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Program Committee
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Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States -
Ginny Hussong Branch Chief, Data Standards, CBER
FDA, United States -
Sarah Powell, RAC President
Powell Regulatory Services, United States -
Jamie Toth, MS Global Head, TMF Management & Records
Beigene, United States -
Venkatraman Balasubramanian, PhD, MBA Healthcare and Life Sciences Strategic Advisor
VB Insights, LLC, United States -
Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
Astellas, United States -
Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
Epista Life Sciences, United States -
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Jake Doran Vice President, Digital
Lykos Therapeutics, United States -
Betsy Fallen, RN Consultant
BAFallen Consulting LLC, United States -
Ron Fitzmartin, PhD, MBA Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Mark A. Gray Senior Project Manager, DSB, CBER
FDA, United States -
Dominique Lagrave, PharmD Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States -
Thomas Noto Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States -
Daniel Orfe, MS President and CEO
Regulatory eSubmissions, LLC, United States -
Vada A. Perkins, DrSc, MSc Vice President, Global Head of Regulatory Intelligence & Policy
Boehringer Ingelheim, United States -
Michiel Stam Management Consultant
MAIN5 Gmbh & Co. Kgaa, Germany -
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States
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