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Program Committee
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Julie Louise Gerberding • Executive Vice President and Chief Patient Officer
Merck & Co., Inc., United States -
Tatsuya Kondo, MD, PhD • President
SH Medical Excellence JAPAN, Japan -
Teresa Ancukiewicz, MA • Senior Manager, Clinical Data Management
Boston Scientific Corporation, United States -
Jonathan Raymond Andrus, MS • Chief Business Officer
Clinical Ink, United States -
Kimberly Belsky, MS • Executive Director Regulatory Policy & Intelligence and Labeling Operations, Reg
Mallinckrodt Pharmaceuticals, United States -
Larry A. Blankstein, PhD • Head of Clinical Operations
Synlogic, United States -
Philip (P.J.) Brooks, PhD • Program Director, Office of Rare Diseases Research
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 -
Susan Callery-D'Amico, BSN • Vice President, R&D Quality Assurance
AbbVie, Inc., United States -
Juan Castano, MBA, PMP • Associate Director, Asset Planner
Pfizer Inc, United States -
Dannis Chang, PharmD • Senior Director, Medical Communications & Operations
Myovant Sciences, United States -
Yeh-Fong Chen, PhD • Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
FDA, United States -
Karla Childers, MS • Senior Director, Strategic Projects, Office of the Chief Medical Officer
Johnson & Johnson, United States -
Leah Christl, PhD • Executive Director, Global Regulatory and R&D Policy
Amgen, United States -
Deborah E. Collyar • President
Patient Advocates In Research (PAIR), United States -
Brenda Crowe, PhD • Senior Research Advisor, Global Statistical Sciences
Eli Lilly and Company, United States -
Sara Doshi, PharmD • Director, Medical Information Strategy and Capabilities, GMI
Eli Lilly and Company, United States -
Ron Fitzmartin, PhD, MBA • Senior Informatics Advisor, Office of the Director, CBER
FDA, 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 -
Jennifer Graff, PharmD • Vice President, Comparative Effectiveness Research
National Pharmaceutical Council (NPC), 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 • Patient Advocacy
bluebird bio, Inc., United States -
Frank Hubbard, PhD, MS • President
Global Regulatory Writing Solutions Inc., United States -
Virginia Hussong • Chief, Data Standards Program, CBER
FDA, United States -
Nita Ichhpurani, PMP • Consultant
Phase One Forward, Canada -
Nadina Jose, MD • Assistant Professor, School of Health Professions, MS Clinical Research Program
Rutgers, The State University of New Jersey, United States -
Sean Y. 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 -
Lisa Palladino Kim, MS • Director of Capstone / Lecturer
Rutgers School of Health Professions, United States -
Agnes Victoria Klein, MD • Senior Medical Advisor
Health Canada, Canada -
Mark Kryah, PMP • Senior Advisor/COO, Bio-Medicines Business Unit
Eli Lilly and Company, United States -
Vicky Martin • Sr Director US Business Development
IDDI Inc., United States -
Chris Matheus, MBA • President
Matheus BD Connections LLC, United States -
Ann Meeker-O'Connell, MS • Vice President, Integrated QMS/OMS
Vertex Pharmaceuticals, United States -
Christine M. V. Moore, PhD • Executive Director and Global Head, CMC Policy
Merck & Co., Inc., United States -
Jean M. Mulinde, MD • Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER
FDA, United States -
Michael Neidl, MBA, MS, MSc • Senior Clinical Research Executive
Clinical Research Consultant, LLC, United States -
David J Pepperl, PhD • Senior Consultant and Nonclinical Group Leader
Biologics Consulting, United States -
Kim Quaintance-Lunn • Vice President and Head, Regulatory Policy, Regulatory Affairs Americas
Bayer US LLC, United States -
Margaret Richards, PhD, MPH • Senior Research Leader, Real World Evidence
Evidera, United States -
Peter Richardson, PhD • Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency, Netherlands -
Steven L. Roberds, PhD • Chief Scientific Officer
Tuberous Sclerosis Alliance, United States -
Khyati Roberts, RPh • Head US/Canada, Regulatory Policy and Intelligence
AbbVie, Inc., United States -
Mitra Rocca, MSc • Associate Director, Medical Informatics, Office of Translational Science, CDER
FDA, United States -
David H. Schubert • Vice President of Regulatory and Quality
Stealth BioTherapeutics, United States -
Leigh Shultz, PhD, PMP • Associate Vice President, Global Project and Alliance Management
Merck & Co., Inc., United States -
Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences
University of Southern California School of Pharmacy, United States -
Meredith Smith, DrPH, PhD, MPA • Director, Risk Management, Global Drug Safety, Research and Development
Alexion Pharmaceuticals, United States -
Elizabeth Somers, MS • Executive Director of Infectious Disease, Global Project and Alliance Management
Merck & Co., Inc., United States -
Jeffrey N. Stuart, PhD • Associate Vice President, Global Regulatory Affairs
Merck & Co., Inc., United States -
Ling Su, PhD • Professor
Shenyang Pharmaceutical University, China -
Veronica Todaro, MPH • Chief Operating Officer
Parkinson's Foundation, United States -
Toshiyoshi Tominaga, PhD • Senior Advisor
Japan Self-Medication Industry, Japan -
Rebecca A. Vermeulen, RPh • Vice President Patients and Society Strategy Lead Product Development
Hoffmann-La Roche Ltd., United States -
Kristin Voorhees, MA • Senior Manager, Patient Advocacy
Ultragenyx Pharmaceutical, United States -
Karen D. Weiss, MD • Vice President, Global Regulatory Affairs
Janssen Pharmaceutical Companies of Johnson & Johnson, United States -
Robin Whitsell • President
Whitsell Innovations, Inc., United States -
Annette S. Williams, MBA, RPh • Vice President, Pharmacovigilance
IQVIA, United States -
Michael Williams • Managing Partner
Facio Consulting Group and Associates, United States -
Amy Xia, PhD • Vice President, Biostatistics, Design & Innovation
Amgen Inc., United States -
Judith Zander, DrMed, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States