DOD Bone Marrow Failure, Investigator-Initiated Research Award | W81XWH 21 BMFRP IIRA

Opportunity Information: Apply for W81XWH 21 BMFRP IIRA

The DOD Bone Marrow Failure, Investigator-Initiated Research Award (FY21) is a Department of Defense funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that supports research and development aimed at improving outcomes for people affected by bone marrow failure (BMF). It is offered under Funding Opportunity Number W81XWH-21-BMFRP-IIRA and uses either a grant or cooperative agreement mechanism. The program sits within the Science and Technology/Research and Development category (CFDA 12.420) and, at least as published, is broadly open to applicants (listed as unrestricted eligibility, with any finer constraints handled in the full eligibility text).

A defining feature of this opportunity is that it is split into two distinct funding levels with different purposes. Funding Level 1 (FL1) is designed for investigator-initiated projects that build on promising ideas or key discoveries and can plausibly drive meaningful advances in BMF research, patient care, and/or quality of life within the program’s stated focus areas. FL1 is intentionally flexible in terms of research type: proposals can be basic, translational, or clinically oriented, and may include animal studies, work with human anatomical substances, and research involving human subjects. FL1 can also support correlative studies that are tied to an already-existing clinical trial, but it cannot be used for projects where the main goal is to run a clinical trial. The solicitation also signals that multidisciplinary collaborations are welcome, which often implies reviewers will value projects that integrate different scientific or clinical perspectives to solve complex BMF problems.

Funding Level 2 (FL2) is more targeted and is meant specifically for IND-enabling work, meaning the practical, preclinical development steps needed to prepare a strong Investigational New Drug (IND) application to the U.S. Food and Drug Administration. The DOD is explicitly recognizing that moving a therapy from a promising lab result into human testing requires substantial resources and structured evidence. FL2 projects are expected to be empirical and product-driven, concentrating on the kinds of data the FDA expects before first-in-human trials can begin. Examples of the required or typical work called out include lead compound characterization, formulation and stability, absorption/distribution/metabolism/excretion (ADME), dose-response studies, and toxicology. The endpoint is not a clinical trial itself (clinical trials are not funded under this mechanism), but rather a package of results that can directly support an IND submission by the end of the award period. FL2 applications must align with the BMFRP focus area of “Find effective BMF treatments and cures,” reinforcing that this track is intended to accelerate concrete therapeutic candidates toward clinical evaluation.

Administratively, the opportunity was posted April 27, 2021, with an original closing date of October 12, 2021. The notice lists an expected two awards. The award ceiling is shown as 0 in the summarized record, which typically means applicants need to consult the full program announcement for the actual maximums by funding level and any budget structure or duration limits. Overall, the program supports both earlier-stage investigator-driven advances (FL1) and later-stage, regulatory-focused preclinical development (FL2), while drawing a clear line that this particular award does not pay for conducting clinical trials as the primary activity.

• 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 27, 2021.
• Applicants must submit their applications by Oct 12, 2021. (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.

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