OpportunityTitle: Defense Medical Research and Development Program Applied Research and Advanced Technology Development Award
Description: The DMRDP Applied Research and Advanced Technology Development Award is being offered for the first time in FY10. These awards are intended to provide support for research that is designed to advance state-of&#150;the-art solutions for world class medical care with an emphasis on post-traumatic stress disorder (PTSD), TBI, prosthetics, restoration of eye sight and advancing eye care, and other conditions directly relevant to the injuries our service members are currently receiving on the battlefield, as well as the capability needs of the JFHP CONOPS. DMRDP efforts will assess scientific and/or military field deployment feasibility of promising new products, pharmacologic agents (drugs and biologics), behavioral and rehabilitation interventions, diagnostic and therapeutic devices, clinical guidance, supporting medical information and training systems, and/or emerging approaches and technologies. These awards are expected to yield potential health products, approaches, or technologies positioned for human testing. Awards under this announcement will consist solely of assistance agreements. This award is focused on applied research, defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility, and advanced technology development, defined as development of candidate solutions and components of early prototype systems up to the point where test and evaluation can be conducted in human trials or other relevant operational environments. Awards may support human studies but may not be used to support clinical trials. Awards may not be used to support fundamental basic research. Other DMRDP Program Announcements/Funding Opportunities for these areas of research are forthcoming. The DMRDP anticipates that approximately $97 million (M) of the FY10 appropriation will be available to support both intramural and extramural applied research and advanced technology development. This announcement is intended only for extramural investigators. A previous announcement was released for intramural investigators. An intramural investigator is defined as FY10 Defense Medical Research and Development Program (DMRDP) 3 a Department of Defense (DoD) employee working within a DoD laboratory or medical treatment facility (MTF) or a DoD activity embedded within a civilian medical center. An extramural investigator is defined as all those not included in the definition of intramural investigator. It is permissible, however, for an intramural investigator to be named as a collaborator in a proposal submitted by an extramural investigator. In such cases, the extramural investigator must include a letter from the intramural collaborator&#146;s Commander or Commanding Officer that authorizes the involvement of the intramural collaborator. The Government reserves the right to increase or decrease the approximately $97M available to support applied research and advanced technology development projects. All applications for DMRDP funding must specifically and clearly address one of the projects (i.e., area of research) and tasks (i.e., specific research needs) identified below. The Government reserves the right to reassign Projects/Tasks identified in applications if submitted under an incorrect Task area. Applications for research on Projects and Tasks (Projects/Tasks), other than those listed below should NOT be submitted in response to this Program Announcement/Funding Opportunity. If the proposed research project is not relevant to the advertised FY10 DMRDP Projects/Tasks, the Government reserves the right to administratively withdraw the application. FY10 DMRDP Projects: &#149; Diagnosis and Treatment of Brain Injury &#149; Polytrauma and Blast Injury &#149; Operational Health and Performance &#149; Rehabilitation &#149; Psychological Health and Well-Being for Military Personnel and Families FY10 DMRDP Projects and Corresponding Tasks: Diagnosis and Treatment of Brain Injury &#149; Mechanisms of Traumatic Brain Injury (TBI). Applied research leading to the identification and characterization of mechanisms of TBI. &#149; Diagnosis and Treatment. Development of far-forward deployable technologies to diagnose and treat TBI. Research in this topic area should include, but is not limited to, noninvasive diagnostic techniques to detect cellular or functional damage, pharmacologic or other agents (e.g., &#147;neutraceuticals&#148;) for neuroprotection or treatment, and techniques to reduce structural and functional neurologic damage after TBI. &#149; Clinical Management. Applied research leading to improved clinical management practices for early intervention in TBI including but not limited to identification and evaluation of the best practices for therapeutic management of TBI. FY10 Defense Medical Research and Development Program (DMRDP) 4 Polytrauma and Blast Injury &#149; Hemorrhage Control. Applied research leading to the development and fielding of U.S. Food and Drug Administration (FDA)-approved therapeutics and logistically supportable interventions to control internal hemorrhage and prevent or treat coagulopathy associated with severe trauma. &#149; Maintain Tissue Viability. Applied research leading to advanced technologies and logistically supportable interventions to maintain tissue viability including but not limited to blood and blood component substitutes/expanders. &#149; Diagnosis and Life Support. Applied research leading to advanced medical technologies to aid first responder diagnosis and life support including but not limited to identifying appropriate treatment end points and developing