HT942525PRMRPTTDA-GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version CD25_01.

Program Announcement for the Department of Defense Defense Health Program

Peer Reviewed Medical Research Program Technology/Therapeutic Development Award

Funding Opportunity Number: HT942525PRMRPTTDA

Pre-Application Due: June 9, 2025

Application Due: July 21, 2025 https://ebrap.org/eBRAP/public/gai.htm?version=CD25_01

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 2

Content

Before You Begin 3

Basic Information Contains a summary of the funding opportunity, funding details, and submission/review dates

Eligibility Details the factors that determine applicant organization and Principal Investigator eligibility

Program Description Describes the program mission and intent of the Technology/Therapeutic Development Award, provides key award information and considerations, and outlines funding restrictions

Application Contents Introduces the two-step application process and provides instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes associated with application compliance review, pre-application and full application selection/notification, and risk assessment. Also details the complete review criteria for pre-application screening and both tiers of the CDMRP’s application review process, Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect to receive if recommended for funding

Post-Award Requirements References policy requirements for funded research, outlines reporting requirements, and restrictions related to Principal Investigator changes or institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

Appendix 3 DOD and VA Websites

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 3

Before You Begin

• Active SAM.gov, eBRAP.org, and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read the funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of the funding opportunity and that all parties meet eligibility requirements.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing Alt + left arrow key (Windows) or command + left arrow key (Macintosh) on your keyboard.

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Contact Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

mailto:help@eBRAP.org mailto:support@grants.gov

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2025 (FY25) Peer Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development Award (TTDA) is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life, for a disease or condition related to one of the FY25 PRMRP topic areas and one of the FY25 PRMRP strategic goals. Products can be tangible items, such as drugs or devices, or can be knowledge products, such as clinical decision making tools or practice guidelines. Products in development should be responsive to the health care needs of military Service Members, Veterans, and their Families.

Distinctive Features: For the PRMRP TTDA, the program expects the research proposed will take an already established proof-of-concept or prototype through the final stages of preclinical development. The PRMRP also expects that the research outcome will be a regulatory filing or translation of findings into clinical practice, as applicable.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot approximately $41.25 million (M) to fund approximately 11 Technology/Therapeutic Development Award applications with direct cost caps of $2.5M. The maximum period of performance is 4 years. It is anticipated that awards made from this fiscal year 2025 (FY25) funding opportunity will be funded with FY25 funds, which will expire for use on September 30, 2031. Awards supported with FY25 funds will be made no later than September 30, 2026.

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 9, 2025

• Application Submission Deadline: 11:59 p.m. ET, July 21, 2025

• End of Application Verification Period: 5:00 p.m. ET, July 28, 2025

• Peer Review: September/October 2025

• Programmatic Review: December 2025 Announcement Type: Initial Funding Opportunity Number: HT942525PRMRPTTDA Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural organizations are eligible to apply, including foreign and domestic organizations, for-profit and non-profit organizations, and public or private entities.

Extramural Organization: An eligible non-Department of Defense (DOD) organization.

Examples of extramural organizations include academic institutions, biotechnology companies, foundations, federal government organizations other than the DOD (i.e., intragovernmental organizations), and research institutes.

Intramural DOD Organization: Refers specifically to DOD organizations including DOD laboratories, DOD military treatment facilities, and/or DOD activities embedded within a civilian medical center.

2.1.2. Principal Investigator

Investigators at or above the level of Assistant Professor (or equivalent) may be named by the organization as the Principal Investigator (PI) on the application.

Industry titles may not be analogous to the faculty hierarchy in academia. For industry, investigators at or above an independent scientist level may be named by the company as the PI on the application.

Each investigator may be named on only one FY25 PRMRP application as a PI, which includes the FY25 PRMRP TTDA and the FY25 PRMRP Clinical Trial Award (HT942525PRMRPCTA). If more than one Letter of Intent (LOI) is submitted by the PI to the FY25 PRMRP, the first submission will be accepted, and the second will be administratively withdrawn.

Individuals affiliated with an eligible organization are eligible to be named as PI regardless of ethnicity, nationality, or citizenship status.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the General Application Instructions, Appendix 1, for additional recipient qualification requirements.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 6

3. Program Description

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC) is the program office managing this FY25 funding opportunity as part of the PRMRP. Congress initiated the PRMRP in 1999 to support medical research projects of clear scientific merit and direct relevance to military health. Appropriations for the PRMRP from FY99 through FY24 totaled $4.19 billion. The FY25 appropriation is $150M.

The vision of the PRMRP is to improve the health, care, and well-being of all military Service Members, and their Families and Veterans, and its mission is to encourage, identify, select, and manage medical research projects of clear scientific merit that lead to impactful advances in health care of Service Members, Veterans, and their Families. The PRMRP challenges the scientific and clinical communities to address the congressionally mandated FY25 PRMRP Topic Areas with original ideas that foster new directions along the entire spectrum of research and patient care.

3.1. Technology/Therapeutic Development Award History

The PRMRP first offered the TTDA mechanism in FY08. In FY21, the TTDA was offered with two funding levels based on the scope of research. In FY24, the PRMRP released the TTDA with only supported research in the final stages of preclinical development, previously referred to as Funding Level 2, and will continue to do so for FY25.

3.2. Intent of the Technology/Therapeutic Development Award

The PRMRP TTDA is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life, for a disease or condition related to one of the FY25 PRMRP topic areas and one of the FY25 PRMRP strategic goals. The proposed experiments may be hypothesis or milestone driven. Products in development should be responsive to the health care needs of military Service Members, Veterans, and their Families. The product(s) to be developed under the FY25 PRMRP TTDA mechanism may be a tangible item, such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product. (A “knowledge product” is a non-materiel product that addresses an identified need in a topic area, is based on current evidence and research, aims to transition into medical practice, training, tools, or to support 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.)

3.2.1. FY25 Topic Areas and Strategic Goals

To meet the intent of the funding opportunity, all applications for FY25 PRMRP funding must specifically address one of the FY25 PRMRP topic areas as directed by the U.S. Congress and have direct relevance to military health. Additionally, the PRMRP implements a portfolio-driven approach by grouping related topic areas with strategic goals as a framework within which to address critical gaps in major research areas. All applications must address one of the FY25 PRMRP strategic goals as it relates to the portfolio-assigned FY25 PRMRP topic area. If the proposed research does not specifically address one FY25 PRMRP topic area and

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 7 one FY25 PRMRP strategic goal, then the government reserves the right to administratively withdraw the application. The government reserves the right to reassign the application’s topic area if submitted to an incorrect topic area. The section below lists the FY25 PRMRP topic areas and strategic goals in each PRMRP portfolio category.

FY25 PRMRP Portfolio Categories with Associated FY25 PRMRP Topic Areas and FY25 PRMRP Strategic Goals

AUTOIMMUNE DISORDERS AND IMMUNOLOGY

All applications under this portfolio must be aligned to Autoimmune Disorders and Immunology by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Celiac Disease

• Eczema

• Food Allergies

• Guillain-Barré Syndrome

• Inflammatory Bowel Disease

• Multiple Sclerosis

• Proteomics

• Scleroderma

STRATEGIC GOALS

Prevention

• Develop and test strategies to prevent the onset, relapse and/or progression of the disease/condition.

Diagnosis

• Develop innovative noninvasive methods (e.g. biomarkers, multi-omics approaches) for the diagnosis and continuous monitoring of inflammation.

• Develop tools to assess neurologic outcomes of the disease/condition.

Treatment

• Develop and test new or improved treatments, including therapeutic and/or lifestyle interventions, to improve outcomes, reduce inflammatory responses, promote tissue healing, provide neuroprotection/repair, improve/delay symptom onset, minimize toxicity, reduce the effects of disease/condition sequelae, and/or mitigate immune-mediated disease/condition states.

• Parallel to treatment development, develop/validate methods (e.g. clinical biomarkers) to evaluate treatment response and/or mechanism of action of a therapeutic intervention.

