Awardee OrganizationUNIVERSITY OF TEXAS MED BR GALVESTON
Description
Abstract Text
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 Center faculty and staff will interact with the Core as it executes its Administration,
Integration, Quality Assurance/Quality Control, and Technology Transfer & Commercialization functions.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AccelerationAdoptionAnalytical ChemistryArumBiochemicalCalibrationCellsChemicalsCollaborationsCommunicationComputer ModelsConsultationsCosmeticsDataData Management ResourcesDatabase Management SystemsDecision MakingDevelopmentDevicesDisciplineDiscipline of obstetricsDivision of Basic SciencesDrug IndustryEducational workshopElementsEnsureEvaluationFAIR principlesFacultyFeedbackFrequenciesFundingGoalsGovernment AgenciesGynecologyHumanHuman ResourcesIndividualIndustryInstitutionJointsKnowledgeLaboratoriesLeadershipMeasurementMedicalMentorsMolecularMonitorPerformancePharmacologic SubstancePregnancyPreparationPrincipal InvestigatorPrivate SectorProtocols documentationPublicationsQualifyingQuality ControlReportingReproducibilityResearchResearch PersonnelResourcesScienceTechnology TransferTestingTexasTissue MicroarrayTissuesTrainingTranslatingTranslational ResearchTranslationsUnited States National Institutes of HealthUniversitiesWomen's HealthWorkclinical developmentclinically relevantcollegecommercializationdata qualitydata sharingdrug developmenteffectiveness evaluationexperienceexperimental studyfollow-upfundamental researchhuman femaleindustry partnermanufacturemeetingsmembermicrophysiology systemoutreachpractical applicationprogramsprospectivequality assurancereproductive organsuccesstechnology platformtool developmenttranslational potential
National Center for Advancing Translational Sciences
CFDA Code
DUNS Number
800771149
UEI
MSPWVMXXMN76
Project Start Date
04-June-2024
Project End Date
31-May-2029
Budget Start Date
01-June-2024
Budget End Date
31-May-2025
Project Funding Information for 2024
Total Funding
$274,929
Direct Costs
$182,083
Indirect Costs
$92,846
Year
Funding IC
FY Total Cost by IC
2024
National Center for Advancing Translational Sciences
$274,929
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 1U2CTR004868-01 7736
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 1U2CTR004868-01 7736
Patents
No Patents information available for 1U2CTR004868-01 7736
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 1U2CTR004868-01 7736
Clinical Studies
No Clinical Studies information available for 1U2CTR004868-01 7736
News and More
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History
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