Peer Reviewed Medical Research Program Impact Award (HT942526PRMRPIPA)

Peer Reviewed Medical Research Program Impact Award (HT942526PRMRPIPA) is sponsored by Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP). The Peer Reviewed Medical Research Program (PRMRP) Impact Award supports applied research that translates basic research outcomes and real-world insights into clinically applicable solutions.

This program announcement must be read in conjunction with the General Application Instructions , version CD26_01 .

# Program Announcement for the Defense Health Agency # Peer Reviewed Medical Research # Funding Opportunity Number: HT94252 6PRM RP IPA # Pre -Application Due: July 23 , 20 26 # Application Due: August 6 , 20 26 FY2 6 Peer Reviewed Medical Impact Award 2 Summarizes the funding opportunity , funding details , submission deadlines and review Details eligibility factors for the applicant organization and Principal Investigator Describes the program mission and intent of the Impact Award ; provides key award information and considerations ; and outlines funding details Presents the two -step application process and instructions for preparing a pre -application Provides locations for application packages , instructions for submitting pre -applications and full applications , and describes application verification Application Review Information Outlines the processes for application compliance review , pre -application and full application selection/notification, and risk assessment .

Also , details the review criteria for pre -application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review Outlines what a successful applicant can expect if recommended for funding References policy requirements for funded research ; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers Outlines criteria for administrative actions including application rejection , modification , Includes a checklist for all full application components to facilitate application submission 47 FY2 6 Peer Reviewed Medical Impact Award 3 • 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 registration s are active and up to date prior to application • Read th is 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 th is funding opportunity and that all parties meet eligibility requirements. • To support application preparation, additional resources are available including an application process FAQ , a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process .

# Who to Contact for Support This document uses internal links ; you can go back to where you were by pressing the Alt + left arrow key s (Windows) or command + left arrow key s (Mac intosh ) on your keyboard . Click to be taken to additional guidance and instruction s within the General Application Instructions ( GAI ).

funding opportunity submission as well as technical assistance related to pre -application or intramural application submission . Grants. gov Support Center International: 1 -606 -545 -5035 and Workspace .

Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 4 # 1. Basic Information About the Funding Opportunity Summary: The fiscal year 2026 (FY26) Peer Reviewed Medical Research Program (PRMRP) Impact Award supports applied research, defined as use -inspired and practice -oriented science that brings together outcomes from basic research, and insights from the real -world environment, to foster clinical applicability.

The Impact Award intends to translate the fun damental understanding of underlying mechanisms toward solution s that have the potential for major near -term impact for patients and clear alignment to one of the congressionally directed FY26 PRMRP topic areas and one of the FY26 PRMRP portfolio -specific strategic Distinctive Features: This funding mechanism allows for multiple Principal Investigators (PIs).

Only the initiating PI’s organization will submit a pre -application, but all PIs’ organizations will need to submit full applications. The partnering PI’s application is an abbreviated package specific to their distinct portion of the research project. Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdra wn.

Funding Details: The Congressionally Directed Medical Research Programs ( CDMRP ) expects to allot roughly $32. 0 M to fund approximately 10 Impact Award applications with total cost cap s of $2. 8M for the Single PI Option , or $3.

6M for the Partnering PI Option . The maximum period of performance is 4 years. It is anticipated that awards made from this FY2 6 funding opportunity will be funded with FY2 6 funds, which will expire for use on September 30, 203 2.

Awards supported with FY2 6 funds will be made no later than September 30, 202 7. Submission and Review Dates and Times Pre -Application (Letter of Intent) Submission Deadline: 5:00 p. m.

Eastern Time (ET), Application Submission Deadline: 11:59 p. m. ET, August 6 , 2 026 End of Application Verification Period: 5:00 p.

m. ET, August 13 , 20 26 Peer Review: October/November 20 26 Programmatic Review: February/March 20 27 Announcement Type: Initial Funding Opportunity Number: HT94252 6PRM RP IPA Assistance Listing Number: 12. 420 Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 5 # 2.

