2022 Innovations in Regulatory Science Summit

The Future of Drug and Device Development

Sunday, January 9, 2022 | 8 am to 3 pm Pacific Time

About This Event

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. 

Save the Date!  More information to come.

Panel Discussions:

  • Early Endpoints and Biomarkers: Opportunities and Pitfalls
  • Biomarkers and Surrogate Endpoints: Alzheimer’s as a Prototype
  • Pandemic and Beyond: The Future of the FDA

Keynote Addresses:

  • Janet Woodcock, MD – Acting FDA Commissioner
  • 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

Sponsorship Opportunities

We are actively looking to partner with organizations that are interested in sponsoring this event. Please contact Lawrence.Lin@ucsf.edu for more information.

About UCSF-Stanford CERSI

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is a joint effort among members of a world-class team of highly collaborative scientists at UC San Francisco, Stanford University, and the U.S. Food and Drug Administration (FDA).

The two academic institutions and the FDA work together on projects that promote regulatory science—including innovative research, education, and scientific exchange—in partnership with foundations and commercial entities interested in the development of FDA-approved medical products. The center collaborates, in particular, with the pharmaceutical, biotechnology, and high-tech industries of the San Francisco Bay Area and the West Coast.

 

Don't Miss the Next CERSI Summit!

The 2022 Innovations in Regulatory Science Summit is scheduled for January 9, 2022. Sign up for details!