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Integrating A Novel Human Mammary Epithelium Assay with Mother-Infant PBPK-PD Modeling for Precision Dosing of OUD Medications in Lactating Mothers

Award Number: R01DA065561
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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Integrating A Novel Human Mammary Epithelium Assay with Mother-Infant PBPK-PD Modeling for Precision Dosing of OUD Medications in Lactating Mothers - Summary/Abstract The increasing prevalence of opioid use disorder (OUD) among women of reproductive age underscores the urgent need for safe and effective treatment strategies during lactation. While medication-assisted treatment (MAT) with buprenorphine, methadone, or naltrexone may be compatible with breastfeeding, data on drug transfer into breast milk and infant exposure across different formulations remain sparse, limiting evidence- based clinical guidance. This project aims to develop a novel, mechanism-based, model-informed drug development (MIDD) framework to predict maternal and infant drug exposure and evaluate infant health impacts. In Specific Aim 1, we will establish a human mammary epithelial bilayer system that mimics lactational physiology to assess drug transport across the mammary barrier. In Aim 2, we will collect paired clinical blood and breast milk samples from lactating mothers on MAT to build physiologically based pharmacokinetic (PBPK) models predicting drug levels in mothers and infants across various formulations. In Aim 3, we will quantify inflammatory biomarkers in breast milk, infant saliva and stools, and analyze infant fecal microbiome, integrating these data into pharmacokinetic-pharmacodynamic (PK-PD) and machine learning (ML) models to assess the effects of maternal drug exposure on infant health. The integrated in vitro, clinical, and computational approaches will generate predictive tools to guide drug dosing in lactating women, support regulatory evaluation, and reduce disparities in OUD treatment for a highly vulnerable population. The proposed framework aligns with NIH priorities in MIDD to accelerate therapeutic innovation and ensure drug safety in special populations.


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 = $689,676 )
2026	2026	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	4400 VESTAL PKWY E	BINGHAMTON	NY	13902	BROOME	USA	Drug Use and Addiction Research Programs	000	1	7/24/2026	NEW	$689,676
														Subtotal = $689,676

Grand Total All Awards = $689,676

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Integrating A Novel Human Mammary Epithelium Assay with Mother-Infant PBPK-PD Modeling for Precision Dosing of OUD Medications in Lactating Mothers

Award Number: R01DA065561

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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