The PRMRP Technology/Therapeutic Development Award (TTDA) is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life, for a disease or condition related to one of the FY23 PRMRP Topic Areas and one of the FY23 PRMRP Strategic Goals. Products in development should be responsive to the health care needs of military Service Members, Veterans, and/or beneficiaries. This award mechanism may not be used to conduct clinical trials.
The product(s) to be developed under the PRMRP TTDA mechanism may be a tangible item, such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product. (A “knowledge product” is a non-materiel product that addresses an identified need in a topic area, is based on current evidence and research, aims to transition into medical practice, training, tools, or to support materiel solutions [systems to develop, acquire, provide, and sustain medical solutions and capabilities], and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.) The Principal Investigator (PI) must provide a transition plan (including potential funding and resources, see Attachment 8, Transition Plan and Regulatory Strategy) showing how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the completion of the PRMRP award. PIs are encouraged to develop relationships with industry and/or other funding agencies to facilitate moving the product into the next phase of development.
Proof of concept demonstrating the potential utility of the proposed product, or a prototype/ preliminary version of the proposed product, should already be established. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature. PIs seeking to identify a product or demonstrate initial proof of concept should consider submitting to the FY23 PRMRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number HT9425-23-PRMRP-IIRA) or the FY23 PRMRP Discovery Award mechanism (Funding Opportunity Number HT9425-23-PRMRP-DA), as appropriate.
Deadlines:
• Required Pre-Application Deadline: April 19, 2023
• Application Submission Deadline: May 31, 2023
PIs at or above the level of Assistant Professor (or equivalent) may be named by the organization as the PI on the application. Each investigator may be named on only one FY23 PRMRP TTDA application as a PI.
Research proposed under this award mechanism may be at different stages of idea and research development. Two different funding levels, based on the scope of the research, are available under this program announcement. The applicant must select the funding level that is most appropriate for the research proposed.
• Funding Level 1: Research that is supported by significant preliminary data but has not advanced to clinical translation. Anticipated direct costs of Funding Level 1 will not exceed $2M.
• Funding Level 2: Research that is in the final stages of preclinical development with potential for near-term clinical development. Applications must provide relevant data that support the rationale for the proposed study. Funding Level 2 recipients must submit or obtain an Investigational New Drug/Investigational Device Exemption (IND/IDE) application to the U.S. Food and Drug Administration (FDA), or must transition the product to clinical practice, within the period of performance. Applications not meeting the requirements of Funding Level 2 will be reassigned to Funding Level 1. Anticipated direct costs of Funding Level 2 will not exceed $4M.