Eligibility Information 2. 1. Eligible Applicants Extramural and intramural U.S. Department of War (DO W) organizations are eligible to apply , including foreign and domestic organizations, for -profit and nonprofit organizations, and public or private entities .

2. 1. 2.

Principal Investigator Independent investigators (e.g., Assistant Professor, Senior Scientist, Principal Scientist, Research Director, or equivalent) may be named by the organization as the Principal Investigator (PI) on the application. For the Partnering PI Option, one partner in the collaboration must be a clinician investigator ( e.g., M. D.

, M. D. /Ph.

D. , D. O.

, or equivalent) with clinical duties and/or responsibilities. Postdoctoral and clinical fellows and other mentored scientists are not eligible to be named as an Initiating or Partnering PI. Each investigator may be named on only one FY26 PRMRP application as the Initiating PI.

If more than one pre -application submitted to the FY26 PRMRP names the same Initiating PI , the first submission will be accepted, and subsequent submissions will be administratively Independent investigators affiliated with an eligible organization are eligible to be named PI on the application , regardless of ethnicity, nationality or citizenship status. Cost sharing is not an eligibility requirement .

Awards are made to eligible organizations , not to individuals. Refer to the G AI for additional recipient qualification requirements . Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 6 The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001).

The CDMRP is the program office managing this FY26 funding opportunity as part of the Peer Reviewed Medical Research Program ( PRMRP ). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D) , which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW .

Congress initiat ed the PRMRP in 1999 to support medical research projects of clear scientific merit and direct relevance to military health. Appropriations for the PRMRP from FY 99 through FY 25 totaled $ 4. 34 billion .

The FY 26 appropriation is $ 370 million . FY26 PRMRP Research Development Pipeline To address the congressionally directed FY26 PRMRP topic areas in a bench -to -bedside fashion, the FY26 PRMRP award mechanisms are aligned to different phases of the research development pipeline illustrated below.

The Use -Inspired Basic Research phase represents novel, exploratory research aimed at generating preliminary data ; and/or preclinical research that is ready for validation through expansion, replication, or comparative studies. While projects may be aiming to understand fundamental physiological phenomena, “basic research, ” they should be driven by a specific clinical need and potential application, “use -inspired.

” Applicants seeking support for research aligning to the Use -Inspired Basic Research phase may consider: FY26 PRMRP Discovery Award (HT942526PRMRPDA ) for novel, high -risk, high reward research projects with the potential to yield high -impact findings and new avenues of investigation. Preliminary data is not allowed.

Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 7 FY26 PRMRP Research Advancement Award (HT942526PRMRPRAA ) for building upon existing preliminary data to validate a concept. The Translational Research phase seeks to transition scientific data towards treatment, diagnostic, and/or preventive strategies. Research projects are expected to have significant near -term impact on patients’ lives.

Examples of projects in the translational phase include product/device development and clinical translation of concepts previously validated through expansion, replication or comparative studies. Applicants seeking support for research aligning to the Translational Research phase may consider: FY26 PRMRP Impact Award (HT942526PRMRPIPA) for mature research pro jec ts that are ready to translate ideas into solutions.

Initial product discovery, development, and optimization are supported. FY26 PRMRP Technology/Therapeutic Development Award (HT942526PRMRPTTDA) for finalizing preclinical development of tangible products (drugs or biologics), knowledge-based products and/or devices. The research outcome should be a regulatory filing or translation of findings into clinical practice, as applicable.

The Translational to Clinical Transition phase represents the final stages of product development with early, phase 0/1, or equivalent, clinical trials. Products may include both knowledge and tangible items that will be used to impact patient care.

FY26 PRMRP Platform Clinical Translation Award (HT942526PRMRPPCTA) for finalizing preclinical development, conducting clinical validation studies, and/or conducting first in human clinical trials for a platform product with the potential to impact clinical care for two or more FY26 PRMRP topic areas.

