVP, Head of Global Drug Safety at Shire, having been appointed to lead the safety organization after... Read More →
avatar for Robyn Bent

Robyn Bent

Director, PFDD Program, OCD, CDER, FDA
Robyn Bent joined the US FDA in 2019 as the director of CDER’s Patient-Focused Drug Development (PFDD) Initiative, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making... Read More →
avatar for Elisabeth Oehrlein

Elisabeth Oehrlein

Senior Director, Research and Programs, National Health Council
Elisabeth M. Oehrlein, Ph.D., MS is Senior Director, Research & Programs at the National Health Council (NHC), a non-profit membership organization dedicated to providing a united voice for people with chronic diseases and disabilities and their family caregivers. Dr. Oehrlein leads... Read More →
avatar for Tjerk Jan Schuitmaker

Tjerk Jan Schuitmaker

IMI-PARADIGM; Assistant Professor, Athena Institute of the Vrije University of Amsterdam
Dr. Tjerk Jan Schuitmaker is assistant professor at the Athena Institute of the VU University Amsterdam. He is interested in the system transformation to sustainable health and care and works on a variety of projects in preventive medicine, maternal care and medicine development... Read More →


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

8:00am EDT

#202 L: Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

The current paradigm of conducting large-scale clinical trials in highly prevalent and chronic diseases does not support timely access of patients to innovative medicines. We will discuss possible ways to transform drug development in these areas.

Learning Objectives

Summarize the patient, regulatory,and industry perspectives on the sustainability of doing large-scale clinical development programs for highly prevalent and chronic diseases and conditions; Name possible alternate and novel approaches to drug development in highly prevalent and chronic disease areas, outside of large-scale clinical trials.

Chair

Max Wegner, PharmD, RPh

Speaker

Industry Perspective
James T. Mayne, PhD

Regulator perspective
Peter P. Stein, MD

Patient Perspective
Sue Peschin, MHS



Speakers
avatar for Max Wegner

Max Wegner

Head Regulatory Affairs, Bayer AG
After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →
JM

James Mayne

Vice President, Scientific Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jim Mayne is Vice President, Science & Regulatory Advocacy at PhRMA, where he provides leadership for PhRMA involvement in a number of science based public-private partnerships and works to support pharma industry efforts to evolve the contemporary R&D ecosystem and drug development... Read More →
avatar for Sue Peschin

Sue Peschin

President and Chief Executive Officer, Alliance for Aging Research
Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research the leading national non-profit organization dedicated to accelerating research to improve aging and health. Ms. Peschin has led the Alliance in efforts to: boost older adult immunization rates; increase NIH... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session

8:00am EDT

#203 L: ICH 30th Anniversary Series: The Role of Multidisciplinary Topics
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-718-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of key ICH Multidisciplinary topics and current efforts to promote more efficient drug development and registration.

Learning Objectives

Discuss the role of the ICH multidisciplinary topics in harmonizing standards for more efficient pharmaceutical registration; Describe the role of standards development organizations (SDOs) and how they impact the development of ICH standards; Explain a new ICH harmonization effort to standardize organization and content of clinical protocols and development of a technical specification.

Chair

Amanda Marie Roache, MS

Speaker

ICH Data Standards and MedDRA
Mary Ann Slack

ICH M11 Clinical electronic Structured Harmonized Protocol
Ron Fitzmartin, PhD, MBA

ICH Electronic Standards for the Transfer of Regulatory Information
Vada A. Perkins, DrSc, MS, MSc



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Vada A. Perkins

Vada A. Perkins

Executive Director, Regulatory Policy and Intelligence, Bayer Pharmaceuticals
Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Intelligence, Head Regulatory Intelligence- Vada A. Perkins, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   09: Regulatory, Session

8:00am EDT

#204 L: Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-604-L04-P; CME 1.00; IACET 1.00; RN 1.00

The modernization of ICH E8 emphasizes a Quality by Design (QbD) approach to trial design. In this forum, discover new QbD resources for sponsors and all stakeholders, and join a discussion on implementation models and best practices.

Learning Objectives

Compare diverse models of QbD implementation at the trial and company/organization levels, and identify best practices; Discuss benefits and best practices for multi-stakeholder engagement in the QbD process, including patients, sites, CROs, and regulators; Explain how to apply freely-available resources for evaluating current state of QbD adoption, developing an implementation and tracking progress.

Chair

Ann Meeker-O'Connell, MS

Speaker

Orion-4: A Case Study of QbD Application at the Trial Level
Sabrina Comic-Savic, MD, MPH

CTTI QbD Maturity Model
Kerstin Koenig, PhD, MSc

Panelist
Fergus Sweeney, PhD



Speakers
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Vice President, Integrated QMS/OMS, Vertex Pharmaceuticals
avatar for Fergus Sweeney

Fergus Sweeney

Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency
Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing... Read More →
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Research and Development Quality, Bristol Myers Squibb
Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Development GMP, GLP, GCP and... Read More →
SC

Sabrina Comic-Savic

Vice President, Quality Assurance, Clinical Project Oversight, The Medicines Company


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum

8:00am EDT

#205 SL: Using Artificial Intelligence to Inform Regulatory and Development Strategies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-565-L04-P; CME 1.00; IACET 1.00; RN 1.00

Artificial intelligence and data science can help increase the efficiency of drug development. We will explore how pharma companies and researchers are leveraging artificial intelligence to identify insights and make predictions about regulatory strategies and drug development, and what is needed for further adoption.

Learning Objectives

Describe how artificial intelligence is being applied in the pharmaceutical industry to inform decisions about regulatory strategies and drug development; Discuss what is needed to enable further use of artificial intelligence to support decision making.

Chair

Nicholas Drago, MS, RAC

Speaker

Can Artificial Intelligence Inform Regulatory Strategy?
Andrew Robertson, JD, PhD

Estimating and Predicting the Probabilities of Success of Clinical Trials: A Data Science Perspective
Andrew Lo, PhD, MA, MBA, PMP



Speakers
avatar for Andrew Robertson

Andrew Robertson

Global Head of Strategy, and Business Transformation, Digital and Data Sciences, Sanofi
Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health... Read More →
avatar for Nicholas Drago

Nicholas Drago

Associate Director, Regulatory Policy and Intelligence, Bayer
Nicholas Drago is Associate Director of Regulatory Policy & Intelligence at Bayer Pharmaceuticals. In this role, he leads projects applying data science to support decision making in regulatory affairs and leads several regulatory policy initiatives. Nicholas has 7 years of experience... Read More →
avatar for Andrew Lo

Andrew Lo

Charles E. and Susan T. Harris Professor of Finance, Sloan School of Management, Massachusetts Institute of Technology (MIT)
Andrew W. Lo is the Charles E. and Susan T. Harris Professor at the MIT Sloan School of Management, director of MIT’s Laboratory for Financial Engineering, and principal investigator at MIT's Computer Science and Artificial Intelligence Laboratory. His research interests include... Read More →


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

8:00am EDT

#206 L: Regulatory Agility During the COVID-19 Pandemic
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-630-L04-P; CME 1.00; IACET 1.00; RN 1.00

The current health crisis has necessitated maximum agility from both regulators and manufacturers to ensure continued supply of quality products for patients. In this session, regulators from multiple health authorities will discuss new regulatory mechanisms and flexibility of regulatory expectations to balance risk and availability.

Learning Objectives

Describe the challenges facing manufacturers related to the current COVID pandemic; Discuss regulatory approaches used by health authorities to endure continued availability of quality medicines for patients.

Chair

Christine M. V. Moore, PhD

Speaker

Update From MHRA
David Churchward, MS

FDA Update
Jeannie David, MS

EMA Update
Noël Wathion, RPh



Speakers
avatar for Christine Moore

Christine Moore

Executive Director, Merck & Co., Inc
Christine Moore is Global Head and Executive Director, CMC Policy at Merck. Christine joined Merck after more than a decade in various positions in the US FDA. Prior to working at FDA, Christine spent 10 years in small and large molecule process development. Throughout her career... Read More →
avatar for David Churchward

David Churchward

Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), Medicines and Healthcare products Regulatory Agency (MHRA)
David Churchward has been a GMP inspector with the UK MHRA since 2004 and is responsible for the strategic direction of the GxP inspectorate. He is experienced in leading the implementation of innovative regulatory approaches and provides GMP input to the MHRA’s Innovation Office... Read More →
avatar for Jeannie David

Jeannie David

Senior Program Management Officer, Drug Shortage Staff, CDER, FDA
Jeannie David has been with the Drug Shortage Staff since 2012 and has worked on several drug shortage mitigation efforts, as well as on the Guidance to Industry Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing, MAPP 5001.1 Drug Product Distribution After... Read More →
avatar for Noël Wathion

Noël Wathion

Deputy Executive Director, European Medicines Agency
Noël Wathion is the Deputy Executive Director of the EMA since February 2016. He is also the Chief of Policy. He joined the Agency in 1996, and has since held several senior managerial positions, including Head of the Post-Authorisation Evaluation of Medicines for Human Use Unit... Read More →


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session

8:00am EDT

Professional and Student e-Posters Gallery
Professional and Student e-Posters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2020. Attendees are invited to scroll through and search e-Posters throughout the duration of virtual meeting. e-Posters run continuously during the meeting. There are no formal or LIVE e-Poster presentations during the DIA 2020 virtual meeting.

Tuesday June 16, 2020 8:00am - 5:00pm EDT
e-Poster Gallery

9:00am EDT

#208.1 SL-IT: IBM Innovation Theater: New Ways to Apply Decentralized Trials During Covid-19
Component Type: Session

The industry is facing an even bigger challenge to recruit, retain, and engage with patients due to COVID-19. This has delayed and de-prioritized many clinical trials across the globe. In response, IBM Watson Health has optimized IBM Clinical Development to enable decentralized trials for its clients, specifically leveraging its eCOA capabilities and its unified, cloud-based CDMS platform that allows remote monitoring and study control. Biorasi will be speaking as a user of this platform on how ICD is helping them overcome COVID-19-related challenges and how to help their Sponsors operate more efficiently.

Chair

Robert DiCicco, PharmD

Speaker

Panelist
Sébastien Bohn



Speakers
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →
avatar for Sébastien Bohn

Sébastien Bohn

Offering Manager Executive, IBM Watson Health
Sebastien Bohn is the Offering Manager Executive for IBM Watson Health’s Life Science’s pillar. As the Offering Manager Executive, he leads the Clinical Development portfolio of offerings which are SaaS based technologies designed with an open, connected, and elegantly designed... Read More →


Tuesday June 16, 2020 9:00am - 9:30am EDT
TBD Virtual Event Horsham, PA 19044
  18: InnovTheater, Session

9:00am EDT

#208.2 SL-IT: Covance Innovation Theater: Managing Complexity: The COVID-19 Road To Recovery and Restoration
Component Type: Session

Abstract: The COVID-19 pandemic expanded globally over the space of a few weeks- disrupting all aspects of our lives including progress with clinical trials. This impact has been far-reaching and the path to recovery and restoration is complex. During this presentation, we will describe our Covance enterprise COVID-19 recovery and restoration roadmap, including proprietary and technology solutions, and few key areas of COVID-19 recovery within our Drug Development organization - each with a unique challenge and opportunity.

Chair

Ryan Baehl, MBA

Speaker

Panelist
Amy Hadley

Panelist
Oren Cohen, MD



Speakers
avatar for Ryan Baehl

Ryan Baehl

Vice President of Global Operations for CLS, Covance
Ryan Baehl is the Vice President of Global Operations for Covance Clinical Trials Testing Solutions. He has been with Covance for 10 years and held positions leading Project Management and Alliance Management, client delivery and process improvement. Ryan holds a BS in Mechanical... Read More →
avatar for Oren Cohen

Oren Cohen

Chief Medical Officer and Head of Clinical Pharmacology Services, Covance
Oren has extensive clinical development experience, most recently from Viamet Pharmaceuticals where he was CMO. He brings more than 30 years of healthcare experience to the role, including several senior medical and operational leadership positions at Quintiles, including Chief Medical... Read More →
avatar for Amy Hadley

Amy Hadley

Global Head of Commercial and Operational Risk, Covance
Amy is Global Head of Commercial and Operational Risk for Covance Enterprise Client Solutions, and currently leading the Clinical Development & Commercialization Solutions COVID-19 Recovery Task Force. She has been with Covance for 2 years and in clinical development for over 17 years... Read More →


Tuesday June 16, 2020 9:00am - 9:30am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#209 L: Data Driven Monitoring Enabled Through Analytics and Quality Risk Management
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-655-L04-P; CME 1.00; IACET 1.00; RN 1.00

ICH E6 (R2) has set an expectation for the clinical research industry to implement Risk-Based Quality Management (RBQM), including a call for increased use of centralized and remote methods of monitoring study conduct and data quality. In this session we will learn about and explore various innovative data-driven methods being implemented to enable a more effective and efficient approach to quality oversight and monitoring of clinical trials.

Learning Objectives

Describe several data-driven approaches to enable more effective and efficient oversight of clinical trials; Discuss both the benefits and challenges associated with these methods.

Chair

Stephen Young, MSc

Speaker

Leveraging Analytics to Ensure Data Quality and Integrity
Stephen Young, MSc

The Case for Remote Source Data Verification
Karen Ooms, MS

Impact of Advanced Analytics Using Artificial Intelligence on Clinical Trial Management
Patrick McManus, MSc



Speakers
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →
avatar for Patrick McManus

Patrick McManus

Chief Development Officer, Exom Group Srl
Holding a Master of Science in Clinical Research from the Danube University Krems and a diploma in Business Administration and Computational Sciences from the Academy of Public and Business Administration in Munich Patrick is bringing more than 12 years of experience in Business Development... Read More →
avatar for Karen Ooms

Karen Ooms

Executive Vice President and Head of Statistics, Quanticate
Karen Ooms is a statistician with over 30 years experience, including 20 years in clinical research and development. At the start of her career, she was lucky enough to join Rothamsted Experimental Station's Statistics Department, benefitting from the rich vein of knowledge developed... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#210 SL: Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-656-L04-P; CME 1.00; IACET 1.00; RN 1.00

Creation of a new guideline to specify a comprehensive clinical protocol organization and flexible content components was mandated by the ICH assembly in June 2018 and the established Expert working group {ICH M11 EWG} has made substantial progress. The purpose of this is to engage all relevant stakeholders and get early input on important design and content considerations which have been developed by the EWG.

This session will include the business plan and perceived benefit of this effort expressed by SMEs from regulators and the sponsors, high-level design principles followed, as well as the overall deliverables, status and roadmap to delivery in order to get early input for consideration. Interdependencies with other ongoing ICH efforts and alignment steps will also be presented.

Learning Objectives

Discuss the status of the harmonization efforts of the clinical trial protocol template under the umbrella of ICH; Outline early feedback from various stakeholders for early consideration.

Chair

Mary Lynn Mercado, PhD

Speaker

ICH Overview
Noemi Manent

Reviewer Perspective
Vaishali Popat, MD, MPH

Breadth and Integration
Ken Sakushima, MD, PhD, MPH

Work Plan and Next Steps
Mary Lynn Mercado, PhD



Speakers
avatar for Mary Lynn Mercado

Mary Lynn Mercado

US Group Head Regulatory Medical Writing, Pharma, Novartis Pharmaceuticals Corporation
Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas... Read More →
avatar for Noemi Manent

Noemi Manent

Scientific Administrator, Compliance and Inspection, European Medicines Agency
Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is involved in the coordination of EMA Good Clinical Practice (GCP) and pharmacovigilance inspections. She also has a major role... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →
KS

Ken Sakushima

Medical Reviewer, Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA)


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum |   02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum

9:30am EDT

#211 L: Balancing Clinical Trial Disclosure and Transparency With Global Data Protection Regulations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-639-L04-P; CME 1.00; IACET 1.00; RN 1.00

Global clinical trial disclosure requirements and initiatives result in extensive amounts of clinical data in the public domain. This session will discuss how the increasing transparency demands and competing privacy obligations are being addressed.

Learning Objectives

Discuss the competing challenges of increasing demand to make more clinical data publicly available and data privacy obligations; Describe approaches industry is taking in preparing clinical documents for public disclosure to minimize risks of patient re-identification; Recognize patients’ concerns on disclosure risks.

Chair

Robert Paarlberg, MS

Speaker

Legal Challenges in Balancing Data Transparency and Data Privacy Obligations
Michael A. DiMaio, JD

How Health Literacy Strategies Help Create Usable Clinical Trial Information for Patients
Catina O'Leary, PhD

Preparing Global Clinical Documents for Disclosure
Eileen Girten, MS



Speakers
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory... Read More →
avatar for Michael DiMaio

Michael DiMaio

Attorney, Ropes & Gray LLP
Michael DiMaio is an associate in the health care group at Ropes & Gray. He advises health care providers, pharmaceutical and medical device manufacturers, contract research organizations, and other health care organizations regarding a broad range of privacy, regulatory, compliance... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media (HLM)
Catina O’Leary, PhD, LMSW, is President & CEO of Health Literacy Media (HLM), a nonprofit health communications company located in Saint Louis, Missouri and working around the world. HLM provides training for health care providers in clear verbal and written health communication... Read More →
avatar for Eileen Girten

Eileen Girten

Director, Medical Writing, Pfizer Inc
Eileen M. Girten is Director of Medical Writing at Pfizer and is experienced in regulatory and publications writing, submissions, and mentoring. She is an Adjunct Assistant Professor at the University of the Sciences in Philadelphia and has taught Regulatory Documentation Processes... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session

9:30am EDT

#212 L: Qualitative, Quantitative, and Mixed Method Approaches to Capture the Patient Experience
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-721-L04-P; CME 1.00; IACET 1.00; RN 1.00

This workshop will assist attendees in implementing methods for generating robust and meaningful patient experience data to inform medical product development and regulatory decision-making. Pragmatic approaches will be shared.

Learning Objectives

Explain how to select the appropriate method(s) to use to collect patient experience data; Determine how to integrate qualitative and quantitative methodologies in order to generate both meaningful and useful patient experience data; Identify best practices for how to conduct qualitative, quantitative, and mixed method research; Determine innovative approaches to data collection.

Chair

Ebony Dashiell-Aje, PhD

Speaker

Facilitator
Naomi Knoble, PhD

Facilitator
Emily Freeman, PhD, MSc

Facilitator
Heather Gelhorn, PhD



Speakers
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Director, Patient-Centered Outcomes Research, Biomarin Pharmaceutical Inc.
Dr. Dashiell-Aje is a leading expert in clinical outcome assessment (COA) design and implementation, advising on COAs, study endpoint issues and regulatory science. As a health outcomes researcher and methodologist, Dr. Dashiell-Aje is driven by her passion for public health and promoting... Read More →
avatar for Emily Freeman

Emily Freeman

Senior Director, Global Regulatory Behavioral Science, Sanofi
Dr. Emily Freeman is experienced patient centered science leader with a primary goal of accelerating the adoption of social/behavioral sciences within the pharmaceutical industry. She has worked to ensure the patient experience is incorporated into key regulatory decisions informing... Read More →
avatar for Heather Gelhorn

Heather Gelhorn

Senior Research Leader, Patient-Centered Research, Evidera
Heather Gelhorn, PhD, is a Senior Research Leader with Evidera’s Patient-Centered Research group. Dr. Gelhorn has over 15 years of experience in designing and conducting health outcomes research in a variety of therapeutic areas (e.g., oncology, respiratory, endocrinology, rheumatology... Read More →
NK

Naomi Knoble

Senior Staff Fellow, Office of New Drugs, CDER, FDA


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#213 L: Project Management in Times of Crisis
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-560-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166GGYON6; RN 1.00

Project Management professionals can play an instrumental role in crisis management situations. PM roles have vast intra-organizational networks, an understanding of how the divisions/departments of an organization are connected and a keen understanding of the overall integrated business processes and regulations.

Learning Objectives

Describe how technical project management skills, leadership presence, and communication skills seen in PM professionals can guide an organization to understanding business impact and contribute to sound decision making; Discuss key topics: trust building, internal and external communications,integrated planning, scenario building and assessments, best practices for working in crisis management teams.

