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

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.

While we had originally planned for this to be a hybrid virtual/in-person event, pandemic restrictions have forced us to transition this to a 100% virtual event.

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, featuring FDA commissioners:
    • Janet Woodcock, MD (2021-present)
    • Scott Gottlieb, MD (2017-2019)
    • Robert Califf, MD (2016-2017)
    • Margaret Hamburg, MD (2009-2015)
    • Mark McClellan, MD, PhD (2002-2004)

Keynote Addresses:

  • Patrizia Cavazzoni, MD – Director, Center for Drug Evaluation and Research at FDA
  • Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research at FDA
  • Janet Woodcock, MD – Acting FDA Commissioner

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

Advancing the Manufacturing of Biologics: Lessons from the Pandemic

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
Julia Beaver, MD – Chief of Medical Oncology, Oncology Center of Excellence at FDA
Congresswoman Anna Eshoo – Chair of the Health Subcommittee at U.S. House of Representatives
Michelle McMurry-Heath, MD, PhD – President and CEO at BIO
Sean Tunis, MD – Principal at Rubix Health

9:50 - 10:00 am

Break

10:00 - 11:00 am

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

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

Panelists:
Robert M. Califf, MD, MACC – Head of Clinical Policy and Strategy for Verily and Google Health
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 – Former Head of Research & Development at Biogen
Daniel Skovronsky, MD, PhD – Chief Scientific and Medical Officer at Eli Lilly

11:00 - 11:30 am

The (Near-term) Future of the FDA

Janet Woodcock, MD – Acting Commissioner at FDA

11:30 - 11:50 am

Break

11:50 - 12:10 pm

Meeting Unmet Needs Through Expedited Regulatory Pathways and Inclusive Clinical Trials

Patrizia Cavazzoni, MD – Director, Center for Drug Evaluation and Research at FDA

12:10 - 12:20 pm

Break

12:20 - 1:20 pm

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

Room 1 -
Biologics / Big Data

Moderators:
Deanna Kroetz, PhD – Professor of Bioengineering and Therapeutic Sciences at UCSF

Joseph Wu, MD, PhD – Professor & Director, Stanford Cardiovascular Institute

 

Speakers:

Asthma Biologics in the Real World of Clinical Practice
Molly Jeffery, PhD – Assistant Professor of Health Services Research at Mayo Clinic

Understanding the Use of Animal Models in Evaluating SARS-CoV-2 Vaccine Efficacy
Tony Wang, PhD – Principal Investigator,  OVRR/CBER at FDA

Risk Modeling and the Use of Large Databases for Biologics
Richard Forshee, PhD – Associate Director for Research/OBE/CBER at FDA

Quantifying the Severity of Adverse Drug Reactions Using Social Media
Russ Altman, MD, PhD – Professor of Bioengineering at Stanford

Room 2 -
Medical Devices

Moderators:
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford

Michelle Tarver, MD, PhD – Deputy Director, Office of Strategic Partnerships and Technology Innovation/CDRH at FDA

 Speakers:

Rapid Well-Intended COVID Responses via Additive Manufacturing: Perspectives from UMD’s Fischell Institute for Biomedical Devices
William Bentley, PhD – Professor of Bioengineering at University of Maryland

HIV Genomic Surveillance in Cameroon by Metagenomic Next-Generation Sequencing
Charles Chiu, MD, PhD – Professor of Laboratory Medicine at UCSF

TAP: Transforming the Medtech Innovation Ecosystem
Doug Kelly, MD, MBA – Deputy Director for Science/CDRH at FDA

A Tour Round OSEL Regulatory Research Programs: Linking Regulatory Science Tools with Upstream Innovation
Ed Margerrison, PhD – Director, Office of Science and Engineering Laboratories/CDRH at FDA

Room 3 -
Health Disparities

Moderators:
Anne Wojcicki – Co-founder and CEO of 23andMe

Jason Sello, PhD – Professor of Pharmaceutical Chemistry at UCSF

 

Speakers:

FDA Office of Minority Health and Health Equity: Partnering to Advance Health Equity
RADM Richardae Araojo, PharmD, MS – Associate Commissioner for Minority Health at FDA
Christine Lee, PharmD, PhD – Strategic Research Engagement Lead/OMHHE at FDA

Making Precision Medicine Socially Precise
Esteban Burchard, MD, MPH – Professor of Bioengineering and Therapeutic Sciences at UCSF

Measuring Disparity in Empirical Research: From Statistical Concerns to Value Judgements
John Jackson, ScD – Assistant Professor of Epidemiology at Johns Hopkins

OneSource: Towards Rapid, Efficient and Unbiased Data Collection
Kathleen Liu, MD, PhD – Professor of Medicine at UCSF

1:20 - 1:30 pm

Break

1:30 - 1:50 pm

A Conversation with UC President Michael Drake

Michael V. Drake, MD – President, University of California
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF

1:50 - 2:50 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 A. Hamburg, MD – FDA Commissioner from 2009-2015
Mark McClellan, MD, PhD – FDA Commissioner from 2002-2004

2:50 - 2:55 pm

Closing Remarks From Stanford

Lloyd B. Minor, MD – Dean, Stanford University School of Medicine

2:55 - 3:00 pm

Closing Remarks From UCSF

Talmadge E. King Jr, MD – Dean, UCSF School of Medicine

3:00 pm

Adjournment

Kathy Giacomini, PhD – Co-Director of UCSF-Stanford CERSI
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University

Confirmed Speakers, Panelists, and Moderators

Russ Altman

Stanford University

RADM Richardae Araojo

U.S. Food and Drug Administration

Hal Barron

GlaxoSmithKline

Julia Beaver

U.S. Food and Drug Administration

William Bentley

University of Maryland

Esteban Burchard

University of California San Francisco​

Robert Califf

Former FDA Commissioner

Patrizia Cavazzoni

U.S. Food and Drug Administration

Charles Chiu

University of California San Francisco

Michael Drake

University of California

Mark Duggan

Stanford University

Anna Eshoo

U.S. House of Representatives

Laura Esserman

University of California San Francisco

C. Simone Fishburn

BioCentury

Richard Forshee

U.S. Food and Drug Administration

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

John Jackson

Johns Hopkins University

Molly Jeffery

Mayo Clinic

Doug Kelly

U.S. Food and Drug Administration

Talmadge King

University of California San Francisco

Deanna Kroetz

University of California San Francisco

Christine Lee

U.S. Food and Drug Administration​

Kathleen Liu

University of California San Francisco

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)

Lloyd Minor

Stanford University

Tina Morrison

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

Biogen

George Scangos

Vir Biotechnology

Jason Sello

University of California San Francisco​

Kuldev Singh

Stanford University

Daniel Skovronsky

Eli Lilly and Company

Michelle Tarver

U.S. Food and Drug Administration

Marc Tessier-Lavigne

Stanford University

Sean Tunis

Rubix Health

Tony Wang

U.S. Food and Drug Administration

Anne Wojcicki

23andMe

Janet Woodcock

U.S. Food and Drug Administration

Joseph Wu

Stanford University

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
Executive Director
UCSF-Stanford Center of Excellence in Regulatory Science and Innovation
Lawrence.Lin@ucsf.edu

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