The Clinical Research phase represents small - and large -scale confirmatory trials and/or applied clinical research that will revolutionize the clinical management of the diseases and conditions assigned to the program as topic areas.

Applicants seeking support for trials and st udies aligned to the Clinical Research phase may consider: FY26 PRMRP Lifestyle and Applied Health Research Award (HT942526PRMRPLAHRA) for clinical trials focused on efficacy of non-pharmacological interventions or noninvasive devices or clinical research to examine the impact of prevention, diagnostic, treatment or health care delivery approaches on health outcomes.

Animal research is not allowed. FY26 PRMRP Clinical Trial Award (HT942526PRMRPCTA) for projects to determine the safety or efficacy outcomes of pharmacological interventions, devices or implants on prospectively recruited human participants. Animal research, preclinical experiments, and optimization/validation of the intervention are not allowed.

NOTE: The scope of research proposed in applications in response to the FY26 PRMRP program announcements must align with the research phases outlined above. It is the responsibility of the applicant to select the award mechanism that aligns with the scope of the proposed research. The funding mechanism should be selected based on the research scope defined in the program announcement, and not on the amount of the budget.

Applications submitted under a mechanism that is not deemed appropriate for the scope o f research proposed will not be funded . Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 8 The PRMRP first offered the Impact Award mechanism in FY 24 . Since then, 129 Impact Award applications were received, and 19 applications, representing 30 awards , were recommended 3.

2 . Intent of the Impact Award The FY26 PRMRP Impact Award supports applied research, defined as use -inspired and practice -oriented science that brings together outcomes from basic research, and insights from the real -world environment, to foster clinical applicability.

The Impact Award intends to translate the fundamental understanding of underlying mechanisms toward clinical applications that have the potential for major near -term impact on patients and have clear alignment to one of the congressionally directed FY2 6 PRMRP Topic Areas .

Proposed research should refine mature concepts and ideas into translatable solutions with a view toward evaluating technical feasibility of promising new pharmacological agents, knowledge products, behavioral and rehabilitation interventions, diagnostic a nd therapeutic techniques, clinical guidance, and/or emerging approaches and technologies.

Research projects should include mature relevant preliminary data to support the rationale and feasibility of the approach and demonstrate readiness to be translated to the clinic in the near term. Preliminary data may include published data from the scientific literature and/or unpublished data from the laboratory of the PI or a member of the research team. The FY2 6 PRMRP Impact Award is not intended to support basic research.

For the purposes of this funding opportunity, basic research is defined as exploratory science directed toward greater knowledge or understanding of the fundamental aspects of phenomena or outcomes, without specific applications toward clinical solutions . Examples include, but are not limited to, high -risk/high -gain approaches, mechanistic studies, and preliminary data generation/validation.

Applicants seeking funding for research that meets this definition should consider one of the other FY2 6 PRMRP progra m announcements being offered. For information about these award mechanisms, see information contained in the FY26 PRMRP Research At the conclusion of a successful Impact Award , investigators should have generated the necessary data for the building blocks of an intervention.

The Impact Award is meant to support early -stage translational research. By the end of the period of performance investigators are expected to have demonstrated proof of concept for a potential solution product and be ready to propose experiments to finalize development, conduct regulatory -enabling studies, or otherwise move the product towards clinical validation o r testing . 3.

2. 1 . FY26 PRMRP Topic Areas and Strategic Goals To meet the intent of the funding opportunity, all applications for FY26 PRMRP funding must specifically address one of the FY26 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 FY26 PRMRP strategic goals as it relates to the portfolio -assigned FY26 PRMRP topic area.

The FY2 6 PRMRP strategic goals for each portfolio are aligned to the categories of the continuum of care (foundational studies, epidemiology, prevention, diagnosis and treatment).

If the proposed research does not specifically address one FY26 Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 9 PRMRP topic area and one FY26 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 FY26 PRMRP topic areas and strategic goals in each PRMRP portfolio category. FY26 PRMRP Portfolio Categories With Associated FY26 PRMRP Topic Areas and FY26 All applications under this portfolio must be aligned to Autoimmune Disorders and Immunology by addressing one topic area and one strategic goal listed below.