Chair

Elizabeth Somers, MS

Speaker

Project Management in Times of Crisis
Claire Blanchette, PMP



Speakers
avatar for Elizabeth Somers

Elizabeth Somers

Executive Director of Infectious Disease, Global Project and Alliance Management, Merck & Co., Inc.
Liz is an Executive Director of Infectious Diseases in Global Project and Alliance Management at Merck. In addition to accountability for the ID TA, she manages a team focused on Discovery collaborations which leverages her experience managing complex cross functional drug development... Read More →
avatar for Claire Blanchette

Claire Blanchette

Vice President, Program Management - Oncogenic Signaling, Bayer
Claire Blanchette is a Vice President in Program Management at Bayer. Claire currently manages a group of Program Leaders and Program Managers in the Oncology Strategic Business Unit. She has also been acting as a Program Leader in various drug development programs teams since 2011... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Session |   08: R-D Quality-Compliance, Session

9:30am EDT

#214 L: GCP Quality and Compliance: The Regulators’ Perspective
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-742-L04-P; CME 1.00; IACET 1.00; RN 1.00

As the clinical trials become more complex and the science behind innovative therapies more advanced, the quality objectives of clinical development remain unchanged – protection of research volunteers and data integrity. A comprehensive Quality Management System, sophisticated risk-based approaches, and robust oversight models are now the standard for executing a compliant clinical trial and lapses in these and other GCP expectations continue to arise, potentially delaying delivery of important new therapies to patients. In this forum, leaders from regulatory authorities will present trends they are seeing in inspections, discuss emerging compliance challenges, and answer questions on expected practices that support success in quality in clinical development.

Learning Objectives

Discuss trends observed in recent inspections and understand specific areas of interest of regulatory authorities; Describe how quality management systems and risk-based approaches need to evolve to address emerging challenges; Recognize regulatory expectations.

Chair

David William Fryrear, MS

Speaker

FDA Update
David C. Burrow, JD, PharmD

FDA Update
Sean Y. Kassim, PhD

MHRA Update
Andrew Gray, PhD



Speakers
avatar for Andrew Gray

Andrew Gray

Deputy Director, Inspection Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA)
Andrew joined the MHRA in January 2003. In 2006 Andrew took on the role of Heads of the UK Good Laboratory Monitoring Authority and subsequently the role of Unit manager for half of the MHRA’s Inspectorate. In 2018 Andrew was appointed as Head of the MHRA’s Inspectorate and Deputy... Read More →
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA
David Burrow currently serves as the Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, he is responsible for the strategic administration... Read More →
avatar for David Fryrear

David Fryrear

Senior Vice President and Head of Clinical and Research QA, Medical and Dev, Astellas
David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas. David... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum

9:30am EDT

#215 L: ACTIV: A Public-Private Partnership to Speed COVID-19 Therapies and Vaccines
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-759-L04-P; CME 1.00; IACET 1.00; RN 1.00

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership brings together senior leaders from the Foundation for the National Institutes of Health (FNIH), NIH, FDA, BARDA, CDC, EMA, and the pharmaceutical industry to advance vaccines and therapies for COVID-19. The goal for the ACTIV partnership is to develop a framework to prioritize vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates. In this session, representatives from the NIH, BARDA, EMA, FDA, and industry will provide an overview of the activities that are being undertaken by the ACTIV partnership.

Learning Objectives

Describe how government and industry are collaborating to develop an international strategy for a coordinated research response to the COVID-19 pandemic; Discuss how a collaborative framework will prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes, and/or leverage assets.

Chair

Robin M. Weinick, PhD

Speaker

FDA Update
Peter W. Marks, MD, PhD

Industry Update
Thomas Hudson, MD

FNIH Update
David Wholley, MA



Speakers
avatar for Thomas Hudson

Thomas Hudson

Senior Vice President, Research and Development, and Chief Scientific Officer, AbbVie
Thomas Hudson leads the company’s R&D organization and a global team of scientists who work across therapeutic areas to identify potential new treatments for a variety of diseases. Dr. Hudson leads R&D strategy for the company as well as providing leadership for the many scientific... Read More →
avatar for Robin Weinick

Robin Weinick

Senior Vice President and Managing Director, Americas and Global Program Officer, DIA Global
Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also... Read More →
DW

David Wholley

Senior Vice President of Research Partnerships, Foundation for National Institutes of Health (FNIH)
David Wholley manages the Research Partnerships Division of the Foundation, which is responsible for major research collaborations including the Accelerating Medicines Partnership (AMP), the Biomarkers Consortium, the LungMAP precision medicine trial in lung cancer, and the Alzheimer’s... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session
  • Featured Topics COVID 19 - Pandemic
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:45am EDT

#217 SL-IT: ArisGlobal Innovation Theater: The Evolving Role of CTMS in Risk Management
Component Type: Session

Explore how the CTMS footprint is evolving with the advent of a quality by design approach to clinical operations. As great risk management is a truly cross-functional exercise, how are innovative organizations leveraging more of their CTMS to plan and manage studies? What role can rule based processing and AI technologies play in reducing alert fatigue for your teams experiencing data overload?

Chair

Sondra Pepe


Speakers
avatar for Sondra Pepe

Sondra Pepe

Sr. Director, Head of Clinical Product Management, ArisGlobal
Sondra Pepe is an experienced consultant to sponsors in planning the financial aspects of clinical trials through almost 9 years at Medidata. She also presents at industry conferences with special attention to investigative site needs and behavior.


Tuesday June 16, 2020 10:45am - 11:30am EDT
TBD Virtual Event Horsham, PA 19044

10:45am EDT

#218 SL-IT: Veeva Innovation Theater: The Next Big Step Toward a Collaborative Clinical Ecosystem
Component Type: Session

The ability to exchange trial information easily is one of the greatest areas of opportunity for improving how sponsors, CROs, and sites work together. Yet efforts to do so have been stymied by legacy systems, processes, and business models that limit data sharing and collaboration. Join us to learn how Veeva is addressing the collaboration challenge by making it easier for study partners to work together across the full trial lifecycle.

Chair

Jason Methia, MSc

Speaker

Panelist
Rachel Sheppard, MBA

Panelist
Garrick Myers



Speakers
avatar for Garrick Myers

Garrick Myers

Director, Technology and Operations Innovation, Vertex Pharmaceuticals
Garrick Myers is currently a Director of Technology and Operations Innovation at Vertex Pharmaceuticals, supporting its Global Clinical Operations function. He has over 15 years of experience designing, developing and deploying life sciences technology and business process solutions... Read More →
avatar for Rachel Sheppard

Rachel Sheppard

Clinical Regulatory Director, Clinical Trials Unit (CTU), University of Louisville
Rachel obtained her Master’s degree in Business Administration from the University of Louisville, and holds certifications as a certified clinical research coordinator, and a certified clinical research associate through ACRP. She is currently the Clinical and Regulatory Director... Read More →
avatar for Jason Methia

Jason Methia

VP, Vault Site Connect and eTMF, Veeva Systems
Jason is responsible for Veeva’s site engagement strategy. Prior to joining Veeva in 2013, Jason held a variety of roles within clinical development at the Dana Farber Cancer Institute, Wyeth Research and Vertex Pharmaceuticals. Jason received his M.S. in drug development and regulatory... Read More →


Tuesday June 16, 2020 10:45am - 11:30am EDT
TBD Virtual Event Horsham, PA 19044

10:45am EDT

#219 SL-IT: Google Innovation Theater: Next Generation Biomedical and Clinical Research Platform with Google Cloud and Deloitte
Component Type: Session

Life Science and research organizations are seeing an explosion of scientific data and seek a solution that can effectively store and efficiently analyze data for meaningful insights. In this session hear from leaders across Google Cloud and Deloitte and learn how they are solving these challenges together with a next-generation solution managing compute and storage in the cloud to enable collaborative biomedical research.

Chair

Shweta Maniar

Speaker

Panelist
Dina Mikdadi, MPA



Speakers
avatar for Shweta Maniar

Shweta Maniar

Life Science and Medical Device Strategy Lead, Google Cloud
Shweta is the strategy and market leader responsible for Healthcare and Life Sciences. Shweta has quickly risen through the ranks as a well-known innovator, game-changer, and relationship ambassador. With 18+ years’ experience in clinical research, Healthcare and Bio Tech, she has... Read More →
avatar for Dina Mikdadi

Dina Mikdadi

Data Scientist, Deloitte
Dina Mikdadi is a Data Scientist with Deloitte Consulting LLP. She focuses on clinical and biomedical research informatics, data integration, analytics, and program management in life sciences and healthcare. Her keen attention to detail and in-depth understanding of data structures... Read More →


Tuesday June 16, 2020 10:45am - 11:30am EDT
TBD Virtual Event Horsham, PA 19044

10:45am EDT

#216 L-RT: Round Table Discussion: Patient-Centricity: How Do We Measure Progress in Involving Patients in Drug Development and Drug Safety?
Component Type: Forum

Join DIA Patient Engagement Community for a round table discussion tied to session #201 L: Patient-Centricity: How do we Measure Progress in Involving Patients in Drug Development and Drug Safety? (Tuesday, June 16, 8:00AM - 9:00AM). Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message that the meeting has been locked by the host. To include special guests from the session: Mariette Boerstoel-Streefland, Robyn Bent, Katherine Capperella, Elisabeth Oehrlein.

Chair

Mary Murray, MBA, MPH


Speakers
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →


Tuesday June 16, 2020 10:45am - 11:15pm EDT
TBD Virtual Event Horsham, PA 19044

11:30am EDT

#220 L: Disruptive Transformation in Safety Organizations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-651-L04-P; CME 1.00; IACET 1.00; RN 1.00

Pharmacovigilance (PV) transformation is top-of-mind for safety leaders. Internal and external stakeholders demand fresh thinking regarding operating models and capabilities for PV organizations. Forward-thinking leaders are pulling on multiple strategic levers, from bringing in new ways of thinking to acquiring a different type of talent to implementing game-changing technologies. The pharma companies that will be the most competitive in the future are the ones that are able to quickly transform.

Learning Objectives

Discuss how to transform their PV organizations into more strategic and elevated operating models; Describe how to adapt agile methods and approaches to the safety-critical, compliance-driven environment of healthcare;Identify how to apply the agile approach to areas other than software development.

Chair

William Gregory, PhD

Speaker

Workload! What Can We Pull Out of Our Pharmacovigilance Toolkit to Spell Success in 2030?
William Gregory, PhD

The Secret Ingredients to Reinventing Drug Safety Organizations
Kemi Yusuf, MBA, PMP

Agility and Safety: Are They Compatible?
Alan M. Hochberg



Speakers
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Kemi Yusuf

Kemi Yusuf

Head, International PV Strategy and Office of the Product Safety Team, AbbVie, Inc.
Kemi Yusuf leads International Pharmacovigilance (PV) Strategy and Office of the Product Safety Team within AbbVie. She has over 15 years of experience in developing and implementing global transformational strategies to elevate business performance, expand capabilities, strengthen... Read More →
avatar for Alan Hochberg

Alan Hochberg

Scientific Enablement Leader, F. Hoffmann- La Roche
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →


Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

11:30am EDT

#221 L: Non-Traditional Clinical Trials Require a Non-Traditional Workforce
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-615-L04-P; CME 1.00; IACET 1.00; RN 1.00

Decentralized clinical trials offer many advantages compared to traditional clinical research, including faster patient recruitment, improved patient retention, and more. These “non-traditional” clinical trials leverage new and emerging technologies

Learning Objectives

Define decentralized clinical trials and recognize related technologies/processes; Identify core competency requirements of clinical research professionals; Explain emerging competencies required for decentralized clinical trial execution; Discuss how to apply core competency requirements and emerging competencies in workforce development planning.

Chair

James Kremidas

Speaker

Moderator
Kenneth A. Getz, MBA

Workforce Perspectives from CRO
Sy Pretorius, MD, MBA, MS, MSc

Workforce Perspectives from Sites and Tech Suppliers
Mark Steven Hanley



Speakers
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is currently the Executive Director of the Association of Clinical Research Professional (ACRP). Earlier in his career he developed the patient enrollment team at Eli Lilly where he worked for 24 years. Most recently he spent for 6 years at a global CROs. He is on the... Read More →
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Sy Pretorius

Sy Pretorius

Executive Vice President, Chief Medical & Scientific Officer, Parexel
y Pretorius is the CMO & CSO at PAREXEL. As a member of the executive team, he is responsible for the overall leadership of several service lines & business units. Sy is passionate about drug development and leads several company-wide initiatives focused on clinical trial and drug... Read More →
avatar for Mark Hanley

Mark Hanley

Chief Executive Officer, VirTrial
Mark Hanley is a visionary in the healthcare industry who has dedicated his career to improving the quality of care across multiple disciplines. As CEO of VirTrial, a ground-breaking telehealth platform provider, Hanley is currently focused on driving responsible and measured innovation... Read More →


Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

11:30am EDT

#222 L: Patient-Centricity: How Do We Talk to and Listen to Patients?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-532-L04-P; CME 1.00; IACET 1.00; RN 1.00

As patient engagement with their own health increases, they continue to seek information from pharmaceutical companies concerning their medications. The amount and depth of information that should be provided to patients are different than the information for a healthcare provider. This workshop aims to provide an overview of the creation and provision of patient standard response documents and the writing skills necessary to craft a patient-focused document. The focus will center on the basics of writing for patients at an appropriate reading level, which is critical for the creation of useful material, and helpful resources. Participants will work in small groups to create a short summation of clinical information that is appropriate for patients and present their summaries for shared learning with the entire group. Aggregating the content of patient interactions from across the center can provide medical information leaders with direction on which patient questions should be prioritized for standard responses. The contact quality monitoring process can be an effective way to gather and synthesize information. This session will provide a case study on how one organization is using artificial intelligence (AI) tools to generate accurate insights with greater efficiency and employee satisfaction.

Learning Objectives

Identify information to be communicated to patients in a patient-facing standard response document; Create a summary of clinical information using patient-friendly language; Illustrate how artificial intelligence (AI) is renovating the value of quality monitoring in the contact center; Recognize pitfalls to avoid and simple AI tools to be used to increase the value of QM; Illustrate examples of how combining human and automated monitoring can be used to unlock the value of your contact center.

Chair

Pete G. Guillot, MBA

Speaker

Enhancing Patient-Centric Channels: How Can We Talk to Patients?
Manahil Malik, PharmD

Listening to Customers: Using Human-in-the-Loop AI for Contact Center QM
Pete G. Guillot, MBA



Speakers
avatar for Pete Guillot

Pete Guillot

President, Centerfirst
Pete Guillot is the president and founder of Centerfirst. Pete started Centerfirst in 2004 with the mission of helping pharma leaders make better decisions with insights derived from their contact centers. Centerfirst has worked with 11 of the top 20 bio-pharma companies and is a... Read More →
MM

Manahil Malik

Medical Information, Associate Director, Pfizer Inc
Manahil Malik completed her PharmD from Midwestern University, Chicago College of Pharmacy in 2016 and successfully completed a Medical Information Fellowship at Shire Pharmaceuticals in Oncology and Hematology. Currently, she is an Associate Director with Pfizer Oncology Medical... Read More →


Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session |   05: Patient Engagement, Session

11:30am EDT

#223 L: Next Generation Analytics: Harnessing the Power of Nonclinical SEND Datasets to Improve Success in Early Clinical Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-663-L04-P; CME 1.00; IACET 1.00; RN 1.00

The nonclinical SEND data standard represents a tremendous opportunity to enable large-scale data analytic approaches for nonclinical data, but further harmonization of SEND compliant data is necessary. The panel discussion will discuss both the opportunity represented by SEND, the further harmonization needed to realize this opportunity, and potential solutions to address the current gaps in data harmonization.

Learning Objectives

Recognize the opportunity that SEND compliant datasets represent to enable the implementation of large-scale, robust analytic approaches to assess pre-clinical data; Identify the current challenges of performing cross-study analysis using SEND compliant nonclinical data; Discuss solutions that will address the challenges with cross-study analysis to enable large-scale analytics.

Chair

Todd Page, PhD

Speaker

Novel Opportunities and Technical Challenges Utilizing SEND Compliant Nonclinical Data
Kevin Snyder, PhD

Cross-Study Analysis: Lessons Learnied From Collaboration
Todd Page, PhD

Panelist
Susan DeHaven, MSc

Panelist
Debra Oetzman



Speakers
TP

Todd Page

Director, Toxicology, Eli Lilly and Company
Dr. Page received a doctorate degree in pharmacology from the University of Nebraska Medical Center. He then completed a postdoctoral fellowship at the University of Wisconsin-Madison studying immunotoxicology. He is currently a Director of Toxicology at Eli Lilly and Company. In... Read More →
avatar for Susan DeHaven

Susan DeHaven

Director, Data Standards and Business Applications, Sanofi
DO

Debra Oetzman

Senior Information Scientist, Data Standards Lead, Instem LSS Ltd.
avatar for Kevin Snyder

Kevin Snyder

Pharmacologist, CDER/OND, FDA


Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Forum

11:30am EDT

#224 SL: Sponsor and Regulator Challenges, Risks, and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-644-L04-P; CME 1.00; IACET 1.00; RN 1.00

As required by ICH E6(R2) and by regulators such as the FDA and MHRA, sponsors retain the ultimate responsibility for activities that are outsourced to vendors providing services critical to the successful outcome of a clinical study. Sponsors delegating study activities to a vendor or a vendor’s vendor should take measures to pre-identify risks and ensure the vendor and any subcontractors are consistently delivering products or services of acceptable quality. This and more will be presented in this session, including communication pathways between clinical teams and the quality teams, and types of plans for management of risks by clinical teams. Some of the challenges of managing CROs/other vendors will be discussed such as how vendors are evaluated – per study or across a program area and regional challenges. Who does the initial assessment of the vendor (the operational group or QA?). Risk-based approaches to vendor quality management will be presented that includes how the vendors can be risk assessed and audited, along with how the vendor risk assessment information flows to the assessor completing the tool. Lastly, examples of the type of documentation expected by the FDA and MHRA to demonstrate oversight of vendors will be presented.

Learning Objectives

Explain how to perform a risk-based vendor assessment including how to pre-identify risks; Identify the different types of plans for managing risks to ensure that there is a communication pathway and recommendations to mitigate risks; Describe the documentation requirements by the FDA and MHRA to demonstrate oversight of vendors and any regional differences that may need to be considered; Discuss how to use the risk assessment data collection tools available to evaluate vendors.

Chair

Sherri Ann Hubby

Speaker

Sponsor Challenges, Risks and Mitigation Strategies for in Assessing Vendors for Clinical Trials
Sherri Ann Hubby

Demonstrating Sponsor Oversight: Regulatory Perspectives
Gail Francis

FDA Perspective
Cheryl Grandinetti, PharmD



Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Sherri Hubby

Sherri Hubby

Director, Vendor Compliance, Gilead Sciences
Sherri A. Hubby has over 20 years of Global Quality Assurance management, auditing and training experience with emphasis in the GCP and GMP area for vendors, and sites including inspection hosting experience for the (CRO)/Pharmaceutical/Biotech/Medical Device and IRB industry. In... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →


Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum |   02: ClinTrials -ClinOps, Forum |   07: ProjMgt-StrategicPlanning, Forum

11:30am EDT

#225 L: Accelerated Approval and Emerging Surrogate Endpoints
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-566-L04-P; CME 1.00; IACET 1.00; RN 1.00

Accelerated drug approval pathways may allow investigational cancer drugs to be approved early by demonstrating a favorable benefit-risk profile based on a surrogate endpoint (e.g., progression-free survival) that is expected to predict a real clinical benefit (e.g., overall survival). Typically, once a drug is approved under this pathway, it must undergo postapproval confirmatory studies to evaluate the actual clinical benefit . As oncology therapies become more effective and targeted, clinical trials are becoming more difficult to enroll and conduct. Traditional endpoints like overall survival become untenable due to the availability of patients to participate in the study and the amount of time needed to demonstrate a statistically significant difference. Extended development times delay the ability to get new and innovative therapies to patients, and, at the pace of new molecule development, risk making effective therapies obsolete before they ever get approved. Surrogate endpoints are important, even critical, tools in improving how cancer drugs are developed and evaluated. This session will focus on the successes and challenges of various accelerated approval mechanisms and discuss the regulatory and clinical challenges of new and innovative surrogate endpoints that may soon be used to provide patients with early access to new and innovative therapies.

Learning Objectives

Describe successes and challenges of various accelerated approval mechanisms; Discuss regulatory and clinical challenges of new and innovative surrogate endpoints.

