Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed)

This Notice of Funding Opportunity (NOFO) invites applications that propose to use mouse models to conduct rigorous preclinical testing of drugs or drug combinations currently used for other conditions, as well as investigational drugs at various stages of clinical development, predicted to be efficacious in AD/ADRD. This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes. The central goal is to establish robust proof of concept that will enable rational drug repurposing and combination therapy development for the treatment and prevention of AD/ADRD.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

The major elements in evaluating proposals include assessments of: the scientific merit and general significance of the proposed study and its objectives; the technical adequacy of the experimental design and approach; the competency of the proposed investigator or group to successfully pursue the project; the adequacy of the available and proposed facilities and resources; the necessity of the budget components requested in relation to the proposed project; and the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed...