US Army Medical Research and Material Command

1. US Army Medical Research and Material Command

2. COMMAND OVERVIEWMission and Vision

3. Command Relationships and Personnel The USAMRMC is a Major Subordinate Command (MSC) of MEDCOM. The USAMRMC has: Six laboratory major subordinate commands: USAARL USAISR USAMRICD USAMRIID USARIEM WRAIR Two Advanced Development major subordinate commands: USAMMDA USAMMA Two Logistics major subordinate commands: USAMMA USAMMCE One IMIT major subordinate command: USAMITC One health facilities planning major subordinate command. One contracting command (support activity): USAMRAAThe USAMRMC is a Major Subordinate Command (MSC) of MEDCOM. The USAMRMC has: Six laboratory major subordinate commands: USAARL USAISR USAMRICD USAMRIID USARIEM WRAIR Two Advanced Development major subordinate commands: USAMMDA USAMMA Two Logistics major subordinate commands: USAMMA USAMMCE One IMIT major subordinate command: USAMITC One health facilities planning major subordinate command. One contracting command (support activity): USAMRAA

4. USAMRMC Customer-Focused The USAMRMC has five programs leading to four major external customer-focused outcomes.The USAMRMC has five programs leading to four major external customer-focused outcomes.

5. Core Medical Research and Technology (R&T) The Warfighter can be exposed to a number of medical threats when deployed. These threats can range from diseases endemic to the specific region to local environmental threats. These threats are augmented by the stressors from the operational environment such as sleep deprivation and traumatic stress. The USAMRMC is also responsible for developing diagnostics, drugs, and vaccines against biological and chemical warfare compounds as well as developing better treatments for casualties on the battlefield. You can see that USAMRMC is responsible for developing and delivering medical products and information throughout the entire military environment, from initial entry to active duty and the garrison to the battlefield and evacuation from it. The Warfighter can be exposed to a number of medical threats when deployed. These threats can range from diseases endemic to the specific region to local environmental threats. These threats are augmented by the stressors from the operational environment such as sleep deprivation and traumatic stress. The USAMRMC is also responsible for developing diagnostics, drugs, and vaccines against biological and chemical warfare compounds as well as developing better treatments for casualties on the battlefield. You can see that USAMRMC is responsible for developing and delivering medical products and information throughout the entire military environment, from initial entry to active duty and the garrison to the battlefield and evacuation from it.

6. Core Medical R&T  Programs

7. USAMRMC Laboratories � Proximity to HBCU/MI

8. MedicalAdvanced Development Conversion of tech-base concepts or commercial products into FDA-approved war-ready medical products (drugs, biologics, devices) Liaison to the Food and Drug Administration (FDA) Responsible for directing, planning, and implementing all regulatory activities for OTSG-sponsored products Includes developing regulatory strategies for new product registration and submission to the appropriate regulatory agency A key component of the advanced development program is its interface with the FDA. Medical products are unique in the military as they usually require FA approval before they can be generally used in humans. The USAMMDA�s Regulatory Affairs division works with the FDA to ensure USAMRMC products attain FDA approval.A key component of the advanced development program is its interface with the FDA. Medical products are unique in the military as they usually require FA approval before they can be generally used in humans. The USAMMDA�s Regulatory Affairs division works with the FDA to ensure USAMRMC products attain FDA approval.

9. Medical Advanced DevelopmentPrograms and Commodities Drugs Products derived from synthesized chemicals with the intent of being metabolized by the body Pills/IVs/Creams FDA: Center for Drug Evaluation and Research (CDER) Biologics Products derived from living sources (animal, human, microorganisms) Vaccines, blood, allergenics, tissues FDA: Center for Biologics Evaluation and Research (CBER) Devices Instruments, apparatus, machines, implants used in the clinical diagnosis or treatment with the intent to affect the structure or function of the body X-rays, lab equipment, bandages, & tongue depressors FDA: Center for Devices and Radiological Health The advanced development program is aligned under programs and commodities. The USAMRMC�s advanced development programs reflect the Army R&T programs: military infectious diseases, combat casualty care, and military operational medicine. Advanced development of products from the R&T chem/bio program is executed by DOD agencies. The advanced development commodities reflect the classification of product being developed: drugs, biologics, and devices.The advanced development program is aligned under programs and commodities. The USAMRMC�s advanced development programs reflect the Army R&T programs: military infectious diseases, combat casualty care, and military operational medicine. Advanced development of products from the R&T chem/bio program is executed by DOD agencies. The advanced development commodities reflect the classification of product being developed: drugs, biologics, and devices.

