Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed)

The National Institutes of Health, within the U.S. Department of Health and Human Services, through the National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases, administers this funding opportunity as part of its broader Catalyze innovation program. This program is designed to accelerate the translation of basic scientific discoveries into viable therapeutic products that address heart, lung, blood, and sleep-related diseases. The initiative supports early-stage translational research and aims to bridge the gap between discovery and preclinical development by providing structured funding, milestone-driven oversight, and access to commercialization expertise. The purpose of this funding opportunity is to support projects focused on identifying and validating therapeutic targets and developing preliminary compounds or biologic candidates. The program uses a phased R61/R33 mechanism, where the initial R61 phase supports exploratory work such as target validation, compound screening, and assay development. The subsequent R33 phase advances promising leads toward preclinical development, including characterization, optimization, and early pharmacokinetic evaluation. Projects must demonstrate strong biological rationale, preliminary data, and a clear path toward therapeutic application. Funding supports a wide range of activities including synthesis of therapeutic agents, assay development, screening of compounds, and validation of biological activity. However, the program explicitly excludes clinical trials, device development, biomarker discovery, and manufacturing for clinical use. Applicants must also develop intellectual property and regulatory strategies, even at early stages, and demonstrate how their work could lead to commercialization or further funding. The program emphasizes milestone-based progress, requiring detailed timelines and measurable outcomes for both phases. Eligibility is broad and includes higher education institutions, nonprofit organizations, for-profit entities including small businesses, and various levels of government entities. Foreign organizations are not eligible to apply, although foreign components of U.S. organizations are permitted. Applicants must complete required federal registrations, including SAM, Grants.gov, and eRA Commons, prior to submission. Individuals serving as principal investigators must demonstrate the necessary expertise and institutional support to carry out the proposed research. Applications must be submitted electronically through NIH-approved systems such as ASSIST or Grants.gov Workspace. Required components include a detailed research plan, specific aims for both phases, milestone timelines, budget justification, and an intellectual property and regulatory strategy attachment. Applications are evaluated through NIH’s peer review process based on significance, innovation, rigor, feasibility, investigator expertise, and project management structure. Additional considerations include data management plans and compliance with federal policies. The application timeline follows multiple annual cycles with deadlines in February, June, and October each year through 2027. Applications are due by 5:00 PM local time of the applicant organization. Review and award timelines are structured, with scientific review occurring several months after submission and earliest start dates approximately 10 months after submission. The program is recurring, with multiple submission opportunities annually, and is expected to continue through its expiration date in December 2027.

Ensure milestones are specific measurable and tied to phase transition; emphasize translational impact and unmet clinical need; demonstrate strong biological rationale and reproducibility