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: Is There a New Future for Clinical Development?
  • Model-informed, Adaptive Clinical Trials to Accelerate Development and Evaluation of Next Generation Drugs and Biologics
  • Accelerating the Approval of Innovative Devices to Mitigate Investment Risk
  • The Evolving Regulatory Science of Digital Health
  • 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 panelists include:

  • Jay Bradner, MD | President of Novartis Institutes for Biomedical Research
  • Robert Califf, MD | Former FDA Commissioner and Scientific Advisor at Verily Life Sciences
  • Laura Esserman, MD, MBA | Professor of Surgery and Radiology at UCSF
  • Kathy Giacomini, PhD | Co-Director of UCSF-Stanford CERSI
  • Amita Joshi, PhD | Vice President, Global Head of Clinical Pharmacology at Genentech
  • Ian Knemeyer, PhD | Director of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck
  • Joe Polli, PhD | Senior Director at GlaxoSmithKline
  • George Scangos, PhD | CEO of Vir Biotechnology
  • Kuldev Singh, MD | Professor of Ophthalmology at Stanford
  • Anne Wojcicki | CEO and Co-Founder of 23andMe
  • Joe Wu, 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.