Inflammatory Bowel Disease Pediatric Acute -Onset Neuropsychiatric Syndrome (PANS) and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Investigate the mechanisms driving the pathobiology of the disease/condition.

Investigate factors affecting disease/condition onset, progression, or heterogeneity, such as environmental exposures, comorbidities, behaviors, genetics, stress, infections, neuroimmune interactions, or microbiome dynamics. Investigate sex differences in the immune system.

Conduct patient -centered research to identify factors driving incidence trends, including Conduct patient -centered studies to better understand differences between childhood - and adult -onset immune -mediated diseases/conditions, focusing on underlying pathobiology Conduct population -based studies to identify risk factors and enhance methods for detecting individuals at high risk.

Conduct research to better understand sex differences in incidence and/or outcomes. Conduct population -based studies to examine variations in incidence and outcomes across different population subgroups. Develop and test innovative strategies to prevent the onset, relapse, and/or progression of Identify and test approaches to establish immune tolerance early in life.

Identify and validate biomarkers for continuous monitoring of disease/condition progression or to evaluate intervention response. Develop and validate improved diagnostic tools to enable early, accurate detection and to standardize diagnostic strategies. Develop and test curative and immune reset interventions.

Develop and test therapies effective across all or multiple allergens or autoantigens. Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 10 Develop and test strategies to improve outcomes, reduce inflammation, promote healing, provide neuroprotection, delay symptom onset, or minimize toxicity, including lifestyle changes, targeted drugs, nutraceuticals, and personalized treatments.

Generate evidence for repurposing and off -label use of potential treatments. All applications under this portfolio must be aligned to Cardiovascular Health by addressing one topic area and one strategic goal listed below. Brain Injury Impact on Cardiac Health • Hypoxia Investigate the mechanisms driving the pathobiology of the disease/condition.

Investigate the mechanisms driving cardiovascular dysfunction following brain injury. Enhance understanding of oxygen sensing and the biological response to low oxygen Identify risk factors, with a focus on comorbidities and genetic predispositions. Conduct population -based studies to monitor cardiovascular changes over time.

Conduct population -based research to identify risk factors, including but not limited to brain injury, and improve methods to detect individuals at high risk. Conduct population -based studies to examine variations in incidence and outcomes across different population subgroups. Develop and test strategies to prevent or reduce the impact of the disease/condition on the heart, brain, arteries, and additional target organs.

Develop and test strategies to reduce/prevent risk factors associated with disease onset, progression, or complications. Develop and test strategies to enhance detection accuracy and sensitivity, including strategies to identify maladaptive vascular remodeling or to enable continuous monitoring or detection of tissue - or cell -specific oxygen levels. Develop and validate less invasive diagnostic methods.

Identify and validate biomarkers that reliably predict outcomes. Generate evidence to support the repurposing and off -label use of treatments, including research on optimal dosing regimens. Develop and test innovative therapeutic strategies, with an emphasis on targeted, localized, and personalized approaches.

All applications under this portfolio must be aligned to Infectious Diseases by addressing one topic area and one strategic goal listed below. Congenital Cytomegalovirus Investigate the mechanisms of infection, transmission, pathogenicity, or drug resistance.

Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 11 Develop innovative preclinical models to investigate disease pathobiology, host response, and to support drug discovery and testing. Enhance understanding of interactions between infection and comorbid conditions. Identify risk factors contributing to adverse outcomes.

Discover and evaluate new drug targets. Conduct population -based studies to collect data on disease trends, including those establishing, affiliated with, or contributing to clinical networks, biorepositories, or Conduct population -based studies to improve understanding of transmission, disease progression, and risk factors for complications. Conduct retrospective studies to assess the impacts of disease on quality of life.

