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Program Committee
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Michelle L. Charles, MPH • Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
University of Pennsylvania, Perelman School of Medicine, United States -
Virginia Hussong • Chief, Data Standards Program, CBER
FDA, United States -
Sarah Powell, RAC • President
Powell Regulatory Services, United States -
Jamie Marie Toth, MS • Director/Head of TMF Operations
Daiichi Sankyo, Inc., United States -
Venkatraman Balasubramanian, PhD, MBA • President and CEO
Cabeus, Inc., United States -
Christian A. Buckley, MBA, RAC • Associate Director, Regulatory Affairs
Astellas, United States -
Brooke Casselberry, MS, RAC • Director, Consulting Expert
CGI Technologies, United States -
Cindy Chiu • Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Jake Doran • Chief Technology Officer
Genpact, United States -
Betsy Fallen, RN • Consultant
BAFallen Consulting LLC, United States -
Ron D. Fitzmartin, PhD, MBA • Data Standards Staff, Office of the Director, CBER
FDA, United States -
Mark A. Gray • Senior Project Manager, BSS, CBER
FDA, United States -
Dominique Lagrave, PharmD • Director, Global Regulatory Affairs and Safety Operations
Amgen, United States -
Thomas J. Noto • Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States -
Daniel F. Orfe, MS • President and CEO
Regulatory eSubmissions, LLC, United States -
Vada Perkins • Regulatory Policy and Intelligence
Bayer Pharmaceuticals, United States -
Michiel Stam • Regulatory Information Scientist
eCTDconsultancy B.V., Netherlands -
Stacy Tegan • Sr. Program Manager
Transcelerate Biopharma, Inc., United States
