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Program Committee

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH • Director, Regulatory Affairs, Gene Therapy Program
    University of Pennsylvania, Perelman School of Medicine, United States
  • Virginia Hussong
    Virginia 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 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
    NNIT Inc., 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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