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Qualification of Patient-Derived Biomimetic Liver MPS as Drug Discovery Tools for Drug Metabolism, Toxicity, Drug Efficacy Testing and Clinical Trial Cohort Selection

Award Number: U2CTR004863
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2024
PERIOD OF PERFORMANCE END DATE: 12/31/2028

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Qualification of Patient-Derived Biomimetic Liver MPS as Drug Discovery Tools for Drug Metabolism, Toxicity, Drug Efficacy Testing and Clinical Trial Cohort Selection - The University of Pittsburgh TraCe (Pitt-TraCe) proposal is rooted in strong expertise and experience in large program Administration, management of Resources and early steps toward Qualification of Drug Development Tools (DDTs). The Pitt-TraCe proposal addresses multiple Food and Drug Administration (FDA) needs that will expand the FDA’s ability to progress regulatory science and decision-making capabilities using our extensive expertise and experience. The overall goal of the Pitt-TraCe proposal is to qualify our patient-derived structured, biomimetic liver Microphysiology Systems (MPS) platform in 4 contexts of use (CoUs) as DDTs that are being made commercially available. To reach this goal, the Pitt-TraCe includes strong administrative, MPS resources and qualification sections to accelerate the translational application of our liver MPS for specific CoUs. We will qualify our externally validated, structured, biomimetic liver MPS that recapitulates critical liver structures and functions with 4 liver cell types mimicking the liver acinus as DDTs. Induced pluripotent stem cell (iPSC)-derived liver cells from non-alcoholic fatty liver disease (NAFLD) patients enrolled in the University of Pittsburgh Medical Center Fatty Liver, Obesity, and Wellness Clinic (UPMC FLOW Clinic) that exhibit heterogeneity based on genetics, environment, and lifestyle will be used to define the role of patient heterogeneity in drug discovery, development, and clinical trials. NAFLD patient-derived liver MPS will serve as the disease background for developing the DDTs since this heterogeneous and progressive disease impacts >25% of the world population. This is a critical platform to define mechanisms of action (MOA) in the liver MPS in medium throughput to complement other high throughput, but simpler liver MPS for other CoU applications. We will qualify 4 CoU liver MPS that can be applied as DDTs including 1) quantifying hepatic clearance and identifying major metabolites; 2) quantifying liver toxicity; 3) drug testing for safety and efficacy; and 4) selecting clinical trial cohorts. Collaborations with pharmaceutical and biotechnology companies will yield materials including cells, media, and reagents critical for the qualification of the DDTs. Through a collaborative effort with Nortis Inc. and BioSystics, Inc., we will implement a medium throughput, high content and automated platform called the Automated Biomimetic Analytic MPS (ABAMPS) platform. The ABAMPS platform will deliver a more efficient and accurate use of structured, biomimetic MPS for MOA studies that will result in commercially available, FDA qualified DDTs.


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: 2026 ( Subtotal = $1,510,923 )
2026	2026	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	National Center for Advancing Translational Sciences	000	3	2/6/2026	NON-COMPETING CONTINUATION	$1,510,923
														Subtotal = $1,510,923

Issue Date FY: 2025 ( Subtotal = $1,540,258 )
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	National Center for Advancing Translational Sciences	001	2	8/12/2025	NON-COMPETING CONTINUATION	$154,025
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	National Center for Advancing Translational Sciences	000	2	3/1/2025	NON-COMPETING CONTINUATION	$1,386,233
														Subtotal = $1,540,258

Issue Date FY: 2024 ( Subtotal = $1,561,914 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	National Center for Advancing Translational Sciences	000	1	12/22/2023	NEW	$1,561,914
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	National Center for Advancing Translational Sciences	001	1	9/11/2024	NEW	$0
														Subtotal = $1,561,914

Grand Total All Awards = $4,613,095

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Qualification of Patient-Derived Biomimetic Liver MPS as Drug Discovery Tools for Drug Metabolism, Toxicity, Drug Efficacy Testing and Clinical Trial Cohort Selection

Award Number: U2CTR004863

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 01/01/2024

PERIOD OF PERFORMANCE END DATE: 12/31/2028

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