Develop and test strategies to prevent complications and adverse outcomes following Develop and test innovative strategies to prevent disease onset or inhibit its progression. Develop and test methods to eliminate maternal -fetal transmission. Develop and validate innovative diagnostic tools, focusing on less - or non -invasive methods, point -of -care applications, early detection, or improved sensitivity.

Identify and validate biomarkers to improve infection diagnosis and/or prognosis, assess infection -related complications, or measure protection against infection. Develop and test curative interventions or treatments that eliminate all symptoms, including precision medicine approaches and those that address latent infection.

Develop and assess new therapeutic strategies that are more potent, act directly, require shorter dosing regimens, provide longer -lasting effects, better mitigate complications, address treatment resistance, and/or address latent infection.

Generate evidence for optimal treatment regimens, including strategies tailored to specific age groups, combination therapies, and antiviral or vaccine dosing schedule All applications under this portfolio must be aligned to Internal Medicine by addressing one topic area and one strategic goal listed below.

Accelerated Aging Processes Associated with Military Service Infertility Associated with Military Aviators and Aviation Support Personnel Polycystic Kidney Disease Improve understanding of how military service or exposures contribute to physiological dysregulation, reproductive health issues, the aging process, and epigenetic changes.

Investigate the mechanisms and pathophysiology underlying disease onset and/or Improve understanding of disease/condition heterogeneity, comorbidities, systemic impacts, and long -term complications.

Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 12 Conduct comparative studies to determine military -specific risks and enhance understanding of diseases/conditions that have increased incidence in the active -duty and Conduct population - and/or patient -based studies to improve understanding of disease heterogeneity and phenotypic variability.

Conduct research to better understand sex differences in incidence and/or outcomes. Conduct population -, occupational -, and/or patient -based studies to identify risk factors that influence disease development, progression, treatment, and outcomes. Develop and test strategies to reduce the health impacts of military service and exposures and prevent long -term consequences.

Develop and test innovative strategies to prevent disease onset, progression, and/or associated comorbidities. Develop and validate screening tools to detect conditions associated with premature aging Develop and validate innovative diagnostic approaches, focusing on less invasive methods, faster timelines, and methods that account for disease heterogeneity.

Develop and validate biomarkers, imaging techniques, or other tools for diagnosis, objective prognosis, subtype differentiation, monitoring, or assessing treatment response. Develop and validate methods for identifying and measuring toxic agents and their pathophysiological effects. Develop and test efficacy of lifestyle and other non -drug interventions.

Develop and test novel treatment strategies aimed at cures or improved symptom management to enhance quality of life, including drug repurposing studies, combination therapies, and innovative drug delivery techniques.

Develop and assess strategies to enable personalized care recommendations or optimize treatments for specific population subgroups, including studies on the efficacy of existing Develop and test innovative approaches for pain management as a symptom of the Develop and test innovative approaches to improve organ transplant outcomes or transplant alternatives, such as artificial organs, xenotransplants, and novel strategies to All applications under this portfolio must be aligned to Neuroscience and Mental Health by addressing one topic area and one strategic goal listed below.

Brain Injury impact on Cardiac Health Intranasal Ketamine Anesthetics Myalgic Encephalomyelitis/Chronic Post -Traumatic Stress Disorder Sleep Disorders and Restrictions Suicide Prevention Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 13 Investigate the mechanisms underlying disease/condition pathobiology, progression, and associated comorbidities at multi -organ/system, circuit, or cellular/molecular levels.

Identify factors that predispose individuals to the disease/condition, predict adverse outcomes, or contribute to resilience. Enhance understanding of disease/condition heterogeneity, including variations in phenotypic, symptom, and behavioral presentation. Develop and evaluate innovative models that can be used to understand etiology and will facilitate drug discovery and testing.

Conduct population -based studies to identify and track trends and treatment responses, generating data on treatment efficacy to inform the development of personalized Conduct population -based studies to enhance understanding of risk factors and progression of disease/condition.

