The NIH's "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)" program supports research aimed at developing in vitro and ex vivo assays to identify and characterize new therapeutic agents for neurological or neuromuscular disorders. The purpose of this initiative is to create assays that can screen potential treatments, with a focus on identifying promising neurotherapeutics. This funding mechanism is designed to support projects that may later advance into more mature translational programs, such as the NIH Blueprint Neurotherapeutics Network (BPN). The program encourages the use of high-throughput technologies and aims for well-validated assays capable of efficiently identifying new therapeutic candidates.

This funding opportunity uses the R61/R33 Phased Innovation Award mechanism, where the R61 phase focuses on the development and refinement of assays, while the R33 phase supports the screening of therapeutic agents and further characterization of potential candidates. Transitioning between the phases depends on meeting pre-defined, quantifiable milestones. This FOA seeks projects with strong biological rationale and a clear focus on developing therapeutics that address unmet needs in neurological and neuromuscular conditions. Special emphasis is placed on the robustness of the assays and their potential to facilitate therapeutic discovery. The initiative also prioritizes projects targeting underrepresented patient populations.

The program offers grants for direct costs up to $499,000 per year, and the total direct costs over the three-year project period must not exceed $750,000. The R61 phase can last for up to two years, and the R33 phase can extend for an additional two years. The FOA specifically prohibits clinical trials and focuses on preclinical work involving assay development and therapeutic screening. Eligible applicants include higher education institutions, non-profits, small businesses, and foreign institutions. Collaborations with drug development experts and diverse research teams are strongly encouraged to increase the project's success rate and innovation.

Applications must clearly outline the biological rationale, assay development plan, and milestones for transitioning from the R61 to R33 phases. They must also demonstrate how the proposed work fits within the broader therapeutic development pipeline for neurological disorders. The funding also encourages diversity within research teams and emphasizes collaborative efforts with industry experts to foster translational success. Applicants should be aware that compliance with the guidelines and timely registration with relevant systems, such as Grants.gov and NIH eRA Commons, is mandatory.

Key submission deadlines are available through 2024, and applicants should ensure that all documents meet the specific requirements outlined in the application guide. The next critical deadlines are February 20, 2024, for standard applications, and later cycles will follow through June 2025.