Thursday, November 21, 2024 11/21/2024

Critical Path Public Private Partnerships

Award Number: U18FD005320
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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PROJECT SUMMARY The Critical Path Institute (C-Path) was established in 2005 as a public-private partnership with FDA under the auspices of the Agency’s Critical Path Initiative, with a mission to be a catalyst in the development of new approaches to advance medical innovation and regulatory science. This mission is realized by leading teams of stakeholders from industry, government, academia, and patient advocacy organizations that share data, knowledge, and expertise, resulting in sound, consensus-based regulatory science solutions and advances to address unmet needs in drug development. Developing such solutions and advances require C-Path competencies in data management and science, quantitative modeling and analytics, development of clinical outcome assessments (COAs) and biomarkers as well as knowledge of the appropriate regulatory pathways for the review and potential endorsement of such solutions. C-Path has established core competencies in these areas that allow our collaborations to achieve meaningful impact on unmet drug development needs. C-Path’s core competencies also function to further their respective fields (e.g., refine data management practices, develop new analytic and modeling techniques, develop specific COAs, or train future regulatory scientists) and to create a neutral collaborative environment for experts and stakeholders to address specific needs in drug development. Over the past 5 years, C-Path has launched new consortia and two extensive programs in rare and orphan diseases, as well as supporting the qualification of COAs, the fit-for-purpose endorsement of disease progression models and clinical trial simulation tools, the generation of new data standards and databases, the creation of a new data and analytics platform, and educational initiatives that advance regulatory science and model informed drug development. These accomplishments can decrease the time, resources, and number of patients needed to develop and approve medical products and thus de-risk and expedite the medical product development process. This proposal aims to maintain and expand on C- Path’s core competencies and continue to support the FDA to modernize drug development and potentially support future projects in real-world evidence/real-world data, artificial intelligence and machine learning, digital health technologies, and to establish new consortia in areas of critical unmet need. Altogether, these efforts support the FDA in its mission to promote public health and ensure the safety, efficacy, and efficiency of medical product development.


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	2024	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	11	11/13/2024	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $15,490,596 )
2024	2024	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	11	6/20/2024	COMPETING CONTINUATION	$2,100,000
2024	2024	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	003	11	8/28/2024	SUPPLEMENT FOR EXPANSION	$13,390,596
2024	2024	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	002	11	8/27/2024	COMPETING CONTINUATION	$0
2024	2024	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	004	11	9/7/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	10	11/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $15,490,596

Issue Date FY: 2023 ( Subtotal = $16,465,708 )
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	006	10	9/12/2023	NON-COMPETING CONTINUATION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	004	10	9/5/2023	SUPPLEMENT FOR EXPANSION	$828,817
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	010	10	9/25/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	002	10	8/2/2023	NON-COMPETING CONTINUATION	$15,636,891
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	008	10	9/20/2023	NON-COMPETING CONTINUATION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	007	10	9/14/2023	NON-COMPETING CONTINUATION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	011	10	9/26/2023	NON-COMPETING CONTINUATION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	009	10	9/20/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	005	10	9/11/2023	NON-COMPETING CONTINUATION	$0
2023	2023	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	003	10	8/29/2023	NON-COMPETING CONTINUATION	$0
2023	2022	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	9	2/1/2023	NON-COMPETING CONTINUATION	$0
2023	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	9	11/15/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $16,465,708

Issue Date FY: 2022 ( Subtotal = $19,625,858 )
2022	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	006	9	8/15/2022	NON-COMPETING CONTINUATION	$3,995,916
2022	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	002	8	4/19/2022	SUPPLEMENT FOR EXPANSION	$973,739
2022	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	005	9	8/10/2022	NON-COMPETING CONTINUATION	$12,881,203
2022	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	007	9	9/8/2022	NON-COMPETING CONTINUATION	$1,500,000
2022	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	003	8	5/3/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	8	11/18/2021	SUPPLEMENT FOR EXPANSION	$275,000
2022	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	8	11/18/2021	NON-COMPETING CONTINUATION	$0
2022	2018	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	004	5	6/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $19,625,858

Issue Date FY: 2021 ( Subtotal = $12,412,997 )
2021	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	003	8	9/13/2021	NON-COMPETING CONTINUATION	$14,997
2021	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	002	8	8/5/2021	NON-COMPETING CONTINUATION	$12,398,000
2021	2020	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	7	12/21/2020	NON-COMPETING CONTINUATION	$0
2021	2020	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	7	6/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $12,412,997

Issue Date FY: 2020 ( Subtotal = $12,100,011 )
2020	2020	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	004	6	6/9/2020	SUPPLEMENT FOR EXPANSION	$1,399,179
2020	2020	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	007	7	8/27/2020	NON-COMPETING CONTINUATION	$21,369
2020	2020	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	005	6	6/25/2020	SUPPLEMENT FOR EXPANSION	$265,063
2020	2020	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	006	7	8/12/2020	NON-COMPETING CONTINUATION	$10,414,400
2020	2019	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	003	6	3/23/2020	COMPETING CONTINUATION	$0
2020	2019	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	6	12/13/2019	COMPETING CONTINUATION	$0
2020	2018	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	002	5	12/26/2019	NON-COMPETING CONTINUATION	$1,015,927
2020	2018	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	5	12/13/2019	NON-COMPETING CONTINUATION	-$1,015,927
														Subtotal = $12,100,011

Issue Date FY: 2019 ( Subtotal = $8,595,141 ) (Continued on the next page)
2019	2019	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	002	6	8/27/2019	COMPETING CONTINUATION	$7,964,256
2019	2019	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	004	6	9/17/2019	COMPETING CONTINUATION	$0
2019	2019	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	003	6	9/12/2019	COMPETING CONTINUATION	$150,000
2019	2019	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	005	6	9/25/2019	COMPETING CONTINUATION	$480,885
2019	2018	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	5	10/25/2018	NON-COMPETING CONTINUATION	$0
Grand Total All Awards = $98,190,224

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Critical Path Public Private Partnerships

Award Number: U18FD005320

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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