Conduct comparative studies to identify military -specific aspects of diseases/conditions, including risk factors, comorbidities, quality of life impacts, treatment preferences, prevalence, and ability to return to duty. Conduct research to better understand sex differences in incidence and/or outcomes. Conduct population -based studies to examine variations in incidence and outcomes across different population subgroups.

Develop and test strategies to prevent the disease/condition, as well as its downstream complications, including methods for relapse prevention or mitigation of risk factors.

Develop and test innovative strategies to maintain optimal cognitive functioning and Develop and validate objective diagnostic methods that are accurate, sensitive, enable early detection, and account for heterogeneity in disease/condition phenotypes, includes Identify and validate biomarkers that predict risk for the primary disease/condition and its Develop and validate methods for continuous monitoring and evaluating treatment Develop and test treatments to achieve curative or regenerative outcomes, preserve cognition, and enhance quality of life, including gene therapies, noninvasive stimulation techniques, alternatives to brain surgery, pharmaceuticals, and behavioral interven tions.

Evaluate repurposed drugs to accelerate strategies for improving symptom management and enhancing quality of life. Develop and assess guidelines for optimal intervention use, including evidence for safety and efficacy across diverse populations, precision medicine approaches, dosing regimens, safety monitoring, side effect management, and delivery methods.

Develop and test innovative strategies to increase access to treatments, such as telemedicine approaches and adaptations tailored to specific populations. Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 14 All applications under this portfolio must be aligned to Orthopaedic Medicine by addressing one topic area and one strategic goal listed below.

Accelerated Aging Processes Associated Orthotics and Prosthetics Outcomes Investigate mechanisms driving musculoskeletal disease/condition pathology and progression, focusing on muscle, connective tissue, genetics, epigenetics, aging, pain, sex differences, physical or mental stress, mechanobiology, cell senescence, and/or Identify risk factors for orthopaedic diseases/conditions, including those that accelerate musculoskeletal degeneration, contribute to adverse outcomes, or lead to more severe Develop and evaluate disease/injury using preclinical models to improve understanding of mechanisms and support intervention discovery and testing.

Develop and evaluate small joint disease/injury models improve understanding of mechanisms and support intervention discovery and testing. Investigate the impact of life stage impacts musculoskeletal health and related diseases/ conditions, including the effects of childhood growth, hormonal changes throughout the lifespan, and aging -related processes.

Leverage large data sets to generate evidence -based treatment guidelines to optimize Conduct patient -reported outcomes research incorporating both objective measures and quality -of -life metrics to evaluate treatment efficacy and guide intervention decisions. Conduct research to better understand sex differences in incidence and/or outcomes.

Conduct comparative studies to better understand musculoskeletal degeneration in Veterans and identify military -specific risk factors. Develop and test strategies that improve point -of -injury care, focusing on reducing the risk of secondary complications and promoting joint preservation. Optimize and test personalized treatment or rehabilitation plans to address adverse outcomes and mitigate risk factors.

Develop and test strategies to prevent inflammatory joint damage caused by aging or Develop and validate strategies for early and precise diagnosis of musculoskeletal dysfunction, including screening methods tailored for pediatric populations. Identify and validate biomarkers that indicate the severity or progression rate of musculoskeletal disease or age -associated degeneration.

Identify and validate biomarkers or outcome measures to monitor disease/condition progression, understand variability, assess treatment efficacy, and evaluate impacts on Advance innovative treatment strategies targeting etiology, preserving joint integrity, retaining functionality for daily activities, improving muscle strength and range of motion, reducing pain or fatigue, and/or regenerating damaged tissues.

Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 15 Develop and assess treatment strategies to enhance quality of life by increasing mobility, halting/slowing disease progression, or accelerating return to duty, including exercise regimens, regenerative or immune -modulating therapies, and device optimizatio n.

Develop and assess methods to optimize treatment, including patient -specific strategies, combination therapies, or refinement of intervention timing and dosing. Develop and test improved orthopedic devices, such as AI -driven auto -adjusting devices, better integrated designs for enhanced stability or accelerated healing, improved braces, prosthetic limbs, joint replacements, and strategies to enhance comfort.

