DoD Bone Marrow Failure Investigator-Initiated Research Award | HT9425 23 BMFRP IIRA

Opportunity Information: Apply for HT9425 23 BMFRP IIRA

The DoD Bone Marrow Failure Investigator-Initiated Research Award (IIRA) is a Department of Defense-funded opportunity under the FY23 Bone Marrow Failure Research Program (BMFRP) designed to move bone marrow failure (BMF) research forward through investigator-driven projects with clear potential to advance science and ultimately improve patient care. It is run through the Department of Defense, Department of the Army (USAMRAA), and supports science and technology research and development activities. The program is structured around two distinct funding levels, each with a different purpose, allowing applicants to align their proposals with either advanced research development goals or late-stage preclinical work aimed at preparing a therapy for FDA review.

Funding Level 1 (FL1) is meant for strong, mature research ideas that are ready to be pushed further. Projects in this track should build on solid prior work, expand key discoveries, and aim for meaningful advances within the FY23 BMFRP Focus Areas. The scope is broad in terms of research approach: FL1 can include translational studies and clinically oriented research, including work in animal models, studies using human data or human anatomical substances, and research involving human subjects. It can also include correlative studies that connect to an existing clinical trial (for example, biomarker or mechanistic studies that leverage samples or data from a trial that is already underway). A key restriction is that FL1 funds cannot be used to run a clinical trial itself. The solicitation also explicitly encourages multidisciplinary collaboration, signaling that teams combining different specialties (for example, hematology, immunology, genomics, and drug development) are viewed as a good fit.

Funding Level 2 (FL2) is more narrowly targeted and is specifically intended to support IND-enabling efforts, meaning the set of empirical, product-focused studies required to assemble a credible Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration. The rationale is that promising therapies often stall between the lab and first-in-human testing because the preclinical package needed for regulatory review is expensive and technically demanding. FL2 is intended to fund the concrete studies that generate this required dataset, such as lead candidate characterization, formulation and stability work, absorption/distribution/metabolism/excretion (ADME) studies, dose-response studies, and toxicology. The emphasis is on a defined therapeutic product rather than exploratory discovery. Applicants must name at least one and no more than three specific lead therapeutic candidates at the time they apply, which reinforces the expectation that the project is centered on a real, prioritized candidate headed toward an IND submission. The announcement also draws a bright line around what does not fit: library screening and drug optimization efforts are not considered responsive for FL2, because those activities are earlier-stage discovery and refinement rather than IND package generation. Like FL1, FL2 does not support conducting clinical trials; instead, it supports the work that positions a candidate to enter clinical testing next. FL2 applications also have an additional requirement: they must address the FY23 BMFRP Focus Area, "Find effective BMF treatments and cures," aligning this track directly with therapeutic advancement.

Administratively, the opportunity is listed under Funding Opportunity Number HT9425 23 BMFRP IIRA, with funding provided through either grants or cooperative agreements. Eligibility is described as unrestricted, meaning it is broadly open to different entity types unless further limited by additional eligibility language in the full notice. The CFDA/Assistance Listing number is 12.420. The opportunity was created April 21, 2023, and the original closing date was September 20, 2023. The listing indicates an expected number of awards of two, and shows an award ceiling of 0 in the summary fields (which typically means applicants need to refer to the full program announcement for the actual maximums or that the ceiling was not populated in the abstracted listing).

Overall, the IIRA mechanism is set up to support two kinds of high-impact BMF work: FL1 for robust, advanced research efforts that can materially move understanding and care forward (without paying for a clinical trial), and FL2 for practical, regulatory-oriented preclinical studies that can carry a specific therapeutic candidate across the threshold into FDA IND submission and eventual clinical evaluation (again stopping short of funding the trial itself).

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Bone Marrow Failure Investigator-Initiated Research Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Apr 21, 2023.
• Applicants must submit their applications by Sep 20, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for HT9425 23 BMFRP IIRA

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