Epidemiology

• Conduct patient-centered research on onset, exacerbation, outcomes, treatment preferences, and quality of life measures.

• Conduct population-based studies to identify risk factors that contribute to onset and/or progression of the disease/condition and its comorbidities.

• Conduct research to better understand and decrease disparities in incidence and/or outcomes in populations affected disproportionately or differently.

• Conduct research, including natural history and longitudinal studies, to better understand incidence, prevalence, diagnosis rates, treatment regimens, and/or progression of the disease/condition.

CARDIOVASCULAR HEALTH

All applications under this portfolio must be aligned to Cardiovascular Health by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Cardiac Health

• Congenital Heart Disease

• Proteomics

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DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 8

STRATEGIC GOALS

Prevention

• Develop strategies to understand and prevent disease onset.

• Develop and test strategies to prevent or reduce the impact of the disease/condition on the heart, brain, arteries, and additional target organs.

Diagnosis

• Develop and test strategies to enable detection before clinical symptoms are apparent.

• Develop and rigorously test novel technologies for accurate diagnosis, predicting clinical outcomes and comorbid conditions, and tracking disease progression, including analytical tools, noninvasive methods and/or screening tools.

Treatment

• Develop and evaluate novel therapeutics or improved treatment regimens.

Epidemiology

• Conduct population-based studies to identify risk factors that contribute to the disease/condition.

• Conduct research to better understand and decrease disparities in incidence and/or outcomes in populations affected disproportionately or differently.

INFECTIOUS DISEASES

All applications under this portfolio must be aligned to Infectious Diseases by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Congenital Cytomegalovirus

• Far-UVC Germicidal Light

• Hepatitis B

• Malaria

• Post-Acute Sequelae of SARS CoV-2 Infection

• Proteomics

• Tick-Borne Disease

• Tuberculosis

STRATEGIC GOALS

Prevention

• Develop or optimize vaccine strategies, vaccine platforms, or compounds (including active or passive immunoprophylaxis), to prevent disease onset or inhibit disease progression;

research on agile platforms is encouraged.

• Develop strategies to eliminate/reduce maternal-fetal transmission.

• Develop strategies for rapid prediction of protective antigens/epitopes.

Diagnosis

• Identify testable correlates of protection induced by prophylactic treatment or natural infection.

• Develop pathogen-agnostic diagnostic tools/assays, or improve existing next-generation tools, that use noninvasive, patient-derived samples (e.g., urine, sweat, biometrics).

Treatment

• Expand upon current treatments or establish new disease-specific clinical networks for therapeutic drug testing for severe or chronic disease (does not include discovering or testing new chemical entities).

• Develop and test more effective and shorter treatment regimens, including those that address treatment resistance (does not include discovering or testing of new chemical entities).

Epidemiology

• Identify strategies for surveillance or develop modeling tools and/or biomarkers to predict outbreaks or epidemics.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 9

INTERNAL MEDICINE

All applications under this portfolio must be aligned to Internal Medicine by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Endometriosis

• Focal Segmental Glomerulosclerosis

• Interstitial Cystitis

• Menopause

• Nephrotic Syndrome

• Pancreatitis

• Polycystic Kidney Disease

• Proteomics

• Reconstructive Transplantation

• Vision

STRATEGIC GOALS

Prevention

• Develop and test strategies to prevent the onset, progression, recurrence, and/or comorbidities of the disease/condition/injury.

Diagnosis

• Develop and test tools or technologies for early detection, accurate diagnosis, or tracking of disease/condition/injury progression, including analytical tools, noninvasive methods, and/or screening tools.

• Conduct prognostic or diagnostic biomarker and genetic studies to better understand and differentiate subtypes, heterogeneity, progression and measuring/monitoring of disease/condition.

Treatment

• Develop and test novel treatments (including but not limited to, new pharmacological interventions, devices, lifestyle/behavioral interventions, and surgical treatment strategies), and/or improve upon existing treatments (includes repurposed drugs, personalized medicine approaches to optimize treatment, and preservation methods for allografts) to improve outcomes (including psychosocial functioning and quality of life).

• Develop and test combination therapy and/or intervention treatment approaches to slow the progression of the disease/condition/injury, restore function, and/or address long-term pain management (includes pharmaceuticals, lifestyle/behavioral changes, devices and surgical interventions).

• Advance the development of artificial organs, including xenobiology research.

• Test efficacy of excision surgical procedures for endometriosis.*

• Develop and test improved treatment strategies that can couple diagnosis and treatment for endometriosis within a single surgery.* *Multi-institutional partnerships performing complementary endometriosis research are encouraged.

Epidemiology

• Conduct population-based studies to identify risk factors (e.g., medication toxicity, genetic predisposition, infections, environmental exposures) that influence development, progression, and outcomes (including psychosocial functioning and quality of life).

• Conduct population-based studies to inform the development of surrogate endpoints to accelerate approval of new treatments.

• Conduct population-based studies to improve functional-based and patient-reported information to measure treatment outcomes.

• Develop and test the effectiveness of health educational and health tracking programs and platforms to increase awareness for prevention and/or to contribute to shared decision making and treatment preferences.

NEUROSCIENCE AND BEHAVIORAL HEALTH

All applications under this portfolio must be aligned to Neuroscience and Behavioral Health by addressing one topic area and one strategic goal listed below.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 10

TOPIC AREAS

• Autism

• Dystonia

• Eating Disorders

• Hydrocephalus

• Maternal Mental Health

• Myalgic Encephalomyelitis/Chronic Fatigue

Syndrome

• Parkinson’s

• Peripheral Neuropathy

• Proteomics

• Sleep Disorders and Restrictions

• Suicide Prevention

• Traumatic Brain Injury and

Psychological Health

STRATEGIC GOALS

Prevention

• Develop and test the efficacy of strategies (e.g., screening, education programs, counseling, etc.) to prevent or reduce risk factors associated with the disease/condition and/or associated comorbidities.

• Develop and test approaches to maintain optimal cognitive functioning and mental resilience.

Diagnosis

• Improve and validate methods for initial diagnosis, prognostic prediction, and/or real-time monitoring of symptoms for neurological and/or psychological health, which may include developing and testing personalized clinical decision-making tools or objective diagnostic criteria.

• Develop and test strategies to identify and prioritize at-risk individuals who would benefit from screening and/or diagnostic testing.

Treatment

• Develop and evaluate novel pharmacological or nonpharmacological treatments or intervention strategies, which may include repurposing of existing drugs.

• Conduct studies to optimize intervention strategies for improved patient outcomes.

Epidemiology

• Conduct population-based studies to identify risk factors that contribute to disease/condition onset and/or progression.

• Conduct research to better understand and decrease disparities in incidence and/or outcomes in populations affect disproportionately or differently.

• Conduct population-based studies to assess prevalence, medical service usage, and/or quality of life for those affected by the disease/condition.

ORTHOPAEDIC MEDICINE

All applications under this portfolio must be aligned to Orthopaedic Medicine by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Orthotics and Prosthetics Outcomes

• Proteomics

STRATEGIC GOALS

Prevention

• Optimize patient-specific rehabilitation regimens, including focus on provider competencies and/or patient training, to mitigate secondary health deficits.

Diagnosis

• Develop and test novel proteomic-based strategies for early and precise diagnosis of orthopaedic conditions.

• Develop and test standardized assessments of joint function following treatment with an orthotic or prosthetic device.

Treatment

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 11

• Develop and test proteomics-based strategies to halt/slow orthopaedic disease progression.

• Develop and test computational strategies or artificial intelligence approaches to inform appropriate device choice.

• Optimize and test rehabilitation regimens and/or device use to enhance functionality.

• Evaluate which orthotic and prosthetic interventions can provide the most improvement in health status, functionality, and quality of life.

Epidemiology

• Conduct patient-reported outcomes research to inform device choice; research with a focus on large data sets is encouraged.

