DOD Reconstructive Transplant, Advanced Technology Development Award

Description

The FY23 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation.Important aspects of this award mechanism include:• Study Design and Feasibility: The proposed study design should be clearly described, rigorous, well-integrated, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, if applicable. It should be clear how the proposed study design of this project will position the product for the next phase of development as described in the post-award Transition Plan (Attachment 9).• Impact/Military Relevance: The short- and long-term impacts of the proposed research should be clearly articulated. Projects must address at least one of the FY22 RTRP Advanced Technology Development Award Focus Areas listed in Section II.A.1 above. All products to be developed must be responsive to the health care needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers, or clinicians, as well as the general public. Collaboration with military and VA researchers and clinicians is encouraged but not required.• Transition Plan: The post-award Transition Plan (Attachment 9) should include potential funding and resources and show how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the successful completion of this award. A regulatory strategy as applicable to the proposed research/product should also be included.• Preliminary Data: Proof of concept demonstrating the potential utility of the proposed product, or a prototype/preliminary version of the proposed product, must already be established. Preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed study must be included (these data may be unpublished if from a member of the research team or from the published literature).Important Note: Leveraging novel findings from solid organ transplant research for testing in a VCA setting is acceptable if the rationale and benefits for doing so are appropriately explained and justified. For example, it should be clear why the anticipated result might be different in VCA, or why it is important to confirm the result is the same in VCA, or why repeating the study in a VCA setting could lead to new mechanistic insights or a better understanding of unique aspects of VCA.

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