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Patient-specific, combinatorial NAMs for gastrointestinal diseases and drug response prediction

Award Number: UM1TR006070
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: 02/09/2026
PERIOD OF PERFORMANCE END DATE: 12/31/2030

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Patient-specific, combinatorial NAMs for gastrointestinal diseases and drug response prediction - ABSTRACT Millions of people in the US are impacted by gastrointestinal diseases including Inflammatory Bowel Disease (IBD), Metabolic Disfunction Associated Steatotic Liver Disease (MASLD) and Pancreatitis. There are only a small number of drugs for IBD and MASLD, and none for Pancreatitis, making this a critically significant clinical question. Animal models have proven inadequate surrogates for these diseases and reliance on current preclinical evaluations are considered to be among the most problematic steps in drug discovery. The goal of Cincinnati Advanced NAM Development and Operational Research center (CANDOR) is to develop combinatorial New Approach Methodologies (NAMs) that more accurately model the pathophysiologic complexity and drug responses in patients with these gastrointestinal (GI) diseases. We have established an interdisciplinary team of collaborators of clinicians, scientists, experimental and computational biologists with a history of developing in vitro organoid and in silico NAMs with a focus on inflammatory diseases of the GI tract. CANDOR will provide a collaborative pipeline starting with existing cohorts of deeply phenotyped patients with IBD, MASLD, and Pancreatitis. Clinical data and patient samples will be used to build in silico NAMs, based on molecular pathways and cell-cell interactions that corelate with patient outcome and drug response. Each disease will have a corresponding in vitro NAM comprising intestinal, liver, and pancreatic organoids each with immune cells. Pluripotent stem cell banks have been generated from patients with each of these diseases, and healthy controls, and all organoid platforms are established and benchmarked to human samples. The aims of CANDOR are to establish in vitro NAMs that accurately model clinical features of IBD, MASLD, and Pancreatitis; to build disease-focused in silico NAMs that are based on gene regulatory, cell-cell interactions, and pharmacometric models from patients and combine these with data from in vitro NAMs; and to validate and disseminate combinatorial NAM technologies through training, outreach, and distribution.


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 = $3,240,000 )
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Trans-NIH Research Support	000	1	2/9/2026	NEW	$3,240,000
														Subtotal = $3,240,000

Grand Total All Awards = $3,240,000

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Patient-specific, combinatorial NAMs for gastrointestinal diseases and drug response prediction

Award Number: UM1TR006070

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: 02/09/2026

PERIOD OF PERFORMANCE END DATE: 12/31/2030

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