Saturday, April 19, 2025 4/19/2025

UCSF-Stanford Center of Excellence in Regulatory Science and Innovation

Award Number: U01FD005978
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	000	7	10/22/2024	SUPPLEMENT FOR EXPANSION	$0
2025	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	001	7	11/13/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $4,228,322 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	017	9	9/21/2024	SUPPLEMENT FOR EXPANSION	$1,257,392
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	021	9	9/25/2024	SUPPLEMENT FOR EXPANSION	-$350,000
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	000	8	11/22/2023	SUPPLEMENT FOR EXPANSION	$616,363
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	019	9	9/23/2024	SUPPLEMENT FOR EXPANSION	$691,776
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	013	9	8/30/2024	NON-COMPETING CONTINUATION	$425,000
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	011	8	6/10/2024	SUPPLEMENT FOR EXPANSION	$47,791
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	022	9	9/26/2024	SUPPLEMENT FOR EXPANSION	$350,000
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	020	9	9/25/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	015	9	9/19/2024	SUPPLEMENT FOR EXPANSION	$350,000
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	014	9	9/18/2024	SUPPLEMENT FOR EXPANSION	$240,000
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	018	9	9/22/2024	SUPPLEMENT FOR EXPANSION	$250,000
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	016	9	9/20/2024	SUPPLEMENT FOR EXPANSION	$350,000
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	010	8	4/29/2024	COMPETING CONTINUATION	$114,012
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	002	8	3/21/2024	COMPETING CONTINUATION	$0
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	008	8	4/29/2024	COMPETING CONTINUATION	$3,597,508
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	012	8	7/11/2024	COMPETING CONTINUATION	$0
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	001	8	1/17/2024	COMPETING CONTINUATION	$0
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	004	8	4/29/2024	COMPETING CONTINUATION	$43,347
2024	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	003	7	4/29/2024	SUPPLEMENT FOR EXPANSION	-$43,347
2024	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	006	7	4/29/2024	SUPPLEMENT FOR EXPANSION	-$43,347
2024	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	009	7	4/29/2024	SUPPLEMENT FOR EXPANSION	-$114,012
2024	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	007	7	4/29/2024	SUPPLEMENT FOR EXPANSION	-$245,113
2024	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Food and Drug Administration Research	005	7	4/29/2024	NON-COMPETING CONTINUATION	-$3,309,048
														Subtotal = $4,228,322

Issue Date FY: 2023 ( Subtotal = $6,514,610 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	015	8	9/11/2023	COMPETING CONTINUATION	$564,153
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	013	8	6/5/2023	COMPETING CONTINUATION	$648,858
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	014	8	8/28/2023	COMPETING CONTINUATION	$699,999
2023	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	003	7	12/13/2022	NON-COMPETING CONTINUATION	$0
2023	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	011	7	5/12/2023	NON-COMPETING CONTINUATION	$0
2023	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	007	7	3/20/2023	NON-COMPETING CONTINUATION	$0
2023	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	012	6	5/12/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	005	6	1/6/2023	COMPETING CONTINUATION	$619,259
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	002	6	11/22/2022	COMPETING CONTINUATION	$121,745
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	009	6	3/22/2023	COMPETING CONTINUATION	$6,586
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	008	6	3/22/2023	COMPETING CONTINUATION	$741,005
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	010	6	3/27/2023	COMPETING CONTINUATION	$6,586
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	001	6	11/17/2022	COMPETING CONTINUATION	$1,514,711
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	004	6	1/4/2023	COMPETING CONTINUATION	$1,636,457
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	006	6	2/15/2023	COMPETING CONTINUATION	$76,995
2023	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	000	5	11/17/2022	NON-COMPETING CONTINUATION	-$121,745
														Subtotal = $6,514,610

Issue Date FY: 2022 ( Subtotal = $5,130,672 ) (Continued on the next page)
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	020	7	9/23/2022	NON-COMPETING CONTINUATION	$522,575
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	010	6	4/29/2022	SUPPLEMENT FOR EXPANSION	$200,000
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	019	7	9/15/2022	NON-COMPETING CONTINUATION	$140,086
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	016	7	9/1/2022	NON-COMPETING CONTINUATION	$70,000
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Food and Drug Administration Research	009	6	4/29/2022	SUPPLEMENT FOR EXPANSION	$0
Grand Total All Awards = $37,128,378

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UCSF-Stanford Center of Excellence in Regulatory Science and Innovation

Award Number: U01FD005978

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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