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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...
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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...
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MACPR Student, The Ohio State University
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...
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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...
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Global Risk Management Lead, Hematology and Cell Therapy, BMS
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...
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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...
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Senior Director, Pharmacovigilance Innovation, Bristol Myers Squibb
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...
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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...
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Scientist, Dossier Development and Operations, Janssen Research & Development, LLC
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Senior Director, Bristol-Myers Squibb Company, United States
Solid Tumor Oncology Epidemiology Lead at Bristol Myers Squibb.
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Associate Clinical Scientist, WCG Analgesic Solutions, United States
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.
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Faculty, Rutgers University
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...
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LATAM Regulatory Policy Lead, Roche, Brazil
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...
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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...
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Otsuka Pharmaceutical Co., Ltd.
Author belongs to Clinical Development, Otsuka Pharmaceutical Co., Ltd..
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...
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Associate Director, Global Patient & Site Solutions, IQVIA, United States
In her current role at IQVIA, Becky is accountable for the strategic direction of communication initiatives to support recruiting, engaging and retaining patients in clinical trials. Becky leverages her 20 years of experience in the biopharmaceutical industry and expertise in diversity...
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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...
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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...
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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...
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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...
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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...
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Project Assistant, University of Southern California, United States
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...
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Student, University of Macau
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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...
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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.
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...
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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...
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Director, Patient and Health Impact, Pfizer Inc
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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...
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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...
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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...
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Associate Director, Global Regulatory Policy and Intelligence, Global Regulatory, Janssen Research and Development, United States
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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.
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...
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Undergraduate Research Associate, USC Department of Regulatory Science, United States
Christian Reyes is currently a fourth-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...
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Director, Regulatory Operations, Otsuka Pharmaceutical Development & Commercialization, Inc., United States
Boris Reznichenko is currently a 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, Boris worked...
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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...
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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...
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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...
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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...
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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...
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Chair, Advisory Board, Alliance for Safe Biologic Medicines, United States
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...
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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...
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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...
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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...
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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...
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Director, Global Medical Organization, Johnson & Johnson, United States
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...
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Associate II, Centre of Regulatory Excellence, Duke-Nus Medical School
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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...
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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...
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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...
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Senior Vice President, Real World Research, Syneos Health, United States
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 Research at Syneos Health, where he provides RWE design solutions to study sponsors. Dr...
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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...
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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...
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Project Manager, DIA
DIA Project Manager
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...
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Scientific Lead, Scientific Data Organization, Parexel, United States
I am the Scientific Lead within the Scientific Data Organization at Parexel. My interests are in real-world data applications to scientific questions and the importance of embracing context within the 'data generation process.' Ongoing research is along the intersection of machine...
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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...
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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...
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Chemical Engineer, OLDP, OPQ, CDER, FDA
BS.MMedS.(UNSW) PhD.(USYD), The University of Sydney
Senior Associate, Regulatory Affairs at Phebra Pty Ltd.Dr Tony Yuan's speciality is in the field of pharmaceutical medicine, he holds a PhD in the area of optimizing written medicine information for prescription medicines used by Healthcare Professionals (AUS, EU & USA perspective...
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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...
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Student, University of Macau
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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.
PharmD Student, University of British Columbia