Chair

Julie Lepin, MA

Speaker

FDA Update
Patricia Keegan, MD

Health Canada Update
Kelly Robinson, MSc

EMA Update
Falk Ehmann, MD, PhD, MS

Academic Update
C. Ola Landgren, MD, PhD



Speakers
avatar for Kelly Robinson

Kelly Robinson

Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada
Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly is the Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics in the Biologics and Genetic Therapies... Read More →
avatar for C. Ola Landgren

C. Ola Landgren

Professor of Medicine and Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center
Dr Ola Landgren has designed studies to define biological mechanisms of transformation from myeloma precursor disease to myeloma. He has developed (1) early interventional clinical trials for patients with high-risk smoldering myeloma to delay/prevent transformation; (2) modern intervention... Read More →
avatar for Julie Lepin

Julie Lepin

Vice President, Regulatory Affairs Oncology, Amgen
Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →
avatar for Falk Ehmann

Falk Ehmann

Chair of Innovation Task Force, European Medicines Agency
Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and expertise in European and International law. He is currently chairing the EMA’s Innovation Task Force (ITF). His main areas of expertise include Pharmacogenomics, Nanomedicines and Borderline and Combined Medicinal... Read More →
PK

Patricia Keegan

Associate Director for Medical Policy, Oncology Center for Excellence, FDA
Dr. Keegan is a medical oncologist and served as a Clinical Assistant Professor in Medical Oncology at the University of North Carolina - Chapel Hill, prior to joining FDA. For many years, she was a Division Director in the Center for Biologics Evaluation and Research (CBER) and Center... Read More →


Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

12:30pm EDT

#609 NL: Networking Lounge: Real World Evidence
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Real World Evidence
  • Tags Session

12:30pm EDT

#610 NL: Networking Lounge: COVID-19
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics COVID 19 - Pandemic
  • Tags Session

12:30pm EDT

#611 NL: Networking Lounge: Patient Focused
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Patient Focused
  • Tags Session

12:30pm EDT

#612 NL: Networking Lounge: Emerging Professionals and Students
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Student Programming
  • Tags Session

12:30pm EDT

#613 NL: Networking Lounge: Digital Technology and Artifical Intelligence
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Digital Technology
  • Tags Session

12:30pm EDT

#614 NL: Networking Lounge: Advanced Therapies
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Advanced Therapeutics
  • Tags Session

12:30pm EDT

#615 NL: Networking Lounge: Data Science
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Data Science
  • Tags Session

12:30pm EDT

#616 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Tuesday June 16, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Innovative Trial Design
  • Tags Session

12:45pm EDT

#226 SL-IT: Intersystems Innovation Theater: Investing in Real-Time, Real World Data to Accelerate Clinical Trials and Enhance Market Access
Component Type: Session

With only 15% of trials meeting recruitment goals, pharma and pharma investors want a better return. The panel will discuss an approach to rapid site selection, cohort identification, and patient recruitment, leveraging comprehensive, longitudinal patient health records updated in real time. Drawing on a set of use cases, the team will explore ways to accelerate clinical trials and enhance market access.

Chair

Don Woodlock

Speaker

Panelist
Matthew Stannard

Panelist
Qi Li, MD

Panelist
Alex MacLeod



Speakers
avatar for Qi Li

Qi Li

Physician Executive, InterSystems
Qi Li, MD, MBA is in charge of product innovation for the InterSystems HealthShare health informatics platform. In this role, Dr. Li shapes the global product direction to meet provider organizations’ needs around high performance, patient safety, quality improvement, and cost control... Read More →
avatar for Alex MacLeod

Alex MacLeod

Manager, HealthShare Commercial Initiatives, InterSystems
Alex MacLeod joined InterSystems in January 2001 while working towards her Masters’ Degree in Information Systems. Based at the company’s headquarters Alex is a dual citizen of Germany and the US. During her career with InterSystems, Alex has worked in roles within Implementation... Read More →
avatar for Matthew Stannard

Matthew Stannard

Entrepreneur-in-Residence at Yale University;, Angel Investor Forum of CT
Matthew is a drug and device development professional with more than twenty years of multinational experience spanning the many facets of discovery, development and patient access. He began his career in the laboratory, moving to patient-focused clinical development, and then leadership... Read More →
avatar for Don Woodlock

Don Woodlock

Vice President, HealthShare Business Unit, InterSystems
Don Woodlock joined InterSystems in 2017 to oversee HealthShare, our comprehensive family of products created to empower the transformation of health and care through comprehensive, shared health information. Woodlock is responsible for advancing the HealthShare vision to meet the... Read More →
avatar for Matthew Stannard

Matthew Stannard

Investor, Angel Investor Forum of CT
Matthew is a drug and device development professional with more than twenty years of multinational experience spanning the many facets of discovery, development and patient access. He began his career in the laboratory, moving to patient-focused clinical development, and then leadership... Read More →


Tuesday June 16, 2020 12:45pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

12:45pm EDT

#228 SL-IT: Bioclinica Innovation Theater: Rescuing Clinical Adjudication Studies - Special Considerations When Transitioning From an Under-Performing Adjudication Provider
Component Type: Session

Have you ever considered switching adjudication providers mid-trial? This presentation will use case studies to illustrate how to rescue your study and make the provider transition successful. Topics covered will include setting expectations, project manager location, data transfer, efficiency, regional regulatory requirements, payments, and hospital requirements.

Chair

Janine M. Jones, BSN, MBA, RN


Speakers
avatar for Janine Jones

Janine Jones

Senior Product Manager, BioClinica
Janine Jones, a registered nurse by training, works as a Clinical Solutions Specialist at Bioclinica. There she performs product demonstrations, is a subject matter expert in endpoint adjudication, and serves on the adjudication services team. She brings her adjudication expertise... Read More →


Tuesday June 16, 2020 12:45pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

1:15pm EDT

#229 L-RT: Round Table Discussion: RIM Working Group Update
Component Type: Forum

The DIA RIM Working Group has been leading a number of initiatives within the regulatory affairs community including a) development of the RIM White Paper b) development of a RIM Reference Model and c) Artificial Intelligence related topics and their impact on Regulatory. The first version of the White Paper was released in Jan 2019 and it is currently undergoing updates. Also, the RIM Reference Model workstream has shared the RIM process maps and strawman RIM reference model at the recently concluded RSIDM 2020 with significant participation from the industry including sponsors, product vendors and systems integrators/consulting companies. The extended team has been meeting to further develop the Reference Model. The goal is to publish Version 1.0 of the RIM Reference Model by Summer 2020. Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message that the meeting has been locked by the host.

Chair

Venkatraman Balasubramanian, PhD, MBA


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

Senior Vice President, Life Sciences, Orion Business Innovation
V. “Bala” Balasubramanian is Senior Vice President for Life Sciences at Orion, a global digital transformation products, solutions and services company. With over 3 decades of IT experience, Bala is a thought leader on digital transformation of Life Sciences. Prior to Orion, Bala... Read More →


Tuesday June 16, 2020 1:15pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044

1:30pm EDT

#230 SL-CH: Staying Connected in a Virtual World: Communications Stakeholder Engagement That Drive Results
Component Type: Workshop
Level: Basic

In today’s workplace, it is increasingly common to interact with a population of stakeholders from diverse locations, cultures, backgrounds, organizations, and populations. The inability to clearly communicate with a diverse group of stakeholders directly results in missed business opportunities including but not limited to revenue growth, employee turnover, and corporate reputation. In this session, we will focus on the methods in which participants can learn about ways to craft cross-functional, cross-cultural, global communications that break through the noise and get the attention and results that are needed to drive business.

Learning Objectives

Recognize the day-to-day challenges that are faced in a global, virtual work atmosphere; Identify the impact to their personal and organizational goals; Demonstrate impactful, cost-effective methods to elevate your communications and stakeholder engagement.

Chair

Brian Egan, MA


Speakers
avatar for Brian Egan

Brian Egan

Engagement Manager, TransCelerate BioPharma Inc.


Tuesday June 16, 2020 1:30pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044

1:40pm EDT

#230.2 SL-IT: ConvergeHEALTH by Deloitte Innovation Theater: The Future of Clinical Trials is Now- How Can Digital Transformation Enable More Seamless Recruitment, Increase Patient Engagement, and Improve Adherence and Outcomes?
Component Type: Session

There is a growing body of evidence showing the value of decentralized trials that share real time data between patients and investigators. Decentralized trials which utilize mobile apps and the use of connected medical devices can positively transform the patient experience leading to better recruitment and improved study retention. The use of behavioral insights, by means of nudges and reminders can improve protocol adherence while real time data sharing can better inform decision-making.

Chair

Dawn Anderson, BSN

Speaker

Panelist
Ryan Hoffmeister



Speakers
avatar for Dawn Anderson

Dawn Anderson

Managing Director, Deloitte
Dawn is a Managing Director in Deloitte’s Life Sciences practice, and a leader in Deloitte’s Clinical practice. She has more than 30 years of industry experience in Global Pharma and CROs in Clinical Development & Operations with an emphasis on Clinical Transformation and Digital... Read More →
avatar for Ryan Hoffmeister

Ryan Hoffmeister

Managing Director, Deloitte
Ryan is the Chief Operating Officer for the ConvergeHEALTH business unit and leads portfolio strategy for Life Sciences. In this role, he focuses on creating improved customer experiences and patient outcomes by leveraging data across the commercial ecosystem to gain insights into... Read More →


Tuesday June 16, 2020 1:40pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044

2:00pm EDT

#233 L: Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-632-L04-P; CME 1.00; IACET 1.00; RN 1.00

Evaluation of risk evaluation and mitigation strategies programs in the US or additional risk minimization measures (aRMM) in the EU is required by regulatory bodies in their respective jurisdictions, though the approach, timing, requirements, and available guidance varies. Due to regulatory and cultural differences in global risk minimization practices, successful evaluation of risk minimization programs can be challenging. This forum will share views from varying stakeholder perspectives in the US and Europe for consideration in regulatory discussion, design, and implementation of these programs. Special consideration for practical implementation across different geographic regions in light of a pandemic to meet different regulatory requirements will be discussed. Practical challenges to evaluation implementation (e.g. identification of target population, controlling for selection bias, design options for process and outcome measures and cultural adaptation and consideration—will be discussed. Areas of benefit-risk management and communication will include: Rigorous approaches for evaluation, and practical considerations for planning for evaluation of risk minimization tools Presenters will share examples from their experiences for consideration in the planning, design, and implementation of evaluation of risk minimization programs, with focus on global implementation.

Learning Objectives

Identify at least three design considerations for evaluation of risk minimization programs that should not be compromised despite challenges to resource and logistics; Recognize at least two practical considerations in design of evaluation of a global risk minimization program in light of a pandemic.

Chair

Alicia Gilsenan, PhD, MS, RPh

Speaker

Considerations for REMS Evaluation from US Regulatory Perspective
Cynthia LaCivita, PharmD

Special Considerations for Evaluation of Additional Risk Minimization Measures: European Perspective
Annalisa Rubino, DrSc, PhD, MSc

Practical Considerations for Global Evaluation of REMS and aRMM from Industry Perspective
Meredith Smith, DrPH, PhD, MPA



Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Senior Director and Head, Epidemiology, RTI Health Solutions
Alicia Gilsenan, PhD, is Senior Director and Head, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI... Read More →
avatar for Meredith Smith

Meredith Smith

Director, Risk Management, Global Drug Safety, Research and Development, Alexion Pharmaceuticals, Inc.
Meredith Smith is Risk Management Director at Alexion, Inc. where she leads a team responsible for medicinal product benefit-risk management. She is a behavioral scientist and health services researcher by training with a professional background in public health and academic medicine... Read More →
AR

Annalisa Rubino

Director of Epidemiology, AstraZeneca
Annalisa Rubino is a Director Epidemiology at AstraZeneca, with extensive experience in the strategic and scientific planning, conduct and critical appraisal of complex epidemiological studies to evaluate safety, effectiveness and value of medicines in various therapeutic areas. Her... Read More →
avatar for Cynthia LaCivita

Cynthia LaCivita

Director, Division of Risk Management, OSE, CDER, FDA
Cynthia LaCivita earned her undergraduate degree in microbiology and Doctor of Pharmacy from the University of Maryland (U of MD) and completed an oncology residency at the University of Maryland Cancer Center (UMCC). She was an assistant professor in the Department of Pharmacy Practice... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

2:00pm EDT

#234 SL: Practical Solutions for Designing and Conducting a Digital Health Trial
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-654-L04-P; CME 1.00; IACET 1.00; RN 1.00

This workshop will use a mock digital trial to walk attendees through considerations, solutions, and best practices for incorporating mobile technologies into a clinical trial.

Learning Objectives

Illustrate how to appropriately use mobile technologies in a clinical trial; Discuss how to apply resources that are available to help with patient-focused endpoint development, device selection, preparing a site, participant experience, and conducting a decentralized trial.

Chair

Greg Licholai

Speaker

Facilitator
Karen L. Erickson

Facilitator
Robert DiCicco, PharmD

Facilitator
Lindsay Stiles Kehoe, MS



Speakers
avatar for Greg Licholai

Greg Licholai

Chief Medical Information Officer, PRA Health Sciences
Greg teaches at Yale School of Management, is Co-Director of the Center for Digital Health, and contributes to Forbes. He is Chief Medical and Information Officer at PRA Health Sciences. Previously, he was President of the rare disease venture at Moderna Therapeutics; President and... Read More →
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →
avatar for Lindsay Kehoe

Lindsay Kehoe

Project Manager, Clinical Trials Transformation Initiative (CTTI)
Lindsay Kehoe is a project manager at the Clinical Trials Transformation Initiative (CTTI), currently managing the implementation of CTTI's Mobile Clinical Trials Program. Prior to joining CTTI, she coordinated genetic and rare disease clinical trials at Children’s National Medical... Read More →
avatar for Karen Erickson

Karen Erickson

CTTI Steering Committee Member, Patient Advocate
I am an impatient patient. The drive to create innovative solutions for patients with rare disease is the origin of my work in the biotech industry and of my employment and voluntary positions in rare disease advocacy. My experience in the biotechnology arena as a performance consultant... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Workshop

2:00pm EDT

#235 SL: Examining Diversity in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-717-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will focus on the application of data driven approaches to identify sites in locations of greater diversity as well as targeted patient recruitment and engagement tactics meant to support enrollment of minority patients. Several case studies leveraging these approaches will be shared. Join the DIA Patient Engagement Community for a follow up round table discussion (session #242 L-RT) on Tuesday, June 16, 3:15PM - 4:00PM.

Learning Objectives

Describe how quantitative approaches applied early in the trial planning process can ultimately support minority patient enrollment; Discuss minority patient perspectives as they relate to clinical participation and how these perspectives are considered in targeted patient engagement and recruitment efforts; Identify practical applications of both quantitative and qualitative approaches in recently conducted trials.

Chair

Nicole Turner, MBA

Speaker

Promoting Diversity in Clinical Trials: Quantitative and Qualitative Approaches
Nicole Turner, MBA

Understanding the Needs of Diverse and Minority Populations
Jasmine Elizabeth Benger



Speakers
JB

Jasmine Benger

Research Services Senior Project Manager, CISCRP
Jasmine Benger is the Research Services Senior Project Manager at CISCRP. She is responsible for supporting the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards... Read More →
avatar for Nicole Turner

Nicole Turner

Global Feasibility TA Head, Immunology, Janssen
Nicole is passionate about leveraging data science and advance analytics in the pursuit of optimizing trial strategy and delivery. Nicole has worked in the feasibility space for over 13 years, leading teams at 3 of the top 10 clinical research organizations before joining Janssen... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session

2:00pm EDT

#236 L: FDA Data Standards Update
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-637-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will have speakers from both CBER and CDER present on: CBER CDER Data Standards Program Overview, Identification of Medicinal Products, SEND for CBER, and biocompute objects related to SARS CoV-2 (COVID 19).

Learning Objectives

Explain the FDA data standards program; Outline some of the key data standards projects at FDA; Define biocompute objects related to SARS CoV-2.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

CBER-CDER Data Standards Program Overview
Ray Wang, MBA, MS

SEND @ CBER
Wei (Lisa) Lin, MBA, PMP

Identification of Medicinal Products
Ta-Jen Chen, MS

BioCompute Objects and One Related to SARS CoV-2
Mark O. Walderhaug, PhD



Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Wei (Lisa) Lin

Wei (Lisa) Lin

Study Data Standards Manager, Office of Director, CBER, FDA
Lisa Lin has worked as a Study Data Standards manager at FDA CBER for over a year. Currently she is responsible for all study data standards projects in CBER, including data validation, evaluation and testing of SEND standard for CBER, data analysis tool training and support. Before... Read More →
avatar for Ta-Jen Chen

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ray Wang

Ray Wang

Data Standards Program Lead, OSP, CDER, FDA
Ray Wang, MS, MBA leads the Data Standards Team within CDER’s Office of Strategic Programs. He is responsible for managing CDER’s Data Standards Program portfolio that covers a spectrum of projects that include Study Data, Product Quality Data, Postmarket Data standards development... Read More →
MW

Mark Walderhaug

Associate Director for Risk Assessment, OBE, CBER, FDA
Mark Walderhaug is an interdisciplinary scientist in FDA's Center for Biologics Evaluation and Research (CBER). He works in the Office of Biostatistics and Epidemiology where he is the Associate Office Director for Risk Assessment. He is currently working on incorporating the computational... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum |   09: Regulatory, Forum

2:00pm EDT

#237 L: Patient Voice and Its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-702-L04-P; CME 1.00; IACET 1.00; RN 1.00

Patients are playing an increasing role in drug development. This session discusses on one area where this true -- in understanding clinical meaningfulness and selection and development of clinical outcome measures.

Learning Objectives

Develop endpoints that capture individuals' most burdensome aspect of the disease; Identify the role of the patient voice in endpoint selection and assessment.

Chair

Alexander Varond, JD

Speaker

FDA Perspective
Patroula Smpokou, MD

Industry Perspective
Alison Skrinar, PhD, MPH

Patient Perspective
James E. Valentine, JD, MHS



Speakers
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →
AS

Alison Skrinar

Vice President, Clinical Outcomes Research and Evaluation, Ultragenyx Pharmaceutical
avatar for Patroula Smpokou

Patroula Smpokou

Deputy Director, Office of New Drugs, CDER, FDA
Patroula Smpokou, MD, currently serves as an acting deputy director in the Division of Rare Diseases and Medical Genetics at FDA’s Center for Drug Evaluation and Research where she is involved in the scientific review and regulation of products intended for rare genetic diseases... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session

2:00pm EDT

#238 SL: Utilizing Cloud-Based Platforms in Regulatory Contexts
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-584-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will review the vision for transitioning to a cloud-based platform for regulatory submissions, include examples of using cloud-based platforms in drug regulation, explore additional focused use-cases, and frame questions to help solicit input from industries that have also successfully applied or benefited from cloud platforms. Importantly, these learnings should be in the context of designing an end-to-end cloud-based information network that would facilitate data exchange, analysis, and drug review on a global-scale.

Learning Objectives

Recognize applications of cloud-platforms in regulatory processes; Identify principles and steps towards effective use of cloud systems.

Chair

Andrew Robertson, JD, PhD

Speaker

FDA Update
Mary Ann Slack

Industry Update
Mark Bach, MD, PhD



Speakers
avatar for Andrew Robertson

Andrew Robertson

Global Head of Strategy, and Business Transformation, Digital and Data Sciences, Sanofi
Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

2:00pm EDT

#239 L: The FDA Complex Innovative Trial Design Pilot Program: Case Examples
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-650-L04-P; CME 1.00; IACET 1.00; RN 1.00

A goal of the FDA Complex Innovative Trial Design Pilot Program is to facilitate the use of complex adaptive, Bayesian and other novel designs. This forum will present case examples from the Pilot Program and discuss FDA and industry interactions.

