Mid-Atlantic FLC October 24, 20071

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

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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

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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

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Medical R&D Programs

• Infectious Diseases

• Casualty Care

• Operational Medicine

• Chemical & Biological Defense

• Telemedicine and Medical IT

• Congressional Research Programs

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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

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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

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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

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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

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Marketing Efforts

• 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

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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)

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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

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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

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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

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MRMC Web Sites

• US Army Medical Research and Materiel Commandhttps://mrmc-www.army.mil

• USAMRMC Technology Transfertechnologytransfer.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 paul.mele@amedd.army.mil• Barry Datlof (301) 619-0033 barry.datlof@amedd.army.mil• Sara Miller (301) 619-6975 sara.b.miller@amedd.army.mil

Fort Detrick Technology Transfer Initiative • Ron Kaese (410) 715-4170 rkaese@marylandtedco.org

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Some recent USAMRMC technologies:

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SleepWatchSleepWatch®®

A Management System for Sleep and Performance in the Operational

EnvironmentWalter Reed Army Institute of Research

U.S. Army Medical Research and Materiel Command

ProblemProblemSleep deprivation:- Consequence of sustained operations

- Disrupts performance and cognition- Battlefield mistakes

- Could not be measured objectively

SolutionSolution- 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

ValidationValidation- Laboratory testing

- Battlefield simulation

- Troop performance

2006 Technology Transfer2006 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

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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 GumCaffeinate Supplement Gum

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Combined Camouflage Face PaintCombined 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 environmentNSN 6850-01-493-7309

Ongoing research to provide

CCFP in stick dispensers!

2 colors per stick!

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One-Handed TourniquetOne-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!

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

Non-Contact Respiration MonitorNon-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!

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Lightweight; durable; cost effective

Manufactured from a natural product in shrimp shells called chitosan

Hemorrhage ControlChitosan BandageChitosan 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!Saved Lives!Soldiers WANT it!Soldiers WANT it!

Buddy and Medic Aid used by Buddy and Medic Aid used by the Warfighter!the Warfighter!

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• 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 Adenovirus Vaccine