DoD Military Burn, Technology/Therapeutic Development Award

The MBRP TTDA is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical application in resource-limited settings, particularly within the pre-hospital, or early acute phase of care (military roles of care 1-3) environment and which address one or more of the critical gaps included in the FY23 MBRP TTDA Focus Areas. Products under development must be relevant to military application and address the needs of military Service Members, Veterans, and/or beneficiaries.The product(s) to be developed may be a tangible item such as a medical device or pharmacologic agent (including, but not limited to, drugs or biologics). Knowledge products may be considered, provided that the knowledge is applicable to a technology or therapeutic under development. (A “knowledge product” is a non-materiel product that addresses an identified need in one or more of the FY23 MBRP TTDA Focus Areas. A knowledge product is based on current evidence, aims to transition clinical practice standards, training, or tools into clinical practice, or supports 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 7: 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 MBRP award. At the time of pre-application submission the proposed product must be at a minimum technology readiness level (TRL) or knowledge readiness level (KRL) of 4 (Appendix 2).Proof-of-concept AND a prototype/preliminary version of the proposed product demonstrating its potential utility must be established at the time of pre-application submission. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.This award mechanism is intended to facilitate progression of research that is supported by significant preliminary data but has not yet advanced to the level of clinical use. Examples of the types of research that may be supported include, but are not limited to:• Testing new therapeutic or technologic modalities (e.g., agents, delivery systems, chemical modification of lead compounds, device testing and/or validation) using established or validated preclinical systems• Designing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or technologies for use in advanced preclinical studies• Developing pharmacologic agents through absorption, distribution, metabolism, excretion, and toxicity studies• Investigational New Drug- or Investigational Device Exemption-enabling studiesThe types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.The anticipated total costs budgeted for the entire period of performance for an FY23 MBRP TTDA should not exceed $2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $4M to fund approximately two Technology/Therapeutic Development Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific 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 FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.Impact: The overall impact of the proposed research is a key component of this award mechanism. The potential impact of the research, both short term and long term, in addressing one or more of the FY23 MBRP Focus Areas should be clearly described. High-impact research will, if successful, lead to the development and translation of therapeutic or technologic advances for clinical application in the care of burn-injured casualties, such as detection, diagnosis, treatment, or burn complication prevention. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate highly impactful research:• Explanation of how the project will significantly advance the care of burn-injured Service Members in an austere or resource limited environment• Description of how the proposed research will support the ability to provide care to burn-injured patients at or close to the point of injury, particularly by a combat medic (or equivalent), or a non-medical first responderRelevance to Military Health: Relevance to the health care needs of military Service Members, Veterans, military beneficiaries, and/or the American public is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:• Explanation of how the project addresses an aspect of burn injuries typically associated with combat• Description of how the therapy, technology, or knowledge gained from the proposed research could be implemented to address a military needUse of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military and/or VA patient populations and/or DOD or VA 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. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaboration with DOD or VA investigators is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 3.Clinical trials and clinical research studies ARE NOT PERMITTED under this award mechanism. Projects involving the use of human anatomical specimens are permitted, provided that the use of such specimens is necessary for device validation, or in vitro or ex vivo studies. Applicants interested in proposing clinical research should consider submitting to the FY23 MBRP Clinical Translational Research Award mechanism.A clinical trial is defined 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.Clinical research encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research 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 study 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 tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under §46.104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required.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 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 (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. Projects that include research on animal models are required to submit Attachment 8, Animal Research Plan, as part of the application package to describe how these standards will be addressed. Applicants should consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical All DOD-funded research involving new and ongoing research with human data, human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web page https://mrdc.health.mil/index.cfm/ collaborate/research_protections/hrpo for additional information.If the proposed research involves more than one institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Research Involving Animals: All research funded by the FY23 MBRP TTDA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.
Categories: Science and Technology and other Research and Development.