Learning Objectives

Describe examples of innovative clinical trials in the regulatory setting; Discuss regulatory and industry statistical interactions as a part of the CID Pilot Program

Chair

Dionne Price, PhD

Speaker

Design and Statistical Considerations of a Proposed Master Protocol
JonDavid Sparks, PhD

Exploring Innovative Aspects of a Bayesian Adaptive Trial in Duchenne Muscular Dystrophy
Stephen Lake, DrSc

An Overview of Innovative Designs and Statistical Considerations:Lessons Learned
Laura Lee Johnson, PhD

General Considerations of Complex Innovative Trial Designs
John Scott, PhD, MA



Speakers
avatar for Dionne Price

Dionne Price

Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price promotes collaborative efforts to advance the use of complex innovative trial... Read More →
LL

Laura Lee Johnson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Stephen Lake

Stephen Lake

Vice President, Biometrics, Wave Life Sciences
Steve has 17 years of experience as a statistician in drug development. He is currently the Vice President of Biometrics at Wave Life Sciences. Prior to that he worked at Clementia Pharmaceuticals and for 14 years at Genzyme and Sanofi. He holds a Doctor of Science degrees in biostatistics... Read More →
avatar for John Scott

John Scott

Director, Division of Biostatistics, OBE, CBER, FDA
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored... Read More →
avatar for JonDavid Sparks

JonDavid Sparks

Principal Research Scientist, Eli Lilly and Company
JonDavid received his PhD in Biostatistics from the University of Iowa. He has been at Eli Lilly and Company for 10 years and has primarily worked in the areas of neuroscience, chronic pain, and Alzheimer's disease. He serves as a consultant across the neuroscience therapeutic area... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum

3:15pm EDT

#241 SL-CH: A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World
Component Type: Workshop
Level: Intermediate

Given the current regulatory landscape, we will focus on what each organization should consider using a risk-based approach to be inspection ready, specifically regarding audit trail review and compliance with data integrity.

Learning Objectives

Define GCP for data quality and data integrity specific to audit trail generation and review. Describe the current regulatory framework for organizational data governance, data integrity, audit trail review and inspection readiness within this framework.

Chair

Paula Horowitz


Speakers
avatar for Paula Horowitz

Paula Horowitz

Program Manager, QA, GCP Software Validation, AbbVie
Paula Horowitz is a Quality, Project and Data Management professional with 25+ years experience in Biopharmaceutical, CRO and academic environments. Currently, at AbbVie, Ms. Horowitz is a Program Manager, Software Validation within the QA organization. She provides QA risk-based... Read More →


Tuesday June 16, 2020 3:15pm - 3:45pm EDT
TBD Virtual Event Horsham, PA 19044

3:15pm EDT

#240 L-SB: On the Soapbox: At a Time of High Priced Medicines and a Global Pandemic - How Do We Make Medicines Accessible and Affordable to All?
Component Type: Forum
Level: Basic
CE: ACPE 0.50 Knowledge UAN: 0286-0000-20-760-L04-P; CME 0.50; IACET 0.50; RN 0.50

The Covid-19 pandemic has shed light on what the access to medicines movement has known for more than 20 years - the profit-driven models used to research and develop medicines have led to a system that has failed almost everyone, everywhere. People all over the globe from all backgrounds, ethnicities, levels of status and wealth have been impacted, and will continue to be. Alternative needs-driven, people-centered models already exist and the role of public funds and universities is critical to their success. We are living in a unique global moment with a common enemy that we will need to face - strongly and together in solidarity - or we will inevitably experience further pandemics in our lifetimes, including the greater challenge of facing a pandemic in the form of antimicrobial resistance. All of us are vulnerable, although unequally. More urgently than ever the global need for collaboration and solidarity is being felt by people who had never before paid attention to these issues. Almost everyone, everywhere is waiting for drugs and vaccines that can change lives, history and the current narrative. And an urgent question needs to be answered: who will eventually get access to them and in what order?

Learning Objectives

Discuss ways the current biomedical R&D model we use to make medicines has failed people; Describe the critical role public funds and universities play in the development of life-saving medicines, vaccines etc; Identify what alternative models already exist and what action can be taken and what campaigns, actions and opportunities exist.

Chair

Merith Basey, MSc


Speakers
avatar for Merith Basey

Merith Basey

Executive Director, North America, Universities Allied For Essential Medicines (UAEM)
Merith's commitment to health equity began during the years leading AYUDA, focused on growing youth-led programs for type 1 diabetes communities across Latin America and the Caribbean. After a Master’s degree at the London School of Hygiene and Tropical Medicine and disheartened... Read More →


Tuesday June 16, 2020 3:15pm - 3:45pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Forum
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

3:15pm EDT

#244 SL-IT: Veeva Innovation Theater: It's Time to Rethink Your EDC
Component Type: Session

Innovations in Veeva Vault CDMS will change your expectations for an EDC. You know what a legacy EDC looks like–an online folder of CRFs. The EDC in Vault CDMS is different. For CRAs, it looks like a dynamic to-do list that only displays the work to be done. For medical monitors, it looks like a case management system for assessing clinical data issues and events. Join us to walk through common scenarios during study conduct and see how work becomes easier when using Vault EDC.

Chair

Drew Garty


Speakers
avatar for Drew Garty

Drew Garty

Chief Technology Officer, Vault CDMS, Veeva Systems
Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations, and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious... Read More →


Tuesday June 16, 2020 3:15pm - 3:45pm EDT
TBD Virtual Event Horsham, PA 19044

3:15pm EDT

#245 SL-IT: Parexel and Microsoft Innovation Theater: #KeepingPatientsFirst - An Integrated Research Platform for COVID-19
Component Type: Session

Built by Parexel in collaboration with industry experts and powered by Microsoft, #KeepingPatientsFirst is an integrated research platform with real-world evidence on the natural history of COVID-19 and the various treatments for the disease. The platform accelerates the development of new randomized controlled trials (RCTs) by allowing sponsors to access to real-world evidence, a network of patients and investigators, and provides ongoing reports to participating patients and physicians.

Chair

Peyton R Howell

Speaker

Panelist
Peyton R Howell

Panelist
Ulo Palm, MD, PhD, MBA

Panelist
Patty Obermaier

Parexel and Microsoft Innovation Theater: #KeepingPatientsFirst - An Integrated Research Platform for COVID-19
Gavin Nichols, MBA



Speakers
avatar for Peyton Howell

Peyton Howell

Executive Vice President, Chief Commercial & Strategy Officer, Parexel
Peyton has 25+ years of leadership experience in the healthcare industry, successfully delivering solutions to meet the needs of customers. Prior to joining Parexel, she held leadership positions with AmerisourceBergen, most recently as Executive Vice President and President, Health... Read More →
avatar for Gavin Nichols

Gavin Nichols

Executive Vice President, Parexel Informatics
Gavin brings more than 25 years of experience delivering technology solutions to meet the evolving demands of the pharmaceutical and healthcare sectors. Prior to joining Parexel, Mr. Nichols served as Chief Information Officer and Executive Vice President of Technology at BioClinica... Read More →
avatar for Patty Obermaier

Patty Obermaier

Vice President, US Health and Life Sciences, Microsoft
Patty serves as Microsoft's Vice President for the US Health & Life Sciences Organization. This $3 billion business covers the entire Health and Life Sciences ecosystem, extending across partnerships that drive innovation in this sector. In this capacity, Patty is accountable for... Read More →
avatar for Ulo Palm

Ulo Palm

Co-Founder, The APANDEMIC Initiative
Ulo is the current co-founder of The APANDEMIC Initiative and former Senior VP of Digital Sciences, Allergan. His personal vision is to expedite and improve drug development by linking top medical science to performance excellence and 21st century technology. Especially modern Digital... Read More →


Tuesday June 16, 2020 3:15pm - 3:45pm EDT
TBD Virtual Event Horsham, PA 19044

3:15pm EDT

#242 L-RT: Round Table Discussion: Examining Diversity in Clinical Trials
Component Type: Forum
Level: Intermediate

Join DIA Patient Engagement Community for a round table discussion tied to session #235 SL: Examining Diversity in Clinical Trials (Tuesday, June 16, 2:00PM - 3:00PM). Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message that the meeting has been locked by the host. To include special guests from the session: Jasmine Elizabeth Benger, Nicole Turner.

Chair

Mary Murray, MBA, MPH


Speakers
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →


Tuesday June 16, 2020 3:15pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044

4:00pm EDT

#246 SL: FDA Pre-Market Safety Assessment Program
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-633-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session describes CDER initiatives to bring consistency and improve quality of pre-market safety assessments.

Learning Objectives

Describe various new drug review modernization initiatives related to pre-market safety assessment happening at CDER; Discuss the reasons for the change and their impacts on pre-market safety assessment.

Chair

Vaishali Popat, MD, MPH

Speaker

The FDA Medical Queries Project: This Will Significantly Change How We Do our Safety Signal Detection
Scott Proestel, MD

The Standard Tables and Figures Visualization Project
Preeti Venkataraman, MD

Data Integrity Project
Vaishali Popat, MD, MPH

Planning for Key Risks That are Undertaken Prior to Confirmatory Trial Initiation
Mat Soukup, PhD



Speakers
avatar for Vaishali Popat

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →
avatar for Scott Proestel

Scott Proestel

Senior Medical Officer, Biomedical Informatics and Reg Review Science, OND, CDER, FDA
Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →
MS

Mat Soukup

Deputy Director, Division of Biometrics VII, OB, OTS CDER, FDA
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →
avatar for Preeti Venkataraman

Preeti Venkataraman

Physician, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Preeti Venkataraman is a pediatrician by training and completed her medical degree from Northeast Ohio Medical University. She joined FDA/CDER in January 2014, as first a clinical reviewer and then a Team Leader for Safety within the Division of Gastroenterology and Inborn Errors... Read More →


Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

4:00pm EDT

#247 SL: Engaging Caregivers in Research and Medical Product Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-680-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will address ways for caregivers and care partners to participate as partners to inform R&D activities, including how their roles may be distinct from those of the patients whom they care for. The panel will draw on experiences – including professional experience and lived experience as caregivers – that span the various roles of caregivers in pediatric and adult settings. Panelists will explore ways in which the caregiver’s role can have a direct and positive influence in research activities, including their ability to influence patient participation and engagement in research activities. You’ll leave the session with a new understanding about the large and largely untapped reservoir of information that family caregivers and care partners can contribute to your program and ways to help them prepare for deeper engagement and more meaningful contributions to the research enterprise.

Learning Objectives

Recognize the unique and distinctive roles for caregivers in the setting of patient-centered research and patient-focused drug development; Identify opportunities to leverage caregivers’ unique insights and ways in which early engagement can benefit clinical development programs/projects; Assess hidden challenges that may exist in the patient/caregiver/healthcare provider dynamic that can impact projects and learn strategies to overcome challenges and build more inclusive programs.

Chair

K. Kimberly McCleary

Speaker

Perception Versus Reality: What Are the Training Needs of Patients and Their Care Partners in Healthcare Innovation?
Sarah Krug, MS

Tools for Your Pediatric Clinical Research Engagement Toolkit
Lindsay Singler, MPH



Speakers
avatar for Sarah Krug

Sarah Krug

Chief Executive Officer, CANCER101
Sarah Krüg is the CEO of CANCER101, a patient advocacy organization whose mission is to help patients and caregivers navigate the cancer journey and partner with their healthcare team to make informed decisions. Sarah is also Founder of the Health Collaboratory, a global innovation... Read More →
avatar for K. Kimberly McCleary

K. Kimberly McCleary

Founder and Chief Executive Officer, The Kith Collective, LLC
Kim McCleary has been at the forefront of patient engagement for nearly 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. Kim has authored scores of publications... Read More →
avatar for Lindsay Singler

Lindsay Singler

Associate Director, Research Communications and Engagement, Duke Clinical Research Institute
Lindsay Singler, MPH, has more than a decade of experience in patient engagement from her time at Quintiles (now IQVIA) and the Duke Clinical Research Institute (DCRI). She recently authored a paper “Models of Engagement: Patients as Partners in Clinical Research” for Applied... Read More →


Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum

4:00pm EDT

#248 L: Incorporating the Patient Perspective in a Drug Development Program
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-664-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166OL3FCG; RN 1.00

This session will discuss the value of identification and incorporation of patient needs into the drug development/project management plans, including data gathering and modeling for registration clinical studies. Examples of listening and coaching skills to obtain patient insights and how those have been integrated into development/clinical programs will be shared.

Learning Objectives

Describe why incorporation of patient needs is essential to drug development programs; Discuss examples of patient insights and how those insights have been integrated into drug development plans; Identify how patient needs extends beyond the development program and into the product communication strategy to patients, physicians, and payer

Chair

Mark Kryah, PMP

Speaker

Why Gathering Patient Perspectives is Critical in Drug Development
Kim Ribeiro, MS, MT

Incorporating the Patient Perspective in a Drug Development Program
Nathan Kreischer, MS, PMP



Speakers
avatar for Mark Kryah

Mark Kryah

Senior Advisor/COO, Bio-Medicines Business Unit, Eli Lilly and Company
Mark Kryah is COO/Senior Advisor in Eli Lilly’s Bio-Medicines Business Unit, leading Phase 3 development in Immunology. He has been leading global development projects for 20+ years, with extensive international and partnership experience. Mark has been involved with DIA for over... Read More →
avatar for Kim Ribeiro

Kim Ribeiro

Therapeutic Area Lead, Patient Centric Clinical Development, AbbVie, Inc.
Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategic recruitment and retention planning, digital outreach and raising clinical trial awareness in underrepresented populations... Read More →
avatar for Nathan Kreischer

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc
Nathan is a Director within Global Project & Alliance Management at Merck. He has over 13 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →


Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Session

4:00pm EDT

#249 L: Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-690-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session discusses the work of the Drug Information Association - American Statistical Association Aggregate Safety Assessment Plan (ASAP) and Benefit Risk Assessment Planning (BRAP) task forces. The ASAP promotes a systematic approach to safety planning and evaluation via collaboration of statisticians, epidemiologists, clinicians and other functional experts. The BRAP task force is working to improve collaboration and communications between disciplines within an organization and with regulatory agencies regarding benefit-risk assessments.

Learning Objectives

Describe a model of multidisciplinary collaboration for program-level safety assessment and benefit-risk planning; Cite key aspects of safety planning to consider at various product lifecycle stages including determining reference event rates; Recognize the benefits of proactive safety planning and ongoing aggregate safety evaluations; Discuss ways to enhance communication and collaboration between disciplines and with regulatory agencies regarding benefit-risk assessments.

Chair

Barbara A. Hendrickson, MD

Speaker

Aggregate Safety Assessment in Ongoing Studies
Greg Ball, PhD

Survey of Benefit Risk Assessment Planning Practices
Michael Wright Colopy, PhD, MPH

Role of Epidemiology in Aggregate Safety Assessments
Susan Colilla, PhD, MPH

Benefit-Risk Assessment Planning
Lisa R Rodriguez, PhD



Speakers
avatar for Barbara Hendrickson

Barbara Hendrickson

Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc.
Dr. Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety. She is a physician with subspecialty training in pediatrics and infectious diseases and has over 15 years of pharmaceutical industry experience. In addition, Dr. Hendrickson participates... Read More →
avatar for Greg Ball

Greg Ball

Senior Principal Biostatistician, Merck & Co., Inc
After graduating from Northwestern University with a bachelor’s in economics, Greg served in the Navy for 4 years and taught high school math and physics for 5 years, before going back to school to get a master’s in applied statistics from Purdue University. Eventually, while... Read More →
avatar for Michael Colopy

Michael Colopy

Safety Statistics and Decision Scientist, UCB Biosciences
Mike Wright Colopy, MPH, PhD is a statistical safety scientist at UCB Biosciences in Research Triangle Park, USA. His focus is on Benefit-Risk Assessment, Patient Preference Elicitation, Safety / Benefit-Risk Estimands and Visualization. Mike is an active member of the ASA Safety... Read More →
avatar for Susan Colilla

Susan Colilla

Director and Lead, Epidemiology and RWE, Teva Pharmaceuticals
Susan is currently at Teva Pharmaceuticals leading an Epidemiology & RWE team within its GHEOR Department supporting Clinical Development, Medical Affairs and PV groups. She currently covers Respiratory and Pain/Psychiatric therapy areas at Teva. Prior to that she was at CSL Behring... Read More →
avatar for Lisa Rodriguez

Lisa Rodriguez

Math Statistician, FDA
Dr. Lisa R. Rodriguez is a Team Leader in the Division of Biometrics V, supporting Division of Oncology Products 2. She obtained her Ph.D. degree in Statistics from Cornell University in 2005 and recently obtained a Strategic Decision and Risk Management Certificate from Stanford... Read More →


Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session

4:00pm EDT

#250 L: Projecting a Voice of Confidence in a World of Uncertainty
Component Type: Session
Level: Basic

Much of the world may have come to a stop, but you still have projects that need to move forward. With people working from home and added safety measures for those who are in-person, what worked before isn’t working now. Online meetings allow us to connect in ways that were not possible just a few years ago, but they require a different way of thinking and communicating. You can’t just walk across the hall to brainstorm ideas with a colleague, and it feels strange delivering a presentation or update to a computer screen instead of a room full of people. The communication styles that worked well a few months ago are not as effective in our current climate. The good news is that it doesn’t require a huge shift to adjust the way you interact so you can keep making progress. Join us to learn the most effective communication strategies to use in uncertain times, how the sound of your voice and the words you choose can impact the quality of your online interactions, and the importance of collaborations and celebrations to keep morale high all the way to the finish line.

Learning Objectives

Discuss how to set the tone and utilize the most effective communication style during uncertain times; Exercise specific emotional intelligence principles to keep participants and attendees engaged and productive; Identify how to use the best vocal and verbal strategies to deliver important information more clearly and effectively online; Describe how to incorporate online collaborations and celebrations to keep morale high.

Chair

Lisa Scott, MA


Speakers
avatar for Lisa Scott

Lisa Scott

Founder, Chief Executive Officer, Accentuate
As a nationally-certified speech pathologist and founder and CEO of Accentuate Communication, Lisa Scott has over 30 years’ experience in helping people develop excellent speech and language skills. She specializes in working with companies in the STEM fields, helping their experts... Read More →


Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Session
 
Wednesday, June 17
 

8:00am EDT

#301 SL: Combining Multiple Real World Data Sources to Maximize Value
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-697-L04-P; CME 1.00; IACET 1.00; RN 1.00

No single RWD vendor has perfect and complete data. It is often necessary to partner with many vendors, creating data integration risks as different vendors use different methodologies. This forum will discuss approaches to overcome these challenges.

Learning Objectives

Evaluate best practices for comparing and contrasting multiple data sources; Discuss methods for consolidating and harmonizing data from multiple data sources to maximize the value of using real world data in clinical trial synthetic control arms.

Chair

C.K. Wang, DrMed, MD

Speaker

Combining Multiple Real World Data Sources to Maximize Value
Jeremy A Rassen, DrSc, MS

Combining Multiple Real World Data Sources to Maximize Value
Jennifer Christian, PharmD, PhD, MPH, FISPE

Combining Multiple Real World Data Sources to Maximize Value
Kim Van Naarden Braun, PhD, MPH



Speakers
KV

Kim Van Naarden Braun

Associate Director, Translational Epidemiology, Informatics and Predictive Scien, Bristol-Myers Squibb Company
Dr. Kim Van Naarden Braun is an epidemiologist and the Associate Director of Translational Epidemiology within Informatics and Predictive Sciences at Bristol Myers Squibb. Her work with Real World Data spans 25 years and multiple private and public health care sectors including federal... Read More →
avatar for Jennifer Christian

Jennifer Christian

Vice President, Clinical Evidence and Epidemiology, IQVIA
Jennifer Christian is Vice President of Clinical Evidence & Epidemiology at IQVIA, an adjunct faculty member at Weill Cornell Medical College, and a Fellow of the Institute of Medicine. At IQVIA, her research focuses on strengthening clinical effectiveness and safety evaluations of... Read More →
avatar for Jeremy Rassen

Jeremy Rassen

President and Chief Science Officer, Aetion
Jeremy A. Rassen, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory... Read More →
CW

C.K. Wang

Chief Medical Officer, COTA Healthcare
Dr. C.K. Wang is a medical oncologist who worked in private practice in the Dallas/Fort Worth area from 2006 to 2017. During that time he held multiple management and leadership positions including managing physician with Dallas Oncology Consultants, P.A., Director of Oncology with... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum

8:00am EDT

#302 L: Seamlessly Evolving Global Clinical Trial Liaison Field Medical Resources to Classic MSLs from Phase 3 to Launch
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-620-L04-P; CME 1.00; IACET 1.00; RN 1.00

Panel experts share case studies and best practices to seamlessly evolve Clinical Trial Liaisons (CTLs) into classic MSL roles, efficiently leveraging company resources in support of global product launches. Variable workforce models to be discussed.

Learning Objectives

Discuss how emerging biopharmaceutical companies seamlessly evolve their global Clinical Trial Liaisons (CTLs) into classic Medical Science Liaisons, from Phase 3 to the launch phase; Discuss best practices for deploying these global CTL teams, specifically highlighting workforce models utilized and the hiring, training, management and data documentation systems utilized.

