Notice of Intent to Publish a Funding Opportunity Announcement for Facilitating Preclinical and Early Phase Human Studies for New Therapeutics (UG3/UH3 Clinical Trial Optional)

This Notice informs that the National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) inviting 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, physical functional impairments, heart failure with preserved ejection fraction (HFpEF), and deficits such as immunosenescence. Biologics or stem/progenitor cell therapies for improving injury repair in older adults (e.g., fractures, wound healing) may be proposed. This may include treatments with cytokines, trophic factors, etc., to improve stem/progenitor cell function to promote more efficient repair of injuries or wounds, as well as homeostasis of the damaged tissues. Proposed projects should clearly state the relationship between candidate compound or therapeutic target of interest for preclinical development to the clinical indication (i.e., aging-related condition of interest). Applications focusing on neurodegenerative diseases and Alzheimers disease and Alzheimers disease related dementias (AD/ADRD) will be outside the scope of the NOFO. The NOFO is expected to utilize the Exploratory/Developmental Phased Award Cooperative Agreement UG3/UH3 activity code, which is a milestone-driven, phased innovation mechanism. The UG3/UH3 application must be submitted as a single application. Investigators must propose annual milestones with timelines for the UG3 and UH3 phases. The specified milestones should be quantifiable goals (or deliverables) which can be used to monitor progress at each phase, and for go/no-go decision-making at the UG3/UH3 transition point. This notice is provided to enable advance planning by potential applicants to identify potential collaborators, coordinate and obtain approvals (if needed) for required research resources, and prepare a well-developed research plan for advancing a therapeutic through the stages of preclinical drug development and early phase human studies. The NOFO is expected to be published summer 2024 with an anticipated application due date in fall 2024.These are estimated time frames, and they may change.