1. Mid-Atlantic FLC October 24, 2007 1 Technology Transfer with the U.S. Army Medical Research and Materiel Command Paul C. Mele, Ph.D. Director Office of Research and Technology Applications USAMRMC

2. Mid-Atlantic FLC October 24, 2007 2 USAMRMC Headquartered at Fort Detrick, MD The R&D arm of the Army Medical Command Army’s medical materiel developer ~$2 billion funding in FY 2007

3. Mid-Atlantic FLC October 24, 2007 3 MRMC Mission To provide medical materiel to sustain the health, well being and military readiness of U.S service men and women: - drugs - vaccines - devices - medical IT Basic research, Advanced development, Final Product

4. Mid-Atlantic FLC October 24, 2007 4 Medical R&D Programs Infectious Diseases Casualty Care Operational Medicine Chemical & Biological Defense Telemedicine and Medical IT Congressional Research Programs

5. Mid-Atlantic FLC October 24, 2007 5 MRMC Laboratories Institute of Infectious Diseases (USAMRIID) biodefense – Fort Detrick Telemedicine and Advanced Technology Research (TATRC) medical IT, simulations, telemedicine – Fort Detrick Center for Environmental Health Research (USACEHR) environmental toxicology and monitoring – Fort Detrick Medical Materiel Development Activity (USAMMDA) advanced development, clinical trials – Fort Detrick

6. Mid-Atlantic FLC October 24, 2007 6 MRMC Laboratories Walter Reed Army Institute of Research (WRAIR) infectious diseases, neuroscience, trauma – Silver Spring, MD Institute of Chemical Defense (USAMRICD) chemical defense - Edgewood, MD Aeromedical Research Laboratory (USAARL) aviation medicine, human interface - Fort Rucker, AL Institute of Environmental Medicine (USARIEM) performance, exercise physiology, sports medicine - Natick, MA Institute of Surgical Research (USAISR) trauma, emergency medicine – San Antonio, TX

7. Mid-Atlantic FLC October 24, 2007 7 Facilities & Operations Worldwide research laboratories GMP pilot plant Clinical trials Regulatory experience: FDA & EPA BL-3 & BL-4 laboratories Bioinformatics Sleep ward Burn ward Helicopters & flight simulator

8. Mid-Atlantic FLC October 24, 2007 8 Technology Transfer Instruments Cooperative Research and Development Agreements (CRADAs) Material transfer agreements Patent license agreements Clinical trial agreements Test and evaluation agreements (“work for hire”) Educational partnerships Partnership Intermediaries Grants, contracts, cooperative agreements, SBIR

9. Mid-Atlantic FLC October 24, 2007 9 Marketing Efforts Federal Register Web pages – MRMC & laboratories – https://technologytransfer.detrick.army.milhttps://technologytransfer.detrick.army.mil –Federal Laboratory Consortium (FLC) Shows & exhibits Third party Direct mailings Internet technology exchanges MRMC scientists

10. Mid-Atlantic FLC October 24, 2007 10 DoD Technology Transfer Web Site

11. Mid-Atlantic FLC October 24, 2007 11 Lead Partnership Intermediary

12. Mid-Atlantic FLC October 24, 2007 12 Fort Detrick Technology Transfer Initiative Collaboration between TEDCO and MRMC to promote technology transfer Congressional funding - $50,000 seed grants for collaborations with MRMC FY2008 - $750,000 for grants Partners: Fort Detrick Business Development Office (FDBDO) Frederick County Office of Economic Development (FCOED) Frederick Innovative Technology Center, Inc. (FITCI)

13. Mid-Atlantic FLC October 24, 2007 13 Patent License Agreements VACCINES - Japanese encephalitis - dengue - anthrax - Ebola - Marburg THERAPEUTICS - topical skin protectant - anthrax - anti-infectives DEVICES - absorbable surgical glue - water bio-monitor - chemical weapons decon - critical care platform for litters - medical information system METHODS & ASSAYS - prolonged blood storage - leishmania diagnostic - ultrasound lysis of blood clots

14. Mid-Atlantic FLC October 24, 2007 14 Technology Transfer Issue: Federal Contractors and CRADAs Contractor’s Bayh-Dole rights vs.CRADA partner’s rights Inform CRADA partner of contractor involvement Seek to get a waiver from contractor to CRADA data and intellectual property before work starts

15. Mid-Atlantic FLC October 24, 2007 15 Technology Transfer Issue: Patent License as Procurement: Risks for Licensee Licensee provides resources for further development Government-use rights may be seen as potential competition No assurance government will purchase product March in rights Government encourages competition

16. Mid-Atlantic FLC October 24, 2007 16 MRMC Web Sites US Army Medical Research and Materiel Command https://mrmc-www.army.mil USAMRMC Technology Transfer technologytransfer.detrick.army.mil Fort Detrick Technology Transfer Initiative (TEDCO) www.marylandtedco.com USA Medical Research Acquisition Activity (purchasing, contracting, SBIR) www.usamraa.army.mil

