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

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This Notice of Funding Opportunity (NOFO) from the National Institute on Aging (NIA) invites applications on T1 translational aging research (i.e., bench to bedside) which focus on advancing new therapeutics from preclinical stages to first-in-human (FIH) trials for aging-related conditions such as sarcopenia, heart failure with preserved ejection fraction (HFpEF), and deficits such as immunosenescence. The NOFO will specifically support two categories of milestone-driven projects: 1) traditional de novo drug development (i.e., new chemical/molecular entities) with three specific entry points to the translational pipeline (i.e., screening through preclinical validation, hit to lead through IND, or late-stage preclinical development through FIH studies), and 2) data-driven computational drug repurposing strategies with subsequent validation of predictions and generation of proof-of-concept data in pertinent animal models and/or in human in vitro studies.For the purposes of this NOFO, drug repurposing (also known as drug repositioning, reprofiling or re-tasking) refers to approaches for identifying alternative uses for FDA-approved drugs or investigational therapeutics which are beyond the scope of the original intended clinical indication. The types and scale of proposed translational research activities in the projects are anticipated to vary and will depend on whether the project focuses on traditional drug development pathways or involves drug repurposing. The UG3 phase of this NOFO will support T1 translational research planning activities and preliminary studies. Transition to the UH3 phase (based on achievement of UG3 milestones proposed by the investigators) will enable more comprehensive pharmacology and/or toxicology evaluations of the proposed therapeutics, including replication studies to confirm preliminary findings or experimental validation of predictive models.