2021 Innovations in Regulatory Science Summit
Sunday, January 10, 2021 | 8 am to 3 pm Pacific Time
About This Event
Panel Discussions:
- Scientific Issues that Underlie the Development, Assessment and Repurposing of Medical Products for Infectious Diseases
- Accelerating the Development and Assessment of Novel Therapies for Cancer: What is Needed
- Pandemic Preparedness: Lessons Learned from COVID-19
- Impact of the COVID-19 Pandemic on the Research, Development and Regulatory Review of Medical Products for Other Indications
Keynote Addresses:
- 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
- Janet Woodcock, MD – Director, Center for Drug Evaluation and Research on detail to Operation Warp Speed and
Principal Medical Advisor to the Commissioner at FDA
Schedule
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, MD – 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
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation: Advancing the Development, Approval and Surveillance of Medical Products
Kathy Giacomini, PhD – Co-Director of UCSF-Stanford CERSI
8:30 - 8:50 am
Keynote Address - The US Clinical Trial Ecosystem Is Deficient
Janet Woodcock, MD – Director, Center for Drug Evaluation and Research on detail to Operation Warp Speed and
Principal Medical Advisor to the Commissioner at FDA
Moderated by Kathy Giacomini, PhD – Professor of Bioengineering and Therapeutic Sciences at
UCSF
8:50 - 10:00 am
Panel 1 - Scientific Issues that Underlie the Development, Assessment, and Repurposing of Medical Products for Infectious Diseases
Moderators:
Robert M. Califf, MD, MACC – Head of Clinical Policy and Strategy for Verily and Google Health
Janet Woodcock, MD – Director, Center for Drug Evaluation and Research on detail to Operation Warp Speed and
Principal Medical Advisor to the Commissioner at FDA
Panelists:
Diana Brainard, MD – Senior Vice President and Virology Therapeutic Area Head at Gilead Sciences
George Scangos, PhD – President and Chief Executive Officer of Vir Biotechnology
RADM Denise Hinton, MS – Chief Scientist at FDA
Peter Kim, PhD – Professor of Biochemistry at Stanford
10:00 - 10:10 am
Break
10:10 - 11:20 am
Panel 2 – Accelerating the Development and Assessment of Novel Therapies for Cancer: What is Needed
Moderators:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research at FDA
Panelists:
Gideon Blumenthal, MD – Vice President of Global Regulatory Affairs for Oncology at Merck
Martha Donoghue, MD – Acting Deputy Director, Division of Oncology 2, Offices of Oncologic Diseases at FDA
at FDA
John Tsai, MD – Head of Global Drug Development and Chief Medical Officer at Novartis
George Yancopoulos, MD, PhD – Co-Founder, President and Chief Scientific Officer at Regeneron
11:20 - 11:40 am
Keynote Address - Advancing Bespoke Therapeutics
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research at FDA
Moderated by Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
11:40 - 12:10 pm
Lightning Talks in Regulatory Sciences
Room 1
Moderator:
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
Speakers:
Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment, for Binary, Ordinal, and Time-to-Event Outcomes
Michael Rosenblum, PhD – Associate Professor of Biostatistics at Johns Hopkins
The ISPY COVID Trial: Adapting Lessons Learned in Oncology to Combat the Pandemic
Carolyn Calfee, MD – Professor of Medicine at UCSF
Vaccine Platforms for Rapid Product Development
Wilbur Chen, MD, MS – Professor of Medicine at University of Maryland
Room 2
Moderator:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
Speakers:
Purposeful Trials
Clive Meanwell, MD, PhD – Executive Chairman of Population Health Partners
Studying SARS-CoV-2 through an international collaboration
Nevan Krogan, PhD – Professor of Cellular and Molecular Pharmacology at UCSF