17. Mid-Atlantic FLC October 24, 2007 17 MRMC Web Sites Telemedicine and Advanced Technology Research Center (telemedicine and medical IT) www.tatrc.org Congressionally Directed Medical Research Programs (research grants) http://cdmrp.army.mil Fort Detrick Business Development Office (information of business opportunities with Fort Detrick) www.fdbdo.com

18. Mid-Atlantic FLC October 24, 2007 18 MRMC Contacts USAMRMC Office of Research and Technology Applications Paul Mele (301) 619-6664 paul.mele@amedd.army.milpaul.mele@amedd.army.mil Barry Datlof (301) 619-0033 barry.datlof@amedd.army.milbarry.datlof@amedd.army.mil Sara Miller (301) 619-6975 sara.b.miller@amedd.army.milsara.b.miller@amedd.army.mil Fort Detrick Technology Transfer Initiative Ron Kaese (410) 715-4170 rkaese@marylandtedco.orgrkaese@marylandtedco.org

19. Mid-Atlantic FLC October 24, 2007 19 Some recent USAMRMC technologies:

20. Mid-Atlantic FLC October 24, 2007 20 SleepWatch ® SleepWatch ® A Management System for Sleep and Performance in the Operational Environment Walter Reed Army Institute of Research U.S. Army Medical Research and Materiel Command Problem Sleep deprivation: -Consequence of sustained operations -Disrupts performance and cognition -Battlefield mistakes -Could not be measured objectively Solution -Patented wrist watch with integrated software: The Sleep Performance Model (SPM) -Measures and relates wrist motion to sleep deprivation and decrements in cognitive ability -Combines individual sleep records for management of field units Validation -Laboratory testing -Battlefield simulation -Troop performance 2006 Technology Transfer -Successful non-exclusive license to the manufacturer of the Actigraph watch -Licensing the Sleep Performance Model to a company for treatment of behavioral disorders -An inquiry for licensing SPM in sleep disorders

21. Mid-Atlantic FLC October 24, 2007 21 Biomedical Strategies to Sustain Performance in Fatigued Soldiers MOMRP research focused on strategies to enhance Soldier alertness and cognitive readiness during continuous operations when moderate sleep loss is a common problem This research determined the efficacy of caffeine and provided guidance on optimal dosage and methods of administration The MOMRP’s research showed that caffeine supplement gum is an efficient way of enhancing alertness and performance of soldiers Caffeinate Supplement Gum

22. Mid-Atlantic FLC October 24, 2007 22 Combined Camouflage Face Paint Contains insect repellent with 8+ hour protection Reduces near-IR signature (degree of protection against detection by night vision goggles) Compact has mirror and 5 colors: green, loam, sand, black & white Stowage in BDU pockets Easy to apply/easy to remove NSN 6840-01-493-7334 Also available without insect repellent for bug- free environment NSN 6850-01-493-7309 Ongoing research to provide CCFP in stick dispensers! 2 colors per stick!

23. Mid-Atlantic FLC October 24, 2007 23 USAMMDA U.S. Army Medical Materiel Development Activity One-Handed Tourniquet Provides the soldier who has lost the use of one of his/her extremities, a method of self- administration for the control of a severe life-threatening hemorrhage Can be applied with only the use of one hand, and will control severe arterial, or mixed bleeding Highly cost effective (about $5 per unit) Technical and user testing continue to develop additional sizes & additional uses Self, Buddy, and Medic Aid!

24. Mid-Atlantic FLC October 24, 2007 24 Breadboard prototype demonstrates how respiration of soldiers in MOPP Gear is monitored, and will signal breathing status to the medic Non-Contact Respiration Monitor Device will be totally self- contained, and reliable in high noise & vibration environments such as medical evacuation helicopters Future plans include integration of the device into Army gas masks Initial technical testing was conducted Highly useful for mass triage!

25. Mid-Atlantic FLC October 24, 2007 25 Lightweight; durable; cost effective Manufactured from a natural product in shrimp shells called chitosan Chitosan Bandage Hemorrhage Control Chitosan Bandage Rapid control of Severe external hemorrhage caused by extreme trauma FDA Approved Fielded in OIF and OEF! Research ongoing for internal use Saved Lives! Soldiers WANT it! Buddy and Medic Aid used by the Warfighter!

26. Mid-Atlantic FLC October 24, 2007 26 Vaccine against virus that causes acute respiratory disease common in military recruits Orally administered, enteric-coated live vaccine, very effective from 1971 to 1999 Vaccine production ceased in 1996 due to loss of manufacturer; stocks depleted or expired by 1999 Several outbreaks since 1999 U.S. Army/Barr Laboratories are co- development partners Production facility complete, clinical trials start March 2004 Adenovirus Vaccine