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 Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products funding opportunity by the National Heart, Lung, and Blood Institute (NHLBI) is designed to provide translational support for early-stage therapeutic development targeting heart, lung, blood, and sleep (HLBS) diseases and disorders. The funding utilizes a two-phase mechanism (R61/R33) to identify, validate, and optimize therapeutic candidates. Projects under this program must demonstrate a strong biological rationale and preliminary data to support the development of therapeutics that address unmet medical needs within the NHLBI mission. The R61 phase focuses on target identification and validation, as well as compound screening and initial development. Activities may include assay development, hit compound screening, and preliminary biological assessments. The R33 phase supports lead series optimization and preliminary efficacy testing in vitro and in vivo. For combination products, the R33 phase also involves integrating therapeutic components into a prototype for further testing. This phased approach ensures that projects are sufficiently advanced before transitioning to more extensive preclinical development. Eligibility for funding is broad, including higher education institutions, nonprofits, for-profit organizations (small and large businesses), and government entities. Non-domestic U.S. components are eligible, but foreign entities are not. Applications must align with NHLBI priorities, demonstrating innovative approaches to therapeutic development. Non-responsive applications include those proposing basic research, device or diagnostic development, or projects aiming to develop clinical trials or conduct Investigational New Drug (IND)-enabling studies. Funding for the R61 phase is capped at $400,000 in direct costs annually, with a maximum duration of two years. The R33 phase also has an annual cap of $400,000 in direct costs, with cost-sharing of at least 0.25:1 of non-federal funds required. A key component for R33 phase transition is securing an Accelerator Partner, who will provide commercialization expertise and connections to further advance the therapeutic candidate. Applications must detail specific aims, milestones, and a robust management plan. A preliminary Intellectual Property (IP) and regulatory strategy must be outlined, addressing potential IP constraints and regulatory considerations, even at early stages. Applicants are encouraged to engage institutional technology transfer offices and regulatory consultants to refine their plans. Proposals are evaluated based on their scientific significance, innovation, rigor, feasibility, and potential to achieve therapeutic milestones. Additional considerations include the adequacy of IP and regulatory strategies and the feasibility of project timelines. Transition to the R33 phase requires evidence of milestone completion, third-party investment, and an Accelerator Partner agreement. Applications are due at multiple intervals, starting February 11, 2025, with subsequent deadlines in June, October, and annually through 2027. Proposals must be submitted through Grants.gov, and compliance with NIH policies is mandatory. The NHLBI strongly encourages early engagement with program staff to ensure alignment with program goals and priorities.