Monday, October 2, 2023 10/2/2023

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)

Group Awards By Issue Date FY or Funding FY:

View Award 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.


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: 2023 ( Subtotal = $887,198 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	USA	Food and Drug Administration Research	008	8	9/7/2023	COMPETING CONTINUATION	$0
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	002	7	2/22/2023	SUPPLEMENT FOR EXPANSION	$432,943
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	USA	Food and Drug Administration Research	003	6	3/13/2023	NON-COMPETING CONTINUATION	$0
2023	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	006	6	9/7/2023	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2022 ( Subtotal = $2,592,755 )
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	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	NEW HAVEN	USA	Food and Drug Administration Research	003	6	2/25/2022	SUPPLEMENT FOR EXPANSION	$511,963
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	USA	Food and Drug Administration Research	009	6	8/16/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	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	NEW HAVEN	USA	Food and Drug Administration Research	005	2	6/21/2022	NON-COMPETING CONTINUATION	-$358,195


Issue Date FY: 2021 ( Subtotal = $3,147,736 )
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	007	6	8/12/2021	NON-COMPETING CONTINUATION	$1,442,821
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	005	5	6/21/2021	SUPPLEMENT FOR EXPANSION	$350,000
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	004	5	4/22/2021	SUPPLEMENT FOR EXPANSION	$334,873
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	008	6	8/31/2021	NON-COMPETING CONTINUATION	$868,584
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	010	6	9/16/2021	NON-COMPETING CONTINUATION	$103,000
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	009	6	9/8/2021	NON-COMPETING CONTINUATION	$48,458
2021	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	001	5	11/25/2020	SUPPLEMENT FOR EXPANSION	$0
2021	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	006	5	7/20/2021	NON-COMPETING CONTINUATION	$0
2021	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	003	5	2/19/2021	NON-COMPETING CONTINUATION	$0
2021	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	002	5	12/3/2020	SUPPLEMENT FOR EXPANSION	$0
2021	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	000	5	11/25/2020	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2020 ( Subtotal = $4,105,368 )
2020	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	002	5	7/8/2020	NON-COMPETING CONTINUATION	$550,000
2020	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	005	5	9/25/2020	SUPPLEMENT FOR EXPANSION	$252,000
2020	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	003	5	8/19/2020	NON-COMPETING CONTINUATION	$3,003,368
2020	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	004	5	9/17/2020	SUPPLEMENT FOR EXPANSION	$300,000
2020	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	000	4	11/29/2019	NON-COMPETING CONTINUATION	$0
2020	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	001	4	1/22/2020	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2019 ( Subtotal = $8,720,036 ) (Continued on the next page)
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	011	4	9/19/2019	NON-COMPETING CONTINUATION	$580,248
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	007	4	9/6/2019	NON-COMPETING CONTINUATION	$0
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	012	4	9/23/2019	NON-COMPETING CONTINUATION	$238,834
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	005	4	6/28/2019	NON-COMPETING CONTINUATION	$459,092
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	002	3	6/12/2019	SUPPLEMENT FOR EXPANSION	$3,367,315
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	010	3	9/18/2019	SUPPLEMENT FOR EXPANSION	$0
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	001	3	3/28/2019	SUPPLEMENT FOR EXPANSION	$158,430
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	NEW HAVEN	USA	Food and Drug Administration Research	013	4	9/28/2019	NON-COMPETING CONTINUATION	$361,863
Grand Total All Awards = $23,094,014

Sum of Action Amount is $23,094,014;

Grand Total = $23,094,014

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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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