Chair

Beth Price

Speaker

Seamlessly Evolving Global Clinical Trial Liaison Resources to Classic MSLs from Early Phase to Launch
Lisa M. Burke, BSN, PhD, MBA, RN

Site Engagement is a Team Sport
Kate Bradford, PhD



Speakers
avatar for Beth Price

Beth Price

Vice President, The Medical Affairs Company
Beth Price is VP, BD at TMAC. She is an accomplished sr. executive and strategic team leader with a demonstrated 28-yr history of working in the biopharmaceutical industry. Beth leads TMAC's BD efforts ensuring that all clients receive the strategic, innovative and flexible medical... Read More →
LB

Lisa Burke

Senior Director, Field Medical, Rhythm
Lisa is Sr. Director, Field Medical at Rhythm Pharmaceuticals leading the global Medical Science Liaison teams in both the US and EU. She is an accomplished leader with a 30-year career in the biopharmaceutical industry. She has worked in various leadership roles primarily focused... Read More →
KB

Kate Bradford

Head of International Field Based Medicine, Arena Pharmaceuticals
Kate graduated with a 2i BSc (Hons) in Biochemistry and a Phd in Pharmacology from the University of Southampton, UK. She spent her early career working as a headhunter and directing operations for a financial recuitment consultancy before joining the life sciences industry. Her 19... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session

8:00am EDT

#303 SL: Detection of Anomalies in eCOA Data and Metadata for More Pre-Emptive, Evidence-Based Risk Management
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-582-L04-P; CME 1.00; IACET 1.00; RN 1.00

The purpose of this forum is to explore how anomalies can be detected in eCOA data and metadata with a view to implementing improved risk-based approaches to the monitoring of clinical trials and to share experiences.

Learning Objectives

Describe the utility of eCOA data and metadata in safeguarding data quality; Identify different risk-based approaches to monitoring clinical trials.

Chair

Jill V Platko, PhD

Speaker

Panelist
Willie Muehlhausen, DVM

Panelist
Ian O'Shaughnessy



Speakers
avatar for Jill Platko

Jill Platko

Senior Scientific Advisor, Signant Health
At Signant Health, Dr. Jill Platko provides scientific guidance in both the presales process and for projects. This includes the review of clinical trial protocols, to determine ePRO data collection design. Her role is to ensure that Signant’s technology meets the scientific requirements... Read More →
avatar for Willie Muehlhausen

Willie Muehlhausen

Managing Director, Willie Muehlhausen Ltd
Willie Muehlhausen started his career as a Veterinary Surgeon in Berlin, Germany, before he joined PAREXEL in March 1998. Throughout his career he worked in Germany, UK, USA and Ireland for leading organizations and developed a keen interest in patient-facing technologies such as... Read More →
avatar for Ian O'Shaughnessy

Ian O'Shaughnessy

Director, Business Development, Global Biometrics, ICON plc
Ian joined ICON in 2002 and served in roles of increasing responsibility in Biometrics, including leading regional Data Management organizations in Europe, China, Japan and Australia. Since 2013, Ian has worked in Risk Based Monitoring and Data Analytics, developing ICON’s methodology... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum |   03: Data-Data Standards, Forum

8:00am EDT

#304 L: Strategic Directions from Global Medicines Regulators: The ICMRA Statement on Combatting Antimicrobial Resistance
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-586-L04-P; CME 1.00; IACET 1.00; RN 1.00

The ICMRA recognizes that antimicrobial resistance (AMR) is a complex, global and multi-faceted problem which poses unique challenges and is committing, in collaboration with WHO, to coordinate regulators efforts around the globe for the fight against AMR.

Learning Objectives

Analyze the challenges faced by global regulators for development, commercialization and viability of products that tackle antimicrobial resistance (AMR) and formulate solutions; Recognize the role of the International Coalition of Medicines Regulatory Authorities (ICMRA) in providing strategic directions and coordination to global medicines regulators.

Chair

Agnès Saint-Raymond, DrMed

Speaker

Health Canada Update
Pierre Sabourin, MBA

Panelist
Guido Rasi, MD

Panelist
John Farley, MD, MPH

Panelist
Sini Eskola, MPharm, MSc



Speakers
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →
avatar for Sini Eskola

Sini Eskola

Director Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked... Read More →
JF

John Farley

Deputy Director, Office of Antimicrobial Products, OND, CDER, FDA
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Pierre Sabourin

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

8:00am EDT

#304.1 L: ICH 30th Anniversary: Achievements and Future Prospects
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-563-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will celebrate the key successes of the ICH Association in recognition of its 30th anniversary highlighting how the Association has evolved to respond to the increasingly global market and new advances in pharmaceutical development.

Learning Objectives

Identify key accomplishments of the ICH Association since it was founded in 1990; Discuss how ICH guidelines have contributed to more efficient drug development and increased patient access to pharmaceuticals worldwide; Explain how the reforms completed in 2015 have expanded the global reach of ICH and increased participation from regulators and industry around the world.

Chair

Amanda Marie Roache, MS

Speaker

MHLW/PMDA Perspective
Nobumasa Nakashima, PhD

European Commission Perspective
Lenita Lindström-Gommers, LLM

FDA Perspective
Theresa Mullin, PhD

IGBA Perspective
Nicholas Cappuccino, PhD

Panelist
Peter K. Honig, MD, MPH, FACP

Panelist
Celia Lourenco, PhD



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
NC

Nicholas Cappuccino

Consultant, Compliance, Quality and Scientific Affairs, Dr. Reddy's Laboratories
Dr. Cappuccino is currently a Consultant for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH... Read More →
avatar for Celia Lourenco

Celia Lourenco

Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada
Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

ICH Assembly Chair and Senior Expert, European Commission, European Commission
Lenita Lindström-Gommers is a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is responsible for international relations in the field of pharmaceuticals. Her main work relates to ICH where she was closely involved... Read More →
PH

Peter Honig

Senior Vice President Global Regulatory Affairs and Group Head Development China, Pfizer Inc
Dr. Honig received his baccalaureate, medical and public health degrees from Columbia University in New York. He has postgraduate training and is board-certified in internal medicine, clinical pharmacology and has held senior leadership positions at US Food and Drug administration... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Programs, CDER, FDA
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum

8:00am EDT

#306 L: Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-589-L04-P; CME 1.00; IACET 1.00; RN 1.00

Describe ongoing pilot efforts by statistical and clinical reviewers at FDA to create ‘default’ estimands for different therapeutic areas. Clinical and statistical teams’ experience on estimands in pulmonary-allergy and other areas will be discussed.

Learning Objectives

Discuss the Agency’s pilot experiences and opinions on estimands in a few clinical settings from the regulatory perspective; Demonstrate the value to statisticians and clinicians for clearly understanding medical questions by defining appropriate estimands.

Chair

Yongman Kim, PhD

Speaker

Estimands and ICH E9 (R1): Adoption and Challenges - 3 Years Later
Munish Mehra, PhD, MS, MSc

Estimands Approach Taken in Analgesia and Thoughts for the Future
David M. Petullo, MSc

Why Clinicians are Interested in Estimands: How it Helps Their Reviews and What They Wish to Achieve
Rekha Jhamnani, MD

Estimands Approach Taken in Pulmonology-Allergy-Critical Care Statistics at CDER FDA
Susan Duke, MSc



Speakers
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →
avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susanis is a Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. She became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG, which lead to subsequent interests... Read More →
DP

David Petullo

Mathematical Statistician, OB, OTS, CDER, FDA
David has worked in the pharmaceutical industry for over 20 years with experience at Walter Reed, Human Genome Sciences, Eli Lilly, and FDA. He is currently working as team leader supporting Gastroenterology but worked for over 10 years supporting the Division of Analgesia, Anesthesia... Read More →
avatar for Yongman Kim

Yongman Kim

Lead Mathematical Statistician, OB, OTS, CDER, FDA
Yongman Kim is currently leading an FDA statistical team supporting pulmonary-allergy product review division for about 3 years after reviewing analgesia and rheumatology products about 14 years. Prior to joining FDA, he worked for several drug companies 7 and half years in areas... Read More →
RJ

Rekha Jhamnani

Medical Officer, DPARP, OND, CDER, FDA
Rekha Jhamnani is a medical officer in the Division of Pulmonary Allergy and Critical Care at the FDA. She completed medical school at the George Washington University School of Medicine and internal medicine residency at Georgetown University Hospital. She then completed a fellowship... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session

8:00am EDT

Professional and Student e-Posters Gallery
Professional and Student e-Posters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2020. Attendees are invited to scroll through and search e-Posters throughout the duration of virtual meeting. e-Posters run continuously during the meeting. There are no formal or LIVE e-Poster presentations during the DIA 2020 virtual meeting.

Wednesday June 17, 2020 8:00am - 5:00pm EDT
e-Poster Gallery

9:00am EDT

#307 SL-IT: Salesforce Innovation Theater: Recruit and Engage Trial Participants with a Connected Platform
Component Type: Session

Life Science companies must accelerate their clinical trial timelines to stay competitive. Ongoing patient engagement and taking patient concerns into account is the key to increasing clinical trial success rate and is linked to shortened trial times. Learn how companies are using Salesforce Health Cloud to deliver personalized patient engagement and support across clinical trials.

Chair

Jennifer L Turcotte


Speakers
avatar for Jennifer Turcotte

Jennifer Turcotte

Director, Global Life Science Industry Strategy, Salesforce
Jennifer Turcotte is Director, Global Life Science Industry Strategy at Salesforce . As part of the broader Healthcare and Life Sciences Team, Jennifer works to bring customer successes to biopharmaceutical, contract research organizations, medical device, diagnostic companies and... Read More →


Wednesday June 17, 2020 9:00am - 9:30am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#309 L: If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-634-L04-P; CME 1.00; IACET 1.00; RN 1.00

The challenge of accelerating and streamlining clinical information flow needs to be simultaneous attacked from multiple angles. Learn how a large consortium is laying the foundation for transformation and what enabling solutions are available now.

Learning Objectives

Discuss how to transform study start up from a patchwork of manual processes to a fully automated, digital environment; Identify how to map a high-level path to get to the future vision; Outline how to solicit senior management on foundational changes to make now in order to be ready for the future.

Chair

Todd Georgieff, MBA, RPh

Speaker

Case Study
Nancy Tam, MS

Case Study
Rakesh Maniar, MS



Speakers
avatar for Todd Georgieff

Todd Georgieff

Global Consortia Program Lead, Hoffmann-La Roche Limited
Todd has worked in drug development and clinical operations for 30 years, in roles ranging from global study management to CRO oversight and process development and improvement. He is currently working in Roche's PD Industry Collaborations group, and responsible to coordinate Roche's... Read More →
avatar for Rakesh Maniar

Rakesh Maniar

Global Head, Business Technology Services; Co-Lead, TransCelerate eSource Initia, Novartis Pharmaceuticals Corporation
Rakesh is a TransCelerate eSource Workstream Co-Lead and SCDM eSource Implementation Initiative Co-Chair/Co-founder. At Novartis, area of responsibilities includes technology optimization, enable adoption of new technologies & provide value added services for efficient clinical trial... Read More →
avatar for Nancy Tam

Nancy Tam

Head of Medical Writing, Pfizer Inc
Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. She has been involved with the design and implementation of automation solutions in medical writing throughout her career... Read More →


Wednesday June 17, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session

9:30am EDT

#310 L: Global Rare Disease Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-662-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA and international regulators will address unique regulatory complexities and challenges specific to orphan product development. It will provide key information and updates about programs available to expedite orphan drug development and include audience Q&A.

Learning Objectives

Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA and EMA/Health Canada programs available to expedite the development of orphan products; Recognize new regulatory initiatives and policy developments related to orphan drug review.

Chair

James E. Valentine, JD, MHS

Speaker

Panelist
Hylton Joffe, MD

Panelist
Elizabeth Hart, MD

Panelist
Janet Maynard, MD, MHS

Panelist
Kelly Robinson, MSc



Speakers
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
avatar for Janet Maynard

Janet Maynard

Director, Office of Orphan Products, OC, FDA
Dr. Janet Maynard, as the Director of the Office of Orphan Products Development (OOPD), oversees legislatively mandated designation and grant programs intended to promote the development of products for rare diseases including, orphan drug, rare pediatric disease, and humanitarian... Read More →
avatar for Elizabeth Hart

Elizabeth Hart

Branch Chief, General Medicine 1, OTAT, CBER, FDA
Dr. Elizabeth Hart is the Branch Chief of General Medicine 1 in the Office of Tissue and Advanced Therapies in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). She completed her undergraduate medical training at the University of Pennsylvania... Read More →
avatar for Kelly Robinson

Kelly Robinson

Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada
Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly is the Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics in the Biologics and Genetic Therapies... Read More →
avatar for Hylton Joffe

Hylton Joffe

Acting Director, Office of Rare Diseases, Pediatrics, URM, CDER, FDA
Dr. Hylton Joffe is the acting director of FDA's Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in CDER's Office of New Drugs. Hylton received his medical degree from the University of Arizona then completed his internal medicine residency and endocrinology... Read More →


Wednesday June 17, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum

9:30am EDT

#311 L: ICH 30th Anniversary Series: Advancing Pharmaceutical Safety
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-682-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of ICH safety topics instrumental to the harmonization of pharmaceutical development standards and an introduction to the new and revised topics that are currently underway.

Learning Objectives

Discuss the role of ICH Safety topics in harmonizing standards for more efficient pharmaceutical development and registration;Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development.

Chair

Amanda Marie Roache, MS

Speaker

Regulatory Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
John Leighton, PhD

Industry Perspective: ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Daniel M Lapadula, PhD

ICH S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
Douglas Keller, PhD

ICH E14/S7B Questions and Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential
David Strauss, MD, PhD



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
DL

Daniel Lapadula

Global Head and Vice President, Toxicology, Novartis Institutes for BioMedical Research, Inc.
New York University - Ph. D. 1981. Assistant Professor, Duke University, 1986. Schering-Plough, Principal Scientist General Toxicology 1990. Sandoz, Assistant Director Toxicology 1991; Director,1995. Exectutive Director, 2005; Global Head and Vice President of Toxicology, 2006.
avatar for Douglas Keller

Douglas Keller

Global Head for Development Projects, Preclinical Safety, Sanofi
Ph.D. in Pharmacology from Duke University. Postdoctoral Fellow at the Chemical Industry Institute of Toxicology. Staff toxicologist at DuPont Haskell Laboratory for 10 years. Joined Sanofi in 1998. Currently Global Head for Development Projects, Preclinical Safety in Sanofi.
JL

John Leighton

Director, Division of Hematology Oncology Toxicology, OOD, OND, CDER, FDA
Dr. Leighton received his PhD from the Department of Physiology and Biophysics at the University of Illinois, Urbana-Champaign. Dr. Leighton first came to FDA as a pharmacology and toxicology reviewer in the Center for Veterinary Medicine and moved to the Division of Oncology Drug... Read More →
avatar for David Strauss

David Strauss

Director, Division of Applied Regulatory Science, OCP, OTS, CDER, FDA
Dr. Strauss is a physician-scientist with experience in experimental and clinical research along with regulatory evaluation for drugs and medical devices. He currently serves as Director of FDA's Division of Applied Regulatory Science, which seeks to move new science into the FDA... Read More →


Wednesday June 17, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   01: ClinSafety-PV, Session

9:30am EDT

#312 L: Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-585-L04-P; CME 1.00; IACET 1.00; RN 1.00

An evolving regulatory framework supports and incentivizes pediatric drug development. This session compares recent experience in the US, EU, China, and Canada and explores options for advancing global approaches.

Learning Objectives

Discuss the evolving global regulatory framework for development of pediatric medicines in the US, EU, China, and Canada; Describe common challenges and opportunities faced with global planning and conduct of pediatric programs; Review case studies illustrating a global approach for development of pediatric medicines.

Chair

Max Wegner, PharmD, RPh

Speaker

Health Canada Update
Alysha Croker, PhD

FDA Update
Lynne Yao, MD

NMPA Update
Zhimin Yang, MD



Speakers
avatar for Max Wegner

Max Wegner

Head Regulatory Affairs, Bayer AG
After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →
avatar for Alysha Croker

Alysha Croker

Manager, Office of Paediatrics and Patient Involvement, Health Canada
Following her PhD in cell biology studying the molecular mechanisms of breast cancer metastasis and therapy resistance, Alysha Croker joined the Canadian Institutes of Health Research in 2013 as an analyst. Since then, she has taken on a number of leadership roles managing high profile... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →
avatar for Zhimin Yang

Zhimin Yang

Division Director, Center for Drug Evaluation, National Medical Products Administration (NMPA)


Wednesday June 17, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   12: Value-Access, Session

10:45am EDT

#313 SL-IT: UBC Innovation Theater: What You Need to Know About Assembling an Integrated Registry
Component Type: Session



Speaker

Panelist
Rachel Sobel, DrPH, MPH, FISPE



Speakers
avatar for Rachel Sobel

Rachel Sobel

Vice President, Epidemiology and Strategic Engagement, UBC


Wednesday June 17, 2020 10:45am - 11:15am EDT
TBD Virtual Event Horsham, PA 19044

10:45am EDT

#314 SL-IT: IQVIA Innovation Theater: Modernizing Regulatory Evidence with Real World Studies
Component Type: Session

Although RCTs may be the gold standard for approving new treatments, the results are not always generalizable to less idealized settings or more diverse patients. Real-world evidence (RWE) plays an important role in understanding how well a therapy works, for which patients, and under what conditions. In this session, we review the complementary nature of RCTs and RWE, discuss Friends of Cancer Research learnings, and reinforce the call for methods to guide reliable regulatory use of RWE.

Chair

Nancy A. Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Jeff Allen, PhD

Panelist
Jennifer Christian, PharmD, PhD, MPH, FISPE



Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research
Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. A thought leader on many issues related to FDA, regulatory strategy and healthcare policy, he is regularly published in... Read More →
avatar for Jennifer Christian

Jennifer Christian

Vice President, Clinical Evidence and Epidemiology, IQVIA
Jennifer Christian is Vice President of Clinical Evidence & Epidemiology at IQVIA, an adjunct faculty member at Weill Cornell Medical College, and a Fellow of the Institute of Medicine. At IQVIA, her research focuses on strengthening clinical effectiveness and safety evaluations of... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health... Read More →


Wednesday June 17, 2020 10:45am - 11:15am EDT
TBD Virtual Event Horsham, PA 19044

10:45am EDT

#315 SL-IT: Microsoft Innovation Theater: Journey to the Fully Digital Study Starts with Standards
Component Type: Session

Join Microsoft Health and Life Sciences experts for an overview of our current work and partnerships in the areas of Precision Medicine, Drug Discovery and AI, and Clinical Research Trials. Topics will also include our Clinical Research Platform, IoT, Continuous Patient Monitoring and FHIR Connector.

Chair

Ryan Tubbs, MBA

Speaker

Panelist
Peter Van Reusel



Speakers
avatar for Peter  Van Reusel

Peter Van Reusel

Chief Standards Officer, CDISC
Peter is a data standards expert with a passion for implementing practical solutions that work. He started his career in a large pharma company as a database analyst and has been working with data standards all his career. In 2008, he started the Business & Decision Life Sciences... Read More →
avatar for Ryan Tubbs

Ryan Tubbs

Co-Founder, Clinical Research Innovation Hub, Microsoft
The Clinical Research Innovation Hub is the first industry focused internal startup in Microsoft. Innovation hubs are engines that allow Microsoft to focus on pressing industry problems by combining the speed, agility and autonomy of a startup with resources available to a large enterprise... Read More →


Wednesday June 17, 2020 10:45am - 11:15am EDT
TBD Virtual Event Horsham, PA 19044

11:30am EDT

#316 SL: Report of CIOMS DILI Working Group
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-672-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the principles in the detection, characterization and risk assessment of DILI in clinical trials and post-marketing, liver safety biomarkers and DILI risk stratification, risk minimization measures and risk communication.

Learning Objectives

Describe the accurate identification, assessment, and management of DILI risk; Discuss a new initiative to tackle this problem undertaken by an international working group of industry, academic, and regulatory experts; Examine the findings by CIOMS for best practices in DILI risk assessment and& management and biomarker development in clinical trials and the post-market.

