# UCSF-Stanford Center of Excellence in Regulatory Science and Innovation

> **NIH FDA U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2022 · $245,113

## Abstract

Abstract: The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) brings together a
world-class team of 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 research—generating new knowledge that helps the FDA in its regulatory decision-
making. Our research informs regulatory processes, guidances and policies relevant to the evaluation and
monitoring of safe and effective medical products. The major goal of this two-year competing renewal
application is to advance regulatory sciences primarily through collaborative research projects between
scientists at the FDA and faculty at UCSF and Stanford. A secondary goal is to provide education and training
to students, postdocs and scientists in medical product development. The research strategy includes four
components. The first component is focused on our infrastructure, CERSI-Core. The goal of CERSI-Core is to
support activities of the CERSI through effective management and oversight of the CERSI activities, monitoring
financial transactions, reporting information to the FDA and key stakeholders, and scheduling interactive
meetings. The second and third components of the research strategy is focused on research. Through
strategic collaborative research among academic and FDA scientists, the overall goal of our CERSI research is
to address key scientific issues for advancing FDA’s mission in protecting the public health. The second
component consists largely of eight one-page proposals for research projects from investigators at UCSF and
Stanford that address FDA’s priority areas for the CERSI program. These research projects are proposed for
funding at the initiation of the renewal period. The third component includes 20 half-page research proposals
that may be funded during the course of the two-year renewal period. Areas covered by one-page and half-
page proposals include data analytics, clinical trial design, and digital health, among a broad range of research
proposals. The fourth component consists of a plan for leveraging the FDA investment and procuring non-
federal funds from private donors, our institutions, industry, and through our educational offerings. Finally, we
include a short section on educational and outreach activities of our CERSI, which includes fellowship and
scholarship programs, courses, workshops, meetings and other events. Collectively, the proposed continuing
renewal application of the UCSF-Stanford CERSI will advance the FDA’s regulatory science goals.

## Key facts

- **NIH application ID:** 10692455
- **Project number:** 3U01FD005978-07S2
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** RUSS BIAGIO ALTMAN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $245,113
- **Award type:** 3
- **Project period:** 2016-09-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10692455

## Citation

> US National Institutes of Health, RePORTER application 10692455, UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (3U01FD005978-07S2). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10692455. Licensed CC0.

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