“Every Day, thinking of Deployed Soldiers”

1. “Every Day, thinking of Deployed Soldiers”

2. U.S. Army Medical Materiel Development Activity (USAMMDA) COL Russell E. Coleman, Commander LTC Karen M. Kopydlowski, Deputy Commander Last Updated: FEB 2011 UNCLASSIFIED

3. Mission & Vision Mission . . . to develop and field medical materiel to protect and sustain our deployed Warfighters Vision . . . to integrate with USAMRMC, Federal agencies, commercial partners and the DoD, as a part of the joint biomedical research and materiel community, to focus on delivering the best medical solutions for today and tomorrow

4. MRMC Organization Commanding General MG James Gilman Deputy Commander CAPT Chris Daniel Chief of Staff COL Jeffrey Unger • MIDPR • CCCRP • MOMRP • CRMRP • RM • PPAE • Logistics • Personnel Principal Assistant for Research and Technology Dr. John Glenn Principal Assistant for Acquisition Dr. Kenneth Bertram Principal Assistant Responsible for Contracting Dr. Michaels US Army Medical Research Acquisition Activity (USAMRAA) US Army Aeromedical Research Laboratory (USAARL) US Army Medical Materiel Development Activity (USAMMDA) US Army Medical Materiel Center, Korea (USAMMCK) Walter Reed Army Institute of Research (WRAIR) US Army Institute of Surgical Research (USAISR) US Army Research Institute of Environ-mental Medicine (USARIEM) US Army Medical Materiel Agency (USAMMA) US Army Medical Materiel Center, Europe (USAMMCE) US Army Medical Research Institute for Chemical Defense (USAMRICD) US Army Medical Research Institute of Infectious Diseases (USAMRIID) JPEO-CBD CBMS

5. USAMMDA Organization Commander COL Russell Coleman Deputy Commander LTC Karen Kopydlowski HQ Support Staff ORTA: Ms. Judy Holian PAO: Ms. Carey Phillips Quality: Ms. Beth Coffman Medical Countermeasures T&F Facility Ms. Kathleen Berst HIV PMO COL Jerome Kim Project Management Offices Divisions Medical Support Systems Mr. Steve Hawbecker Hyperbaric Oxygen Treatment COL Scott Miller Armed Forces Institute of Regenerative Medicine Mr. Terry Irgens Medical Knowledge Products Ms. Kathleen Berst Division of Regulated Activities and Compliance Dr. Bob Miller Clinical Service Support Division COL Isiah Harper Pharmaceutical Systems Dr. Lawrence Lightner Force Health Protection LTC Max Teehee Administrative Services Division Ms. Monica German (Acting) Anti-Parasitic Products Non-Medical Support Branch Tech Base Infectious Diseases Products Collaborative Systems Branch Advanced Development Combat Casualty Care Products Medical Prototype Development Laboratory

6. Major Partnerships & Collaborations Mobile Medical International Corporation WRAIR & USUHS USAISR & Ft Sam Houston USAMRU-K Nairobi, Kenya CBMS ALLERMED Naval Medical Research Center Detachment Lima, Peru AFRIMS Bangkok, Thailand NAMRU-2 Jakarta, Indonesia IGR NAMRU-3 Cairo, Egypt

7. Pharmaceutical Systems PMO Dr. Lawrence K. Lightner, Project Manager Mr. Scott Doughty, Deputy Project Manager Mission • Responsible for advanced development of pharmaceutical products for use by the U.S. Military • Pharmaceutical products include: • Drugs • Vaccines • Diagnostics • Blood Products

8. Medical Support Systems PMO Mr. Steve Hawbecker, Project Manager TBD, Deputy Project Manager Mission Manage products, medical equipment sets, and activities associated with the acquisition of non-medical materiel solutions that enhance medical readiness in support of Medical Evacuation and Combat Support Hospital requirements for the Warfighter • 40 products, 24 medical equipment sets, and kits help evacuate and treat common causes of battlefield deaths • Vehicle programs provide medical evacuation and treatment with a focus on medical mission packages • Shelter programs provide forward-deployed healthcare providers with operating room shelters and patient care wards • Activities include: analyzing functional requirements, coordinating with other Program Offices, and providing logistics support and lifecycle management