RARE DISEASES AND CONDITIONS

All applications under this portfolio must be aligned to Rare Diseases and Conditions by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Angelman Syndrome

• Ehlers-Danlos Syndrome

• Epidermolysis Bullosa

• Fibrous Dysplasia/McCune-Albright Syndrome

• Fragile X

• Frontotemporal Degeneration

• Hereditary and Acquired Ataxia

• Hermansky-Pudlak Syndrome

• Mitochondrial Disease

• Myotonic Dystrophy

• Neurofibromatosis

• Proteomics

• Rett Syndrome

• Sickle-Cell Disease

• Tuberous Sclerosis Complex

• Von Hippel-Lindau Disease

STRATEGIC GOALS

Diagnosis

• Identify and validate objective biomarkers to predict onset, response to therapy, disease complications and/or disease progression.

• Develop and validate improved diagnostic criteria and screening tools for early detection, accurate detection, or to track disease progression.

• Determine the physiological impact related to diagnosis and/or timing of a diagnosis.

Prevention

• Develop and test strategies, including advancements in gene therapy, to prevent transmission of rare diseases.

Treatment

• Develop and test pharmacological or nonpharmacological treatments, or improve upon existing treatments, especially those that will minimize side effects.

• Develop and test curative strategies to include tissue engineering, genetic approaches, or protein replacement.

• Develop and test interventions to improve neuropsychological outcomes and cognitive symptoms and other comorbidities as defined by those with lived experience.

• Develop and test strategies to support ongoing treatments during life transitions (i.e., pediatric to adult care).

Epidemiology

• Conduct population-based studies to identify risk (i.e., carrier status), lifestyle determinants of health or protective factors that influence onset, progression and/or outcomes.

• Conduct natural history/longitudinal studies to understand incidence, prevalence, and progression of the disease/condition and carrier and modifier gene status.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 12

• Develop and validate research tools to collect, mine, and integrate real-world data (patient-reported data, longitudinal data, etc.) with electronic medical records to guide precision medicine approaches.

• Develop clinically relevant endpoints for clinical trials.

RESPIRATORY HEALTH

All applications under this portfolio must be aligned to Respiratory Health by addressing one topic area and one strategic goal listed below.

TOPIC AREAS

• Burn Pit Exposure

• Proteomics

• Pulmonary Fibrosis

• Respiratory Health

STRATEGIC GOALS

Prevention

• Develop and test strategies to prevent lung injury caused by trauma, transfusion, mechanical ventilation, infection, or hemorrhagic shock.

• Develop and test interventions to prevent lung diseases following exposure to environmental pollutants and/or occupational respiratory toxicants.

• Develop and test methods and devices to minimize the extent of population exposure to environmental pollutants.

Diagnosis

• Develop and validate physiological sensors to assess environmental pollutants and/or physiological levels of exposure to airborne hazards or toxins.

• Develop a fieldable toolset to monitor lung dysfunction/failure.

• Improve early detection for respiratory illnesses, including developing and validating wearable sensors for early detection of chronic pulmonary diseases.

• Identify biomarkers to diagnose and/or monitor progression of chronic respiratory diseases.

Treatment

• Develop and test novel treatments, including precision medicine approaches, to slow progression and/or promote lung repair.

• Develop improved fieldable systems to treat traumatic/acute lung injury in far forward settings (e.g., miniature and/or semi-automated ventilators or devices that will enable correct airway placement of oxygenation in austere settings).

• Develop and test minimally invasive or noninvasive methods of facilitating gas exchange when the lungs are compromised.

Epidemiology

• Conduct natural history/longitudinal studies to improve understanding of risk factors, outcomes, and disease progression for personalized medicine.

3.2.2. Key Elements for the Technology/Therapeutic Development Award

• Impact: The PRMRP TTDA intends to support research that is in the final stages of preclinical development with potential for near-term clinical development. It is expected that the next step after completion of the proposed work would be either a clinical trial or translation into clinical practice, as appropriate for the product under development. The proposed study should demonstrate how the research will lead to the development of a product that will improve patient outcomes in one of the FY25 PRMRP topic areas and address one of the FY25 PRMRP strategic goals.

