# Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI)

> **NIH FDA U01** · YALE UNIVERSITY · 2020 · $3,553,368

## Abstract

7. PROJECT SUMMARY/ABSTRACT
The Centers of Excellence in Regulatory Science and Innovation (CERSI) program allows the U.S. Food and
Drug Administration (FDA) to form extramural partnerships that foster robust and innovative research to
develop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-
regulated products, supporting regulatory decision-making and the overall mission of the FDA. Over the past
two years, the Yale-Mayo Clinic CERSI has pursued a series of innovative research projects that leverage
routinely-collected, real-world data sources to assess the safety, efficacy, quality, and performance of FDA-
regulated products, informing regulatory decision-making as well as manufacturers, clinicians, and patients in
support of patient-centered decision-making, along with providing and supporting high-quality mentorship and
training in regulatory science. The Yale-Mayo Clinic CERSI will continue this work, conducting high-quality,
high-impact regulatory science research in priority areas identified by the FDA to advance clinical and post-
market surveillance of drugs and biologics, medical devices, and diagnostic tests, to develop and apply novel
analytics to leverage routinely-collected real-world data sources for medical product evaluation, and to foster
patient-centered decision-making. Over the 5-year award, the Yale-Mayo Clinic CERSI will pursue the
following specific aims:
Specific Aim 1. Strengthen existing extramural partnerships between FDA and the Yale-Mayo Clinic CERSI,
bridging the campuses of Yale University and Mayo Clinic, and create and foster new relationships that support
the FDA's regulatory mission.
Specific Aim 2. Conduct high-quality, high-impact regulatory science in collaboration with FDA to develop new
tools, standards, and approaches that provide timely assessments of the safety, efficacy, quality, and
performance of FDA-regulated products, thereby supporting regulatory decision-making.
Specific Aim 3. Provide and support high-quality mentorship and training in regulatory science at Yale
University and Mayo Clinic, strengthening regulatory science at both institutions through educational efforts
and scientific exchange with FDA scientists and across the CERSI network.
Specific Aim 4. Foster collaboration among the Yale-Mayo Clinic CERSI, the CERSI network, FDA, industry
and other key stakeholders, including pursuit of non-federal funding to better leverage FDA-related
opportunities and support the CERSI program.

## Key facts

- **NIH application ID:** 9969079
- **Project number:** 5U01FD005938-05
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Molly Moore Jeffery
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $3,553,368
- **Award type:** 5
- **Project period:** 2016-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969079

## Citation

> US National Institutes of Health, RePORTER application 9969079, Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI) (5U01FD005938-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969079. Licensed CC0.

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