Welcome

Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI

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

Opening Remarks

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

Year in Review

Robert Califf, MD - FDA Commissioner, 2016-2017, 2022-present

Panel 1: Disparities in Clinical Trial Enrollment: What Will it Take to Close the Gap?

Moderators:

Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF

Patrizia Cavazzoni, MD - Director, Center for Drug Evaluation and Research (CDER), FDA

Panelists:

Michael Drake, MD - President, University of California

Congresswoman Anna Eshoo - Chair of the Health Subcommittee in the US House of Representatives

Ricki Fairley, MBA - Chief Executive Officer at Touch, The Black Breast Cancer Alliance

Sohail Rao, MD, MA, DPhil - Founding President & Chief Executive Officer, DHR Health Institute for Research & Development

Ramona Sequeira, MBA - President, Global Portfolio Division, Takeda Pharmaceutical

Panel 2: Cross-Agency Synergy to Accelerate Access to Safe and Effective Medical Products

Moderators:

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

Mark McClellan, MD, PhD - Professor of Business, Medicine, and Policy, Duke University

Panelists:

Rena Conti, PhD - Associate Research Director of Biopharma & Public Policy, Boston University Institute for Health System Innovation & Policy

Lee Fleisher, MD - Chief Medical Officer and Director of the Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services (CMS)

Mathai Mammen, MD, PhD - Executive Vice President, Pharmaceuticals, Research & Development, Johnson & Johnson

Jeff Shuren, MD, JD - Director, Center for Devices and Radiological Health (CDRH), FDA

Panel 3: Building a Global Regulatory Vision for Product and Drug Development: Challenges and Opportunities

Moderators:

Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI

Dan Hartman, MD - Director, Integrated Development, Global Health, Bill & Melinda Gates Foundation

Panelists:

Moji Christianah Adeyeye, PhD,  FAS - Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria

Emer Cooke, MBA - Executive Director of the European Medicines Agency (EMA)

Frank Gupton, PhD - Floyd D. Gottwald, Jr. Chair in Pharmaceutical Engineering and Chair, Professor, Department of Chemical and Life Science Engineering, Virginia Commonwealth University

Peter Marks, MD, PhD - Director, Center of Biologics Evaluation and Research (CBER), FDA

Jacques Mascaro, PhD, MBA - Sr. Vice President, Global Head of Oncology Regulatory Science and Strategy, AstraZeneca

Panel 4: FDA Chiefs Chat

Moderators:

Andy Plump, MD, PhD - President, Research and Development, Takeda Pharmaceutical

Janet Woodcock, MD - FDA Principal Deputy Commissioner

Confirmed Panelists:

Robert Califf, MD - FDA Commissioner, 2016-2017, 2022-present

Scott Gottlieb, MD - FDA Commissioner, 2017-2019

Margaret (Peggy) A. Hamburg, MD - FDA Commissioner, 2009-2015

Mark McClellan, MD, PhD - FDA Commissioner, 2002-2004

Closing Remarks

Janet Woodcock, MD - FDA Principal Deputy Commissioner

Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF

Poster Session & Networking

Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI

Tina Morrison, PhD - Director, Office of Regulatory Science and Innovation (ORSI), FDA