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Program Committee
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Julie Louise Gerberding, MD, MPH • Executive Vice President and Chief Patient Officer
Merck & Co., Inc., United States -
Tatsuya Kondo, MD, PhD • Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Teresa Ancukiewicz, MA • Senior Manager, Clinical Data Management
Boston Scientific Corporation, United States -
Jonathan Andrus, MS • Chief Operations and Data Officer
Clinical Ink, Inc., United States -
Kimberly Belsky, MS • Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence
Mallinckrodt Pharmaceuticals, United States -
Larry A. Blankstein, PhD • Head of Clinical Operations
Synlogic, United States -
Philip Brooks, PhD • Program Director, Office of Rare Diseases Research & Div of Clinical Innovation
NIH, National Center for Advancing Translational Sciences (NCATS), United States -
Jennifer Burgess • Executive Director of Engagement
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, Global Medical Information and Scientific Communications
Halozyme Therapeutics Inc., United States -
Yeh-Fong Chen, PhD • Mathematical Statistician, 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 • Associate Director for Therapeutic Biologics, TBBS, OND, CDER
FDA, 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 D. Fitzmartin, DIAFellow, PhD, MBA • Senior Advisor, Office of Strategic Programs, CDER
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 • 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, International Affairs
European Medicines Agency (EMA), United Kingdom -
Jennifer Helfer, PhD, MA • Patient Advocacy
bluebird bio, Inc., United States -
Frank Hubbard, PhD • President
Global Regulatory Writing Solutions, Inc., United States -
Virginia Hussong • Chief, Data Standards Program, CBER
FDA, United States -
Nita Ichhpurani, PMP •
Canada -
Nadina Jose, MD • Assistant Professor, Clinical Trial Sciences, BioPharma Educational Initiative
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 Kennedy, MPH • Principal, Real World Evidence, Late Stage, Clinical Division
Syneos Health, United States -
Lisa Kim, MS • Director of Capstone / Lecturer
Rutgers School of Health Professions, United States -
Agnes V. Klein, MD • Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
Health Canada, Canada -
Mark A. Kryah, PMP • Senior Advisor/COO, Bio-Medicines Business Unit
Eli Lilly and Company, United States -
Vicky Martin • Senior Director, US Business Development
IDDI, United States -
Chris Matheus, MBA • President
Matheus BD Connections, United States -
Ann Meeker-O'Connell, MS • Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products
Johnson & Johnson, United States -
Christine M. V. Moore, PhD • Global Head and Executive Director, GRACS CMC - Policy
Merck Research Laboratories, United States -
Jean M. Mulinde, MD • Senior Policy Advisor, Office of Scientific Investigations, OC, CDER
FDA, United States -
Michael J. Neidl, MBA, MS • 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, Regulatory Policy, NA
Bayer, United States -
Margaret Richards, PhD, MPH • Executive Director, Scientific Affairs, Real-World Solutions
PRA Health Sciences, United States -
Peter Richardson, PhD • Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency (EMA), European Union, United Kingdom -
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 • Associate Vice President, Project Management
Merck & Co., Inc., United States -
Nancy Pire Smerkanich, DrSc, MS • Assistant Professor, Clinical Pharmacy; Educational Liaison & Instructor, ICRS
University of Southern California, United States -
Meredith Y. Smith, PhD, MPA • Global Risk Management Officer, Global Patient Safety
Amgen Inc., United States -
Elizabeth Somers, MSc, PMP • Executive Director of Infectious Disease, Global Project and Alliance Management
Merck & Co., Inc., United States -
Margaret Stiltner-Richmond • Senior Global Project Manager
Paragon Global CRS, United States -
Jeffrey N. Stuart, PhD, RAC • Global Regulatory Director, Oncology, Immunology, and InVitro Diagnostics
Merck & Co., Inc., United States -
Ling Su, DIAFellow, PhD • Past President, DIA Board of Directors; Professor
Shenyang Pharmaceutical University, China -
Veronica L. Todaro, MPH • Vice President, National Programs
Parkinson's Foundation, United States -
Toshiyoshi Tominaga, PhD • Associate Executive Director (for International Programs)
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Rebecca A. Vermeulen, RPh • Head, Customer Strategy Global Medical Affairs
Hoffmann-La Roche Ltd., Switzerland -
Kristin Voorhees, MA • Senior Manager, Patient Advocacy
Ultragenyx Pharmaceutical, United States -
Karen D. Weiss, MD, MPH • 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, Lifecycle Safety
IQVIA, United States -
Michael Williams • Sales Director and Business Development
Synergistix, United States -
Amy Xia, PhD • Executive Director, Biostatistics
Amgen Inc., United States -
Judith W. Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States