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avatar for Drew Garty

Drew Garty

Veeva Systems
Chief Technology Officer, Vault CDMS
avatar for Heather Gelhorn

Heather Gelhorn

Evidera
Senior Research Leader, Patient-Centered Research
avatar for Kelly George

Kelly George

Consultant
avatar for Todd Georgieff

Todd Georgieff

Hoffmann-La Roche Limited, Canada
Content Standards Lead
avatar for Kenneth Getz

Kenneth Getz

Tufts Center For the Study of Drug Development, United States
Director, Research Professor
avatar for Dalvir Gill

Dalvir Gill

TransCelerate BioPharma Inc.
Chief Executive Officer
avatar for Alicia Gilsenan

Alicia Gilsenan

RTI Health Solutions, United States
Vice President, Epidemiology
avatar for Eileen Girten

Eileen Girten

Pfizer Inc
Director, Medical Writing
avatar for Hannah Glenny

Hannah Glenny

Otsuka Pharmaceutical Development & Commercialization, Inc.
Research Associate
avatar for Richard Gliklich

Richard Gliklich

OM1, United States
Chief Executive Officer
avatar for Dagmar Goertz

Dagmar Goertz

Janssen-Cilag GmbH, Germany
Director External Engagement and Business Insights
avatar for Kate Gofman

Kate Gofman

Astrazeneca
Safety Physician
KG

Kate Gofman

AstraZeneca
Global Safety Physician
avatar for Cammilla Horta Gomes

Cammilla Horta Gomes

Roche, Brazil
LATAM Regulatory Policy Lead
JG

Jacqueline Gough

Astellas
Director, Central Monitoring and Data Surveillance
avatar for Sivakumar Gowrisankar

Sivakumar Gowrisankar

Parexel International, United States
Director, Genomic Medicine
NG

Neal Grabowski

AbbVie, United States
Director, Pharmacovigilance & Patient Safety
avatar for Cheryl Grandinetti

Cheryl Grandinetti

FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
avatar for Andrew Gray

Andrew Gray

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Deputy Director, Inspection Enforcement and Standards
avatar for Stuart Green

Stuart Green

Merck & Co., Inc.
Vice President, Clinical Development
SG

Sarah Greene

Independent Consultant
Strategic Consultant and Advisor
avatar for William Gregory

William Gregory

Pfizer Inc
Senior Director, Safety and Risk Management
avatar for Tim Grey

Tim Grey

AbbVie, Inc.
Senior Director,R&D Quality Systems
avatar for Alberto Grignolo

Alberto Grignolo

Parexel, United States
Corporate Vice President
avatar for Ilona Grosse-Michaelis

Ilona Grosse-Michaelis

Bayer AG
Senior Medical Dictionary Expert
avatar for Anmol Grover

Anmol Grover

Halloran Consulting Group
Clinical Strategy Consultant
avatar for Pete Guillot

Pete Guillot

Centerfirst
President
JG

Javier Guzman

Management Sciences for Health
Technical Director, Medicines, Technologies, and Pharmaceutical...
TG

Thomas Gwise

FDA
Division Director, Division of Biometrics IX, OTS, CDER
avatar for Laura Holmes Haddad

Laura Holmes Haddad

Independent Consultant
Writer & Speaker, Patient Advocate
avatar for Amy Hadley

Amy Hadley

Covance
Global Head of Commercial and Operational Risk
RH

Rebecca Hager

FDA
Mathematical Statistician, OTS, CDER
avatar for Wendy Halpern

Wendy Halpern

Genentech, A Member of the Roche Group
Principal Scientist / Pathologist
avatar for Sara Hamon

Sara Hamon

Regeneron
Director, Precision Medicine Quantitative Translational Sciences
avatar for Mark Hanley

Mark Hanley

VirTrial
Chief Executive Officer
avatar for Melissa Harris

Melissa Harris

Labcorp Drug Development, United States
Director of Global Patient Recruitment & Engagement
avatar for Elizabeth Hart

Elizabeth Hart

FDA
Branch Chief, General Medicine 1, OTAT, CBER
AH

Anand Harugeri

IQVIA
Director, Service Operations, Lifecycle Safety
avatar for Sabine Haubenreisser

Sabine Haubenreisser

European Medicines Agency, Netherlands
Principal Scientific Administrator, Stakeholders and Communication...
RH

Rika Hayashi

Otsuka Pharmaceutical Co., Ltd.
avatar for Niklas Hedberg

Niklas Hedberg

Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Chair EUnetHTA Executive Board; Chief Pharmacist
WH

