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2021 CERSI Innovations in Regulatory Science Summit

January 10, 2021 @ 8:00 am - 3:00 pm

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the inaugural Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development. This event will take place before the 2020 J.P. Morgan Healthcare Conference, and will comprise primarily of panel discussions and short research talks by CERSI investigators on ongoing collaborative research projects with FDA investigators.  Keynotes will be given by Janet Woodcock and Peter Marks from the U.S. Food and Drug Administration.

Panel topics include:

  • Accelerating Clinical Trials in the Development and Approval of Innovative Medical Products
  • Academia, Government and Industry in Regulatory Science: Cross-Sector Collaboration and Avoiding Conflicts of Interest
  • Real-World Evidence, Artificial Intelligence and Novel Medical Devices
  • Advancing Discovery to First-In-Human Clinical Trials for New Medical Products

    Confirmed Speakers

    Amy Abernethy (FDA)
    Hal Barron (GlaxoSmithKline)
    Diana Brenner (Gilead)
    Brook Byers (Kleiner Perkins)
    Robert Califf (Verily)
    Jennifer Cochran (Stanford)
    Joe Derisi (UCSF)
    Martha Donoghue (FDA)
    Laura Esserman (UCSF)
    Kathy Giacomini (UCSF)
    Sam Hawgood (UCSF)
    Denise Hinton (FDA)
    Peter Kim (Stanford)
    Nevan Krogan (UCSF)
    Mathai Mammen (Janssen)
    Peter Marks (FDA)
    Mark McClellan (Duke)
    Andy Plump (Takeda)
    George Scangos (Vir)
    Jason Sello (UCSF)
    Jeff Shuren (FDA)
    Kuldev Singh (Stanford)
    John Tsai (Novartis)
    Leslie Wilson (UCSF)
    Anne Wojcicki (23andMe)
    Janet Woodcock (FDA)
    George Yancopoulos (Regeneron)


January 10, 2021
8:00 am - 3:00 pm
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