10. Medical Logistics USAMRMC is the medical logistician to the Army Medical Department. The execution organizations � U.S. Army Medical Materiel Agency (USAMMA) and the U.S. Army Medical Materiel Center, Europe (USAMMCE) � provide direction and medical material across the full spectrum of health care missions worldwide. They are responsible for identifying specific products for fielding, procuring those products, and delivery of the products to everyone from the aidman to the surgeon at Walter Reed. They need to ensure that when the medical professional needs a product it is there. Additionally, they must maintain a stockpile at proper levels while also ensuring proper rotation of medical materials so that products do not go past their expiration date prior to use. In addition, many medical products including drugs and vaccines must be kept at tightly controlled temperatures. Keeping products at a specified temperature may not seem difficult in medical facilities in CONUS, but the same has to happen when they are delivering drugs and medical products to field hospitals and forward surgical units in the Iraqi desert. USAMRMC is the medical logistician to the Army Medical Department. The execution organizations � U.S. Army Medical Materiel Agency (USAMMA) and the U.S. Army Medical Materiel Center, Europe (USAMMCE) � provide direction and medical material across the full spectrum of health care missions worldwide. They are responsible for identifying specific products for fielding, procuring those products, and delivery of the products to everyone from the aidman to the surgeon at Walter Reed. They need to ensure that when the medical professional needs a product it is there. Additionally, they must maintain a stockpile at proper levels while also ensuring proper rotation of medical materials so that products do not go past their expiration date prior to use. In addition, many medical products including drugs and vaccines must be kept at tightly controlled temperatures. Keeping products at a specified temperature may not seem difficult in medical facilities in CONUS, but the same has to happen when they are delivering drugs and medical products to field hospitals and forward surgical units in the Iraqi desert.

11. War SupplementalPrograms FY07 � $323.407M DHP RDT&E Received ($331.7 M Appropriated) Managed through Broad Agency Announcement Peer Reviewed Post Traumatic Stress Disorder Research - $146.25M Peer Reviewed Traumatic Brain Injury Research - $146.25M Managed by the USAISR Peer Reviewed Burn, Orthopedic, and Trauma Research - $30.907M FY08 � $266.955M DHP RDT&E Received ($273.8M Appropriated) Battle Casualty and Psychological Health Research Multiple management groups and processes Areas for research focus and acceleration of programs Medical Devices Blood Safety & Products Burns Orthopedic, other trauma, and rehabilitation Suicide Traumatic Brain Injury & Psychological Health Injury Prevention Wound Infection and Healing Treatment for Severe Cutaneous Leishmaniasis Wound Infection Vaccines

