Innovations in Regulatory Science Summit


Innovations in Regulatory Science Summit

Saturday, January 5, 2019 from 8 am to 5 pm
Mission Bay Conference Center
1675 Owens St, San Francisco, CA 94158

Register Here:


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 2019 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.


Featuring panel discussions on:

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


Speakers include:

  • Howard Bauchner, MD | Editor-in-Chief of the Journal of the American Medical Association (JAMA)

  • Jay Bradner, MD | President of the Novartis Institutes for Biomedical Research

  • Robert Califf, MD | Former FDA Commissioner and Scientific Advisor at Verily Life Sciences

  • Edward Chang, MD | Professor of Neurological Surgery at UCSF

  • Mildred Cho, PhD | Professor of Pediatrics at Stanford

  • Arthur Ciociola, PhD | Vice President, Head Regulatory Affairs, Global Drug Development Ophthalmology at Novartis

  • Laura Esserman, MD, MBA | Professor of Surgery and Radiology at UCSF

  • Adam Gazzaley, MD, PhD | Professor of Neurology, Physiology and Psychiatry at UCSF

  • Kathy Giacomini, PhD | Co-Director of UCSF-Stanford CERSI

  • Steven Goodman, MD, MHS, PhD | Associate Dean of Clinical and Translational Research at Stanford

  • Sam Hawgood, MD | UCSF Chancellor

  • Amita Joshi, PhD | Vice President, Global Head of Clinical Pharmacology at Genentech

  • Ian Knemeyer, PhD | Director of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck

  • Daphne Koller, PhD | Founder & CEO of Insitro

  • Carol Linden, PhD | Director, Office of Regulatory Science and Innovation at FDA

  • Peter Marks, MD, PhD | Director, Center for Biologics Evaluation and Research at FDA

  • Bakul Patel, MSEE, MBA | Associate Director for Digital Health (CDRH) at FDA

  • Carl Peck, MD | Chairman of NDA Partners

  • Joe Polli, PhD | Senior Director at GlaxoSmithKline

  • Alfred Sandrock, MD, PhD | Executive Vice President, Chief Medical Officer at Biogen

  • George Scangos, PhD | CEO of Vir Biotechnology

  • Kuldev Singh, MD, MPH | Professor of Ophthalmology at Stanford

  • Leslie Wilson, PhD | Professor of Clinical Pharmacy at UCSF

  • Anne Wojcicki | CEO and Co-Founder of 23andMe

  • Janet Woodcock, MD | Director, Center for Drug Evaluation and Research at FDA

  • Joseph Wu, MD, PhD | Director of the Stanford Cardiovascular Institute


Please send questions to Lawrence Lin, PhD, Director of External Relations and Outreach at UCSF-Stanford CERSI.