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DEVELOPMENT AND QUALIFICATION OF A BIOMARKER FOR PRECLINICALLY IDENTIFYING THE PRO-ARRHYTHMIA RISK OF DRUGS BASED ON CONTRACTILITY MEASUREMENTS CONDUCTED IN HUMAN ADULT PRIMARY CARDIOMYOCYTES

Award Number: U01FD006879
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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DEVELOPMENT AND QUALIFICATION OF A BIOMARKER FOR PRECLINICALLY IDENTIFYING THE PRO-ARRHYTHMIA RISK OF DRUGS BASED ON CONTRACTILITY MEASUREMENTS CONDUCTED IN HUMAN ADULT PRIMARY CARDIOMYOCYTES - PROJECT SUMMARY Current strategies for cardiac safety evaluation of drugs have shown significant limitations. Over the past several years, the FDA and pharmaceutical industry have promoted initiatives to develop more predictive human-relevant preclinical platforms to rectify this problem. In this context, AnaBios established an adult human primary cardiomyocyte contractility model, which has the potential to predict drug-induced pro- arrhythmia risk. The correlation between electrical (action potential, AP) and mechanical (contraction) abnormalities, is a consequence of the tight functional coupling between these two processes in adult cardiac cells and tissues. As a result, drug-induced ventricular repolarization irregularities also lead to severe contractility abnormalities. In line with these observations, AnaBios has developed an adult human primary ventricular cardiomyocyte contractility model that simultaneously evaluates pro-arrhythmia risks from the measurement of drug-induced changes in several parameters that are derived from the kinetics of the contractility transient; AnaBios is further combining the parameters into a single biomarker that can be used to predict pro-arrhythmia risk in advance of clinical studies. AnaBios aims to qualify the biomarker derived from the contractility measurements, which will provide critical information for drug developers and regulators with respect to the cardiac risk of drugs at the preclinical stages of drug 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: 2021 ( Subtotal = $0 )
2021	2019	ANABIOS CORPORATION	3030 BUNKER HILL ST STE 312	SAN DIEGO	CA	92109	SAN DIEGO	USA	Food and Drug Administration Research	001	1	7/8/2021	NEW	$0
2021	2019	ANABIOS CORPORATION	3030 BUNKER HILL ST STE 312	SAN DIEGO	CA	92109	SAN DIEGO	USA	Food and Drug Administration Research	000	1	2/2/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	ANABIOS CORPORATION	3030 BUNKER HILL ST STE 312	SAN DIEGO	CA	92109	SAN DIEGO	USA	Food and Drug Administration Research	000	1	8/20/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $247,461 )
2019	2019	ANABIOS CORPORATION	3030 BUNKER HILL ST STE 312	SAN DIEGO	CA	92109	SAN DIEGO	USA	Food and Drug Administration Research	000	1	9/3/2019	NEW	$247,461
														Subtotal = $247,461

Grand Total All Awards = $247,461

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DEVELOPMENT AND QUALIFICATION OF A BIOMARKER FOR PRECLINICALLY IDENTIFYING THE PRO-ARRHYTHMIA RISK OF DRUGS BASED ON CONTRACTILITY MEASUREMENTS CONDUCTED IN HUMAN ADULT PRIMARY CARDIOMYOCYTES

Award Number: U01FD006879

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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