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 Mid-Atlantic FLC October 24, 2007 1

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 Mid-Atlantic FLC October 24, 2007 2

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 Mid-Atlantic FLC October 24, 2007 3

Medical R&D Programs

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

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 Mid-Atlantic FLC October 24, 2007 5

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 Mid-Atlantic FLC October 24, 2007 6

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 Mid-Atlantic FLC October 24, 2007 7

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 Mid-Atlantic FLC October 24, 2007 8

Marketing Efforts

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Federal Register

• Web pages – MRMC & laboratories – https://technologytransfer.detrick.army.mil

– Federal Laboratory Consortium (FLC) • Shows & exhibits • Third party • Direct mailings • Internet technology exchanges • MRMC scientists Mid-Atlantic FLC October 24, 2007 9

DoD Technology Transfer Web Site

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Lead Partnership Intermediary

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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) Mid-Atlantic FLC October 24, 2007 12

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 Mid-Atlantic FLC October 24, 2007 13

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 Mid-Atlantic FLC October 24, 2007 14

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 Mid-Atlantic FLC October 24, 2007 15

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

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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

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MRMC Contacts

USAMRMC Office of Research and Technology Applications • Paul Mele (301) 619-6664 [email protected]

• Barry Datlof (301) 619-0033 [email protected]

• Sara Miller (301) 619-6975 [email protected]

Fort Detrick Technology Transfer Initiative • Ron Kaese (410) 715-4170 [email protected]

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Some recent USAMRMC technologies:

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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

Validation

Laboratory testing Battlefield simulation Troop performance -

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 October 24, 2007 -

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 20 sleep disorders

Caffeinate Supplement Gum

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 Mid-Atlantic FLC October 24, 2007 21

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

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One-Handed Tourniquet

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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

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Can be applied with only the use of one hand, and will control severe arterial, or mixed bleeding

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Highly cost effective (about $5 per unit)

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Technical and user testing continue to develop additional sizes & additional uses

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Self, Buddy, and Medic Aid!

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Non-Contact Respiration Monitor

Highly useful for mass triage!

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Breadboard prototype demonstrates how respiration of soldiers in MOPP Gear is monitored, and will signal breathing status to the medic

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Device will be totally self contained, and reliable in high noise & vibration environments such as medical evacuation helicopters

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Initial technical testing was conducted

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Future plans include integration of the device into Army gas masks

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Hemorrhage Control

Chitosan Bandage

Lightweight; durable; cost effective Manufactured from a natural product in shrimp shells called chitosan Saved Lives!

Soldiers WANT it!

Buddy and Medic Aid used by the Warfighter!

Rapid control of Severe external hemorrhage caused by extreme trauma FDA Approved Fielded in OIF and OEF!

Research ongoing for internal use

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Vaccine against virus that causes acute respiratory disease common in military recruits

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Orally administered, enteric-coated live vaccine, very effective from 1971 to 1999

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Vaccine production ceased in 1996 due to loss of manufacturer; stocks depleted or expired by 1999

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Several outbreaks since 1999

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U.S. Army/Barr Laboratories are co development partners

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Production facility complete, clinical trials start March 2004

Adenovirus Vaccine

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