Whitney Helms

FDA
Pharmacology Supervisor, OOD, CDER, FDA
avatar for Barbara Hendrickson

Barbara Hendrickson

AbbVie, Inc., United States
Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety
avatar for Evelyn Hermes-DeSantis

Evelyn Hermes-DeSantis

Rutgers, The State University of New Jersey
Clinical Professor, Ernest Mario School of Pharmacy
avatar for Cristian Herrera

Cristian Herrera

Organisation For Economic Co-Operation and Development (OECD)
Health Policy Analyst, Directorate for Employment, Labour and Social...
avatar for Steven Hershman

Steven Hershman

Stanford University
Director for Mobile Health
avatar for Jan Hewett

Jan Hewett

FDA
Regulatory Counsel for Policy, OSI, CDER
avatar for Samantha Hewlett

Samantha Hewlett

Amgen, South Africa
Risk-Based Study Execution Capability Lead
avatar for Martin Ho

Martin Ho

FDA
Associate Director, Office of Biostatistics and Epidemiology, CBER
avatar for Alan Hochberg

Alan Hochberg

F. Hoffmann- La Roche, Switzerland
Principal Scientific Enablement Director
avatar for Ryan Hoffmeister

Ryan Hoffmeister

Deloitte
Managing Director
avatar for Cosmina Hogea

Cosmina Hogea

GlaxoSmithKline
Director, Value, Evidence, and Outcomes
avatar for Michelle Hoiseth

Michelle Hoiseth

Parexel, United States
Chief Data Officer
avatar for Alison Holland

Alison Holland

Medable, United States
Executive General Manager, Digital and Decentralized Solutions
PH

Patrick Holmes

Pfizer Inc
Innovation Policy Team Lead
avatar for Julie Holtzople

Julie Holtzople

AstraZeneca, United States
Head of Clinical Transparency and Data Sharing
avatar for Peter Honig

Peter Honig

Pfizer Inc, United States
Senior Vice President Global Regulatory Affairs and Group Head...
avatar for Paula Horowitz

Paula Horowitz

AbbVie
Program Manager, QA, GCP Software Validation
avatar for Peyton Howell

Peyton Howell

Parexel
Executive Vice President, Chief Commercial & Strategy Officer
avatar for Sherri Hubby

Sherri Hubby

Gilead Sciences
Director, Vendor Compliance
avatar for Richard Huckle

Richard Huckle

Osiris Pharma
Regulatory and Development Consultant
avatar for Thomas Hudson

Thomas Hudson

AbbVie
Senior Vice President, Research and Development, and Chief Scientific...
HM

H. M. James Hung

FDA
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
avatar for Raj Indupuri

Raj Indupuri

eClinical Solutions, United States
Chief Executive Officer
avatar for Telba Irony

Telba Irony

FDA
Deputy Director, Office of Biostatistics and Epidemiology, CBER
DI

David Ives

Alexion Pharmaceuticals Inc
Director, Head of TMF Operations
avatar for Jaishree Jaishankar

Jaishree Jaishankar

Dell Technologies
Head of Portfolio and Product management, Data Analytics and...
avatar for Stephanie Jameison

Stephanie Jameison

Otsuka Pharmaceutical Development & Commercialization, Inc.
Senior Director, Promotion Compliance
avatar for Jeffry James

Jeffry James

Wilmington Health and Innovo Research
Chief Executive Officer
JJ

Janine Jamieson

IPQ Publications
European Editor
avatar for Rosanne Janssens

Rosanne Janssens

KU Leuven
PhD Researcher, Department of Pharmaceutical and Pharmacological...
avatar for Thomas Jemielita

Thomas Jemielita

Merck & Co., Inc.
Senior Scientist, Biostatistics
RJ

Rekha Jhamnani

FDA
Medical Officer, DPARP, OND, CDER
avatar for Hylton Joffe

Hylton Joffe

FDA
Acting Director, Office of Rare Diseases, Pediatrics, URM, CDER
avatar for Becky Johnson

Becky Johnson

IQVIA, United States
Associate Director, Global Patient & Site Solutions
avatar for Calvin Johnson

Calvin Johnson

AbbVie Ltd.
Head, International PV Operational Excellence
LL

Laura Lee Johnson

FDA
Director, Division of Biometrics III, Office of Biostatistics, OTS,...
avatar for Jeremy Jokinen

Jeremy Jokinen

Bristol-Myers Squibb Company
Head of Business Capabilities and Innovation, Worldwide Patient Safety
avatar for Janine Jones

