Military Operational Medicine Research Program Overview
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1 Military Operational Medicine Research Program Overview Acting Director: LCDR Chris Steele Ronald Hoover, Ph.D. Psychiatry and Clinical Psychology Research Portfolio Manager US Army Medical Research and Materiel Command 31 May 2018 The views expressed in this presentation are those of the author(s) and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the US Government. Slide 1 of 10
2 MISSION VISION Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter Lead the advancement of military medicine Slide 2Slide of 7 2 of 10
3 Deputy Commander Military Operational Medicine Research Program USAMRMC Organization Commanding General Chief of Staff Deputy Commander Special Staff Dir, Office of Small Business Prog Dir, Office of Research Protections Dir, Quality Management International Affairs Officer Strategic Partnerships Office Other Organizations Congressionally Directed Medical Research Programs (CDMRP) Telemedicine and Advanced Technology Research Center (TATRC) Dir, Military Operational Medicine Res Prog Command Sergeant Major Principal Assistant for Research and Technology Dir, Infectious Diseases Res Prog Dir, Combat Casualty Care Res Prog Dir, Military Operational Medicine Res Prog Dir, Clinical & Rehabilitative Medicine Res Prog Dir, Medical Simulation and Information Sciences Res Prog Dir, CBRN Defense Medical Research Coordination Office Dir, Blast Injury Research Program Coordinating Office Joint Trauma Anal & Prev of Inj in Cmbt (JTAPIC) Commanding General Special Staff Inspector General Principal Assistant Resp. for Contracting Staff Judge Advocate Equal Opportunity Advisor Safety Office SARC/SHARP Principal Assistant for Acquisition Proj Mgr, Pharmaceutical Systems Proj Mgr, Medical Support Systems Proj Mgr, HIV Vaccine Proj Mgr, Armed Forces Inst of Regenerative Medicine Proj Mgr, Hyperbaric Oxygen Proj Mgr, Medical Devices Proj Mgr, Integrated Clinical Systems Proj Mgr, Helicopter Medevac Med Equip Pkg Proj Mgr, USAMRMC Enterprise IM/IT Proj Mgr, Neurology and Psych Health Secretary of the General Staff Chief of Staff Special Staff Dir, Med Systems Office, ASAALT Dir, Plans, Programs, Analysis, & Eval Dir, Materiel Dir, Surety & Environmental Internal Review Protocol Officer Public Affairs Officer Enlisted Senior Career Counselor Transformation Officer Deputy Chiefs of Staff DCS, Human Resources (G1) DCS, Operations (G3) DCS, Logistics (G4) DCS, Info Mgmt / Info Tech (G6) DCS, Resource Management (G8) Medical Advanced Development Commands Slide 3 of 10
4 Overview of MOMRP MOMRP is an extremely diverse program Supports operational health, readiness and performance of the Joint Warfighter across the range of military operations and Service member life-cycle Manages R&D to understand novel mechanisms and develop focused solutions at the group and individual level for Precision Operational Medicine ~90% of MOMRP projects are linked to knowledge products Slide 4 of 10
5 ENVIRO Environmental Health and Protection THREATS Heat/Humidity Stress Dehydration Dust and Air Pollution Toxic Industrial Chemicals and Toxic Industrial Materials (TICs and TIMs) Water Contaminants Cold Stress Altitude/Hypoxia Military Operational Medicine Research Program MOMRP Mission and Focus Areas Science PHYSIO Physiological Health and Performance THREATS Disaggregated/Continuous Operations Sleep Deficit and Circadian Desynchrony Sustained Fatiguing Work (Physical/Mental) Malnutrition Dietary Supplements Misuse Slide 5 of 10 Develop effective medical countermeasures against operational stressors and to prevent physical and psychological injuries during training and operations in order to maximize the health, readiness and performance of Service members and their Families, in support of the Army Human Performance Optimization (HPO), Human Dimension (HD), Multi-Domain Battle (MDB), and the DoD Total Force Fitness (TFF) concepts. INJURY Injury Prevention and Reduction THREATS Musculoskeletal Injury Blast Overpressure Blunt Head/Body Trauma Face/Eye/Spinal Injury Acoustic Trauma Laser Eye/Directed Energy Injury Degraded Visual Environment Biomedical Performance Enhancement Wearables for Health, Readiness and Performance Medical Aspects of Manned/Unmanned Teaming PSYCH Psychological Health (PH) and Resilience THREATS PTSD/Other PH Disorders Suicide Behavior Alcohol/Other Drug Use Co-occurring Mental Disorders Access/Retention in Behavioral Health Care Family Transitions and Well-being
