Event

Innovations in Regulatory Science Summit

Sunday, January 9, 2022
11:00 a.m.-6:00 p.m.
Hybrid Event
Lawrence Lin, Ph.D. (UCSF-Stanford CERSI)
Lawrence.Lin@ucsf.edu
https://cersisummit.com/

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the third annual 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. 

The 2022 CERSI Innovations in Regulatory Science Summit will have a major focus on the use of biomarkers and endpoints in medical product development, and includes an exciting panel featuring past FDA Commissioners discussing how the COVID-19 pandemic has changed the Agency.

The goal of the summit is to stimulate discussion across sectors and to critically consider lessons learned and scientific issues that need addressing to expeditiously and safely advance the development, approval and monitoring of medical products.

This meeting is currently being planned as a hybrid virtual/in-person event, but may transition to a fully virtual meeting if conditions warrant. 

Panels include:

• Issues and Opportunities Generated by Accelerated Approval: Confirmatory Endpoints, Evidence Generation, and Value
• Biomarkers and Surrogate Endpoints: Alzheimer’s as a Prototype
• Pandemic and Beyond: The Future of the FDA (Featuring Former FDA Commissioners)

Keynote Addresses:

• Peter Marks, MD, PhD | Director, Center for Biologics Evaluation and Research at FDA
• Jeffrey Shuren, MD, JD | Director, Center for Devices and Radiological Health at FDA
• Janet Woodcock, MD | Acting FDA Commissioner

Confirmed Speakers Include:

• Russ Altman, MD, PhD | Professor of Bioengineering at Stanford
• RADM Richardae Araojo, PharmD, MS | Associate Commissioner for Minority Health at FDA
• Hal Barron, MD | Chief Scientific Officer at GlaxoSmithKline
• Bill Bentley, PhD | Professor of Bioengineering at University of Maryland
• Esteban Burchard, MD, MPH | Professor of Bioengineering at UCSF
• Robert M. Califf, MD, MACC | Former FDA Commissioner, 2016-2017
• Charles Chiu, MD, PhD | Professor of Laboratory Medicine at UCSF
• Michael Drake, MD | President, University of California
• Mark Duggan, PhD | Professor of Economics at Stanford
• Laura Esserman, MD, MBA | Professor of Surgery and Radiology at UCSF
• C. Simone Fishburn, PhD | Vice President and Editor-in-Chief at BioCentury
• Kathy Giacomini, PhD | Co-Director of UCSF-Stanford CERSI
• Scott Gottlieb, MD | Former FDA Commissioner, 2017-201
• Margaret Hamburg, MD | Former FDA Commissioner, 2009-2015
• Sam Hawgood, MD | UCSF Chancellor
• Molly Jeffery, PhD | Assistant Professor of Health Services Research at Mayo Clinic
• Doug Kelly, MD, MBA | Deputy Center Director for Science/CDRH at FDA
• Christine Lee, PharmD, PhD | Strategic Research Engagement Lead/OMHHE at FDA
• Kathleen Liu, MD, PhD | Professor of Medicine at UCSF
• Ed Margerrison, PhD | Director, Office of Science and Engineering Laboratories/CDRH at FDA
• Mark McClellan, MD, PhD | Professor of Business, Medicine and Health Policy at Duke
• Michelle McMurry-Heath, MD, PhD | President and CEO at BIO
• Tina Morrison, PhD | Director, Office of Regulatory Science and Innovation at FDA
• Richard Pazdur, MD | Director, Oncology Center of Excellence at FDA
• Susan Peschin, MHS | President and CEO at Alliance for Aging Research
• Andy Plump, MD, PhD | President, Research & Development at Takeda
• Gil Rabinovici, MD | Professor of Neurology at UCSF
• Al Sandrock, MD, PhD | Executive Vice President, Research & Development at Biogen
• George Scangos, PhD | CEO of Vir Biotechnology
• Kuldev Singh, MD, MPH | Professor of Ophthalmology at Stanford
• Dan Skovronsky, MD, PhD | Chief Scientific and Medical Officer at Eli Lilly
• Marc Tessier-Lavigne, PhD | President, Stanford University