# Administrative Core

> **NIH NIH U2C** · UNIVERSITY OF ROCHESTER · 2024 · $152,117

## Abstract

Abstract (Administrative Core)
The proposed TRanslational Center for barrier MPS (TRaCe-bMPS) will validate and qualify Drug
Development Tools (DDTs) focused on the integral role of biological barriers in the pathology of underlying
tissues in different disease contexts. The Center is organized as a partnership between the University of
Rochester (UR) and Duke University. TRaCe-bMPS includes more than a dozen faculty, staff, and trainees at
UR, Duke, and the Rochester Institute of Technology (RIT) with scientific and regulatory expertise relevant to
the goals of the Center, along with expert consultants, and strategic industrial partners. To ensure a robust
administrative structure for the large team, we propose the establishment of an Administrative Core (AC) to
efficiently manage and coordinate the Center’s research activities in the Resource Core (RC) and the
Qualification Program (QP) in coordination with data management resources at the UR and Duke Clinical
Translational Science Institutes (CTSI).
The AC provides innovative governance and data flow between the operational units (RC and QP) in at least
two aspects. First, the multi-PI approach in the Executive Committee breaks with the traditional hierarchical
model and allows for deliberative, flexible, and nimble decision-making while fostering communications and
collaborations among the operational arms of the team. Second, the AC's oversight of the integration of data
sets generated by each of the DDTs in the RC is critical. This function ensures that the data is consistently
processed and ready for use in creating validation and qualification documents by the RC and QP,
respectively. The seamless integration of data is essential to achieving the overall research objectives and
ensuring that the TRaCe-bMPS delivers on its milestones.
The AC will aim to: 1) strategically manage the TRaCe-bMPS through an Executive Committee, which will be
in charge of overall governance including administration of personnel, financial oversight, and quality controls
on services and progress of the qualification processes through evaluations at periodically scheduled
meetings; 2) establish relevant scientific expertise on the team and progress towards project aims; 3) foster
communications between TRaCe-bMPS Resource Core and Qualifications Program investigators, as well as
other stakeholders including the NCATS/NIH program staff, the FDA, an Advisory Board, consultants, and
industry and pharma partners; 4) provide oversight over data management and integration for all data sets
generated by the RC for each of the DDTs to facilitate seamless utilization by the QP in preparing validation
and qualification documents; and 5) establish long-term sustainability plans beyond the funding period,
including plans for IP and commercialization.

## Key facts

- **NIH application ID:** 10814020
- **Project number:** 1U2CAG088071-01
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** James L McGrath
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $152,117
- **Award type:** 1
- **Project period:** 2024-01-15 → 2028-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10814020

## Citation

> US National Institutes of Health, RePORTER application 10814020, Administrative Core (1U2CAG088071-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10814020. Licensed CC0.

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