2022 Innovations in Regulatory Science Summit

Movers and Shapers: The Future of Drug and Device Development

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

Mission Bay Conference Center – 1675 Owens St, San Francisco, CA

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.

Panel Discussions:

  • 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

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

Registration

Registration is currently open; you may indicate on the registration page if you are interested in attending in person.

We will provide information on registration for in-person attendance at a later date, depending on local conditions.

Agenda

Times shown in Pacific time (UTC-8)
8:00 - 8:05 am

Welcome

Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University

8:05 - 8:10 am

OPENING REMARKS FROM UCSF

Sam Hawgood, MBBS – Chancellor, University of California San Francisco (UCSF)

8:10 - 8:15 am

OPENING REMARKS FROM Stanford

Marc Tessier-Lavigne, PhD – President, Stanford University

8:15 - 8:30 am

Overview of the CERSI Program

Kathy Giacomini, PhD – Co-Director of UCSF-Stanford CERSI
Tina Morrison, PhD – Director, Office of Regulatory Science and Innovation at FDA

8:30 - 8:50 am

KEYNOTE ADDRESS

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

8:50 - 9:50 am

PANEL 1 - Issues and Opportunities Generated by Accelerated Approval: Confirmatory Endpoints, Evidence Generation, and Value

Moderators:
Robert M. Califf, MD, MACC – Head of Clinical Policy and Strategy for Verily and Google Health
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF

Panelists:
Hal Barron, MD – Chief Scientific Officer at GlaxoSmithKline
Michelle McMurry-Heath, MD, PhD – President and CEO at BIO
Richard Pazdur, MD – Director, Oncology Center of Excellence at FDA
Others TBA

9:50 - 10:00 am

Morning Break

10:00 - 11:00 am

PANEL 2 – Biomarkers and Surrogate Endpoints: Alzheimer’s as a Prototype

Moderators:
George Scangos, PhD – President and Chief Executive Officer of Vir Biotechnology
C. Simone Fishburn, PhD – Vice President and Editor in Chief at BioCentury

Panelists:
Mark Duggan, PhD – Professor of Economics at Stanford University
Susan Peschin, MHS – President and CEO at Alliance for Aging Research
Gil Rabinovici, MD – Professor of Neurology at UCSF
Alfred Sandrock, Jr, MD, PhD – Executive Vice President, Research & Development at Biogen
Daniel Skovronsky, MD, PhD – Chief Scientific and Medical Officer at Eli Lilly
Others TBA

11:00 - 11:20 am

KEYNOTE ADDRESS

Janet Woodcock, MD – Acting Commissioner at FDA

11:20 - 11:50 am

lunch break

11:50 - 12:50 pm

Research Talks in Biologics, Medical Devices and Health Disparities (Concurrent Sessions)

Room 1 -
Biologics / Big Data

Russ Altman, MD, PhD – Professor of Bioengineering at Stanford

Molly Jeffrey, PhD – Assistant Professor of Health Services Research at Mayo Clinic

Other Speakers TBA

Room 2 -
Medical Devices

Charles Chiu, MD, PhD – Professor of Laboratory Medicine at UCSF

Ed Margerrison, PhD – Director, Office of Science and Engineering Laboratories/CDRH at FDA

Doug Kelly, MD, MBA – Deputy Director for Science/CDRH at FDA

Other Speakers TBA

Room 3 -
Health Disparities

Esteban Burchard, MD, MPH – Professor of Bioengineering at UCSF

John Jackson, ScD – Assistant Professor of Epidemiology at Johns Hopkins

RADM Richardae Araojo, PharmD, MS – Associate Commissioner for Minority Health at FDA

Christine Lee, PharmD, PhD – Strategic Research Engagement Lead/OMHHE at FDA

Other Speakers TBA

12:50 - 1:00 pm

AFTERNOON BREAK

1:00 - 1:20 pm

KEYNOTE ADDRESS

Jeff Shuren, MD, JD – Director, Center for Devices and Radiological Health at FDA

1:20 - 2:20 pm

PANEL 3 – PANDEMIC and Beyond: the Future of the FDA

Moderators:
Andy Plump, MD, PhD – President, Research & Development at Takeda
Janet Woodcock, MD – Acting FDA Commissioner

Panelists:
Scott Gottlieb, MD – FDA Commissioner from 2017-2019
Robert M. Califf, MD – FDA Commissioner from 2016-2017
Margaret Hamburg, MD – FDA Commissioner from 2009-2015
Mark McClellan, MD, PhD – FDA Commissioner from 2002-2004

2:20 - 2:40 pm

Special Talk

2:40 - 2:45 pm

closing remarks From Stanford

2:45 - 2:50 pm

closing remarks From UCSF

Confirmed Speakers and Panelists

Russ Altman

Stanford University

RADM Richardae Araojo

U.S. Food and Drug Administration

Hal Barron

GlaxoSmithKline

Esteban Burchard

University of California San Francisco​

Robert Califf

Former FDA Commissioner

Charles Chiu

University of California San Francisco

Mark Duggan

Stanford University

Laura Esserman

University of California San Francisco

C. Simone Fishburn

BioCentury

Kathy Giacomini

University of California San Francisco

Scott Gottlieb

Former FDA Commissioner

Margaret A. Hamburg

Former FDA Commissioner

Sam Hawgood

University of California San Francisco

Molly Jeffery

Mayo Clinic

Doug Kelly

U.S. Food and Drug Administration

Christine Lee

U.S. Food and Drug Administration​

Ed Margerrison

U.S. Food and Drug Administration

Peter Marks

U.S. Food and Drug Administration

Mark McClellan

Former FDA Commissioner

Michelle McMurry-Heath

Biotechnology Innovation Organization (BIO)

Tina Morrison

U.S. Food and Drug Administration

Richard Pazdur

U.S. Food and Drug Administration

susan Peschin

Alliance for Aging Research

Andy Plump

Takeda Pharmaceutical

Gil Rabinovici

University of California San Francisco

Alfred Sandrock, Jr

Biogen

GEORGE SCANGOS​

Vir Biotechnology

Jeffrey Shuren

U.S. Food and Drug Administration​

Kuldev Singh

Stanford University

Daniel Skovronsky

Eli Lilly and Company

Marc Tessier-Lavigne

Stanford University

Janet Woodcock

U.S. Food and Drug Administration

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 the University of California 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.

 

Contact

Lawrence Lin, PhD
Director, External Relations and Outreach
UCSF-Stanford Center of Excellence in Regulatory Science and Innovation
Lawrence.Lin@ucsf.edu

Sponsorship Opportunities

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