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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)

National Institutes of Health

This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to identify and characterize potential therapeutic candidates (compound and lead series) to treat heart, lung, blood, and sleep (HLBS) diseases and disorders. This NOFO is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical program or attract independent development support from other federal or private partners for preclinical optimization and development of therapeutic candidates.

This specific Catalyze Product Definition NOFO will provide the early stage translational support needed for the activities required to develop potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This NOFO is intended to provide support for early stage projects through use of a bi-phasic approach. The R61 phase allows investigators to identify, validate and screen compounds of interest, and develop the individual components of a combination drug product and the R33 phase supports identification of a lead series for pre-clinical testing and development. A companion NOFO ( RFA-HL-26-018 ) is available for more advanced projects that have already completed the activities supported by the R61 phase of this initiative, but need continued support to identify a lead series or further test a combination product. A therapeutic candidate with two or more distinct, individual components should use RFA-HL-26-017 and its companion RFA-HL26-018. Individual components may be include a drug, a biologic, a combination product including a cell or genetic therapy component, or an eligible biologic regulated by the FDA's Center for Biologics Evaluation and Research (CBER), or Center for Drug Evaluation and Research (CDER). Through Catalyze, the small molecule and biologics initiatives have companion initiatives that support development of devices and diagnostics ( RFA-HL-26-019 and RFA-HL-26-020 ) and an initiative that supports the development of enabling technologies and transformative platforms ( RFA-HL-26-016 ). See website for additional information.

Deadlines:

Letter of Intent: 30 days prior to the application due date
Application Due Dates: Feb. 11, 2025; June 18, 2025; Oct 21, 2025; Feb 11, 2026; June 18, 2026; Oct 21, 2026; Feb 11, 2027; June 17, 2027; Oct 21, 2027
AIDS Application Due Dates: April 21, 2025; Aug 21, 2025; Dec 22, 2025; April 21, 2026; Aug 21, 2026; Dec 23, 2026; April 23, 2027; August 23, 2027; Dec 23, 2027

RFA-HL-26-019 Expiration Date: December 24, 2027

Specialties

Cardiothoracic Surgery

Cell Biology

Molecular Biology

Sleep Medicine

Cardiovascular Diseases

Hematology

Pulmonology

Technology Development

Eligibility Requirements

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Local Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type:

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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