UCSF

About

About

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.

Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

Aims

The center aims to meet scientific challenges in issues of critical importance in the development and evaluation of FDA-regulated products and at a time of rapid technological progress by:

  • Advancing regulatory science through the development and application of quantitative and systems-level methodologies.
  • Creating a West Coast presence of the FDA to enhance communication between academia and the pharmaceutical, biotechnology, and high–tech industries, with the FDA, about regulatory science.

Focus areas

The UCSF-Stanford CERSI builds on the enormous strengths of UCSF and Stanford University in the quantitative sciences and pharmacology to provide novel education, exchange, and collaborative research programs that focus on three key FDA priority areas as described in the FDA Strategic Plan for Regulatory Sciences:

  1. Improving preclinical safety and efficacy tests
  2. Improving clinical trials and evaluation
  3. Harnessing diverse data sets through information sciences to accelerate and improve new drug development

Collaboration: interdisciplinary and multidisciplinary

The UCSF-Stanford CERSI is the first regulatory science center on the West Coast. Due to its unique geographic location and proximity to the San Francisco Bay Area pharmaceutical, biotechnology, and high-tech industries it naturally creates a liaison among the FDA, academia, and industry, supporting a collaborative environment within—as well as beyond—the two institutions.

The center is uniquely positioned to foster strong interdisciplinary and multidisciplinary collaborations through its diverse array of schools, departments, and institutes. Both universities bring their individual academic and research strengths to the center.

UCSF

Stanford University

Both universities benefit from having their own medical centers and associated U.S. Veterans Affairs Medical Centers:

FDA CERSI Lecture Series

Lectures are presented by scientists from CERSI Academic Institutions

FDA CERSI Workshops

Workshops are held collaboratively between FDA and CERSI Academic Institutions

Related links

Beginnings

The UCSF-Stanford CERSI was launched in April 2014. See the public announcement.

People

Center leadership

Kathy Giacomini, PhD, BSPharm

Co-Principal Investigator, UCSF-Stanford CERSI
Professor, Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine

Russ Altman

Russ B. Altman, MD, PhD

Co-Principal Investigator, UCSF-Stanford CERSI
Professor, Departments of Bioengineering, Genetics, Medicine and Computer Science
Stanford University, Schools of Engineering and Medicine

Lawrence Lin, PhD

Executive Director, UCSF-Stanford CERSI
Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine

Nathan Dang, PharmD

Program Coordinator, UCSF-Stanford CERSI
Department of Bioengineering and Therapeutic Sciences
UCSF Schools of Pharmacy and Medicine

Mark Dresser, PhD

Educational Program Director, UCSF-Stanford CERSI
UCSF Schools of Pharmacy and Medicine

Scientific Advisory Board

Name Institution Position
Jennifer Cochran, PhD Stanford University Chair, Department of Bioengineering
Harold Collard, MD, MS

UCSF

Associate Vice Chancellor of Clinical Research

Mark Duggan, PhD

Stanford University

Director, Stanford Institute for Economic Policy Research

Robert Harrington, MD

Stanford University

Chair, Department of Medicine

Talmadge King Jr, MD

UCSF

Dean, School of Medicine

Mark McClellan, MD, PhD

Duke University

Director, Duke-Margolis Center for Health Policy

Lloyd Minor, MD

Stanford University

Dean, School of Medicine

Ruth O'Hara, PhD

Stanford University

Senior Associate Dean for Research

Vijay Pande, PhD

Andreessen Horowitz

General Partner

Merdad Parsey, MD, PhD

Gilead Sciences

Chief Medical Officer

Carl Peck, MD

NDA Partners

Founder, Partner and Chairman

Susan Peschin, MHS

Alliance for Aging Research

President and CEO

Andrew Plump, MD, PhD

Takeda Pharmaceutical

President, Research & Development

Ian Purdy, PhD

Intuitive Surgical

Senior Vice President, Regulatory Affairs & Quality Assurance

Michelle Rohrer, PhD

Roche Genentech

Senor Vice President, Global Head of Product Development Regulatory

Anne Wojcicki

23andMe

Co-Founder and CEO