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

Facioscapulohumeral Muscular Dystrophy Fibrous Dysplasia/McCune -Albright Syndrome Frontotemporal Degeneration Hereditary and Acquired Ataxias Hereditary Hemorrhagic Telangiectasia Hermansky -Pudlak Syndrome von Hippel -Lindau Disease Develop and evaluate innovative models for drug discovery and testing, with an emphasis on patient -derived cell models.

Investigate the mechanisms driving symptoms to identify new strategies for symptom management, including novel drug targets and paradigm -shifting insights into Conduct population - or patient -based studies to evaluate intervention efficacy, incorporating patient -reported outcomes and objective metrics to refine clinical guidance, develop personalized treatments, and validate clinically relevant endpoints.

Conduct population -based studies to monitor disease progression and identify factors that drive onset, progression, and outcomes. Conduct population -based studies to improve understanding of relationships between the disease/condition and comorbidities or conditions with shared symptoms. Integrate electronic medical records with real world data to improve the accuracy of prevalence estimates and guide precision medicine approaches.

Develop and test approaches to prevent complications associated with the disease/ Develop and test approaches, including gene therapy, to prevent symptoms or familial aggregation of the disease/condition. Develop and test evidence -based strategies to reduce disease/condition severity, including investigations promoting better health during pregnancy.

Develop and validate diagnostic strategies that are objective, noninvasive, accurate, and enable early detection, subtype distinction, disease progression tracking, and complication prediction. Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 16 Develop and validate methods to objectively measure symptoms and evaluate their impact Develop and validate diagnostic, monitoring, or prognostic biomarkers.

Identify and validate clinically relevant endpoints for assessing treatment response, suitable for use in FDA -regulated clinical trials. Develop and test innovative treatment approaches, emphasizing early intervention, therapies that slow/halt disease/condition progression, therapies that address phenotypic/ subtype differences, and disease -modifying or curative treatments.

Develop and assess strategies to optimize existing treatments to reduce side effects and tailor interventions to specific patients. Generate evidence to support and guide the use of off -label drugs for symptom relief.

Develop and test pharmacological or non -pharmacological interventions to manage symptoms and improve quality of life for patients and caregivers, including strategies for All applications under this portfolio must be aligned to Research and Clinical Tools by addressing one topic area and one strategic goal listed below.

Utilize proteomics to deepen understanding of the molecular mechanisms, progression, comorbidities, and long -term complications of the disease/condition/injury. Investigate the functional impact of post -translational modifications and proteoforms, beyond protein abundance, to guide management of the disease/condition/injury. Further the integration of proteomic databases and validated proteome subsets into advanced informatics tools.

Conduct population -based longitudinal proteomics studies to guide disease/condition/injury management strategies and support the development of personalized care approaches. Leverage existing proteomic databases to conduct large -scale research. Develop and validate proteomics -based technologies to prevent the onset, progression, recurrence, and/or comorbidities of the disease/condition/injury.

Develop and validate proteomics -based technologies or biomarkers for early detection, accurate diagnosis, subtype differentiation, monitoring disease/condition progression, or evaluating treatment response. Develop and test proteomics -based technologies to support personalized treatment Use proteomics -based approaches to identify novel treatments or targets.

Section Shortcuts FY2 6 Peer Reviewed Medical Impact Award 17 All applications under this portfolio must be aligned to Respiratory and Environmental Health by addressing one topic area and one strategic goal listed below. Identify factors driving respiratory distress or chronic respiratory disease progression with the goal of identifying novel treatment targets.

Investigate the mechanisms by which airborne hazards cause respiratory injury/disease, including research linking the toxicant to the specific pathobiology. Conduct population -based studies to generate data on risk factors, disease progression, and treatment outcomes to guide personalized medicine approaches. Conduct retrospective studies to correlate toxicant exposure with long -term