Chair

Mark I. Avigan, MD

Speaker

Introduction to the CIOMS Working Group
Mark I. Avigan, MD

Goals, Initiatives, and Context of the 2020 DILI Report
Herve Le Louet, DrMed, DrSc, MD, PhD, MS

Principles in the Detection, Characterization, and Risk Assessment of DILI in Clinical Trials
Arie Regev, MD

Steps Towards the Identification and Utilization of Liver Safety Biomarkers
Robert J. Fontana, MD

Best Practices in Postmarket DILI Risk Assessment, Risk Minimization, and Communication
Walter Straus



Speakers
avatar for Walter Straus

Walter Straus

Associate Vice President, Therapeutic Area Head, Vaccines & Infectious Disease, Merck Research Laboratories
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →
avatar for Herve Le Louet

Herve Le Louet

President, Head of PV Coordination, CIOMS and APHP
Herve Le Louet is Professor of Clinical Pharmacology. He is currently head of Pharmacovigilance department of Paris University Hospitals (AP-HP). He is an hepatologist by training and has a PhD in Pharmacogenetic from the Paris University. He is the President of CIOMS and immediate... Read More →
avatar for Arie Regev

Arie Regev

Chair, Liver and GI Safety Committee, Eli Lilly and Company
Dr. Regev heads the safety advisory hub and chairs the liver and GI safety advisory committee at Eli Lilly. He serves as co-chair of the CIOMS drug induced liver injury (DILI) working group and co-chair of the immunotherapy working group of the IQ DILI initiative. He is an associate... Read More →
avatar for Mark Avigan

Mark Avigan

Associate Director, Office of Pharmacovigilance and Epidemiology, OPE, CDER, FDA
Mark Avigan, MD, CM, is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology at the FDA. As a clinical hepatologist with expertise both in drug safety science and cellular regulation, he served as a division director in drug safety at... Read More →
RF

Robert Fontana

Professor of Medicine, University of Michigan
Dr. Fontana is a clinical investigator with research interests in drug induced liver injury, viral hepatitis and acute liver failure. Dr. Fontana completed his gastroenterology/ hepatology training and is currently a Professor of Medicine and Medical Director of Liver Transplantation... Read More →


Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

11:30am EDT

#317 L: Evolving Trials for the Digital Age
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-675-L04-P; CME 1.00; IACET 1.00; RN 1.00

Interest continues to increase in harnessing technology solutions to reduce the cost of clinical trials, accelerate and diversify patient recruitment, and streamline processes perceived as burdensome or artificial by patients and site staff. With the number of marketed digital trial solutions growing rapidly, study designers and clinical operations professionals need a better understanding of the fundamental trial processes that can benefit from digital innovations. This session identifies numerous areas in clinical study operations, from study approval through close-out, with potential impact from digital innovation. It also identifies considerations for when digital enhancements may or may not be useful, as well as which elements of clinical operations may actually interfere with digital innovation.

Learning Objectives

Describe key features of traditional clinical trials where technology may reduce the burden of study conduct, as well as limits that should be considered when implementing digital trial technology; Identify assumptions in trial operations that impede technology adoption and employ change management techniques to make trials ready for digital innovation

Chair

Vernon F Schabert, III, PhD

Speaker

Research Operations Best Practices for Site-Based EHR Studies
Vernon F Schabert, III, PhD

Harnessing Mobile Cloud Technology to Improve Clinical Trial Monitoring
MaryAnne Rizk, PhD

Telemedicine: Reducing Patient and Site Burden
Alison Holland



Speakers
avatar for MaryAnne Rizk

MaryAnne Rizk

Senior Vice President, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →
avatar for Michelle Longmire

Michelle Longmire

Co-Founder and Chief Executive Officer, Medable Inc.
Michelle Longmire MD, is Co-founder and Chief Executive Officer of Medable. Dr. Longmire is a Stanford-trained physician-entrepreneur dedicated to transforming healthcare through innovation. Dr. Longmire has a background in epigenetics, novel diagnostics, and imaging. Dr. Longmire... Read More →
avatar for Vernon Schabert

Vernon Schabert

Consultant, Epilogix
Vernon Schabert is an internationally-recognized Real-World Evidence (RWE) strategist and scientist for the life sciences industry. Dr. Schabert has led multi-country research for nearly 25 years, in 20 global markets, with companies including IQVIA, PPD, Certara, and IBM Watson... Read More →
avatar for Alison Holland

Alison Holland

Head of Decentralized Trials, Medable
Alison (Ali) Holland is Head of Decentralized and Remote trials at Medable and is chartered to design and expand the end-to-end capabilities needed to partially or fully virtualize clinical studies, building on the commitment to reduce clinical trial times by 50%. Ali has over 20... Read More →


Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session

11:30am EDT

#318 L: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-575-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data and emerging digital technologies are vital to the success of organizations in healthcare, while privacy and data protection laws regulating this space are quickly evolving. This session will provide guidance on this challenging area. Join the DIA Good Clinical Practices & Quality Assurance Community for a follow up round table discussion (session #322 L-RT) on Wednesday, June 17, 12:45PM - 1:30PM.

Learning Objectives

Discuss currently used data strategy and digital health innovations; Discuss how best to leverage such new innovations/technologies; Explain how to ensure compliance with privacy/data security laws regarding such initiatives.

Chair

Corey Dennis, JD

Speaker

Panelist
Mark Barnes, Esq, JD, LLM

Panelist
Priya M Mannan



Speakers
avatar for Corey Dennis

Corey Dennis

Lead, US Privacy Officer, Sanofi
Corey M. Dennis is Lead, US Privacy Officer, at Sanofi, a Fortune 200 global pharmaceutical company with over $35B in annual revenue and over 100,000 employees. At Sanofi, Corey is responsible for leading and maturing Sanofi’s US Privacy program in compliance with all privacy laws... Read More →
avatar for Mark Barnes

Mark Barnes

Partner, Ropes & Gray, LLP
Mark's law practice at Ropes & Gray focuses on human and animal research, stem cell and genetic research, research grants and contracts, research fraud, and international research. Mark formerly served at Harvard as the Senior Associate Provost for Research, and in 2004 started and... Read More →
PM

Priya Mannan

Executive Director, Assoc. General Counsel, Global Head of Compliance & Privacy, Novartis Institutes for BioMedical Research, Inc.
Priya is a solution based business partner and lawyer who loves to listen and move the business forward in achieving its goals. As she has primarily been a pharmaceutical and medical device lawyer, patients come first to her. She graduated law at the top of her class with a degree... Read More →


Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum

11:30am EDT

#319 L: Leading Through Complexity: Opportunities, Pitfalls, and Best Practices for Managing Successful Partnerships
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-603-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166IEIAHR; RN 1.00

Business to business, public-private, and foundation partnerships add complexity. In this session, you will learn about the pitfalls that plague these relationships and acquire project management tools to achieve alignment, deliver project success, and maximize value.

Learning Objectives

List common pitfalls and illustrate best practices to foster optimal collaboration and maximize mutual value; Discuss effective behaviors needed for successful project delivery while navigating the inherent complexities in a partnership; Outline ways to challenge your ways of thinking and better assess partnership risks; Outline different partnership perspectives from a diverse panel; Discuss overlapping skill sets critical for project and alliance managers.

Chair

Kelly M. George, PhD

Speaker

Managing Partnerships: Perspective From a Not-for-Profit
Jamie Munro, PhD

Taming Orthrus: Ensure your Alliance is the Asset’s Best Friend and not a Two Headed Monster
Anne Kathleen Radcliff, PhD

Partnership Success: Keep it Professional, but Make it Personal
Matthew A Metz, PhD, PMP



Speakers
avatar for Anne Radcliff

Anne Radcliff

Senior Director, Global Project Management, AstraZeneca
Seasoned professional experienced in pharmaceutical pipeline strategy and project management, business development, and alliance management. Collaborative and effective leader and integrator of cross-functional, matrixed teams ensuring optimal program execution. Responsible for the... Read More →
avatar for Matthew Metz

Matthew Metz

Director of Strategic Partnerships, Ossium Health
Dr. Metz has orchestrated R&D partnerships across sectors including large & small businesses, government agencies, not-for-profits, and academic institutions. The breadth of programs he has managed include: stem cell therapies (at Ossium Health), antibiotics (at Achaogen), microbial... Read More →
avatar for Kelly George

Kelly George

Consultant
Kelly George, PhD has gained a diverse R&D skillset by working in both the pharmaceutical and consumer product development sectors. Most recently, Kelly was an Associate Director, Global Project & Alliance Management at Merck, Inc. She has also held roles at L’Oréal, Roche and... Read More →
avatar for Jamie Munro

Jamie Munro

Executive Director, Centre for Innovation in Regulatory Science (CIRS)
Executive Director of CIRS (Centre for Innovation in Regulatory Science), a not-for-profit organisation whose mission is to maintain a leadership role in identifying and applying scientific principles for the purpose of advancing regulatory and HTA policies and processes


Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Session

11:30am EDT

#320 L: Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-728-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the current state and challenges of individualized cell-based therapeutics and gene therapies that will become increasingly important to address the variety of molecular defects present in serious rare diseases.

Learning Objectives

Explain the concept of individualized advanced therapy medicinal products; Outline the technical challenges (preclinical, clinical, manufacturing) involved in their development; Discuss the regulatory challenges of such products from a global perspective.

Chair

Peter W. Marks, MD, PhD

Speaker

NIH Perspective
Philip (P.J.) Brooks, PhD



Speakers
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →


Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   06: PreClin Dev-EarlyPhaseCR, Session

11:30am EDT

#321 L: Recommendations for a Strategic Response to the COVID-19 Pandemic
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-711-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will focus on an overview of strategies and recommendations – by the Duke-Margolis Center for Health Policy, faculty and researchers, and leaders from across the health care and health policy landscape – for collectively addressing the COVID-19 pandemic. Primary areas of focus include the development, scale, and distribution of diagnostics, therapeutics, track and tracing strategies, and vaccines. During this interactive discussion, Dr. McClellan will highlight national initiatives, discuss a road map for reopening and preliminary indicators of impact, and describe short-term efforts over the next six months as well as health and health care changes in the long-term.

Learning Objectives

Describe the roles of vaccines, diagnostics, track and trace practices, and therapeutics in a comprehensive approach to reducing the health and economic impact of the COVID-19 pandemic; Discuss reduction of the COVID-19 disease burden by strategic alignment of regulatory approval and access pathways, increased effectiveness and capacity of clinical trials, management of access to avoid shortages, and real-world data collection to develop evidence on outcomes.

Chair

Mark B. McClellan, MD, PhD

Speaker

Moderator
Sissi Pham, PharmD



Speakers
avatar for Mark McClellan

Mark McClellan

Director and Robert J. Margolis M.D. Professor of Business, Medicine and Policy, Duke-Margolis Center For Health Policy
Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Margolis Center for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care including payment reform, real-world... Read More →
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →


Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Forum

12:30pm EDT

#617 NL: Networking Lounge: Emerging Professionals and Students
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Student Programming
  • Tags Session

12:30pm EDT

#618 NL: Networking Lounge: Real World Evidence
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Real World Evidence
  • Tags Session

12:30pm EDT

#619 NL: Networking Lounge: COVID-19
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics COVID 19 - Pandemic
  • Tags Session

12:30pm EDT

#620 NL: Networking Lounge: Patient Focused
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Patient Focused
  • Tags Session

12:30pm EDT

#621 NL: Networking Lounge: Advanced Therapies
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Advanced Therapeutics
  • Tags Session

12:30pm EDT

#622 NL: Networking Lounge: Digital Technology and Artifical Intelligence
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Digital Technology
  • Tags Session

12:30pm EDT

#623 NL: Networking Lounge: Data Science
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Data Science
  • Tags Session

12:30pm EDT

#624 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness
Component Type: Session

Stop in to our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the ""virtual meeting room"". These lounges can accommodate up to 50 attendees and are designed for attendees to speak outloud and for cameras to be on.

Chair

Meredith Kaganovskiy


Speakers
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

Senior Project Manager, Annual Meeting, DIA


Wednesday June 17, 2020 12:30pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  21: Networking-CommunityEvents, Session
  • Featured Topics Innovative Trial Design
  • Tags Session

12:45pm EDT

#323 SL-IT: IQVIA Innovation Theater: Driving Quality Through Innovative Digital Trial Approaches in a Pandemic Era
Component Type: Session

Amid the wake of COVID-19, sites are increasingly proving to be inaccessible for patients, site staff, and/or site monitors, and regulators halt inspections, while the biopharma industry faces many new challenges to ensure patient safety. Life science stakeholders must come together to join the global effort of driving healthcare forward. This talk discusses how digitally connecting siloed people, applications, and departments create a seamless trial management experience in a virtual or hybrid trial model with eConsent, remote monitoring, and enhanced randomization.

Chair

Jennifer L Turcotte

Speaker

Panelist
MaryAnne Rizk, PhD



Speakers
avatar for MaryAnne Rizk

MaryAnne Rizk

Senior Vice President, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →
avatar for Jennifer Turcotte

Jennifer Turcotte

Director, Global Life Science Industry Strategy, Salesforce
Jennifer Turcotte is Director, Global Life Science Industry Strategy at Salesforce . As part of the broader Healthcare and Life Sciences Team, Jennifer works to bring customer successes to biopharmaceutical, contract research organizations, medical device, diagnostic companies and... Read More →


Wednesday June 17, 2020 12:45pm - 1:15pm EDT
TBD Virtual Event Horsham, PA 19044

12:45pm EDT

#324 SL-IT: JMP Innovation Theater: Adverse Events in Clinical Trials: When Doctors Require a Statistical Perspective
Component Type: Session

Medical reviewers are more sophisticated when evaluating the adverse events associated with treatment than the ICH E3 document reflected 25 years ago. A more modern approach for doctors at regulatory agencies and sponsors is to rely on statistical concepts such as relative risk, incidence rates, time to event and Bayesian statistics to make a more informed decision on the safety of patients in clinical trials. Summarizations using tables and graphs will be shared to illustrate these concepts.

Chair

Kelci Miclaus, PhD, MS

Speaker

Panelist
Geoff Mann, PhD



Speakers
avatar for Geoff Mann

Geoff Mann

JMP Product Manager, Health and Life Sciences, SAS Institute Inc., JMP Division
Geoffrey Mann is JMP Product Manager for the health & life sciences industry. In this role, he explores needs for visual & statistical discovery software in the clinical segment of the pharmaceutical & healthcare industries. After joining SAS in 2000, he helped develop software for... Read More →
avatar for Kelci Miclaus

Kelci Miclaus

Sr Manager, Advanced Analytics R&D, SAS Institute Inc., JMP Division
Dr. Kelci Miclaus is Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute where she manages the R&D team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics from North Carolina... Read More →


Wednesday June 17, 2020 12:45pm - 1:15pm EDT
TBD Virtual Event Horsham, PA 19044

12:45pm EDT

#322 L-RT: Round Table Discussion: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications
Component Type: Forum

Join DIA Good Clinical Practices & Quality Assurance Community for a round table discussion tied to session #318 L: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications (Wednesday, June 17, 11:30AM - 12:30PM). Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message that the meeting has been locked by the host. To include special guests from the session: Priya Mannan, Corey Dennis, Mark Barnes.

Chair

Terry Katz, MS


Speakers
avatar for Terry Katz

Terry Katz

Sr Dir, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →


Wednesday June 17, 2020 12:45pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044

1:15pm EDT

#325 SL-IT: Covance Innovation Theater: Tailoring Your Journey Map Using a Data Driven Approach to Accelerate Patient Recruitment and Improve Patient Retention
Component Type: Session

Patient centricity is a hot topic in 2020, but so is data driven study planning from an investigator performance and real world data perspective. Merging these elements together in the right place and time requires an orchestrated, well timed approach with multiple touch points across the study life cycle to drive maximal impact. Using our proprietary Patient Intelligence, Investigator Recruitment Performance and Real-World data sets, we will take you on a patient journey that accelerates patient

Chair

Melissa Harris

Speaker

Panelist
Earl Seltzer, MBA



Speakers
avatar for Melissa Harris

Melissa Harris

Associate Director, Global Patient Recruitment and Engagement, Covance
Melissa brings 20 years of industry experience including a tenure at a global award winning vendor agency, creating recruitment programs for all phases of studies including paediatric, rare and hard-to-reach patient populations. Melissa engages all of Covance's propriety data set... Read More →
avatar for Earl Seltzer

Earl Seltzer

Senior Director, Feasibility and Site Selection, Covance
Earl Seltzer has nearly 15 years of industry experience shared across clinical investigator sites in the United States and CROs. At Covance, Earl leads the global feasibility team as part of the larger, feasibility recruitment and engagement organization. He has spoken at a number... Read More →


Wednesday June 17, 2020 1:15pm - 1:45pm EDT
TBD Virtual Event Horsham, PA 19044

1:30pm EDT

#329 SL-CH: The New DIA Statistics and Data Science Community
Component Type: Workshop
Level: Basic

The DIA Statistics Community is embracing change. By changing our name to the Statistics and Data Science Community, we aim to broaden the pool of scientists so that collectively, we can develop and advance science faster, and tackle bigger problems.

Learning Objectives

Create awareness about the DIA Statistics and Data Science Community; Idenitfy the vision and the overall goal of the Community.

Chair

Joan Buenconsejo, PhD, MPH


Speakers
avatar for Joan Buenconsejo

Joan Buenconsejo

Senior Director, Biostatistics, AstraZeneca
Joan Buenconsejo is Senior Director, Biostatistics supporting late stage cardiovascular, renal and metabolic therapeutic areas within biopharmaceutical R&D at AstraZeneca. Prior to AZ, she was a statistics team lead at CDER, FDA. Dr. Buenconsejo is chair of the DIA Statistics Community... Read More →


Wednesday June 17, 2020 1:30pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Workshop |   16: Content Hubs, Workshop

2:00pm EDT

#330 L: Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-692-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss a validation framework that extends existing guidance, incorporates best practices from other industries and member companies, and promotes discussion of key considerations to achieve early alignment on validation requirements in advance of future guidance. The ICSR processing workflow is the use case for evaluating intelligent automation opportunities due to its logical progression of process steps, highly manual nature, high volume, and inherent quality risks of errors and operational inefficiencies.

Learning Objectives

Describe the current technology landscape in PV, particularly focusing on the ICSR process; Discuss intelligent automation opportunities within the ICSR process using an industry survey results and online ICSR process map; Identify considerations for validating intelligent automation technologies in pharmacovigilance to promote inspection readiness and inform third party development.

Chair

Neal Grabowski, MBA, MS

Speaker

Case Study
Kate Gofman, MD, PhD

Case Study
Oeystein Kjoersvik, MSc



Speakers
avatar for Kate Gofman

Kate Gofman

Safety Physician, Astrazeneca
Kate Gofman, MD, Ph.D., is currently working as a Global Patient Safety Physician at AstraZeneca. She has been with AstraZeneca for more than five years delivering global safety strategy and oversight for various compounds. Kate serves as an industry expert for automation & digital... Read More →
KG

Kate Gofman

Global Safety Physician, AstraZeneca
Kate Gofman, MD, Ph.D., is currently working as a Global Patient Safety Physician at AstraZeneca. She has been with AstraZeneca for more than five years delivering global safety strategy and oversight for various compounds. Kate serves as an industry expert for automation & digital... Read More →
NG

Neal Grabowski

Director, Pharmacovigilance & Patient Safety, AbbVie
Prior to joining AbbVie, Neal held multiple roles in Patient Safety and Clinical Operations at Amgen, Genzyme and Sanofi. He holds a MS in biomedical engineering and MBA from Pepperdine University.
avatar for Oeystein Kjoersvik

Oeystein Kjoersvik

Product Owner/Business Analyst, Merck & Co., Inc.
Oeystein Kjoersvik is currently a Product Owner/Business Analyst at MSD, functioning as a squad lead for an analytics group supporting QA through utilizing data science and other analytics tools. Oeystein also serves as a Machine Learning SME for TransCelerate's Intelligent Automation... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

2:00pm EDT

#331 L: Globalization of Medical Information
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-638-L04-P; CME 1.00; IACET 1.00; RN 1.00

This will be an innovative global session. Experts from the US will present the perspectives and challenges encountered in the process of globalization of medical information: real experience on the use of translation to generate and utilize global and local scientific content, and real experience on organizational and staffing considerations in the globalization of medical information.

Learning Objectives

Describe successes and challenges, 2) Examine and share best practices and learned lessons; Discuss useful strategies that help increase efficiency and optimization of the processes encountered in the use of translation to generate and utilize global and local scientific content, and organizational and staffing considerations in the globalization of medical information.