Janine Jones

Bioclinica, an ERT Company
Senior Product Manager
avatar for Nadina Jose

Nadina Jose

Rutgers, The State University of New Jersey
Assistant Professor, School of Health Professions, MS Clinical...
avatar for Meredith Kaganovskiy

Meredith Kaganovskiy

DIA
Senior Project Manager, Annual Meeting
avatar for Misha Kapushesky

Misha Kapushesky

Genestack Ltd
Chief Executive Officer
avatar for Alex Karanevich

Alex Karanevich

EMB Statistical Solutions
Biostatistician
avatar for Sean Kassim

Sean Kassim

FDA
Director, Office of Study Integrity and Surveillance, OTS, CDER
avatar for Sylvia Baedorf Kassis

Sylvia Baedorf Kassis

MRCT Center, United States
Program Manager
avatar for Nechama Katan

Nechama Katan

Pfizer Inc, United States
Director Data Science, Data Management
EK

Eva Katz

Janssen Research & Development
Associate Director, Patient Reported Outcomes
avatar for Terry Katz

Terry Katz

Daiichi Sankyo, United States
Senior Director, Biostatistics and DM Planning and Functional...
avatar for Terry Katz

Terry Katz

Merck Animal Health
Director, Head of Global Data Management and Statistics
avatar for Daniel Kavanagh

Daniel Kavanagh

WCG
Senior Scientific Advisor, Gene Therapy
PK

Patricia Keegan

FDA
Associate Director for Medical Policy, Oncology Center for Excellence
avatar for Lindsay Kehoe

Lindsay Kehoe

Clinical Trials Transformation Initiative (CTTI), United States
Project Manager
avatar for Douglas Keller

Douglas Keller

Sanofi
Global Head for Development Projects, Preclinical Safety
JK

Jackline Kemboi

African Institute For Mathematical Science (aims)-Rwanda
Student
avatar for Anna Kettermann

Anna Kettermann

FDA
Mathematical Statistician, OB, OTS, CDER
avatar for Lauren Key

Lauren Key

PPD
Operations Manager
avatar for Sadhna Khatri

Sadhna Khatri

FDA
Regulatory Officer, PASES, OCD, CDER
avatar for Sean Khozin

Sean Khozin

Janssen Research & Development, LLC
Global Head of Data Strategy
avatar for Usha Kidambi

Usha Kidambi

Daiichi Sankyo
Director, Global Project Management and Leadership
avatar for Yongman Kim

Yongman Kim

FDA
Lead Mathematical Statistician, OB, OTS, CDER
avatar for Michelle Kissner

Michelle Kissner

Pfizer Inc
Director, Publications Management
avatar for Oeystein Kjoersvik

Oeystein Kjoersvik

Merck & Co., Inc., Czech Republic
Product Owner/Business Analyst
avatar for Agnes Klein

Agnes Klein

Health Canada
Senior Medical Advisor
NK

Naomi Knoble

FDA, United States
Reviewer, Division of Clinical Outcome Assessment, OND, CDER
avatar for Chandi Kodthiwada

Chandi Kodthiwada

Takeda
Head of Product Management, R&D IT
avatar for Kerstin Koenig

Kerstin Koenig

Bristol-Myers Squibb Company, United States
Vice President, Research and Development Quality
avatar for Albert Kraus

Albert Kraus

Pfizer Inc
Senior Director, Global Regulatory Portfolio Lead Breast and Women's...
avatar for Nathan Kreischer

Nathan Kreischer

Merck & Co. Inc., United States
Director, Global Project & Alliance Management
avatar for James Kremidas

James Kremidas

Association of Clinical Research Professionals (ACRP)
Executive Director
avatar for Sarah Krug

Sarah Krug

CANCER101, United States
Chief Executive Officer
avatar for Mark Kryah

Mark Kryah

Eli Lilly and Company, United States
Senior Advisor/COO, Bio-Medicines Business Unit
avatar for Stefanie Kuhner

Stefanie Kuhner

AiCure
Head of Corporate Development, Clinical Research
avatar for Joe Kunakorn

Joe Kunakorn

Janssen Research & Development, LLC
Associate Director, Oncology Risk Management
avatar for Elizabeth Kunkoski

Elizabeth Kunkoski

FDA, United States
Health Science Policy Analyst, OMP, CDER
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

DIA, United States
Global Chief Executive
avatar for Sherina Kuruvilla

Sherina Kuruvilla

Novo Nordisk A/S
Associate Director, Global Patient Relations
avatar for Sandra Kweder

Sandra Kweder

FDA, United States
Deputy Director, Europe Office, Office of Global Programs and...
avatar for Cynthia LaCivita

