DOD Bone Marrow Failure, Investigator-Initiated Research Award

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The FY21 BMFRP Investigator-Initiated Research Award will offer two funding levels with different intent: Funding Level 1 (FL1): To support studies that further develop ideas, expand upon key discoveries, and have the potential to make significant advances in research, patient care, and/or quality of life in the FY21 BMFRP Investigator-Initiated Research Award Focus Areas. Investigator-Initiated Research Award applications may involve basic, translational, and clinically oriented research, including studies in animal models, research with human anatomical substances, and research with human subjects, as well as correlative studies associated with an existing clinical trial; however, FL1 awards may not be used to support studies where the primary objective is a clinical trial. Multidisciplinary collaborations are encouraged. Funding Level 2 (FL2): To support Investigational New Drug (IND)-enabling efforts. The BMFRP recognizes the scientific and financial challenges associated with advancing promising, potentially life-changing, therapeutic agents from the laboratory to clinical evaluation. Data related to lead compound characterization; formulation and stability; absorption, distribution, metabolism and excretion (ADME); dose/response; and toxicology are required before clinical trials can commence. The proposed studies under the FL2 IND-enabling efforts are expected to be empirical in nature, product-driven, and focused on the accumulation of data that will be used in an IND submission to the Food and Drug Administration (FDA) at the end of the period of performance. The intent of FL2 awards is to perform the necessary evaluation of promising therapies that will lead to clinical trials; however, clinical trials themselves are not supported by this mechanism. FL2 applications must address the FY21 BMFRP Focus Area “Find effective BMF treatments and cures”.

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