Wednesday, February 5, 2025 2/5/2025

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

Award Number: U01FD005938
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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 seven years, the Yale-Mayo Clinic CERSI has pursued a series of innovative research projects that leverage 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 optimizing patient-centered care, 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 modernize development and evaluation of FDA- regulated products, strengthen post-market surveillance and labelling of FDA-regulated products, and invigorate public health preparedness and response of FDA, patients, and consumers. 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.


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 = -$1,203 )
2025	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	008	8	1/3/2025	COMPETING CONTINUATION	$4,832,208
2025	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	007	8	1/2/2025	COMPETING CONTINUATION	$0
2025	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	005	7	12/31/2024	SUPPLEMENT FOR EXPANSION	-$104,255
2025	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	006	7	12/31/2024	SUPPLEMENT FOR EXPANSION	-$432,943
2025	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	002	6	12/16/2024	SUPPLEMENT FOR EXPANSION	-$347,000
2025	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	009	6	1/6/2025	SUPPLEMENT FOR EXPANSION	-$424,786
2025	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	004	7	12/31/2024	NON-COMPETING CONTINUATION	-$2,091,987
2025	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	003	6	12/19/2024	SUPPLEMENT FOR EXPANSION	-$87,177
2025	2021	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	001	5	12/16/2024	SUPPLEMENT FOR EXPANSION	-$283,552
2025	2021	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	000	6	12/16/2024	NON-COMPETING CONTINUATION	-$1,061,711
														Subtotal = -$1,203

Issue Date FY: 2024 ( Subtotal = $1,358,911 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	014	9	9/19/2024	SUPPLEMENT FOR EXPANSION	$174,880
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	013	9	9/18/2024	SUPPLEMENT FOR EXPANSION	$400,000
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	012	9	8/30/2024	NON-COMPETING CONTINUATION	$350,000
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	008	8	3/18/2024	SUPPLEMENT FOR EXPANSION	$434,031
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	010	8	6/7/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	011	8	7/3/2024	COMPETING CONTINUATION	$0
2024	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	007	7	3/12/2024	SUPPLEMENT FOR EXPANSION	-$432,943
2024	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	006	8	3/12/2024	COMPETING CONTINUATION	$4,832,208
2024	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	005	7	3/12/2024	SUPPLEMENT FOR EXPANSION	-$104,255
2024	2023	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	009	8	5/22/2024	COMPETING CONTINUATION	$0
2024	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	000	8	1/17/2024	COMPETING CONTINUATION	$0
2024	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	004	6	3/12/2024	SUPPLEMENT FOR EXPANSION	-$347,000
2024	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	002	7	3/12/2024	NON-COMPETING CONTINUATION	-$2,091,987
2024	2022	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	003	6	3/12/2024	SUPPLEMENT FOR EXPANSION	-$511,963
2024	2021	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	001	6	3/12/2024	NON-COMPETING CONTINUATION	-$1,344,060
														Subtotal = $1,358,911

Issue Date FY: 2023 ( Subtotal = $887,198 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	002	7	2/22/2023	SUPPLEMENT FOR EXPANSION	$432,943
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	005	8	5/24/2023	COMPETING CONTINUATION	$350,000
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	000	7	11/2/2022	SUPPLEMENT FOR EXPANSION	$104,255
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	008	8	9/7/2023	COMPETING CONTINUATION	$0
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	007	7	9/7/2023	NON-COMPETING CONTINUATION	$0
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	004	7	3/14/2023	NON-COMPETING CONTINUATION	$0
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	001	7	2/2/2023	NON-COMPETING CONTINUATION	$0
2023	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	006	6	9/7/2023	NON-COMPETING CONTINUATION	$0
2023	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	003	6	3/13/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $887,198

Issue Date FY: 2022 ( Subtotal = $2,592,755 )
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	004	6	4/14/2022	SUPPLEMENT FOR EXPANSION	$347,000
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	010	7	9/7/2022	NON-COMPETING CONTINUATION	$70,000
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	006	6	7/12/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	008	7	8/16/2022	NON-COMPETING CONTINUATION	$2,021,987
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	009	6	8/16/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	003	6	2/25/2022	SUPPLEMENT FOR EXPANSION	$511,963
2022	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	000	6	12/22/2021	NON-COMPETING CONTINUATION	$0
2022	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	007	6	8/16/2022	NON-COMPETING CONTINUATION	$0
2022	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	001	6	1/28/2022	NON-COMPETING CONTINUATION	$0
2022	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	002	6	2/11/2022	NON-COMPETING CONTINUATION	$0
2022	2017	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Food and Drug Administration Research	005	2	6/21/2022	NON-COMPETING CONTINUATION	-$358,195
														Subtotal = $2,592,755

Issue Date FY: 2021 ( Subtotal = $3,147,736 ) (Continued on the next page)
Grand Total All Awards = $24,451,722

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

Award Number: U01FD005938

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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