algorithms for decision-assist tools and to predict the need for lifesaving interventions. &#149; Maxillofacial Injury. Applied research leading to improved materials and strategies for repair of maxillofacial injuries including but not limited to image-guided surgery, rapid prototyping technologies and associated materials for bone and soft tissue reconstruction, and solutions for dental reconstruction. &#149; Evacuation Applications. Applied research leading to advanced, automated, and portable medical systems for forward critical care and ground and aeromedical patient transport including but not limited to closed-loop control of delivery of life support interventions (i.e., ventilation, oxygen, and fluids) and advanced litter technologies to reduce impact of G-forces and vibration on casualties. &#149; Evacuation Practices. Applied research leading to improved clinical practices for aeromedical transport of patients with TBI and other severe injuries including but not limited to improved strategies and systems for patient care during transport. &#149; Forward Surgical Applications. Applied research leading to advanced and portable medical applications for forward surgical care including but not limited to damage control surgery, acute head injury stabilization, and other surgical stabilization. &#149; Blast Injury Models and Performance Standards for Protection Systems. Applied research leading to a physiologically integrated model of existing blast injury models and/or test devices/systems and methods/standards for employing the integrated injury prediction model. &#149; Scar Contracture. Applied research directed toward minimizing deleterious effects of contracture on function and mobility. &#149; Diagnosis, Treatment, Mitigation, Restoration, and Rehabilitation of Ocular/Visual System Injury. Applied research to develop treatments for traumatic injuries and war-related injuries to ocular structures and the visual system, including blast and burn injuries; lid, adnexal, ocular, and orbital injuries; treatments to slow/stop loss of vision following injury; and ocular drug delivery. &#149; Rapid Screening of Fresh Whole Blood. Applied research leading to the development and fielding of an FDA-approved, rapid detection, multiplex nucleic acid-based, handheld system to screen whole blood pre-transfusions for blood-borne pathogens with FY10 Defense Medical Research and Development Program (DMRDP) 5 a high degree of sensitivity for use far forward in a wartime environment with primary focus on hepatitis B and C, followed by HIV-1 and HIV-2, and then other blood-borne pathogens. &#149; Wound Infection Prevention and Management. Applied research directed toward identification and characterization of biomarkers associated with immune response and/or predictive of infection/wound closure or early detection of antimicrobial resistance; identification of nosocomial pathogens and mitigation of contamination in the military medical environment (e.g., ozone, vaporized hydrogen peroxide, phage, chitosan, and chlorine dioxide); and development of an in vivo polytrauma/blast wound infection model. &#149; Antimicrobial Countermeasures. Applied research directed toward mitigation of virulence factors and/or metabolic pathways associated with wound infection pathogens (e.g., Acinetobacter, Pseudomonas aeruginosa, MRSA (methicillin-resistant Staphylococcus aureus), ESBL (extended spectrum beta lactamase)-producing Klebsiella pneumoniae), including characterization and mitigation of biofilm formation. Preference will be for discoveries with applicability to polymicrobial infections leading to FDA-approved products to combat wound infections. Novel treatment approaches (e.g., chelators, antibody, phage, antimicrobial peptides, quorum-sensing inhibitors, lysine, and host immunoaugmentation including antibody) are encouraged. Treatment efforts should be focused on topical approaches. Proposals incorporating drug screening, including high-throughput screening and in silico modeling, are discouraged. Operational Health and Performance &#149; Fundamental Mechanisms of Training and Operational Injury. Applied research leading to a predictive model for musculoskeletal injury and comprehensive assessment of in-theater (Operation Iraqi Freedom and Operation Enduring Freedom) load carriage of warriors. &#149; Physiological Interactions of Nutrition and Dietary Supplements. Applied research leading to improved standards for over-the-counter dietary supplement use in relation to prescription medication and/or medical events (i.e., clotting factors and concussion). &#149; Fundamental Mechanisms of Performance Sustainment in Extreme Environments (Heat, Cold, and Altitude). Applied research leading to predictive models for altitude illness and potential pharmaceutical interventions for prevention and/or early treatment for extreme environment-related illness and injury. &#149; Post-Deployment Health Risks. Applied research leading to improved inclusion/ exclusion criteria for longitudinal prospective military cohort studies (e.g., target and follow severely wounded over time, broaden study to identify interventions to develop in response to gathered epidemiological data, include additional topics such as accidents, criminal activities of veterans, other negative outcomes, and protective factors). Rehabilitation &#149; Neuromusculoskeletal Injuries. Applied research directed toward strategies for rehabilitation in patients with complicating factors (e.g., TBI, PTSD, and other FY10 Defense Medical Research and Development Program (DMRDP) 6 comorbidities), functional outcome assessments focusing on return-to-duty and/or community