Welcome

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

Opening Remarks from UCSF

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

Opening Remarks from Stanford

Marc Tessier-Lavigne, PhD - President, Stanford University

Overview of the CERSI Program

Kathy Giacomini, PhD - Co-Director of UCSF-Stanford CERSI

Tina Morrison, MD - Director, Office of Regulatory Science and Innovation at FDA

Advancing the Manufacturing of Biologics: Lessons from the Pandemic

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

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 McMurr-Heath, MD, PhD - President and CEO at BIO

Sean Tunis, MD - Principal at Rubix Health

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

The (Near-term) Future of the FDA

Janet Woodcock, MD - Acting Commissioner at FDA

Meeting Unmet Needs Through Expedited Regulatory Pathways and Inclusive Clinical Trials

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

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 University

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 - E.G. 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 and 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 Judgments - 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

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

Panel 3 - Pandemic and Beyond: the Future of the FDA

Moderators:

Andy Plumb, MD, PhD - President, Research & Development at Takeda

Janet Woodcock, MD - Acting Commissioner at FDA

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

Closing Remarks from Stanford

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

Closing Remarks from UCSF

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

Adjournment

Kathy Giacomini, PhD - Co-Director of UCSF-Stanford CERSI

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