# UCSF-Stanford Center of Excellence in Regulatory Science

> **NIH FDA U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $381,058

## Abstract

ABSTRACT
The UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation (CERSI) brings together a
world-class team of collaborative scientists from two outstanding academic institutions, with the goal of
collaboratively supporting the FDA's mission to protect the public's health. Launched in 2014, our CERSI
focuses on mission-driven regulatory science—generating new knowledge that helps the FDA in its regulatory
decision-making. During our first two years, we have developed a novel and disruptive paradigm for research
in regulatory sciences; CERSI research should be collaborative between academic and FDA scientists, and
should be evaluated based on its potential to change in regulatory processes, guidances or policies relevant to
the approval and monitoring of safe and effective medical products. The goals of this competing renewal
application are to advance regulatory sciences through interactive programs in education and
research, and to support collaborative interactions between scientists at the FDA and faculty at UCSF
and Stanford). The UCSF-Stanford CERSI includes four components, each with a distinct goal: C1. CERSI-
Core: The goal of CERSI-Core is to support our education, research and collaborations units by providing
management and oversight, and effective communications among the components and between the CERSI
and key stakeholders in regulatory sciences. C2. CERSI-Education: The goal of CERSI-Education is to
provide state-of-the-art training and educational programs for students, postdoctoral fellows, faculty and
scientists in the industry and at FDA. C3. CERSI-Collaborations: The goal of CERSI-Collaborations is to
sponsor and support a robust FDA Visiting Scientist program, and conduct workshops and seminars in
regulatory sciences at both UCSF and Stanford and at the FDA. C4. CERSI-Research: Through strategic
collaborative research efforts, the goal of CERSI-Research is to conduct mission-driven research in innovative
regulatory sciences that addresses key scientific issues for advancing FDA's mission in protecting the public
health. This proposal also contains a plan (C5) for leveraging the FDA investment and procuring non-federal
funds from private donors and industry and through our online course materials. Collectively, the education,
research and collaboration components of the UCSF-Stanford CERSI serve to accelerate training and
research in innovative regulatory sciences and advance the mission of the FDA in ensuring the public health.

## Key facts

- **NIH application ID:** 10174158
- **Project number:** 3U01FD005978-04S5
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** RUSS BIAGIO ALTMAN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $381,058
- **Award type:** 3
- **Project period:** 2016-09-15 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174158

## Citation

> US National Institutes of Health, RePORTER application 10174158, UCSF-Stanford Center of Excellence in Regulatory Science (3U01FD005978-04S5). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10174158. Licensed CC0.

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