2021 Innovations in Regulatory Science Summit

Sunday, January 10, 2021 | 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 second 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 2021 CERSI Innovations in Regulatory Science Summit will have a major focus on the COVID19 pandemic including panel discussions on infectious disease and pandemic preparedness as well as how the pandemic continues to affect the development and approval of medical products targeted to other diseases.  We also include a panel focused on the development of innovative medical products for cancer.  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, particularly for infectious disease but also for oncology and other diseases.  

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