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Program Committee

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
    University of Pennsylvania, Perelman School of Medicine, United States
  • Ginny  Hussong
    Ginny Hussong Chief, Data Standards Program, CBER
    FDA, United States
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Jamie Marie Toth, MS
    Jamie Marie Toth, MS Director, Head of TMF Operations
    Daiichi Sankyo, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Senior Vice President, Life Sciences
    Orion Business Innovation, United States
  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
    Astellas, United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Senior Director, R&D Consulting
    NNIT, United States
  • Cindy  Chiu
    Cindy Chiu Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, DSS, CBER
    FDA, United States
  • Dominique  Lagrave, PharmD
    Dominique Lagrave, PharmD Director, Global Regulatory Affairs and Safety Operations
    Amgen, United States
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Vada A.  Perkins, DrSc, MSc
    Vada A. Perkins, DrSc, MSc Executive Director, Regulatory Policy and Intelligence
    Bayer Pharmaceuticals, United States
  • Michiel  Stam
    Michiel Stam Head of Data Management and Regulatory Information Scientist
    Qdossier, Netherlands
  • Stacy  Tegan
    Stacy Tegan Senior Program Manager
    Transcelerate Biopharma Inc., United States
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