12. Congressional Special Interest (CSI) Programs Although the previous RDA programs make up the core RDA effort for USAMRMC, their funding is less than 40% of the USAMRMC RDA budget. Each year, in the DoD Appropriations Bill and accompanying reports, Congress specifically identifies additional research efforts for funding. These congressionally directed research efforts make up approximately 60% or more of the USAMRMC RDA budget. These programs range from focus areas that are extremely supportive of the overarching military mission to those less apparently militarily relevant. Although they vary in their utility in military medicine, USAMRMC manages them to maximize their military relevance. Congressionally directed research funds are placed into every research thrust area within the USAMRMC as well as special offices developed for the CSI programs: CSI directly relevant to core RDA programs managed by the RADs and USAMMDA (39% of CSI funding) Telemedicine and advanced technologies research managed by TATRC (29% of CSI funding) Cancer and disease-specific research managed by CDMRP (32% of CSI funding) Each of these three areas receives anywhere from $250M to $300M in CSI funding each year, which can be compared to $45M to $70M for the individual core RDA programs. Although the previous RDA programs make up the core RDA effort for USAMRMC, their funding is less than 40% of the USAMRMC RDA budget. Each year, in the DoD Appropriations Bill and accompanying reports, Congress specifically identifies additional research efforts for funding. These congressionally directed research efforts make up approximately 60% or more of the USAMRMC RDA budget. These programs range from focus areas that are extremely supportive of the overarching military mission to those less apparently militarily relevant. Although they vary in their utility in military medicine, USAMRMC manages them to maximize their military relevance. Congressionally directed research funds are placed into every research thrust area within the USAMRMC as well as special offices developed for the CSI programs: CSI directly relevant to core RDA programs managed by the RADs and USAMMDA (39% of CSI funding) Telemedicine and advanced technologies research managed by TATRC (29% of CSI funding) Cancer and disease-specific research managed by CDMRP (32% of CSI funding) Each of these three areas receives anywhere from $250M to $300M in CSI funding each year, which can be compared to $45M to $70M for the individual core RDA programs.

13. Business OpportunitiesGood Ideas to Fielded Medical Policies, Information, and Products There is an organized system to make good ideas into policies, information and products for the soldier.There is an organized system to make good ideas into policies, information and products for the soldier.

14. Business OpportunitiesWhere To Learn More BUSINESS OPORTUNTIES: Many opportunities for private industry, academia and government agencies to partner with USAMRMC Streamlined methods of technology transfer Encourage collaboration to ensure our Warfighters and the Nation have state-of-the-art the medical products USAMRMC Broad Agency Announcement (BAA) One BAA Always open Details research requirements Provides pre-proposal and proposal format Program Announcements (PAs) Multiple PAs (one for each special program) Limited time frame for proposal submission Detail research requirements Provide pre-proposal and proposal format Small Business Innovation Research (SBIR): Contract program for small businesses supporting Defense and commercial applications Advertsies interest in specific research topics Small businesses submit research proposals Successful proposal is funded for 6 months (Phase I) Successful Phase I and compete for 2 year funding (Phase II) Small Business Technology Transfer (STTR): Program: Companion to SBIR program Work must be performed by small businesses in collaboration with non-profit research organizations Same process as SBIRBUSINESS OPORTUNTIES: Many opportunities for private industry, academia and government agencies to partner with USAMRMC Streamlined methods of technology transfer Encourage collaboration to ensure our Warfighters and the Nation have state-of-the-art the medical products USAMRMC Broad Agency Announcement (BAA) One BAA Always open Details research requirements Provides pre-proposal and proposal format Program Announcements (PAs) Multiple PAs (one for each special program) Limited time frame for proposal submission Detail research requirements Provide pre-proposal and proposal format Small Business Innovation Research (SBIR): Contract program for small businesses supporting Defense and commercial applications Advertsies interest in specific research topics Small businesses submit research proposals Successful proposal is funded for 6 months (Phase I) Successful Phase I and compete for 2 year funding (Phase II) Small Business Technology Transfer (STTR): Program: Companion to SBIR program Work must be performed by small businesses in collaboration with non-profit research organizations Same process as SBIR

15. Grants.gov

16. Fort Detrick Business Development Office

17. Maryland Research and Applied Science Consortium

18. USAMRMC in Context As we have seen, USAMRMC is not an isolated program. We interact with the broader Army policy and doctrine community to understand the needs of the warfighter. We work with an extensive network of extramural collaborators and partners. Currently USAMRMC has approximately 1,150 CRADAs with outside collaborators. They bring ideas and technologies to allow us to accomplish our job: Provide the best medical products for the US Warfighter.As we have seen, USAMRMC is not an isolated program. We interact with the broader Army policy and doctrine community to understand the needs of the warfighter. We work with an extensive network of extramural collaborators and partners. Currently USAMRMC has approximately 1,150 CRADAs with outside collaborators. They bring ideas and technologies to allow us to accomplish our job: Provide the best medical products for the US Warfighter.