9. Armed Forces Institute of Regenerative Medicine (AFIRM) Mr. Terry Irgens, Project Manager LTC Brian Moore, Deputy Project Manager Mission • Develop new products and therapies to heal & reset our warriors who have suffered catastrophic traumatic injuries • New Project Management Office – Established 2010 • Multi-institutional: DoD and two Consortia • Rutgers – Cleveland Clinic Consortium • Wake Forest – Pittsburgh Consortium • Institute of Surgical Research, Fort Sam Houston, Texas • Interdisciplinary network of scientists, focused on 5 key areas • Burn Repair • Craniofacial Reconstruction • Limb and Digit Salvage • Scarless Wound Healing • Compartment Syndrome

10. Hyperbaric Oxygen (HBO2) Research PMO COL Scott Miller, Project Manager TBD, Deputy Project Manager Mission • Evaluate the benefit of hyperbaric oxygen in the treatment of chronic symptoms of mild traumatic brain injury (TBI) or post-concussion syndrome • New Project Management Office – Established 2010 • HBO2: Administration of oxygen in a chamber at greater than atmospheric pressure, resulting in higher then normal amounts of oxygen delivered to body tissues • Anecdotal evidence suggests HBO2 may be beneficial in treatment of acute and chronic symptoms associated with TBI • Well controlled clinical trials needed to demonstrate HBO2 is effective

11. Division of Regulated Activities and Compliance (DRAC) • Dr. Robert E. Miller, Director LTC David Shoemaker, Deputy Director Mission • Provide full-service regulatory support for products through the DoD acquisition spectrum, from individual investigator-initiated clinical studies to products in the advanced development pipeline • Serves as Department of the Army Office of The Surgeon General (OTSG) Sponsor • Primary point-of-contact with all formal and informal communications with the U.S. FDA • Develops and executes regulatory strategies for compliant use and FDA approval of OTSG-sponsored drugs, vaccines and devices • Supports researchers and laboratories throughout the Army and the DoD

12. Clinical Service Support Division • COL Isiah Harper, Director TBD, Deputy Director Mission • Provides clinical support services for the development and advancement of medical products, in the following areas: • Investigational New Drug (IND) product manufacturing, testing and accountability • Clinical study monitoring • Clinical Data Management • Biostatistical support, including study design and data analysis • Adverse event monitoring and reporting

13. Force Health Protection Division • LTC Max Teehee, Director CPT Ray Casteline, Deputy Director Mission • Provides for the medical use of the best available Investigational New Drug (IND) countermeasures and prophylaxis for Biological events and endemic disease threats, when there is no FDA approved drugs, in support of the Nation’s Warfighters throughout the world • Established by Executive Order 13139 – Administration of IND to Members of the Armed Forces • Only given to individuals who volunteer and who sign an Informed Consent document • Pre-positioned strategic stockpiles • Specialized MEDCOM Response Capabilities – IND Team (SMRC-IND)

14. Acquisition • What does USAMMDA purchase? • Commercial Goods/Services – FY10 = $23.2M • Administrative Materials and Supplies • Administrative/Budgetary Support Services • Professional, Scientific and Technical Consulting Services • Research and Development – FY10 = $92.8M • Clinical Trials and Support Activities • Developmental and Operational Testing • Investigational Product Testing, Storage, and Shipping • Manufacturing

15. Acquisition • How does USAMMDA procure goods and services? • Commercial Goods/Services • Credit Card • New and Established Contract Vehicles • Research and Development Services • New and Established Contract Vehicles • Grants and Cooperative Agreements • Cooperative Research and Development Agreements (CRDA) • Interagency Agreements • USAMRAA is the primary contracting office used by USAMMDA.

16. Conclusion “Every Day, thinking of Deployed Soldiers” “Every Day, developing Products for Deployed Soldiers” “Every Day, doing your part for Deployed Soldiers” www.usammda.army.mil