“Unconventional” Therapeutics: Host-Directed Anti-Infective Agents
Jason Sello, PhD – Professor of Pharmaceutical Chemistry at UCSF
Room 3
Moderator:
Kathy Giacomini, PhD – Professor of Bioengineering and Therapeutic Sciences at
UCSF
Speakers:
Pediatric Drug Policies Supporting Safe And Effective Use Of Therapeutics In Children
Florence Bourgeois MD, MPH – Associate Professor of Pediatrics at Harvard
Quantifying Physical Function Using Wearables and Patient Reported Outcomes in Cancer Patients Undergoing Chemotherapy
Gita Thanarajasingham, MD – Assistant Professor of Medicine at Mayo Clinic
Hard to Control Diabetes State Preference for Islet Cell Transplant: FDA Biologics Sponsored Studies
Leslie Wilson, PhD – Professor of Clinical Pharmacy at UCSF
12:10 - 12:20 pm
Break
12:20 - 1:30 pm
Panel 3 – Pandemic Preparedness: Lessons Learned from COVID-19
Moderators:
Joe Derisi, PhD – Professor of Biochemistry and Biophysics at UCSF
Anne Wojcicki – CEO and Co-Founder of 23andMe
Panelists:
Amy Abernethy, MD, PhD – Principal Deputy Commissioner at FDA
Michael Drake, MD – President, University of California
Sam Hawgood, MD – UCSF Chancellor
Mark McClellan, MD, PhD – Professor of Business, Medicine and Health Policy at Duke
Jeff Shuren, MD, JD – Director of the Center for Devices and Radiological Health at FDA
1:30 - 1:50 pm
Keynote Address - Update from CDRH
Jeff Shuren, MD, JD – Director of the Center for Devices and Radiological Health at FDA
Moderated by Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
1:50 - 3:00 pm
Panel 4 – Impact of the COVID-19 Pandemic on the Research, Development and Regulatory Review of Medical Products for Other Indications
Moderator:
Jennifer Cochran, PhD – Chair of Bioengineering at Stanford
Andy Plump, MD, PhD – President, Research & Development at Takeda
Panelists:
Hal Barron, MD – Chief Scientific Officer at GlaxoSmithKline
Patrizia Cavazzoni, MD – Acting Director, Center for Drug Evaluation and Research at FDA
Mathai Mammen, MD, PhD – Global Head of Research and Development at Janssen Pharmaceutical Companies of Johnson & Johnson
Clive Meanwell, MD, PhD – Executive Chairman of Population Health Partners
George Yancopoulos, MD, PhD – Co-Founder, President and Chief Scientific Officer at Regeneron
Amy Abernethy
U.S. Food and Drug Administration
Hal Barron
GlaxoSmithKline
Gideon Blumenthal
Merck & Co.
Florence Bourgeois
Harvard Medical School
Diana Brainard
Gilead Sciences
Carolyn Calfee
University of California San Francisco
Robert Califf
Verily Life Sciences / Google Health
Patrizia Cavazzoni
U.S. Food and Drug Administration
Wilbur Chen
University of Maryland
Jennifer Cochran
Stanford University
Joe Derisi
University of California San Francisco
Martha Donoghue
U.S. Food and Drug Administration
Michael Drake
University of California
Laura Esserman
University of California San Francisco
Kathy Giacomini
University of California San Francisco
Sam Hawgood
University of California San Francisco
Denise Hinton
U.S. Food and Drug Administration
Peter Kim
Stanford University
Nevan Krogan
University of California San Francisco
Mathai Mammen
Johnson & Johnson
Peter Marks
U.S. Food and Drug Administration
Mark McClellan
Duke University
Clive Meanwell
Population Health Partners
Andy Plump
Takeda Pharmaceutical
Michael Rosenblum
Johns Hopkins University
George Scangos
Vir Biotechnology
Jason Sello
University of California San Francisco
Jeff Shuren
U.S. Food and Drug Administration
Kuldev Singh
Stanford University
Marc Tessier-Lavigne
Stanford University
Gita Thanarajasingham
Mayo Clinic
John Tsai
Novartis
Leslie Wilson
University of California San Francisco
Anne Wojcicki
23andMe
Janet Woodcock
U.S. Food and Drug Administration
George Yancopoulos
Regeneron Pharmaceuticals
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 UC 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
Summit Sponsors
