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Program Committee
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Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
Epista Life Sciences, United States -
Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States -
Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Ron Fitzmartin, PhD, MBA Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States -
Danielle Beaulieu, PhD Senior Director, Global Regulatory Business Capabilities
Bristol-Myers Squibb, United States -
Ethan Chen, MBA, MS, PMP Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States -
Jake Doran Head of Digital
Lykos Therapeutics, United States -
Ginny Hussong Branch Chief, Data Standards, CBER
FDA, United States -
Joanne Malia, MS, MSc Director, Development Records Management
Regeneron Pharmaceuticals, United States -
Karen McCarthy Schau Director, Risk-based Study Management
Vertex Pharmaceuticals, United States -
Thomas Noto Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States -
Daniel Orfe, MS President and CEO
Regulatory eSubmissions, LLC, United States -
Michiel Stam Management Consultant
MAIN5 Gmbh & Co. Kgaa, Germany -
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States -
Peter Terbeek, MBA Senior Director, Regulatory Operations
United States -
Kevin Tompkins, MBA Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States
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