Administrative Core

NIH RePORTER · NIH · U2C · $152,117 · view on reporter.nih.gov ↗

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
UNIVERSITY OF ROCHESTER
Principal Investigator
James L McGrath
Activity code
U2C
Funding institute
NIH
Fiscal year
2024
Award amount
$152,117
Award type
1
Project period
2024-01-15 → 2028-12-31