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 organize 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 is intended as a pre-conference to the 2019 J.P. Morgan Healthcare Conference. This meeting 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:

  • Artificial Intelligence, Deep Learning and Novel Statistical Approaches: Applications to All Aspects of Regulatory Science
  • Accelerating Clinical Trials in the Development and Approval of Innovative Medical Products
  • Integrating Digital Health Devices into Clinical Evaluation
  • Patient Participation and Real-World Evidence to Guide Regulatory Science
  • Expertise vs Perceived Conflict of Interest: Best Practices for Physicians and Scientists to Advise Regulatory Agencies
  • The Role of Academia, Government and Industry in Regulatory Science: New Models for Cross-Sector Collaboration
  • Advancing Discovery to First-In-Human Clinical Trials for New Medical Products


Confirmed speakers/panelists 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

  • 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 and Co-Founder of Coursera

  • 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

  • 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


Download a printable flyer here: PDF iconFlyer


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