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DoD Reconstructive Transplant, Advanced Technology Development Award

ID: HT942524RTRPATDA • Type: Posted

Description

The FY24 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation.

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.

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). If a model system is included in the research, it should be appropriate for the study and applicable to VCA.

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 FY24 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.

Advancing Women's Health Research and Innovation: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women's health outcomes and/or advancing knowledge for women's health. The RTRP therefore encourages research that addresses how various aspects of reconstructive transplant affect women uniquely, disproportionately, or differently from men.

Multiple Principal Investigator (PI) Option: The Advanced Technology Development Award includes an option for up to four PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI(s) will be identified as Partnering PI(s). All PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section II.D.2, Content and Form of the Application Submission.

Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (http://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.

Use of Department of Defense (DOD) or VA Resources: Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the VA, and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

For research involving animals, human subjects, human anatomical substances, or human cadavers, please see to the General Application Instructions, Appendix 6, for more information.

Clinical trials are not allowed under this funding opportunity. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is allowed under this funding opportunity. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.

(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under 46.104(d)(4) of the Common Rule.

In-Progress Review: The RTRP holds annual In-Progress Review meetings in a virtual setting as a forum for award performers to present progress updates to the Programmatic Panel and RTRP staff. Award recipients may receive an invitation to present their project at one of these meetings during the period of performance of their award.

The funding instrument for awards made under the program announcement will be grants (31 USC 6304).

The anticipated total costs budgeted for the entire period of performance for an FY24 RTRP Advanced Technology Development Award should not exceed $1.0M for single PI applications and $1.5M for applications submitted under the Multiple PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $3.5M to fund approximately three Advanced Technology Development Award applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Background
The FY24 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation. The RTRP challenges the scientific community to design innovative research that will advance science and standardized clinical practice of vascularized composite allotransplantation (VCA) to improve access, safety, and quality of life for catastrophically injured Service Members, Veterans, and the American public.

Grant Details
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. Important aspects of this award mechanism include study design and feasibility, impact/military relevance, transition plan, preliminary data, advancing women’s health research and innovation, multiple principal investigator (PI) option, rigor of experimental design, and use of Department of Defense (DOD) or VA resources.

Eligibility Requirements
Applications from investigators within the military services and applications involving multi-institutional and multidisciplinary collaborations among academia, industry, the military services, the Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. The RTRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men. The Advanced Technology Development Award includes an option for up to four PIs. Clinical trials are not allowed under this funding opportunity.

Period of Performance
Awards supported with FY24 funds will be made no later than September 30, 2025. The CDMRP expects to allot approximately $3.5M to fund approximately three Advanced Technology Development Award applications. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Grant Value
The anticipated total costs budgeted for the entire period of performance for an FY24 RTRP Advanced Technology Development Award should not exceed $1.0M for single PI applications and $1.5M for applications submitted under the Multiple PI Option.

Overview

Category of Funding
Science and Technology and other Research and Development
Funding Instruments
Grant
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 6/27/24 U.S. Army Medical Research Acquisition Activity posted grant opportunity HT942524RTRPATDA for DoD Reconstructive Transplant, Advanced Technology Development Award with funding of $3.5 million. The grant will be issued under grant program 12.420 Military Medical Research and Development. It is expected that 3 total grants will be made.

Timing

Posted Date
June 27, 2024, 12:00 a.m. EDT
Closing Date
Oct. 23, 2024, 12:00 a.m. EDT Due in 101 Days
Last Updated
June 27, 2024, 3:17 p.m. EDT
Version
1
Archive Date
Nov. 22, 2024

Eligibility

Eligible Applicants
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Award Sizing

Ceiling
Not Listed
Floor
Not Listed
Estimated Program Funding
$3,500,000
Estimated Number of Grants
3

Contacts

Contact
Joshua D McKean Grants Officer
Contact Email
Email Description
CDMRP Help Desk
Contact Phone
(301) 619-4046

Documents

Posted documents for HT942524RTRPATDA

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