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 DukeUniversity. 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.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
Autoimmune DiseasesBiologicalBiometryCellsCentral Nervous System DiseasesChargeCollaborationsCommunicationDataData Management ResourcesData SetDecision MakingDevelopmentDiseaseDrug PackagingDrug UtilizationEnsureEvaluationFacultyFeedbackFibrosisFosteringFundingGlassGoalsHuman ResourcesIndividualIndustrializationIndustryIntellectual PropertyLeadLeadershipLegal patentLettersMembraneModelingMusculoskeletalNational Center for Advancing Translational SciencesOpticsOsteomyelitisOutcomePathologyPermeabilityPlayProcessProgress ReportsQualifyingQuality ControlRegulatory AffairsResearchResearch ActivityResearch PersonnelResolutionResource DevelopmentResourcesRoleScheduleSepsisServicesSiliconStructureTechnologyThickTissue MicroarrayTissuesTranslatingTranslational ResearchUnited States National Institutes of HealthUniversitiesValidationWorkarmclinical translationcommercializationdata integrationdata managementdisease modeldrug developmentdrug discoveryfabricationflexibilityinduced pluripotent stem cellindustry partnerinnovationmanufacturemeetingsmicrophysiology systemnanomembranenew technologyprogramssensorsuccesstool development
No Sub Projects information available for 5U2CAG088071-02 7169
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 5U2CAG088071-02 7169
Patents
No Patents information available for 5U2CAG088071-02 7169
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 5U2CAG088071-02 7169
Clinical Studies
No Clinical Studies information available for 5U2CAG088071-02 7169
News and More
Related News Releases
No news release information available for 5U2CAG088071-02 7169
History
No Historical information available for 5U2CAG088071-02 7169
Similar Projects
No Similar Projects information available for 5U2CAG088071-02 7169