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Sample Collection and Analysis to Support the Qualification Plan for Drug Induced Skeletal Muscle Injury Biomarker Panel for DDT-BMQ-000081.

Award Number: U01FD007466
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT This project seeks to increase our understanding of the sensitivity of the four proposed skeletal muscle injury biomarkers to detect drug-induced skeletal muscle injury (DIMI), which will address an unmet need in drug development for detecting and monitoring DIMI. The evidence generated by this project is necessary to support the qualification of four skeletal muscle specific proteins (skeletal troponin I (TNNI2), myosin light chain 3 (MYL3). Fatty acid binding protein 3 (FABP3), and creatine kinase MM (CKM)) as biomarkers of skeletal muscle injury by the Food and Drug Administration’s (FDA’s) Biomarker Qualification Program (BQP). This qualification effort is being led by the Predictive Safety Testing Consortium’s Skeletal Muscle Injury Working Group, for which these four biomarkers serve as safety biomarkers to detect DIMI was accepted into the Biomarker Qualification Program. In order to progress to the next stage of qualification, the Skeletal Muscle Injury Working Group must prepare a Qualification Plan which summarizes the performance of these four biomarkers in the learning phase studies and proposes the confirmatory studies to support the proposed context of use under consideration by the Biomarker Qualification Program. To date, the Skeletal Muscle Injury Working Group has limited clinical data in DIMI or muscle injury populations. To address this gap, the Critical Path Institute (C-Path) proposes the following research aim. Specific Aim 1 will conduct a study to determine the sensitivity of the proposed drug-induced muscle injury biomarkers (TNNI2, MYL3, FABP3, and CKM). The study will collect single samples from 125 subjects at the University of Michigan Hospital with adjudicated skeletal muscle injury due to DIMI, skeletal muscle injury, or skeletal muscle disease and 125 healthy subjects. This study will support the future submission of a Qualification Plan for DDT# DDTBMQ000081 by defining the sensitivity of the proposed drug-induced muscle injury biomarkers in muscle injury patients.


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: 2024 ( Subtotal = -$2,538 )
2024	2021	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	1	4/29/2024	NEW	-$2,538
														Subtotal = -$2,538

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	1	7/8/2022	NEW	$0
2022	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	1	6/27/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $249,769 )
2021	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	1	8/17/2021	NEW	$249,769
														Subtotal = $249,769

Grand Total All Awards = $247,231

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Sample Collection and Analysis to Support the Qualification Plan for Drug Induced Skeletal Muscle Injury Biomarker Panel for DDT-BMQ-000081.

Award Number: U01FD007466

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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