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
8:05 - 8:10 am
Opening Remarks from 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
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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