Cynthia LaCivita

FDA
Director, Division of Risk Management, OSE, CDER
avatar for Michael Laddin

Michael Laddin

ResultsMatter
Managing Partner
avatar for Michael Laddin

Michael Laddin

ResultsMatter, United States
Managing Partner
avatar for Katherine Laessig

Katherine Laessig

IQVIA
Vice President
avatar for Rushabh Lagdiwala

Rushabh Lagdiwala

University of the Sciences, Philadelphia College of Pharmacy
Student
avatar for Stephen Lake

Stephen Lake

Wave Life Sciences
Vice President, Biometrics
avatar for C. Ola Landgren

C. Ola Landgren

Memorial Sloan Kettering Cancer Center
Professor of Medicine and Chief of Myeloma Service
DL

Daniel Lapadula

Novartis Institutes for BioMedical Research, Inc.
Global Head and Vice President, Toxicology
avatar for Erik Laughner

Erik Laughner

FDA, United States
Project Manager, Business Operations Staff, OD, CBER
KL

Kristina Lauritsen

FDA
Combination Products Regulatory Policy Advisor, OEP, CDER
NL

Nirosha Lederer

Duke-Robert J. Margolis, MD, Center for Health Policy
Managing Associate, Real World Evidence
avatar for Kerry Jo Lee

Kerry Jo Lee

FDA
Clinical Advisor, Office of New Drug Policy, CDER
avatar for Sau Lee

Sau Lee

FDA
Director, Office of Testing and Research, OPQ, CDER
JL

John Leighton

FDA
Director, Division of Hematology Oncology Toxicology, OOD, OND, CDER
avatar for Brad Leissa

Brad Leissa

FDA
Deputy Director, Counter-Terrorism and Emergency Coordination Staff,...
avatar for Julie Lepin

Julie Lepin

Amgen
Vice President, Regulatory Affairs Oncology
avatar for Benjamin Letson

Benjamin Letson

SFL Scientific
Data Scientist
avatar for Patricia Letwink

Patricia Letwink

Bayer U.S. LLC
Strategic Initiatives, Communications and Change Management
avatar for Heidi Levens

Heidi Levens

Bristol-Myers Squibb Company
Head of Country for Pharmacovigilance
avatar for David Leventhal

David Leventhal

Pfizer Inc, United States
Senior Director, Clinical Trial Experience, Global Product Development
GL

Gregory Levin

FDA
Deputy Director, DBIII, OB, OTS, CDER
avatar for Bennett Levitan

Bennett Levitan

Janssen Research & Development, LLC
Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology
ML

Meijuan Li

Foundation Medicine
Vice President, Head of Biometrics and Biomarkers
avatar for Qi Li

Qi Li

InterSystems
Physician Executive
avatar for Greg Licholai

Greg Licholai

PRA Health Sciences
Chief Medical Information Officer
avatar for Wei (Lisa) Lin

Wei (Lisa) Lin

FDA
Study Data Standards Manager, Office of Director, CBER
avatar for Mika Lindroos

Mika Lindroos

Signant Health
Director, Product Management, eConsent
avatar for Mika Lindroos

Mika Lindroos

Signant Health
Director, Product Management
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

European Commission
ICH Assembly Chair and Senior Expert, European Commission
SL

Shari Ling

Centers for Medicare an Medicaid Services
Acting Chief Medical Officer
avatar for Rebecca Lipsitz

Rebecca Lipsitz

Janssen, United States
Director, Regulatory Policy
avatar for Charles Liss

Charles Liss

CSL Behring
Associate Director, Global Biostatistics
avatar for Daniel Liu

Daniel Liu

Beijing Clinical Service Center
Chief Science Officer
QL

Qi Liu

FDA
Senior Science Advisor, Office of Clinical Pharmacology, OTS, CDER
avatar for Andrew Lo

Andrew Lo

Massachusetts Institute of Technology (MIT)
Charles E. and Susan T. Harris Professor of Finance, Sloan School of...
avatar for Michelle Longmire

Michelle Longmire

Medable Inc., United States
CEO and Founder
avatar for Marianne Hamilton Lopez

Marianne Hamilton Lopez

Duke-Margolis Center For Health Policy, United States
Research Director, Value-Based Payment Reform
KL

Kenneth Lord

GlaxoSmithKline
Medical Writing and Clinical Submission Planning Director
avatar for Herve Le Louet

Herve Le Louet

CIOMS and APHP
President, Head of PV Coordination
avatar for Celia Lourenco

Celia Lourenco

Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate,...
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

