2023 Innovations in Regulatory Science Summit

Accelerating Healthcare Innovation through a Regulatory Lens

Sunday, January 8, 2023 | 8 am to 3 pm Pacific Time

Hybrid Meeting - Virtual & In-Person
Mission Bay Conference Center, San Francisco, CA

About This Event

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the fourth 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 2023 CERSI Innovations in Regulatory Science Summit will have a major focus on emerging issues in regulatory science including diversity in clinical trials, FDA/CMS decision making, and global drug development. In addition, we will be bringing back our exciting panel from 2022 featuring former FDA Commissioners discussing the latest issues facing 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.

Panel Discussions:
  1. Ending Disparities in Clinical Trial Enrollment: What Will It Take?
  2. Cross Agency Synergy to Accelerate Access to Safe and Effective Medical Products
  3. Building a Global Regulatory Vision for Product and Drug Development: Challenges and Opportunities
  4. FDA Chiefs Chat

Call for Posters:
The 2023 Innovations in Regulatory Science Summit Planning Committee invites abstract submissions to be presented at our in-person poster session in San Francisco, CA on Sunday, January 8, 2023. We invite all trainees and researchers to share their regulatory science research at our summit.

Deadline for Submissions:
Friday, November 4, 2022 by 11:59 pm Pacific Time

Notification of Acceptance:
By Thursday, December 1, 2022

Draft Agenda

Times shown in Pacific time (UTC-8)
8:00 - 8:05 am

Welcome

8:05 - 8:10 am

OPENING REMARKS FROM UCSF

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

8:10 - 8:15 am

Opening Remarks from Stanford

8:15 - 8:35 am

Year in review talk

8:35 - 9:35 am

Panel 1 – Ending Disparities in Clinical Trial Enrollment: What Will it Take?

Moderator:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
Patrizia 
Cavazzoni, MD – Director, Center for Drug Evaluation and Research at FDA

Panelists:
Anna Eshoo – Member of Congress (CA-18) at the US House of Representatives
Ricki Fairley, MBA – Chief Executive Officer at Touch, The Black Breast Cancer Alliance
Michelle McMurray-Heath, MD – President and CEO at Biotechnology Innovation Organization (BIO)

9:35 - 9:55 am

Break

9:55 - 10:55 am

PANEL 2 – Cross Agency Synergy to Accelerate Access to Safe and Effective Medical Products

Moderators:
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
Mark McClellan, MD, PhD – Professor of Business, Medicine, and Policy at Duke University

Panelists:
Mark Duggan, PhD, MS – Trione Director of the Stanford Institute for Economic Policy Research at Stanford University
Jeff Shuren, MD, JD – Director, Center for Devices and Radiological Health (CDRH) at FDA
Lee Fleisher, MD – Chief Medical Officer and Director of the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services (CMS)

10:55 - 11:55 am

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

Moderators:
Kathy Giacomini, PhD – Co-PI of UCSF-Stanford CERSI
Dan Hartman – Director, Integrated Development, Global Health at Bill & Melinda Gates Foundation

Panelists:
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA
Jacques Mascaro, PhD, MBA – Senior Vice President, Global Head of Oncology Regulatory Science and Strategy at AstraZeneca
Moji Christianah Adeyeye, PhD, FAS – Director-General at the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria
Frank Gupton, PhD – Floyd D. Gottwald, Jr. Chair in Pharmaceutical Engineering and Chair, Professor, Department of Chemical and Life Science Engineering at Virginia Commonwealth University
Emer Cooke, MBA – Executive Director of the European Medicines Agency (EMA)

11:55 am - 1:00 pm

lunch

1:00 - 2:00 pm

Panel 4 – FDA Chiefs Chat

Moderators:
Andy Plump, MD, PhD – President, Research and Development at Takeda
Janet Woodcock, MD – Principal Deputy Commissioner at FDA

Panelists:
Mark McClellan, MD, PhD – FDA Commissioner from 2002-2004
Margaret A. Hamburg, MD – FDA Commissioner from 2009-2015
Scott Gottlieb, MD – FDA Commissioner from 2017-2019

2:00 - 2:10 pm

CLOSING REMARKS

Kathy Giacomini, PhD – Co-PI of UCSF-Stanford CERSI

2:10 - 3:00 pm

Poster Session and Networking

Kathy Giacomini, PhD – Co-PI of UCSF-Stanford CERSI
Tina Morrison, PhD – Director, Office of Regulatory Science and Innovation at FDA

3:00 pm

Adjournment

Confirmed Speakers, Panelists, and Moderators

Moji Christianah Adeyeye

National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria

Patrizia Cavazzoni

U.S. Food and Drug Administration

Emer cooke

European Medicines Agency

Mark Duggan

Stanford University

Anna Eshoo

U.S. House of Representatives

Laura Esserman

University of California San Francisco

Ricki Fairley

Touch, The Black Breast Cancer Alliance

Lee Fleisher

Centers for Medicare and Medicaid Services

Kathy Giacomini

University of California San Francisco

Scott gottlieb

U.S. Food and Drug Administration

Frank gupton

Virginia Commonwealth University

Margaret A. Hamburg

Former FDA Commissioner

Dan Hartman

Bill & Melinda Gates Foundation

Sam Hawgood

University of California San Francisco

Peter Marks

U.S. Food and Drug Administration

jacques mascaro

AstraZeneca

Mark McClellan

Duke University

Michelle McMurry-Heath

Biotechnology Innovation Organization (BIO)

Tina Morrison

U.S. Food and Drug Administration

Andy Plump

Takeda Pharmaceutical

Jeff shuren

U.S. Food and Drug Administration

Kuldev Singh

Stanford University

Janet Woodcock

U.S. Food and Drug Administration

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

For information or questions about this event, please contact the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation at info@ucsfstanfordcersi.org.

Sponsors

We are happy to partner with organizations that may be interested in sponsoring this event. For sponsorship opportunities, please contact info@ucsfstanfordcersi.org.

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