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to reconstructive transplantation and support the rationale for the proposed study must be included (these data may be unpublished if from a member of the research team or from the published literature).
Proposed research and products to be developed may be materiel products such as drugs, biologic agents, devices, or knowledge-based products such as technical reports and clinical practice guidelines that inform clinical/operational decisions and promote evidence-based changes in clinical practice and standard of care. Proposed research may include preclinical studies in animal models, human subjects, or human anatomical substances, as well as correlative studies associated with an existing clinical trial.
Deadlines:
• Required Pre-Application Deadline: July 19, 2023
• Invitation to Submit an Application: Aug 2023
• Application Submission Deadline: Oct. 11, 2023
To meet the intent of the FY23 RTRP Advanced Technology Development Award mechanism, applicants must address at least one of the FY23 RTRP Advanced Technology Development Award Focus Areas listed below (select both a bolded Focus Area and the appropriate subtopic):
Advance existing tissue preservation strategies to extend the timeline between procurement and transplantation. • Develop promising biopreservation strategies and technologies for translation to the clinic. • Develop mitigation strategies for immune activation resulting from ischemia reperfusion injury in VCA.
Identify and/or validate reliable non-invasive prognostic or diagnostic biomarkers, methods, or tools for monitoring VCA immunosuppression or rejection, including applications that would be suitable for point-of-care testing or home monitoring. • Identify and/or validate reliable non-invasive biomarkers for monitoring acute and chronic VCA graft rejection in the clinic (i.e., human clinical samples). • Develop assays or devices for clinical graft monitoring utilizing validated biomarkers. Proposed devices should take into account human use factors unique to VCA recipients. • Identify and/or validate reliable non-invasive approaches to measuring/monitoring in vivo/clinical immunosuppression levels.
Independent investigators at all academic levels (or non-academic equivalent) are eligible to be named as a PI (or Initiating or Partnering PI[s] for the Multiple PI Option).
There are no limitations on the number of applications for which an investigator may be named as a PI (or Initiating or Partnering PI[s] for the Multiple PI Option); however, the RTRP strongly encourages PIs to focus on the quality of their applications rather than quantity.
An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization.
The anticipated total costs budgeted for the entire period of performance for an FY23 RTRP Advanced Technology Development Award should not exceed $1M for Single PI applications and $1.5M for applications submitted under the Multiple PI Option applications. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