• Preliminary Data: Proof of concept demonstrating the potential utility of the proposed product, or a prototype/preliminary version of the proposed product, should already be

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 13 established. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.

Unpublished data should originate from the laboratory of the PI or a member of the research team.

Applications supported by this award must begin with lead compounds in hand, a device prototype, or appropriate proof of concept for knowledge products and must include preliminary data relevant to the phase of development, such as:

○ Proof of identity and purity.

○ Selectivity for the intended target over closely related targets.

○ Availability of primary and secondary in vitro bioactivity assays for optimization or structure-activity relationship studies.

○ Availability of clear efficacy data in at least one relevant model system, with adequate power and methods.

○ Demonstration of diagnostic or prognostic prediction in at least one relevant disease model.

○ Demonstration of initial phases of prototype development and/or software development.

○ Demonstration of access to data or tools needed to generate a knowledge product that will inform patient care.

• Product Development: Award recipients are expected to submit or obtain an

Investigational New Drug/Investigational Device Exemption (IND/IDE) application to the U.S.

Food and Drug Administration (FDA), or must transition the product to clinical practice or to the intended end user, within the period of performance. Examples of the type of activity expected for this stage of product development include, but are not limited to:

○ Confirming efficacy and/or safety of therapeutic modalities (agents, delivery systems, and chemical modification of lead compounds) using established or validated preclinical systems.

○ Implementing full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials.

○ Validating pharmacologic agents through absorption, distribution, metabolism, excretion, and toxicity studies.

○ Developing pharmacologic agents to IND stage for initiation of phase 1 clinical trials.

○ Developing prototype devices to IDE stage or abbreviated IDE stage for initiation of clinical trials.

○ Optimizing diagnostic or treatment devices for field deployment.

○ Performing retrospective clinical studies to inform clinical care.

○ Developing clinical decision making tools to the clinical testing stage.

• Relevance to Military Health: Relevance to the health care needs of military Service Members, Veterans, and their Families 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:

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 14

○ Explanation of how the project addresses an aspect of the target disease/condition/ technology that has direct relevance to the health of military Service Members, Veterans, and their Families.

○ Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need.

○ Use of military or Veteran populations, samples, or datasets in the proposed research, if appropriate.

○ Collaboration with DOD or U.S. Department of Veterans Affairs (VA) investigators or consultants. 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 within the FY25 PRMRP topic areas can be found in Appendix 3.

3.2.3. Other Important Considerations for the Technology/Therapeutic Development Award

Applications to the FY25 PRMRP TTDA must support product development and may not support clinical trials.

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. An intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

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 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.

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 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104

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DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 15 standards are described in SC Landis et al., “A call for transparent reporting to optimize the predictive value of preclinical research,” Nature 490 (2012): 187-191, https://doi.org/10.1038/nature11556. 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.

Applications from investigators within the DOD and applications involving multidisciplinary collaborations among academia, industry, the DOD, 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.

3.3. CDMRP-wide Encouragements

The following encouragements are broadly applicable across many CDMRP programs, including the PRMRP. Investigators are encouraged to consider addressing these areas in their applications if doing so is appropriate for their line of research and meets the intent of this funding opportunity.

Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of Service Members, Veterans and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men. Such research should relate anticipated project findings to improvements in women's health outcomes and/or advancing knowledge for women's health.

3.4. Funding Instrument

The funding instrument for awards made under the program announcement will be grants (31

USC 6304).

3.5. Funding Details

Period of Performance: The maximum period of performance is 4 years.

Cost Cap: The application’s direct costs budgeted for the entire period of performance should not exceed $2.5M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

https://doi.org/10.1038/nature11556 https://doi.org/10.1038/nature11556 https://doi.org/10.1038/nature11556

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DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 16

The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for up to two investigators to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY25 PRMRP TTDA.

Must not be requested for:

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

• Tuition

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DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 17

4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOD organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Step 1: Pre-Application Components

Pre-application submissions must include the following components.

When starting the pre-application, applicants will be asked to select the following:

• Select the FY25 PRMRP portfolio addressed by the proposed research.

• Select the FY25 PRMRP topic area addressed by the proposed research.