Chair

Debora Weiss, PharmD, MS, RPh

Speaker

Organizational Considerations in a Global Medical Information Team
Lauren Key, PharmD, MBA

Utilization of Local and Global Scientific Content Across Therapeutic Areas Through Use of Translation
Debora Weiss, PharmD, MS, RPh



Speakers
avatar for Debora Weiss

Debora Weiss

Associate Director, Global Scientific Content, Merck & Co., Inc.
Debora Weiss works in Global Scientific Content in the Vaccines & Infectious Diseases team, within Global Medical Affairs at Merck, supporting the content for pneumococcal, herpes zoster, and RSV vaccines to be used by medical information and field medical personnel. Debora serves... Read More →
avatar for Lauren Key

Lauren Key

Operations Manager, PPD
Lauren Key earned her Doctor of Pharmacy at Wingate University and her Masters of Business Administration from the University of Mount Olive. In her 12 years in the pharmaceutical industry, Lauren has experience in both direct customer care and in a dynamic medical information contact... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session

2:00pm EDT

#332 SL: Optimizing Communication with Patients to Support Meaningful Feedback into the Research Process
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-722-L04-P; CME 1.00; IACET 1.00; RN 1.00

Patient engagement is an essential component of the drug development process. Involving the patient community early on can accelerate and enhance research efforts. The process of securing input from the patient community in research is often conducted as a bidirectional process between industry sponsors and a community of people living with a common illness/disease experience. This process can be enhanced by including stakeholders with unique expertise in patient engagement and communication. These stakeholders enhance credibility and relationship building between industry and patient communities, which increases the success and quality of patient engagement, and optimizes the process of learning from patient communities. Patient advocacy organizations, patient engagement experts within a biopharmaceutical company and consulting organizations are all stakeholders that have unique expertise. In this session, examples of successful partnership with the patient community facilitated by each of these stakeholders will be discussed.

Learning Objectives

Recognize the different models of patient engagement and benefits of leveraging each to ensure early involvement of the patient community in drug development; Describe methods to encourage collaboration in therapeutic areas with multiple patient stakeholders to create and leverage a unified community voice; Identify best practices for capturing and interpreting meaningful input from special patient populations, such as people with cognitive impairment.

Chair

Karlin Schroeder, MA

Speaker

Panelist
Patricia Davies

Panelist
Fernanda D. Copeland, MS

Panelist
Madeline Corrigan, PhD



Speakers
MC

Madeline Corrigan

Senior Account Manager, SmithSolve
Madeline is an engineer by training and former clinical investigator, where she developed and evaluated an assistive exoskeleton for individuals with Duchenne muscular dystrophy (DMD). She has a unique, user-centered approach to developing new technologies, and applies the same patient-centered... Read More →
avatar for Karlin Schroeder

Karlin Schroeder

Senior Director, Community Engagement, Parkinson's Foundation
Karlin Schroeder, M.A., is the Senior Director of Community Engagement at the Parkinson’s Foundation, where she leads the Parkinson’s Advocates in Research program (PAIR). Through this program, Karlin creates and directs projects to incorporate patient expertise into research... Read More →
avatar for Patricia Davies

Patricia Davies

Reasearch Advocate, Parkinson's Foundation
Pat originates from the UK where she was Managing Director of a professional conference organizing company in London for many years. In 1991 she moved to Washington DC to head up the arrangements for the Annual Meetings of the World Bank Group & the International Monetary Fund, a... Read More →
avatar for Fernanda Copeland

Fernanda Copeland

Executive Director, Global Head of Patient Advocacy and Engagement, AVROBIO, Inc
Fernanda Copeland, MS, RD, CDE is a board-certified registered dietitian who spent the first 10 years of her career working with patients to educate and help manage medical conditions in inpatient and outpatient settings. Fernanda leads the Global Patient Advocacy & Engagement function... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044

2:00pm EDT

#333 SL: Driving Quality Through Innovative Approaches
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-726-L04-P; CME 1.00; IACET 1.00; RN 1.00

This potpourri of presentations by industry speakers will present new approaches to improve quality and compliance in clinical trials. Speakers will discuss: • How emerging digital technologies may transform industry’s approach to risk management, clinical trial oversight and auditing
• Deploying effective and efficient risk-based monitoring in clinical trials
• Challenges in identifying, classifying, tracking and analyzing protocol deviations and the toolkit developed by the Protocol Deviations Initiative to assist with protocol deviation management.

Learning Objectives

Discuss new technologies can be used to improve quality and compliance in clinical trials; Describe how risk-based monitoring impacts the conduct of clinical trials; Recognize why good protocol deviation identification, classification, tracking, and analysis methods are essential to maintaining quality in clinical trials.

Chair

Jean M. Mulinde, MD

Speaker

Modernizing R&D Quality and Compliance
Federico Feldstein, JD

Risk-Based Monitoring: An Examination of Probabilities and Rewards
MaryAnne Rizk, PhD

Solving Protocol Deviations Challenges: from Protocol Creation to CSR
Laura Galuchie



Speakers
avatar for Jean Mulinde

Jean Mulinde

Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Federico Feldstein

Federico Feldstein

Vice President, Head of R&D Quality Compliance, Johnson & Johnson
Federico Feldstein is Vice President, Head of R&D Quality & Compliance at Johnson & Johnson. Over the past 5 years, Federico has led the J&J R&D quality strategy leveraging the organizations’ strengths across the sectors (Medical Devices, Consumer, Pharmaceuticals) to enhance the... Read More →
avatar for Laura Galuchie

Laura Galuchie

Director, Global Clinical Trial Operations, Merck & Co., Inc. (MSD outside US and Canada)
Laura has a unique role which blends internal and external components. Externally, she is a member of TransCelerate BioPharma's Oversight Committee and has co-lead several workstreams. Internally, as the TransCelerate Program Lead, she has responsibility for driving engagement, and... Read More →
avatar for MaryAnne Rizk

MaryAnne Rizk

Senior Vice President, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Session

2:00pm EDT

#334 L: Best Practices for Virtual Meetings with FDA!
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-706-L04-P; CME 1.00; IACET 1.00; RN 1.00

Meetings with FDA during development are key to inform product strategies and increase probability of success. Given the recent COVID-19 pandemic, everyone has adjusted to a new 'norm' - virtual meetings. Hear from FDA and industry experts on best practices for holding a virtual meetings.

Learning Objectives

Identify the best practices for virtual PDUFA meetings; Describe how to change the way you prepare for virtual meetings.

Chair

Khyati Roberts, RPh

Speaker

Best Practices for Virtual Meetings: Industry Perspective
Todd Paporello, PharmD, MBA

FDA Update and Best Practices for Virtual Meetings
Khushboo Sharma, MBA

Best Practices for Meeting Requests and Briefing Packages
Lisa Yanoff, MD



Speakers
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas, Bayer
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD... Read More →
avatar for Khushboo Sharma

Khushboo Sharma

Deputy Director for Operations, Office of New Drugs, CDER, FDA
Khushboo Sharma is the OND Deputy Director for Operations in CDER's Office of New Drugs. In this role, Khushboo has oversight of business processes and staff providing key support for regulatory review and oversight of resource capacity planning including staffing for OND. Khushboo... Read More →
LY

Lisa Yanoff

Division Director, OND, CDER, FDA
Dr. Lisa Yanoff trained in Diabetes, Endocrinology, and Metabolism at the National Institutes of Health and joined FDA in 2008 in the Division of Metabolism and Endocrinology Products in CDER's Office of New Drugs (OND). She is currently the acting director of the Division of Diabetes... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

3:15pm EDT

#335 SL-CH: Role of Medical Communications Experts in Building Accelerated Regulatory Dossiers and Securing First-Attempt Approvals
Component Type: Workshop
Level: Advanced

This Content Hub will discuss the role of medical communications experts in driving regulatory submissions and approvals, with focus on document strategy, authoring, review, quality control, and stakeholder management for accelerated submissions.

Learning Objectives

Identify critical steps to accelerate the submission process; Formulate an effective communication strategy; Produce an effective storyboard; Complete a successful submission; Illustrate the fundamental role of a medical communications expert in delivering a successful submission.

Chair

Monica Chiaramonte, PhD


Speakers
avatar for Monica Chiaramonte

Monica Chiaramonte

Medical Communications Scientist, AstraZeneca
Monica Chiaramonte is a Principal Medical Communications Scientist at AstraZeneca, with more than 20 years’ experience in the medical and scientific field, and 13 years’ experience in Medical Writing, in both CRO and pharmaceutical setting. She has a PhD in immunology and has... Read More →


Wednesday June 17, 2020 3:15pm - 3:45pm EDT
TBD Virtual Event Horsham, PA 19044

4:00pm EDT

#338 L: Immunogenicity of Biologics: Clinical Consequences
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-693-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the clinical consequences of the immunogenicity of 1) biologics for autoimmune diseases, 2) biologics for oncology, and 3) biosimilars.

Learning Objectives

Identify the immunologic basis for adverse events caused by biologics used for autoimmune and oncology indications; Recognize and manage the clinical consequences of immunogenicity; Discuss how to study the immunogenicity of biologics and biosimilars and manage the clinical risk.

Chair

Michael Blum, MD, MPH

Speaker

Lessons Learned from Biologic Agents in Rheumatology – Immunogenicity
Vibeke Strand, MD, FACP

Monitoring and Assessment of the Impact of Immunogenicity on Clinical Safety for Oncology Biologics in Development
Dina Tresnan, DVM, PhD

Immunogenicity in the Biosimilars Space
Daniela Verthelyi, MD, PhD



Speakers
avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
avatar for Vibeke Strand

Vibeke Strand

Adjunct Professor, Stanford U School of Medicine; Biopharmaceutical Consultant, Loftis/Strand Consulting
Vibeke Strand, MD, MACR, FACP is an Adjunct Clinical Professor, Division of Immunology /Rheumatology at Stanford University and has served as a biopharmaceutical consultant since 1991. She has participated in the development of new therapies in RA, SLE, gout, PsA, SpA, vasculitis... Read More →
avatar for Dina Tresnan

Dina Tresnan

SSRM Disease Area Cluster Lead - Oncology, Pfizer Inc
Dina directs the pharmacovigilance and development, implementation, and evaluation of global risk management strategies aimed at achieving optimum benefit-risk for medicinal products throughout their lifecycle, with a particular interest in biotherapeutics, advanced medicinal therapies... Read More →
DV

Daniela Verthelyi

Chief, Laboratory of Immunology, OBP, OPQ, CDER, FDA
Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA. She currently heads the Laboratory of Innate Immunity and chairs CDER’s newly formed Center for Excellence in Infectious Diseases and Inflammation. She directs a lab focused... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

4:00pm EDT

#339 SL: The Development of Novel Digital Endpoints
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-617-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will be used to present two examples of novel digital endpoint development with live chat and Q&A discussion to follow.

Learning Objectives

Discuss the novel digital development framework through industry examples; Identify the concept of interest, the context of use, and the design of validation will be included.

Chair

Michelle Crouthamel, PhD

Speaker

Itching for Feedback: Framework for Qualifying Novel Digital Outcomes
Robert Mather, PhD

The Development of Novel Digital Endpoints
Rinol Alaj, MBA

The Development of Novel Digital Endpoints
Sara Hamon, PhD



Speakers
avatar for Michelle Crouthamel

Michelle Crouthamel

Director of Digital Health and Innovation, AbbVie, Inc.
Michelle Crouthamel is a recognized industry leader who integrates digital health in pharmaceutical development and collaborates broadly with academics, tech, consortia, and health authorities to create impact. As the Director of Digital Health & Innovation at AbbVie, Michelle leads... Read More →
avatar for Rinol Alaj

Rinol Alaj

Director, COA and Innovation, Regeneron; Representative, TransCelerate Biopharmaceuticals
Rinol’s professional focus is centered around integrated Innovation, design thinking, and clinical operation with 15 years of experience in startup and pharma industry. Savvy, results-oriented leader with proven success in transforming and building eCOA organizations from the ground... Read More →
avatar for Sara Hamon

Sara Hamon

Director, Precision Medicine Quantitative Translational Sciences, Regeneron
Sara is the head of Precision Medicine Quantitative Translational Sciences. Her group designs and performs biomarker analysis on both traditional biomarkers such a genetics and transcriptomics , and non-traditional biomarkers such as data collected from wearables and imaging. Her... Read More →
avatar for Robert Mather

Robert Mather

Executive Director, Early Clinical Development, Pfizer Inc
Joe has over twenty years of pharmaceutical research and clinical development experience. Joe joined the Digital Medicine team after tenures with both Pfizer and Astra Zeneca’s research & development organizations where he led groups focused on late stage research and early clinical... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

4:00pm EDT

#340 SL: Approaches for Cross-Functional Teams to Enhancing Quality of Decision-Making During the Development and Review of Medicines
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-683-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166IGDVAV; RN 1.00

This session illustrates how implementation of decision science and quality decision-making practices can improve transparency and accountability, minimise bias and ultimately enable better processes for cross-functional company and agency teams.

Learning Objectives

Discuss how to increase the awareness of decision science including types of biases and potential solutions for teams; Describe tools for assessing the quality of decision-making practices, ensuring their implementation and documentation; Illustrate experiences from a company and an agency on the practical application of such approaches to enhance decision transparency and accountability across teams.

Chair

Magda Bujar, PhD, MSc

Speaker

Regulatory Agency Viewpoint: Update on HPFB Regulatory Decision Guide
Marilena Bassi, MA

Pharmaceutical Company Viewpoint
Jeremy Jokinen, PhD, MS

Decision Professional Viewpoint
Carl Spetzler, PhD



Speakers
avatar for Magda Bujar

Magda Bujar

Manager, Strategic Development, Centre For Innovation In Regulatory Science (CIRS)
Dr Magda Bujar is the Manager of Strategic Development at CIRS. In her current role, she is responsible for developing and executing strategies for engaging with CIRS stakeholders - pharmaceutical companies as well as major regulatory authorities. Magda also initiates and coordinates... Read More →
avatar for Marilena Bassi

Marilena Bassi

Senior Executive Director, Therapeutic Products Directorate, Health Canada
Marilena Bassi has been with Health Canada since 2004 where she has held various policy, evaluation and performance management related positions. Currently she is the Senior Executive Director of the Therapeutic Products Directorate at Health Canada.
avatar for Jeremy Jokinen

Jeremy Jokinen

Head of Business Capabilities and Innovation, Worldwide Patient Safety, Bristol-Myers Squibb Company
Jeremy is the Head, Business Capabilities and Innovation, Worldwide Patient Safety, for Bristol-Myers Squibb. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early... Read More →
avatar for Carl Spetzler

Carl Spetzler

Chief Executive Officer, Strategic Decisions Group
Dr. Spetzler has developed creative business strategies for major financial institutions, capital-intensive companies, high-technology manufacturers, and systems businesses. Dr. Spetzler works with top management and boards of directors to improve the risk-informed decision making... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Session

4:00pm EDT

#341 L: Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-709-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data Monitoring Committee (DMC) plays a vital role in determining the direction of an ongoing clinical trial. The DMC gets ongoing views of trial data and findings before submission to any regulatory agency. The results of the interim analysis can affect crucial trial design changes, such as sampling methodology, recalculation of sample size, or early stopping decisions due to futility, safety signals, or overwhelming efficacy. Therefore, the DMC might recommend altering the trial from its original design based on issues arising during the trial. Since the DMC has a unique opportunity for first view of the unblinded data, it can assist in monitoring the progress of the trial and oversee data quality issues to ensure the trial integrity. On the other hand, central data monitoring and proper statistical process control during the trial can mitigate issues caused by data anomalies and the impact of trial misconduct, before the submission is sent for regulatory review. Familiarity with available data monitoring tools will help in accomplishing these tasks. This session will provide a platform for trial designers and analysts from industry and regulatory agencies to discuss the proper role of the DMC, in particular, how it can be utilized to address issues of data quality and detect potential misconduct.

Learning Objectives

Discuss with trial designers and analysts from industry and regulatory agencies the proper implementation of the DMC; Describe how it can be utilized to address issues of data quality and detect potential misconduct.

Chair

Anna Kettermann, MA, MS

Speaker

The Role of DMCs in Ensuring Reliable Data
Janet Turk Wittes, PhD

How to Apply Statistical Process Control to Monitor Clinical Trials Aiming to Detect Performance and Data Quality Issues
Nechama Katan, MA, MS

Panelist
Sylva Collins, PhD

Panelist
Kenneth A. Getz, MBA



Speakers
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Nechama Katan

Nechama Katan

Associate Director, RBM, Pfizer Inc
Nechama Katan, is a “Data Wizard with Personality.” Nechama has been the technical lead for the RBM team at Pfizer and is working on understanding the best ways to upskill SMEs so that they can drive Data Science Discussions. She helps organizations access and use their data to... Read More →
avatar for Janet Wittes

Janet Wittes

President, Statistics Collaborative Inc.
Janet Wittes is President of Statistics Collaborative, a company that consults on design of clinical trials. She has participated in many Data Safety Monitoring Committees for government and for industry. Her research deals with statistical monitoring of randomized trials.
avatar for Anna Kettermann

Anna Kettermann

Mathematical Statistician, OB, OTS, CDER, FDA
Anna Kettermann has 15 years of experience as a biostatistician working on interdisciplinary projects hand-in-glove with teams of physicians, medical officers, pharmacologists, and other scientists, reaching 10 years in FDA last year and 5 in CDER. Anna came to FDA following 5 years... Read More →
avatar for Sylva Collins

Sylva Collins

Director, Office of Biostatistics, OTS, CDER, FDA
Dr. Collins is the Director of the Office of Biostatistics, OTS/CDER/FDA. Prior to joining the FDA in August 2019, she has spent more than 30 years leading large global biometrics organizations and has contributed to dozens of successful regulatory submissions in multiple jurisdictions... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session

4:00pm EDT

#342 L: Drug Pricing in the United States: How and Why is it Different Than in the Rest of the World
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-671-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug Pricing in the United States continues to be a hotly debated subject. As candidates head into the US 2020 election, the topic will only garner more attention. This session will review the differences in worldwide drug pricing regulations and practices. The future landscape of drug pricing in the United States will be discussed, with a review of drug pricing proposals.

Learning Objectives

Compare US and non-US drug pricing regulations; Discuss the future landscape of US drug pricing;

Chair

Christopher Marrone, PharmD, RPh

Speaker

Global Perspective: Benchmarking Prescription Drug Price and Access Around the World
Scott Roberts, MBA

Pharmaceutical Pricing in the US Healthcare Market
Johann Odermann

Patient Affordability: Caught at the Intersection of Manufacturer and “System” Dynamics in Specialty Products
Aria Cohen, MBA



Speakers
avatar for Christopher Marrone

Christopher Marrone

Outcomes Liaison, Eli Lilly and Company
Chris received his BS in Pharmacy from Rutgers University, and his PharmD from the University of Texas at Austin. He completed a Pharmacy Practice Residency at The University of Vermont Medical Center, and a Drug Information Specialty Residency with Lilly and Purdue University. Chris... Read More →
avatar for Aria Cohen

Aria Cohen

Senior Director, US Market Access, Apellis Pharmaceuticals
Aria Cohen is the Senior Director, Payer and Channel Marketing at Apellis Pharmaceuticals. Aria is focused on developing customer engagement strategies and tactics that maximize the patient access opportunity for Apellis' products with US payers. Prior to joining Apellis, Aria was... Read More →
avatar for Johann Odermann

Johann Odermann

Principal, JustSo Marketing
Johann provides strategic insight into the payer, managed markets, and policy worlds leveraging his 30 years of biopharmaceutical experience in large and small biopharmaceutical companies as well as agencies - including the past 20 years calling on payers or developing market access... Read More →
avatar for Scott Roberts

Scott Roberts

Managing Partner, Citrus Health Group
Co-founder of CiTRUS Health Group and head of CiTRUS Market Access, Scott guides biotechs and life sciences companies in global market access & pricing strategy, reimbursement, and value evidence. He is passionate about helping clients find innovative solutions in categories where... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session

4:00pm EDT

#343 L: Mindfulness: Beyond Meditation
Component Type: Workshop
Level: Basic

There has been a surge of popularity of mindfulness, but there is still confusion about what it is and how the practice can help at work. This session will provide clarity and practical techniques that are easily applied in the workplace.

Learning Objectives

Recognize that mindfulness is more than yoga and meditation; Describe practical techniques that are easy to do in the workplace.

