Facilitating T1 Translational Aging Research: Preclinical and Early Phase Human Studies (UG3/UH3 Clinical Trial Optional)

The NIH's "Facilitating T1 Translational Aging Research: Preclinical and Early Phase Human Studies" grant, administered by the National Institute on Aging (NIA), funds translational research in aging-related conditions to support drug development and repurposing projects. This opportunity targets aging-related conditions such as sarcopenia, heart failure with preserved ejection fraction, and immunosenescence, advancing from preclinical studies through to early-phase human trials. Neurodegenerative diseases, Alzheimer's, and related dementias are excluded from this funding opportunity. The award employs the UG3/UH3 phased cooperative agreement mechanism, with the UG3 phase focused on preliminary translational activities, including screening, hit-to-lead optimization, and pre-IND protocol development. The UH3 phase, contingent on successful completion of UG3 milestones, funds comprehensive pharmacology, toxicology studies, and first-in-human (FIH) trials. This grant has an estimated total funding of $2,500,000 in fiscal year 2025, with a maximum of five awards anticipated. For the UG3 phase, applicants can request up to $350,000 per year in direct costs, and up to $700,000 per year in the UH3 phase. The UG3 phase is capped at two years, while the UH3 phase may not exceed three years, resulting in a maximum project period of five years. Projects may involve traditional drug development or data-driven computational drug repurposing, utilizing methods such as structural databases, protein-protein interactions, and clinical data mining. Eligible entities include higher education institutions, nonprofit organizations, small businesses, and government entities. Foreign organizations, however, are not eligible. Projects require interdisciplinary teams with expertise in relevant scientific areas, such as computational biology, clinical research, translational medicine, and data science. Applications need to include a detailed multi-phase research strategy with clear quantitative milestones, as funding for the UH3 phase depends on successful UG3 milestone achievement. Submission requirements include a project narrative, budget, and various federal forms. Key personnel must be registered in NIH’s eRA Commons, and applicants are required to complete registrations through SAM.gov, NCAGE (for foreign applicants), and Grants.gov. Applications are due by January 10, 2025, with a non-binding letter of intent encouraged by December 10, 2024. Following scientific merit review, recommended projects proceed to NIA's advisory review, with awards announced as early as September 2025. Evaluation criteria cover significance, innovation, investigator expertise, and approach, with additional requirements for projects involving human subjects. Applications must address the planned use of study populations, informed consent, recruitment plans, and data handling. Intellectual property considerations are vital, with institutions retaining IP rights but expected to pursue patent protection. The NIH expects adherence to compliance standards, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), to ensure FDA-readiness. Grantees will submit annual progress reports and a final report to track and demonstrate the program’s progress toward translational aging research goals.