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Consortium Led Evaluation of Integrated Human-Relevant Approaches to Identify Drug Induced Cardiovascular Liabilities

Award Number: U01FD006676
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Consortium Led Evaluation of Integrated Human-Relevant Approaches to Identify Drug Induced Cardiovascular Liabilities - Title: Consortium Led Evaluation of Integrated Human-Relevant Approaches to Identify Drug Induced Cardiovascular Liabilities FOA Title and Number: Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed), RFA- FD-19-002 Proposed project start date: September 30, 2019 Proposed end date: September 30, 2022 Project Summary/Abstract: Cardiovascular drug-induced toxicity remains a major cause of drug attrition in both preclinical and clinical phases of drug development (Laverty et al., 2011). This is likely due to gaps in the traditional preclinical models used to assess cardiotoxicities. Additionally, many of the traditional methods are deployed in later stages of drug development causing costly late stage attrition. Advancements in both in vitro technology platforms and human stem cell-derived cardiomyocytes (hSC-CMs) offer an opportunity to improve the current preclinical testing paradigm by using mechanistically-relevant assays earlier in the drug development process. A paradigm shift like this will require appropriate confidence in the assay platforms, cells and underlying mechanisms associated with the cardiotoxicities, as well as gathering expertise to conduct evaluation and validation, a complex task. These efforts are best suited to a collaborative effort between multiple stakeholders including individual scientists and organizations. This proposal includes an effort to first define cellular mechanisms of cardiovascular toxicity, followed by a process to test and build confidence in the in vitro methods capable of predicting said toxicities. The objective of this proposed research aligns well with the FDA’s area of interest, “1. Modernize Toxicology to Enhance Product Safety.” Skilled scientific coordination and management is a requirement for the efficient design and execution of multi-site collaborative science. This is particularly essential for the studies proposed here that are intended to provide direct value to applied drug development and drug safety via engagement of public and private sector scientists. This multi-sector and multi- disciplinary expertise will allow the proposed program to effectively define core cardiovascular liabilities and build consensus on the utility of novel in vitro assays that provide insights into these liabilities. The organizational experience, in addition to a broad scientific membership, gives HESI the credibility needed to conduct unbiased science and give the drug development community confidence in these new assays. HESI is the right organization to tackle these challenges and address the cardiovascular safety issues from a novel and twenty-first century science perspective.


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	2021	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	3	12/18/2024	NON-COMPETING CONTINUATION	$0
2025	2021	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	3	1/8/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $347,618 )
2023	2023	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	3	1/12/2023	SUPPLEMENT FOR EXPANSION	$347,618
2023	2021	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	3	7/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $347,618

Issue Date FY: 2022 ( Subtotal = $421,342 )
2022	2022	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW STE 600	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	002	3	6/22/2022	SUPPLEMENT FOR EXPANSION	$421,342
2022	2021	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW STE 600	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	003	3	8/9/2022	NON-COMPETING CONTINUATION	$0
2022	2021	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	006	3	8/11/2022	NON-COMPETING CONTINUATION	$0
2022	2020	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	2	1/6/2022	NON-COMPETING CONTINUATION	$0
2022	2020	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	2	1/4/2022	NON-COMPETING CONTINUATION	$0
2022	2020	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	005	2	8/11/2022	NON-COMPETING CONTINUATION	$0
2022	2019	HEALTH & ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	004	1	8/11/2022	NEW	$0
														Subtotal = $421,342

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2021	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW STE 600	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	3	8/30/2021	NON-COMPETING CONTINUATION	$0
2021	2020	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW STE 600	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	2	2/2/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $498,961 )
2020	2020	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW STE 600	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	2	8/27/2020	NON-COMPETING CONTINUATION	$498,961
														Subtotal = $498,961

Issue Date FY: 2019 ( Subtotal = $500,000 )
2019	2019	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW STE 600	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	7/1/2019	NEW	$500,000
														Subtotal = $500,000

Grand Total All Awards = $1,767,921

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Consortium Led Evaluation of Integrated Human-Relevant Approaches to Identify Drug Induced Cardiovascular Liabilities

Award Number: U01FD006676

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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