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.

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 biomedical, quantitative sciences, and pharmacology to provide novel collaborative research and educational programs that focus on three key FDA priority areas as described in FDA's Regulatory Science Framework:

Modernize development and evaluation of FDA-regulated products
1. Alternative Methods
2. Advanced Manufacturing Approaches
3. Analytical and Computational Methods
4. Biomarkers
5. Clinical Outcome Assessment
6. Complex and Novel Clinical Trial Design
7. Predictive Toxicology
8. Methods for Assessing Behavioral, Economic, or Human Factors
9. Approaches to Incorporate Patient and Consumer Input
10. Methods to Assess Real-World Data to serve as Real-World Evidence
11. Methods to Assess Data Source Interoperability
Strengthen post-market surveillance and labeling of FDA-regulated products
1. Methods to Assess Real-World Data to Support Regulatory Decision-Making
2. Using and Validating Artificial Intelligence Approaches
3. Novel Clinical Trial Design, Statistical and Epidemiologic Methods
4. Automated Reporting Tools for Adverse Events and Active Surveillance
5. Methods to Improve Communication About Risk to Patients and Consumers
6. Approach to Expand Data Capacity, and Increase Data Quality and Usen
7. Efforts to Harmonize Existing and Emerging Data Standards
Invigorate public health preparedness and response of FDA, patients & consumers
1. Reinforce Medical countermeasures Initiative (MCMi)
2. Antimicrobial Resistance
3. Patient and Consumer Engagement
4. Substance Use and Misuse
5. One Health Approaches
6. Global Product Safety net
7. Emerging Technologies

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

School of Pharmacy, which is ranked top nationwide in National Institutes of Health (NIH) research funding among pharmacy schools since 1979 and for its Doctor of Pharmacy degree program
School of Medicine
School of Dentistry
School of Nursing
Novel Department of Bioengineering and Therapeutic Sciences, which is a joint department between the School of Pharmacy and the School of Medicine.
Well-established Clinical and Translational Science Institute funded by the NIH
California Institute for Quantitative Biosciences-UCSF (QB3-UCSF)
UCSF Medical Center and Veterans Affairs Medical Center, San Francisco

Stanford University

Large efforts in medical devices and quantitative sciences through its School of Medicine and School of Engineering
Law School
School of Business
Strong Department of Bioengineering
NIH-funded Clinical and Translational Science Award
Stanford University Medical Center and Veterans Affairs Medical Center, Palo Alto

FDA CERSI Lecture Series

Lectures are presented by scientists from CERSI Academic Institutions

FDA CERSI Lecture Series Schedule

FDA CERSI Workshops

Workshops are held collaboratively between FDA and CERSI Academic Institutions

FDA CERSI Workshop Schedule

Have questions?

Still have questions about the CERSI collaboration and research.

Email us with your questions

Beginnings

The UCSF-Stanford CERSI was launched in April 2014.

See the public announcement