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项目委员会
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Jonathan Andrus, MS • Past Chair/Current Treasurer
Society For Clinical Data Management, United States -
Matt Baldwin, MS • Biomedical Data Stewardship Senior Manager
Amgen, United States -
David Bowers, PharmD • Senior Director, Operations
PPD, United States -
Philip (P.J.) Brooks, PhD • Deputy Director, Division of Rare Diseases Research Innovation
National Center for Advancing Translational Sciences (NCATS), NIH, United States -
Jennifer Burgess, MBA, MPH • Vice President, Global Engagement and Communications
TransCelerate Biopharma Inc., United States -
Bill Byrom, PhD • Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Signant Health , United Kingdom -
Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie
United States -
Dannis Chang, PharmD • Director, Hematology Medical Information Team Lead
Genentech, Inc., United States -
Yeh-Fong Chen, PhD • Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States -
Karla Childers, MS • Head, Bioethics-Based Science and Technology Policy
Johnson & Johnson, United States -
Deborah Collyar • President
Patient Advocates In Research (PAIR), United States -
Sonya Eremenco, MA • Executive Director, PRO Consortium
Critical Path Institute, United States -
Ron Fitzmartin, PhD, MBA • Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
David Fryrear, MS • Executive Vice President and Head of Quality Assurance
Astellas, United States -
Barbara Gladson, PhD, MS • Director of Biopharma Initiative; Interim Chair, Health Informatics
Rutgers School of Health Professions, United States -
Richard Gliklich, MD • Chief Executive Officer
OM1, United States -
William Gregory, PhD • Senior Director, Safety and Risk Management
Pfizer Inc, United States -
Marianne Hamilton Lopez, PhD, MPA • Research Director, Value-Based Payment Reform
Duke-Margolis Center For Health Policy, United States -
Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands -
Jennifer Helfer, PhD • Senior Director, Patient Advocacy and Engagement, Corporate Affairs
Viridian Therapeutics, Inc., United States -
Nita Ichhpurani, PMP • Consultant To Daiichi Sankyo, Inc.
Phase One Forward, Consultant, Canada -
Jeremy Jokinen, PhD, MS • Vice President and Head, Safety Evidence and Sciences
Bristol-Myers Squibb Company, United States -
Nadina Jose, MD • Assistant Professor, School of Health Professions, MS Clinical Research Program
Rutgers, The State University of New Jersey, United States -
Sean Kassim, PhD • Director, Office of Study Integrity and Surveillance, OTS, CDER
FDA, United States -
Sean D. Kennedy, MPH • Global Head, Real World Evidence
ICON plc, United States -
Agnes Klein, MD • Senior Medical Advisor
Health Canada, Canada -
Darryl L'Heureux, PhD, MPharm, MSc • Director, Clinical Science, Medical Writing, and Publications
Ambrx, Inc, United States -
Erik Laughner • Project Manager, Business Operations Staff, OD, CBER
FDA, United States -
Rebecca Lipsitz, PhD • Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
AstraZeneca, United States -
Chris Matheus, MBA • Chief Commercial and Networking Officer
Global Life Sciences Alliance (GLSA), United States -
K. Kimberly McCleary • Founder and Chief Executive Officer
The Kith Collective, LLC, United States -
Ann Meeker-O'Connell, MS • Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States -
Christine Moore, PhD • Executive Director, Global External Advocacy and Standards
Organon & Co., United States -
Jean M. Mulinde, MD • Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States -
Nobumasa Nakashima • Health Policy Director, National Healthcare Policy Secretariat
Cabinet Office, Japan -
Michael Neidl, MBA, MS, MSc • Senior Consultant
Clinical Research Quality Consultant, United States -
David O Olaleye, PhD, MSc • Senior Manager and Principal Research Statistician
SAS Institute Inc., United States -
David J Pepperl, PhD • Senior Consultant and Nonclinical Group Leader
Biologics Consulting, United States -
Sissi Pham, PharmD • Chief Executive Officer
AESARA, United States -
Kim Quaintance-Lunn • Vice President, Head of Regulatory Science and Execution
Alexion, United States -
Giuseppe Randazzo, MS • Vice President, Sciences and Regulatory Affairs
Association for Accessible Medicines, United States -
Margaret Richards, PhD, MPH • Executive Director, Solutions
Panalgo, United States -
Amanda Marie Roache, MS • Senior Director, Science and Regulatory Advocacy
Phrma, United States -
Steven L. Roberds, PhD • Chief Scientific Officer
Tuberous Sclerosis Alliance, United States -
Khyati Roberts, RPh • Retired
Retired, United States -
Khushboo Sharma, MBA • Chief Regulatory Innovation Officer
Accumulus Synergy, United States -
Leigh Shultz, PhD, PMP • Executive Director, Human Health Commercial Operations
Merck & Co., Inc., United States -
Nancy Slater, MBA, PMP • Senior Director, Portfolio Program Management Therapeutic Area Head
AbbVie, Inc., United States -
Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences
University of Southern California School of Pharmacy, United States -
Meredith Smith, PhD, MPA, FISPE • Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States -
Elizabeth Somers, MS • Executive Director, Global Project and Alliance Management
Merck Sharp & Dohme LLC, United States -
Jeffrey N. Stuart, PhD • Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States -
Ling Su, PhD • Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China -
Rachel Turow, JD, MPH • Managing Counsel, FDA Regulatory
Walmart, Inc., United States -
Kristin Voorhees, MA • Director, Patient Advocacy
Ultragenyx, United States -
Robin Whitsell • President
Whitsell Innovations, Inc., United States -
Amy Xia, PhD • Vice President, Center for Design and Analysis
Amgen Inc., United States -
Judith Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States