The FY23 BMFRP IIRA will offer two funding levels with different intent:
Funding Level 1 (FL1): To support studies that further develop mature ideas, expand upon key discoveries, and have the potential to make significant advances in research and/or patient care in the FY23 BMFRP Focus Areas. IIRA applications may involve translational and clinical research including studies in animal models, research with human data and/or 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 a clinical trial. Multidisciplinary collaborations are encouraged.
Funding Level 2 (FL2): To support Investigational New Drug (IND) application-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; 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 for a lead therapeutic candidate that will be included in an IND application submission to the U.S. Food and Drug Administration (FDA). At least one and no more than three lead therapeutic candidates must be named at the time of application submission to meet the intent of the FL2 mechanism. Library screening or drug optimization studies do not meet the intent of FL2. 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 FY23 BMFRP Focus Area, “Find effective BMF treatments and cures.”
Deadlines:
To meet the intent of the award mechanism, applications must address at least one of the FY23 BMFRP Focus Areas listed below. Selection of the appropriate Focus Area is the responsibility of the applicant.
• Understand the causes and progression of BMF diseases
• Find effective BMF treatments and cures
An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization. Investigators at or above the level of Assistant Professor (or equivalent) may be named by the applicant organization as the PI or Partnering PI on the application.
The anticipated direct costs budgeted for the entire period of performance for an FY23 BMFRP IIRA FL1 Award should not exceed $675,000, and the anticipated direct cost budgeted for the entire period of performance for an FY23 BMFRP IIRA FL2 award will not exceed $850,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
