The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), has issued a Funding Opportunity Announcement (FOA) under the Catalyze program titled "Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33)." This program supports the early-stage development of potential therapeutic candidates aimed at treating heart, lung, blood, and sleep (HLBS) diseases and disorders. The FOA provides funding for projects focused on identifying and validating therapeutic targets and advancing lead compound development, using a phased approach to progress from preliminary discovery through preclinical optimization.

The FOA offers a bi-phasic R61/R33 award structure, with the R61 phase focusing on target identification, validation, and screening of therapeutic candidates. The subsequent R33 phase supports further development and characterization of promising lead compounds, preparing them for preclinical testing. Projects must demonstrate potential for significant advances in HLBS therapeutic development, with emphasis on innovative approaches, strong biological rationale, and a clear path to preclinical testing.

Applicants can request up to $350,000 per year in direct costs for both the R61 and R33 phases, with the combined project period lasting up to three years. Notably, for the R33 phase, a 0.25:1 non-federal cost match is required. Additionally, partnerships with Accelerator Partners—commercialization experts—are encouraged to help projects progress toward market readiness.

The types of activities funded under the R61 phase include the development of assays for specificity and potency, hit-to-lead optimization, and preliminary target screening. In the R33 phase, activities focus on advancing lead compounds by evaluating pharmacokinetics, toxicity, and early in vivo efficacy. Proposals should include clear milestones for transitioning from the R61 to the R33 phase, as funding for the R33 phase is contingent on achieving the specified goals of the R61 phase.

Eligible applicants include public and private institutions of higher education, nonprofits, small businesses, and for-profit organizations, as well as state, local, and tribal governments. Non-domestic components of U.S. organizations are eligible, but foreign institutions are not. Applications from diverse backgrounds, including underrepresented racial and ethnic groups, are highly encouraged.

The submission deadlines are cyclical, with the next due date on November 21, 2023. Applicants are encouraged to submit letters of intent 30 days before the application due date. This FOA is part of NHLBI’s broader Catalyze innovation program, which aims to accelerate the transition of basic scientific discoveries into tangible health solutions through robust project management and commercial partnerships.