reintegration, rehabilitative strategies for neuromusculoskeletal injury (including limb salvage patients), novel and evidence-based strategies to support rehabilitative approaches following regenerative medicine therapies to restore tissue and function, amputee-specific technologies and rehabilitative strategies that address/assess residual limb health, exercise and fitness systems and strategies for rehabilitation and sustainment of fitness in amputees, and the prevention of heterotopic ossification. &#149; Chronic Pain Management. Applied research to support the development of best practices for assessing and managing acute pain episodes in the context of chronic pain, strategies for the management of acute pain to prevent the development of chronic pain, strategies to identify and treat pain generators (including the pathophysiology of pain and improved objective diagnostic tools for pain), improved strategies for management of chronic pain (including novel pain control methods, complementary and alternative medicine techniques, and epidemiology of incidents of chronic pain and functional outcomes), and addressing psychosocial aspects of managing pain (including patient empowerment, family and other support systems, resilience and risk factors, and sleep management). The interest is in management of pain associated with traumatic or war-related injuries. &#149; Regenerative Medicine. Applied research directed toward the use of regenerative medicine-based techniques to repair functional nerve deficits (other than central nervous system or spinal cord), repair/replace neuromuscular tissue units of the face and composite facial features (including eyelids, lips, and nares), and wound management and tissue preservation (not to include infection control). &#149; Restoration and Rehabilitation of Sensory System Traumatic Injury (Vision, Hearing, and Balance). Applied research to support the development of strategies for the diagnosis, treatment, and mitigation of dysfunction associated with TBI and war-related injuries, and the restoration of sensory systems (including regeneration and tissue repair following traumatic injury). Psychological Health and Well-Being for Military Personnel and Families &#149; Suicide Prevention. Applied research leading to evidence-based, standardized evaluation criteria for suicidal patient intake and improved cognitive behavioral intervention as a treatment for suicidality. &#149; Diagnosis and Treatment of PTSD. Applied research leading to accelerated cognitive behavioral therapy for combat-related PTSD. &#149; Diagnosis and Treatment of Deployment-Related Psychological Health Problems. Applied research leading to enhanced methods to prevent health risk behaviors (e.g., accidents and tobacco use) and improved methods for the diagnosis and treatment of PTSD in the presence of other comorbid mental health problems (e.g., depression, anger, grief, and guilt). &#149; Psychological Resilience. Applied research leading to improved methods to enhance psychological resilience (e.g., environmental enrichment, yoga, and other complementary FY10 Defense Medical Research and Development Program (DMRDP) 7 alternative medicine methods, positive psychology interventions, and enhancement of traditional training). &#149; Military Family and Community Health and Resilience. Applied research leading to improved, evidence-based family and community resilience programs and methods to maintain strong relationships during deployment/extended separation. All applications must be responsive to the health care needs of the Armed Forces. Examples of the types of research that may be supported include, but are not limited to: &#149; Collection and analysis of data for developing and validating clinical guidance &#149; Developing new behavioral or rehabilitation interventions &#149; Testing new therapeutic modalities (e.g., agents, delivery systems, and chemical modification of lead compounds) using established or validated novel preclinical systems &#149; Exploratory studies of medical device technologies in well-defined laboratory and/or animal model(s) to identify and assess potential safety problems, adverse events, and side effects &#149; Comparative activity/efficacy testing of candidate pharmacologic agents to define a single lead agent from a limited library of candidates &#149; Designing and implementing pilot Good Manufacturing Practice production of therapeutics and/or delivery systems &#149; Developing pharmacologic agents through the elements of absorption, distribution, metabolism, excretion, and toxicity &#149; Preclinical development of pharmacologic agents to Investigational New Drug stage to include preclinical studies of agents under Good Laboratory Practice guidelines &#149; Preclinical development of prototype devices for diagnosis or treatment to Investigational Device Exemption stage &#149; Development and validation of assays and reagents required to measure biological responses and molecular end points &#149; Optimizing diagnostic or treatment devices and other medical countermeasures for field deployment Awards may support human studies but may not be used to support clinical trials. Awards may not be used to support fundamental basic research. Proposals must include preliminary and/or published data relevant to the hypothesis/aims of the proposed research project. Other DMRDP Program Announcements/Funding Opportunities will be released in the future that will provide support for clinical trials and basic research.
GrantorContactEmailDescription: Help Desk
GrantorContactText: PA HELP:  301-619-7079; cdmrp.pa@amedd.army.mil &lt;br/&gt;Pre-application HELP: 301-682-5507; help@cdmrp.org  &lt;br/&gt;