TBI Intramural Advanced Technology-Therapeutic Development Award

The summary for the TBI Intramural Advanced Technology-Therapeutic Development Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.

TBI Intramural Advanced Technology-Therapeutic Development Award: The FY07 TBI Intramural Advanced Technology - Therapeutic Development Award mechanism targets ongoing DOD and VA demonstration studies of pharmaceuticals (drugs, biologics, and vaccines) and medical devices in preclinical systems and/or testing of therapeutics and devices in clinical studies. The intent of the TBI Intramural Advanced Technology - Therapeutic Development Award is to accelerate ongoing DOD and VA research on TBI therapeutics and devices for prevention, detection, diagnosis, and treatment of TBI. Proposal for new ideas should be submitted through one of the USAMRMC (non-accelerated) TBI award mechanisms currently available in Grants.gov. The overall goal of this award mechanism is to accelerate the introduction of improved therapies, treatments, devices, or technologies for TBI into the clinical setting by supporting (1) cognitive/behavioral clinical studies, (2) clinical interventions, (3) the generation of the preclinical data (e.g., Good Laboratory Practice [GLP] animal safety and toxicity, identifying endpoints of clinical efficacy or its surrogate in animal models, and data collection sufficient to support an investigational new drug [IND] or investigational device exemption [IDE] application) necessary to conduct clinical trials after completion of the proposed research and/or (4) the generation of safety and/or efficacy data (e.g., Phase I or Phase I/II clinical studies) on therapeutics and devices in clinical trials. The proposed studies are expected to be empirical in nature and product-driven and are expected to be beyond Biomedical Technology Readiness Level (TRL) 4 (for descriptions of TRL(s) please see pp 126-138 of the document located at http://www.ceros.org/documents/TRA_Deskbook).Proposals must include preliminary and/or published data relevant to the development process covered by the research in their proposals. Preliminary data is unpublished data. If the preliminary and/or published data is generated from a source other than the applicant, appropriate acknowledgement is required. For example, if the preliminary data has been generated by a colleague, acknowledgement should be made by listing the investigator's name, institution, and a statement that the data has been obtained via personal communication. Describe previous experience most pertinent to this proposal. Cite relevant literature references for published data. Proposals must explain clearly how the proposed products are directly relevant and applicable to proposed or future clinical studies for individuals with TBI. Successful TBI Intramural Advanced Technology - Therapeutic Development Award proposals will clearly outline the necessary steps to ultimately provide military-relevant health products or technologies positioned for advanced development that target TBI prevention, detection, diagnosis, and treatment. A plan for further product or technology development and/or transition to advanced development (including potential funding and resources) is required. If the proposed study includes an extension of an ongoing clinical study, PIs must provide a copy of the clinical protocol(s) approved to support the ongoing study.