AstraZeneca
Regulatory Affairs Director, BioPharmaceuticals R&D, Late-stage...
avatar for Annie Ly

Annie Ly

University of Southern California, United States
Project Assistant
LL

Liyang Lyu

University of Macau
Student
avatar for Rod Mackenzie

Rod Mackenzie

Pfizer Inc
Executive Vice President, Chief Development Officer
avatar for Alex MacLeod

Alex MacLeod

InterSystems
Manager, HealthShare Commercial Initiatives
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

FDA, United States
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER
MM

Manahil Malik

Pfizer Inc
Medical Information, Associate Director
DM

Diane Maloney

FDA
Associate Director for Policy, CBER
avatar for Noemi Manent

Noemi Manent

European Medicines Agency
Scientific Administrator, Compliance and Inspection
NM

Nag Mani

Gilead Sciences
Data Scientist
avatar for Rakesh Maniar

Rakesh Maniar

Novartis Pharmaceuticals Corporation
Global Head, Business Technology Services; Co-Lead, TransCelerate...
avatar for Shweta Maniar

Shweta Maniar

Google Cloud
Life Science and Medical Device Strategy Lead
avatar for Marie Manley

Marie Manley

Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
avatar for Geoff Mann

Geoff Mann

SAS Institute Inc., JMP Division
Manager of the Advanced Analytics, JMP Life Sciences
PM

Priya Mannan

Novartis Institutes for BioMedical Research, Inc.
Executive Director, Assoc. General Counsel, Global Head of Compliance...
avatar for Yuri Maricich

Yuri Maricich

Pear Therapeutics
Chief Medical Officer and Head of Development
avatar for Joe Marion

Joe Marion

Berry Consultants
Statistical Scientist
avatar for Peter Marks

Peter Marks

FDA, United States
Director, Center for Biologics Evaluation and Research
avatar for Christopher Marrone

Christopher Marrone

Eli Lilly and Company, United States
Outcomes Liaison
avatar for Kevin Marsh

Kevin Marsh

Evidera
Exec Director, Patient Centred Research
avatar for David Martin

David Martin

FDA
Associate Director for Real World Evidence Analytics, OMP, CDER
avatar for Steve Matas

Steve Matas

Advanced Clinical
Vice President, Strategic Solutions
avatar for Robert Mather

Robert Mather

Pfizer Inc
Executive Director, Early Clinical Development
avatar for Chris Matheus

Chris Matheus

Matheus BD Connections LLC
President
avatar for Rie Matsui

Rie Matsui

Pfizer R&D, Japan
Senior Director, Regional Labeling Head for APAC
avatar for Gwendolyn Mayes

Gwendolyn Mayes

Gwenco Health
Patient Story Coach
avatar for Janet Maynard

Janet Maynard

FDA
Director, Office of Orphan Products, OC
JM

James Mayne

Pharmaceutical Research and Manufacturers of America (PhRMA)
Vice President, Scientific Advocacy
avatar for Susan Mayo

Susan Mayo

FDA, United States
Mathematical Statistician, OB, DB3, OTS, CDER
avatar for Neil McAuslane

Neil McAuslane

Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Director
avatar for K. Kimberly McCleary

K. Kimberly McCleary

The Kith Collective, LLC, United States
Founder and Chief Executive Officer
avatar for Mark McClellan

Mark McClellan

Duke-Margolis Center For Health Policy, United States
Director and Robert J. Margolis M.D. Professor of Business, Medicine...
avatar for Mary McGowan

Mary McGowan

The Myositis Association
Executive Director
avatar for Deven McGraw

Deven McGraw

Ciitizen
Chief Regulatory Officer
avatar for Patrick McManus

Patrick McManus

Exom Group Srl
Chief Development Officer
avatar for Jill McNair

Jill McNair

CISCRP
Senior Director, Health Communication Services
avatar for Lindsay McNair

Lindsay McNair

WIRB-Copernicus Group (WCG), United States
Chief Medical Officer
avatar for Christopher McSpiritt

Christopher McSpiritt

Veeva Systems
Senior Director, Vault Clinical
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Vertex Pharmaceuticals
Vice President, Integrated QMS/OMS
avatar for Munish Mehra

Munish Mehra

Tigermed
Executive Director
avatar for Timothe Menard

Timothe Menard

F. Hoffmann- La Roche, Switzerland
Head of Quality Data Science
avatar for Mary Lynn Mercado

Mary Lynn Mercado

Novartis Pharmaceuticals Corporation
US Group Head Regulatory Medical Writing, Pharma
MM

Michael Merchlinsky

BARDA
Scientific Program Manager


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