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 - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33) funding opportunity is offered by the National Institutes of Health under the U.S. Department of Health and Human Services, specifically through the National Heart, Lung, and Blood Institute with participation from the National Institute of Allergy and Infectious Diseases. This program is part of the broader Catalyze innovation initiative, which is designed to accelerate the translation of early-stage scientific discoveries into viable therapeutic products addressing heart, lung, blood, and sleep disorders. The program emphasizes bridging the gap between basic research and preclinical development by supporting early translational efforts that can attract further funding or transition into advanced development programs. The purpose of this funding opportunity is to provide early-stage translational support for the identification, validation, and development of therapeutic candidates, including small molecules, biologics, and combination products. The program is structured as a phased award, consisting of an R61 phase followed by an R33 phase. The R61 phase focuses on target identification, validation, and compound screening, while the R33 phase supports the identification of a lead series suitable for preclinical testing. The overall goal is to generate robust datasets and validated therapeutic leads that can advance toward preclinical optimization or secure independent investment. Funding under this opportunity supports a wide range of allowable activities related to therapeutic discovery and development. During the R61 phase, applicants may conduct compound synthesis, assay development, structure-activity relationship studies, and preliminary screening to assess biological activity. In the R33 phase, activities expand to include characterization of lead compounds, pharmacokinetic assessments, computational modeling, and validation studies. The program explicitly excludes clinical trials, manufacturing for clinical use, and purely basic research without translational intent. The award budget allows up to 400000 dollars in direct costs per year for each phase, with a maximum combined project period of three years. A cost matching requirement applies specifically to the R33 phase, where recipients are expected to provide a minimum non-federal cash match at a ratio of 0.25 to 1 relative to federal direct costs. This requirement reflects the program’s emphasis on commercialization readiness and leveraging external investment. Additionally, applicants must identify or secure an Accelerator Partner by the transition point between phases, which will provide expertise in commercialization, regulatory strategy, and market development. These partners play a critical role in advancing projects toward private sector engagement and long-term sustainability. Eligibility for this opportunity is broad and includes higher education institutions, nonprofits, for-profit organizations, government entities, tribal organizations, and other eligible entities. Foreign organizations are not eligible to apply directly, although foreign components of U.S. organizations are permitted. Applicants must complete required registrations in systems such as SAM, Grants.gov, and eRA Commons prior to submission. Individuals serving as principal investigators must demonstrate the necessary expertise and resources to carry out the proposed research. Applications must be submitted electronically through Grants.gov using approved systems such as ASSIST or Workspace, with tracking through eRA Commons. Required components include detailed research plans for both phases, milestone-driven timelines, intellectual property and regulatory strategy documentation, and a data management and sharing plan. Applications are evaluated based on significance, innovation, rigor, feasibility, investigator expertise, and project management structure. Milestones are a critical component, as progression from the R61 to the R33 phase depends on successful completion of predefined objectives. The application timeline includes multiple recurring submission deadlines each year, including February 11, June 18, and October 21 cycles. Applications are due by 5:00 PM local time of the applicant organization. The opportunity is open for submissions beginning January 11, 2025, and remains active through December 24, 2027. Review cycles include scientific merit review, advisory council review, and earliest start dates, which vary depending on the submission cycle. Applicants are encouraged to apply early and consult program staff prior to submission for guidance on project alignment and expectations.

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