• Select the FY25 PRMRP continuum of care category addressed by the proposed research.

• Select the FY25 PRMRP strategic goal addressed by the proposed research.

Letter of Intent (one-page limit): Provide a brief description of the research to be conducted.

Include the PRMRP portfolio, FY25 PRMRP topic area, and FY25 PRMRP strategic goal under which the application will be submitted.

4.3. Step 2: Full Application Components

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov

Submissions Only): Refer to the General Application Instructions, Section IV.B.(a), for detailed information.

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines listed in the General Application Instructions, Appendix 2.

○ Attachment 1: Project Narrative (18-page limit): Upload as “ProjectNarrative.pdf”.

The page limit of the Project Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair https://ebrap.org/eBRAP/public/index.htm

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DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 18 competitive advantage is prohibited and may result in administrative withdrawal of the application.

Describe the proposed project in detail using the outline below.

– Background: Describe the product to be developed. The application must provide sound scientific rationale behind the proposed work, including relevant literature citations. Describe previous experience most pertinent to the project to demonstrate feasibility. Include relevant preliminary data and/or promising preclinical findings that demonstrate proof of concept of the product or a prototype/preliminary version of the product. Preliminary data should be appropriate for the proposed stage of development and include the following as appropriate: proof of identity and purity, demonstrate selectivity, demonstrate availability and/or feasibility of assays, show efficacy in an appropriate model system, etc. The data may be unpublished or from the published literature.

Unpublished preliminary data should originate from the laboratory of the PI or a member of the study team.

– Hypothesis/Objective: State the hypothesis to be tested and/or the objective(s) to be reached. State which FY25 PRMRP Topic Area the proposed research addresses. Additionally, describe how the proposed research project addresses one of the FY25 PRMRP Strategic Goals.

– Specific Aims: Concisely explain the project’s specific aims. These aims should agree with the primary aims and associated tasks described in the Statement of Work (SOW). If the proposed work is part of a larger study, present only the aims that this DOD award would fund.

– Research Strategy and Feasibility: Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for analysis. Provide a well-developed, well-integrated research strategy that supports the translational feasibility and promise of the approach. Define the specific study outcomes and how they will be measured. Address potential problem areas and present alternative methods and approaches. Describe how data will be collected and handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, and identification of primary endpoints/outcomes.

– If animal studies are proposed, briefly describe the key elements of the study/studies as they relate to the overall project. Explain how and why the animal species, strain, and model(s) being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology. Describe the randomization and blinding procedures for the study and any other measures to be taken to minimize effects of subjective bias during animal treatment and assessment of results. If randomization and/or blinding will not be utilized, provide justification.

– If human subjects or human biological samples will be used, describe the study population and include a detailed plan for the recruitment of human subjects or the acquisition of samples. Describe the availability of the proposed study population and past successes in recruiting similar populations. If active-duty military, military Families, and/or Veteran population(s) or dataset(s) will be used in the proposed research project, describe the feasibility of accessing the population(s)/dataset(s).

This award may not be used to conduct clinical trials.

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DOD FY25 Peer Reviewed Medical Technology/Therapeutic Development Award 19

– For all applications proposing clinical research describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial, and ethnic group, and an accompanying rationale for the selection of subjects. If human subjects will be recruited, state the inclusion and exclusion criteria with sound rationale for the criteria. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity should be provided as part of the application’s Supporting Documentation (Attachment 2).

– Describe how the research project will be completed within the proposed period of performance.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”. Start each document on a new page. The Supporting Documentation attachment should not include additional information such as figures, tables, graphs, photographs, diagrams, chemical structures, or drawings. These items should be included in the Project Narrative.

There are no page limits for any of these components unless otherwise noted.

Include only those components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited (including URLs, if available) in the

Project Narrative using a standard reference format.

List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols.

Facilities, Existing Equipment, and Other Resources: Describe the facilities and equipment available for performance of the proposed project and any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference should be made to the original or present government award under which the facilities or equipment items are now accountable. There is no form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (if applicable): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work.