# Administrative Core

> **NIH NIH U2C** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2024 · $274,929

## Abstract

ADMINISTRATIVE CORE ABSTRACT
The Administrative Core is the central hub for all activities of the proposed Translational Center for
Microphysiological Systems-Based Drug Development Tools for Pregnancy and Women's Health. The Core will
be coordinating activities across three laboratories at two institutions (University of Texas Medical Branch at
Galveston and Texas A&M University in College Station) and ensuring that the overall goal of the Center, which
is “to translate a comprehensive set of MPS aimed at replicating all aspects of human female reproductive organs
involved in pregnancy into drug development tools that are qualified for regulatory decision-making,” is met. The
Core is organized around four key functions that will enable it to be an effective and nimble coordinator of the
proposed research, outreach, training, and translation activities: (1) administration and fiscal management, (2)
research integration, (3) quality control and quality assurance, and (4) research translation and
commercialization. The Core will be physically located within the Division of Basic Science and Translational
Research in the Department of Obstetrics & Gynecology at UTMB. The overall PI, Dr. Menon is director of the
Division, and he will be assisted in the Core by TAMU MPIs, Drs. Rusyn and Han; together, three MPIs will form
a Steering Committee that will oversee all functions of the Core and the Center. The MPIs have extensive
experience working together through joint funding, publications, and co-mentoring of trainees. Other personnel
in the Core include Center Manager and Quality Assurance/Quality Control Manager. The overall strategy used
by the Administrative Core for achieving success will consist of: (i) regular Center-wide and inter-core
interactions; (ii) monthly tracking of the products of the Center’s work (preparation of the resources, delivery of
the resources to the QC, completed qualification experiments, qualification package submissions to the FDA,
and interactions with stakeholders); and (iii) coordinating research translation. The Core’s work is organized
around five Specific Aims. First, the Core will provide effective administrative and fiscal management. The Core
will conduct program planning and evaluation and assessment of Center performance. Second, the Core will
facilitate integration of cutting-edge research, qualification, and regulatory science activities. Third, the Core will
establish and maintain quality assurance and control protocols for both resources, experiments, and data to
ensure rigor and reproducibility in research and to maintain FAIR data management system through integration
with the MPS Database. Fourth, the Core will promote dissemination of the Center’s knowledge to other
academic researchers, government agencies, and the industry end-users. Finally, the Core will advance the
practical application of the Center-qualified MPS as drug development tools through technology transfer and
commercialization. All Cen...

## Key facts

- **NIH application ID:** 10816254
- **Project number:** 1U2CTR004868-01
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** RAMKUMAR MENON
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $274,929
- **Award type:** 1
- **Project period:** 2024-06-04 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10816254

## Citation

> US National Institutes of Health, RePORTER application 10816254, Administrative Core (1U2CTR004868-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10816254. Licensed CC0.

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