Chair

David Onks, MS

Speaker

Utilizing Mindfulness to Diminish Stress, Cultivate Mental Clarity, and Bring a Positive, Focused Approach to Your Work
Gina Calarco, BSN, MPH



Speakers
avatar for Gina Calarco

Gina Calarco

Director of Pediatric Strategy and Planning, Covance
Gina Calarco is Director of Operational Strategy and Planning for the Rare Disease and Pediatric Team at Covance. She is a nurse and received her MPH from the University of Kansas. She is an affiliate member of the American Academy of Pediatrics Section on Advances in Therapeutics... Read More →
avatar for David Onks

David Onks

Founder and Chief Executive Officer, Sparked Professional Coaching
Founder and CEO of Sparked, LLC, an Executive and Leadership Coaching practice based in Raleigh, NC that helps people who are experiencing or desire a pivot point in their career. His global leadership experiences over 23 years of change in GlaxoSmithkline enable an empathetic yet... Read More →


Wednesday June 17, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
 
Thursday, June 18
 

8:00am EDT

#401 L: Digital Risk Minimization: How Can We Advance Adoption?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-694-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will examine current challenges to the use of digital approaches to risk minimization, and explore opportunities for overcoming them to facilitate their wider adoption. Challenges and opportunities will be assessed from the perspectives of 1) regulators, including representatives from both the US and the European regulatory authorities; 2) industry sponsors at the global headquarters who plan the risk minimization strategy; and, 3) local safety officers who are responsible for coordinating the implementation of the risk minimization measures, typically in conjunction with healthcare professionals at the local country level.

Learning Objectives

Describe the state of the art in terms of the use of digital approaches for therapeutic risk minimization purposes; Discuss challenges and constraints faced by sponsors and regulators in terms of adopting digital approaches to risk minimization; Identify at least two steps that can be taken to further advance adoption of digital technologies for risk minimization purposes.

Chair

Meredith Smith, DrPH, PhD, MPA

Speaker

Industry Sponsor Perspective: What are Digital Risk Minimization Measures? What are the Challenges Sponsors Face in Developing Them? How Can we Overcome Them?
Meredith Smith, DrPH, PhD, MPA

Regulatory Perspective: Opportunities and Challenges for Adopting Digital Risk-Minimization Measures
Gita Toyserkani, PharmD, MBA

Regulator Viewpoint
Fakhredin Sayed Tabatabaei, MD, PhD

Local Safety Officer Perspective: What Are the Advantages and Challenges to Implementing Digital Approaches to Risk Minimization at the Local Country Level and How Can They be Addressed?
Carla Perdun Barrett, PharmD



Speakers
avatar for Carla Barrett

Carla Barrett

Sr Director, Patient Safety Risk Mgmt, PRA Health Sciences
Dr. Carla Barrett is Senior Director, Risk Management at PRA Health Sciences. Carla has over 20 years of pharmaceutical industry experience (Wyeth, Pfizer, Allergan) in the strategic and operational aspects of pharmacovigilance risk management programs for products in development... Read More →
avatar for Meredith Smith

Meredith Smith

Director, Risk Management, Global Drug Safety, Research and Development, Alexion Pharmaceuticals, Inc.
Meredith Smith is Risk Management Director at Alexion, Inc. where she leads a team responsible for medicinal product benefit-risk management. She is a behavioral scientist and health services researcher by training with a professional background in public health and academic medicine... Read More →
avatar for Gita Toyserkani

Gita Toyserkani

Associate Director for Research & Strategic Initiatives, CDER, FDA
Gita Toyserkani, PharmD, MBA, is the Associate Director for Research and Strategic Initiatives in the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology. She has over 15 years of experience in risk management and advises on pre and post-marketing activities... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

8:00am EDT

#402 L: FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-749-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will discuss FDA efforts to modernize clinical trials through real world evidence (RWE), decentralized clinical trials and the inclusion of digital health technologies. FDA experts will provide their perspectives on best practices for implementation.

Learning Objectives

Design modern clinical trials to collect real-world data in real-world evidence settings; Discuss key principles of decentralized clinical trials and key aspects for their implementation; Discuss how to plan for the inclusion of digital health technologies for remote data acquisition in modern clinical trials.

Chair

Elizabeth Kunkoski, MS

Speaker

Panelist
Leonard Sacks, MD

Panelist
Isaac R. Rodriguez-Chavez, MHS, PhD, MS



Speakers
avatar for Elizabeth Kunkoski

Elizabeth Kunkoski

Health Science Policy Analyst, OMP, CDER, FDA
Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Officer, Clinical Research Methodology, Reg Compliance & Medical Policy, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →
LS

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum

8:00am EDT

#403 L: Best Practices in Developing Medical Information Responses
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-658-L04-P; CME 1.00; IACET 1.00; RN 1.00

Healthcare providers routinely request information from pharmaceutical companies’ medical information departments. The information provided in scientific response documents to these unsolicited requests need to be evidence-based, practical and useful, and provide a systematic summation of the medical literature. Additionally, the information needs to meet the needs of the healthcare provider requesting the information, for example oncology nurses who are at the forefront of therapy decisions and patient support. This session will provide best practices for: the sections of a scientific response document; content and channels to meet the needs of specific audiences such as oncology nursing; and structured authoring and reuse of content for improving efficiencies.

Learning Objectives

Describe the appropriate sections of a scientific response document; Evaluate content of a scientific response document for appropriateness for oncology nurses; Describe efficiencies achieved with structured authoring and reuse of material.

Chair

Evelyn R. Hermes-DeSantis, PharmD

Speaker

Scientific Response Documents: Developing the Best Content
Evelyn R. Hermes-DeSantis, PharmD

Differentiate Content Quality and Demonstrate Efficiency with Reuse and Structured Authoring
John April, MA



Speakers
avatar for Evelyn Hermes-DeSantis

Evelyn Hermes-DeSantis

Clinical Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey
Evelyn Hermes-DeSantis, PharmD, BCPS, is a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey and is the Director of Drug Information Services at Robert Wood Johnson University Hospital. She received her undergraduate and graduate... Read More →
avatar for John April

John April

Content Strategy Advisor, Global Scientific Communications, Eli Lilly & Company
Nineteen years of drug development experience focused on medical writing. Highlights include developing a content reuse strategy for Lilly, retooling Lilly's medical writing staff to structure its content, leading a medical writing start-up in India, designing a Question Based Review... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session

8:00am EDT

#404 L: Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide an opportunity for key stakeholders, including regulators, product developers and patients, to discuss the incorporation of patient input into medical product development and regulatory decision-making.

Learning Objectives

Describe current and upcoming efforts across FDA’s medical product centers to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Describe considerations that should be addressed in order to realize the full potential for patient input to support medical product development and regulatory decision-making.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Robyn Bent, MS, RN

Panelist
Michelle Tarver, MD, PhD

Panelist
Martin Ho, MS



Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Senior Research Analyst, Office of the Center Director, CDER, FDA
Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and... Read More →
avatar for Robyn Bent

Robyn Bent

Director, PFDD Program, OCD, CDER, FDA
Robyn Bent joined the US FDA in 2019 as the director of CDER’s Patient-Focused Drug Development (PFDD) Initiative, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making... Read More →
avatar for Martin Ho

Martin Ho

Associate Director, Office of Biostatistics and Epidemiology, CBER, FDA
Mr. Martin Ho is Associate Director of Quantitative Patient Inputs & Real-World Patient Evidence at Office of Biostatistics & Epidemiology, CBER, US FDA. Prior, he was the Director of Quantitative Innovation at Center for Devices, turning new data sources into regulatory-grade evidence... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, PSE, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Her program interacts with digital health... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum

8:00am EDT

#406 SL: FDA-PAHO: Landscape Report of Regulatory Situation in the Americas
Component Type: Session
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-605-L04-P; CME 1.00; IACET 1.00; RN 1.00



Speaker

Moderator
Charles Preston, MD, MPH, FACPM

Panelist
Javier Guzman



Speakers
JG

Javier Guzman

Technical Director, Medicines, Technologies, and Pharmaceutical Services (MTaPS), Management Sciences for Health
CP

Charles Preston

Advisor, Regulatory System Strengthening for Medicines & Other Health Technology, Pan American Health Organization (PAHO)
Charles Preston is a board certified preventive medicine and public health physician. He is an advisor on regulatory system strengthening at PAHO/WHO and based in Washington, DC. Prior to his work with PAHO, he was a medical officer at FDA.


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

8:00am EDT

#405 L: Catalyzing the Integration of Digital Technologies in Healthcare Solutions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-727-L04-P; CME 1.00; IACET 1.00; RN 1.00

Increasingly medicine development utilizes digital technologies including digital therapeutics with the potential to provide transformative treatment opportunities. Challenges to the current regulatory framework need to be translated into opportunity. This session will discuss examples of complex healthcare solutions and analyze enabling factors to facilitate their progress from early proof of principle to market access.

Learning Objectives

Describe how digital (therapeutic) technologies are transforming drug development and their regulation; Identify opportunities on how to catalyze for more integrative approaches in the development and regulation of medicines and digital (therapeutic) technologies; Discuss scientific and regulatory opportunities how to enable the integration of digital (therapeutic) technology in medicines development.

Chair

Falk Ehmann, MD, PhD, MS

Speaker

Identified Challenges and Opportunities Using Digital Technologies in Drug Development and Patient Treatment: Available Support Offered by FDA
Bakul Patel, MBA, MS

Floodlight Development: A Case Study
Seya Colloud, PharmD

Identified Challenges and Opportunities Using Digital Technologies in Drug Development and Patient Treatment: Available Support by EMA
Armin Ritzhaupt, PhD, MPH



Speakers
avatar for Falk Ehmann

Falk Ehmann

Chair of Innovation Task Force, European Medicines Agency
Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and expertise in European and International law. He is currently chairing the EMA’s Innovation Task Force (ITF). His main areas of expertise include Pharmacogenomics, Nanomedicines and Borderline and Combined Medicinal... Read More →
avatar for Seya Colloud

Seya Colloud

Global Regulatory Director, F. Hoffmann-La Roche Ltd
Seya Colloud is a pharmacist by training and holds a Masters in International Drug Regulatory affairs from University Paris-Sud, (France). She works as Global Regulatory Director in the personalized healthcare team for F. Hoffmann La Roche in Switzerland. Her area of expertise and... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Division, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →
avatar for Armin Ritzhaupt

Armin Ritzhaupt

Scientific Administrator, European Medicines Agency
Armin Ritzhaupt, is a scientific administrator in the Regulatory Affairs Office at EMA providing regulatory support to development, evaluation and surveillance of medicinal products for human use with a focus on activities related to the implementation of the new medical device and... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

8:00am EDT

#410 SL: Statistical Considerations for Using External Controls in Clinical Trials
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-747-L04-P; CME 1.00; IACET 1.00; RN 1.00

A synthetic control arm (SCA) has been suggested as possibly advantageous as an external control to aid in the interpretation of clinical trials where a randomized concurrent control is clinically unethical, practically infeasible, or unacceptable to patients. Because the SCA is made up of patient level data from the real world or from historical clinical trials, there is opportunity to match the patient composition of the SCA to that of the experimentally treated group in baseline demographics and disease specific characteristics. This may be a considerable advantage over traditional external controls such as benchmarking with static results from medical literature or clinical intuition with populations that may not be sufficiently similar to the experimentally treated group. Speakers will provide a brief introduction to SCA and will discuss a variety of statistical approaches for the creation and use of SCAs. Discussion may include the use of clinical trials data and real-world data for construction of SCAs, various statistical matching and weighting methods for creation of the SCA, the possible impact of unobserved or unavailable historical information on the balancing process and the treatment effect, and others.

Learning Objectives

Define a synthetic control arm (SCA) and the proposal for use of SCA in indications where a concurrent randomized control is not ethical or not feasible; Discuss the advantages and disadvantages of real world data and clinical trials data in a SCA; Describe a variety of statistical methods associated with construction and use of SCAs.

Chair

Jennifer Clark, PhD

Speaker

Synthetic Control Arms as External Controls in Evaluation of Treatment Effects in Drug Development
Ruthie Davi, PhD, MS

Treatment Effect and Variability When Using External Comparators in RCTs: A Statistical Epistemological Approach
Luis Rojas, PhD, MS

Industry Perspective
Andrew E. Mulberg, MD



Speakers
avatar for Andrew Mulberg

Andrew Mulberg

Head, Senior Vice President, Global Regulatory Affairs, Amicus Therapeutics
He is responsible for directing global regulatory strategies for all Amicus programs to bring multiple therapies to patients with rare and devastating diseases. Dr. Mulberg is a pediatric gastroenterologist who has spent the past 6 years working at the U.S. Food and Drug Administration... Read More →
avatar for Luis Rojas

Luis Rojas

Senior Principal Statistician, Parexel
Luis holds a PhD in Statitics and has over 30 years of experience that expands to the pharmaceutical, CRO, academia and medical device industry. He is currently a Senior Principal Statistician at Parexel and the former Head of Study Designs / Adaptive Design unit within Advisory Service... Read More →
JC

Jennifer Clark

Mathematical Statistician, OB, OTS, CDER, FDA
Jennifer Clark completed her PhD in biostatistics in 2013 at the University of North Carolina and is currently working at the FDA. While her current work lies within the realm of clinical trials, past research interests included work in high dimensional data with applications in bioinformatics... Read More →
avatar for Ruthie Davi

Ruthie Davi

Vice President, Data Science, Acorn AI, a Medidata Company
Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI, a Medidata company, and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics... Read More →


Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session

8:00am EDT

Professional and Student e-Posters Gallery
Professional and Student e-Posters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2020. Attendees are invited to scroll through and search e-Posters throughout the duration of virtual meeting. e-Posters run continuously during the meeting. There are no formal or LIVE e-Poster presentations during the DIA 2020 virtual meeting.

Thursday June 18, 2020 8:00am - 5:00pm EDT
e-Poster Gallery

9:30am EDT

#411 L: Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-751-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this interactive panel discussion, we will explore the critical role that providers, sponsors, and collaboratives play in driving greater adoption of decentralized clinical trials (DTs). Attendees are encouraged to engage in the discussion.

Learning Objectives

Define familiarity with the use of technologies and approaches enabling DTs; Identify challenges of vendor qualification for DTs versus traditional trials; Describe key risks when qualifying DT service providers; Characterize change management elements of success and how providers can support this effort; Describe role collaboratives and standards play in facilitating broader adoption of DTs.

Chair

Dennis Salotti, MBA, MS

Speaker

Panelist
Alison Holland

Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight
Heather Zigmund, PharmD



Speakers
avatar for Dennis Salotti

Dennis Salotti

Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director... Read More →
HZ

Heather Zigmund

Senior Director, Global Head of Study Management Early Stage Development BioPhar, AstraZeneca
Heather Zigmund, Pharm.D. is Senior Director & Global Head of Study Management Early Stage Development, BioPharmaceuticals at AstraZeneca. Heather is passionate about the use of data & technology in the clinical development process and its potential to shorten development timelines... Read More →
avatar for Alison Holland

Alison Holland

Head of Decentralized Trials, Medable
Alison (Ali) Holland is Head of Decentralized and Remote trials at Medable and is chartered to design and expand the end-to-end capabilities needed to partially or fully virtualize clinical studies, building on the commitment to reduce clinical trial times by 50%. Ali has over 20... Read More →


Thursday June 18, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

9:30am EDT

#412 L: Telling Health Stories for Drug Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-700-L04-P; CME 1.00; IACET 1.00; RN 1.00

Health stories are everywhere. The challenge for medical writers and communicators is to convert these stories into meaningful action in drug development. These patient-communicators will share how they influence research execution through stories.

Learning Objectives

Describe the evolving role of patient health stories in the context of patient-focused drug development; Identify how to become an effective health storyteller and listener; Describe how to apply diverse patient stories to protocol writing and clinical trial patient-facing materials.

Chair

Mary Murray, MBA, MPH

Speaker

Lynch Syndrome and Furthering Patient-Centric Research
David Dubin

Eliciting Stories from Vulnerable Populations to Improve Health Outcomes
Adebola Adedimeji, MBA, MS

Listening and Learning: Patient Experience and the Evolution of Research Protocols
Amy Fesmire-Baus, MS



Speakers
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →
avatar for David Dubin

David Dubin

Founder, AliveandKickn
3x Lynch Syndrome Cancer survivor, co-Founder AliveAndKickn foundation for hereditary cancer, Vice President of Sales Kailos Genetics, above average soccer coach.
AA

Adebola Adedimeji

Associate Professor of Epidemiology and Population Health, Albert Einstein College of Medicine
Professor Adedimeji is a socio-behavioral epidemiologist and global public health researcher with 25+ years of experience in multiple countries in sub-Saharan Africa, Southeast Asia, Western Europe, and the United States. He is a subject matter expert with skills in social epidemiology... Read More →
AF

Amy Fesmire-Baus

Senior Medical Writer, Bristol-Myers Squibb Company
Amy has 10 years of industry experience, including 7 years of writing drug development protocols. She is completing her fieldwork study and expects to graduate in August of 2020 with a Masters in Public Health with a concentration in epidemiology. She also has been a patient advocate... Read More →
avatar for Mary Murray

Mary Murray

VP, Collaborative Action Networks, National Minority Quality Forum
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →


Thursday June 18, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Forum

9:30am EDT

#413 L: Orphan Drug Development in Personalized Medicine
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-739-L04-P; CME 1.00; IACET 1.00; RN 1.00

For many years, drug development in oncology focused on treatments for tumors in specific parts of the body. However , with the advent of genomic sequencing, it has become clear that anatomically different tumors can have the same mutation that result in susceptibility to a drug, and that it is those mutations, rather than the anatomical site of the tumor, that should drive patient selection in clinical trials. This same approach, grouping patients based on molecular targets rather than clinical phenotypes, has broader implications for orphan drug development beyond oncology. In this session, the speakers will cover a variety of topics related to this issue, including rare mutation oncology trials, innovative study designs, and perspectives on orphan drug development in the age of personalized medicine.

Learning Objectives

Discuss insights for overcoming barriers to successful precision medicine development in rare mutation oncology trials; Describe different types of study designs for orphan drug development in personalized medicine; Identify different perspectives on orphan drug development in the age of personalized medicine.

Chair

Philip (P.J.) Brooks, PhD

Speaker

Rare Mutation Oncology Trials: Learnings Over Barriers and Enablers for Successful Precision Medicine Development
Angela Qu, MD, PhD

Innovative Study Designs for Better Outcomes
Richard Huckle, MSc

Adapting the Oncology Basket Trial Model to Rare Diseases: Grouping Patients by Underlying Etiology Rather Than Clinical Characteristics to Accelerate Clinical Trials
Philip (P.J.) Brooks, PhD



Speakers
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →
avatar for Richard Huckle

Richard Huckle

Regulatory and Development Consultant, Osiris Pharma
Richard is the regulatory and development Consultant at Osiris Pharma. In addition to running the day-to-day business operations of the company, Richard consults with clients on strategic regulatory issues facing their drug and biologic development programmes, with regularly stakeholder... Read More →
avatar for Angela Qu

Angela Qu

Vice President, Genomic Medicine, Parexel
Dr. Qu is Vice President in Parexel Translational Medicine, leading therapeutic strategy development and implementation of genomics and biomarker clinical studies, provision of scientific guidance, and consulting on partnerships across therapeutic areas. She serves as a core member... Read More →


Thursday June 18, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session

9:30am EDT

#414 SL: ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-708-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of ICH quality topics instrumental to the harmonization of pharmaceutical development and manufacturing standards and an introduction to the new and revised topics that are currently underway.

Learning Objectives

Discuss the role of ICH quality topics in harmonizing standards for more efficient pharmaceutical development and manufacturing; Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development and manufacture.

Chair

Amanda Marie Roache, MS

Speaker

ICH Strategy to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
Ashley Boam, MS

Industry Perspective on ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Produce Lifecycle Management
Andrew Chang, PhD

Q2(R2)/Q14 Analytical Procedure Development and Validation
Nina S. Cauchon, PhD, RAC

Q13 Continuous Manufacturing
Sau L Lee, PhD



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk
Dr. Chang has more than 20 years of experience in the development, regulation and quality of biologics and pharmaceuticals. As Vice President, Quality and Regulatory Compliance, Novo Nordisk, he is responsible for external affairs, providing strategic advice and solutions for quality... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. She is chair of the AAPS CMC Community, and is also active in ISPE, CASSS/WCBP, and PQRI. Her areas... Read More →