# A Translational Center for Microphysiological Systems-Based Drug Development Tools for Pregnancy and Women's Health

> **NIH NIH U2C** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2024 · $1,529,674

## Abstract

A Translational Center for Microphysiological Systems-Based
Drug Development Tools for Pregnancy and Women's Health
Overall Program Description: Human pregnancy and parturition are fascinating and biologically complex
phenomena. Two independent physiological systems, namely the fetus and the mother, co-exist for a defined
period of time to maintain pregnancy, aid fetal growth and development.1 This co-existence ends with parturition,
a unique synchronized process that terminates all homeostatic states of pregnant uterine tissues2-6.
Unfortunately, an unacceptable and growing number of pregnancies do not end at term with a delivery of a fully
developed fetus. Approximately 25-30% of the 3.5 million births per year in the United States alone occur in the
context of a range of placenta-, fetal membrane-, decidua/myometrium-, and/or cervix (maternal)-mediated
adverse pregnancy outcomes such as preterm birth, preeclampsia, small-for-gestational-age birth, gestational
diabetes, and others.7-10 Globally, preterm labor and delivery (birth at <37 weeks of gestation) accounts for 15
million births and 1 million neonatal deaths per year. 11-14 Survivors of adverse pregnancy outcomes face lifelong
challenges, and mothers who deliver preterm often face medical complications.15-17 Therefore, reducing the risk
of adverse pregnancy outcomes is a global need;13,18 however, pregnant women are excluded from most clinical
trials.19-23 Instead, “women who may become pregnant” are a population of interest in drug development. Indeed,
unique physiological characteristics of the mother-fetus co-existence during pregnancy are difficult to study.
Challenges in conducting research and/or drug development in pregnancy include (i) recruitment hurdles due to
paucity of data needed to convince the clinicians, subjects, and regulators on the utility of a drug in pregnancy,
(ii) lack of suitable preclinical models (in vitro or animal models) to address both pharmacokinetics and
pharmacodynamics, and (iii) absence of informative biomarkers to assess the feto-placental response to
therapeutics. These limitations lead to systematic exclusion of pregnant women from medical interventions and
therapeutics research.20,24 Recent advances in our group’s efforts to create a suite of five pregnancy and
women's health-focused human microphysiological systems (MPS) that model 'healthy' and 'disease' states of
intrauterine tissues25-32 present a unique opportunity to translate them into drug development tools. These MPS
use cell lines created from both human placenta and lower and upper uterine tissues (feto-maternal membrane),
to faithfully recreate the mother-fetus interface in pregnancy, parturition, and in adverse pregnancy outcomes.
Collectively, these MPS and cells form a RESOURCE for drug development that will be tested for its suitability
under several drug development contexts of use with a range of small molecules and a biological agent. We will
also use our years of experience test...

## Key facts

- **NIH application ID:** 10816253
- **Project number:** 1U2CTR004868-01
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** Arum Han
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,529,674
- **Award type:** 1
- **Project period:** 2024-06-04 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10816253

## Citation

> US National Institutes of Health, RePORTER application 10816253, A Translational Center for Microphysiological Systems-Based Drug Development Tools for Pregnancy and Women's Health (1U2CTR004868-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10816253. Licensed CC0.

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