6 Clinical Psych Challenges & Priorities Posttraumatic Stress Disorder (PTSD) and other anxiety disorders Psychotherapeutic Treatments Treatment duration, modality, and efficacy can deter service members from seeking healthcare (Accessibility, Treatment Interval, Patient satisfaction, Scheduling, other considerations) Psychotherapy challenges (not evidence-based, eclectic, scheduling, patient fit, variable and unpredictable outcomes Current evidence-based psychotherapies for PTSD are moderately effective but only if treatment is completed. Pharmacologic Interventions Only 2 FDA-approved medications for PTSD: sertraline (Zoloft), paroxetine (Paxil) Both have limited efficacy, include significant unwanted side effects, and have compliance issues. Off label prescribing: help for the patient, may impede research Need for far-forward, immediate treatments Veterans and Service members can participate in medication trials PTSD comorbidities also need to be addressed (e.g., depression, substance use, sleep disorders, chronic pain, anxiety disorders ) Slide 6 of 10
7 Clinical Psych Challenges & Priorities Major Depressive Disorder (MDD) and Suicidality MDD is the most frequent behavioral health diagnosis among Service members. Better antidepressant medications immediate interventions for risk mitigation (psychotherapeutic and pharmacologic) Substance Use Disorders As either a primary diagnosis or as a comorbidity of PTSD and/or MDD. Current research focus: Alcohol Abuse, Opioids, Synthetic Cannabis Increased interest in Sleep Sleep disorders Sleep cycle pertubations (shift work, sleep disruption) Slide 7 of 10
8 Previous PTSD Medication Studies Global Symptoms olanzapine venlafaxine tramadol??? Sleep, Nightmares prazosin risperidone nabilone Comorbid AUD topiramate doxazosin prazosin??? SSRI-Resistant ketamine quetiapine??? Avoidance/ Numbing venlafaxine??? Re- Experiencing risperidone??? Which would be best? Slide 8 of 10
9 PTSD State of the Science Summit (SoSS) Held June 2017 ~140 participants from government, industry and academia Included knowledge experts in the fields of PTSD pathophysiology, endocrinology, neuroimaging, genomics, and CNS drug development Aim is to shape future medical science and strategy in the development of medications to treat PTSD and its associated symptoms and comorbid disorders Identify the most promising drug targets Initiate future Advanced Development partnerships Desirability of Adaptive Designs in Pharmacologic Research MTEC program announcement Slide 9 of 10
10 Funding Opportunities Broad Agency Announcements (BAAs) or e.g., Psychological Health and Resilience: The psychological health research program area is interested in research aimed at increasing resilience and psychological health and decreasing post-traumatic stress disorder (PTSD), suicide, and risk behaviors (e.g., substance abuse, anger/aggression, sexual harassment and assault, and violence within the military). Additional psychological health areas of interest.. from BAA W81XWH-17-R-BAA1 at grants.gov website. Open year round for pre-application (pre-proposals) submissions Pre-applications are submitted electronically to the Electronic Biomedical Research Application Portal (ebrap) Full applications, following an invitation to submit, are submitted electronically to Medical Technology Enterprise Consortium (MTEC) conduct research and prototyping to support the USAMRMC requirements capitalization of private-sector and government opportunities provide funding for critical studies that may attract other investors commercialization of government intellectual property Slide 10 of 10
11 Funding Opportunities cont d Congressionally Directed Medical Research Program (CDMRP) Program Announcements (PAs) Peer Reviewed Medical Research Program (PRMRP) e.g., Technology/ Therapeutic Development Award - Translation of promising preclinical findings into clinical applications for prevention, detection, diagnosis, treatment, or quality of life. Product-oriented (e.g., device, drug, clinical guidelines). The product(s) to be developed may be a tangible item such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product. Topic Specific Program Announcements occasionally occur throughout the year and usually have a limited window of time for submissions often fairly narrow in terms of research proposal sought, focused to fill a clearly identified capability gap regular monitoring of grants.gov ensures opportunities are not missed MOMRP does maintain a list-server where we recipients when a PA of this nature is released. Drs. Hoover or Renosky to be added to the list-server (contact information on next page) Slide 11 of 10
12 MOMRP Contacts LCDR Christopher Steele Acting Program Area Director Military Operational Medicine Research Program (MOMRP) Fort Detrick, MD LTC James McKnight Acting Deputy Director Military Operational Medicine Research Program (MOMRP) Fort Detrick, MD Ron Hoover, PhD Psychiatry and Clinical Psychology Research Portfolio Manager Ronda Renosky, PhD Psychiatry and Clinical Psychology Research Deputy Portfolio Manager Slide 12 of 10
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