FDA Tropical Disease Vouchers by hedongchenchen

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									Medical Technology Transfer
Product Development and Commercialization
       Thru Partnering and Licensing


                      Barry M. Datlof

                       Licensing Officer
        Office of Research and Technology Applications
      U.S. Army Medical Research and Materiel Command
                     Fort Detrick, Maryland




                                                          Barry Datlof
                                                         26 April 2011
  Technology Transfer Mission

The exchange of
knowledge and
materials among
cooperating parties
for the development
and utilization of new
products and services


                            Barry Datlof
                           26 April 2011
3    Barry Datlof
    26 April 2011
              Many Partners Are Leveraged
                for Technology Transfer
                             Partnership
        Industry                                    Government          Not for Profits
                           Intermediaries
  Startups & Established   DOD PIAs             Federal Laboratory      Tech Transfer
        Companies           • Techlink          Consortium               • AUTM
                            • Miltech                                    • LES
Biotech                     • Techmatch         OSD                      • T2 Society
Pharmaceuticals             • Firstlink
Medical devices             • Springboard       HHS                     Tech Council MD
Diagnostics                 • T2 Bridge
                                                Frederick Innovative    Frederick
Consumer products          Maryland TEDCO       Technology Center       Entrepreneur
Military products                                                       Council
                           University of        Ft. Detrick Business
SBIR/STTR                  Maryland InvenioIP      Development Office   Bio

Investors                                       UK Research Labs        Gates Foundation+
                                                                         • Path Foundation
Contract Research                                                        • MMV
Organizations                                                            • MVI

Contract Manufacturers



                                                4                                       Barry Datlof
                                                                                       26 April 2011
Technology Transfer Instruments

• Patent License Agreements (PLAs)
• Cooperative Research and Development
  Agreements (CRADAs)

•   Material transfer agreements
•   Clinical trial agreements
•   Test and evaluation agreements
•   Technical assistant agreements
•   Educational partnerships
•   Partnership Intermediaries
•   Grants, contracts and cooperative agreements

                                                    Barry Datlof
                                                   26 April 2011
Licensing Moves A Variety of Products Toward Commercialization
                                       Therapeutics 13%
                                                       Antimicrobial
                                             Antivrial Peptides
                                             Small               Nerve
                                             Molecules           Gas
                                                                 Poisoning
                           Dengue
                                              Tafenoquine                                        Flavivirus
     Vaccines                                                   Hepatitis C                         Malaria
                        Chikungunya
                                                                                                                        Diagnostics
       18%
                                                                                        Botulinum
                                                           Broad
                 IXIARO
                 (Japanese
                                      Shigella             Spectrum
                                                           Antibacterial
                                                                                        Nerve
                                                                                                     Anthrax               23%
                                                                                        Agents
                 Encephalitis)
                                    Rift Valley                                                                Nerve
                                                               Clot                           Vaccinia
                                    Fever                                                                      Agent
             Immunogenic                                       Lysis
                                                                             PCR                               Sensor
             Peptide                       SEA/SEB                                        Dengue
                         Alphavirus                                          Internal
             Vaccine
                         Replicon                                            Positive
                                                 Malaria
                                                                             Control                   Leishmania
                                                                                          Meningitis
             Fish              Water                 Mosquito
             Hatching          Biomonitor            Breeding                                                  Liver
                                                                           BMIST
                                                                                                               Cells
                            Actigraph       Tissue                         Mobile Medical
                SMEED
                                            Adhesive
                                                                                          Cognitive
                          Fibrin Sealant                                        SAFTE
                                      Transdermal                                         Performance
                                                                                Sleep
                 AeroMP               Delivery
                                                                                Performance Raman
                               FEBSS             RBC
                                                                                            Spectra
                    Hemostasis                   Storage
                                                                                            Database
                    FVIIa+Fib        Critical
                                     Care      Inhalation
                                                                                                                       Medical IT
                           Bednet                                                         ANAM
                                     Litter    Tox Exposure
         Devices
                                                                                          Traumatic
                                                                                          Brain
                                                                                                                         10%
          36%
                                        Treadmill      Leukosep            Personal       Injury
                                                                           Water
                                                    Detox Sponges          Additive




                                                                       6                                                       Barry Datlof
                                                                                                                              26 April 2011
MRMC Licensed Products Are Sold Worldwide
  1.    Taqman Internal Positive Control for Polymerase Chain Reaction (PCR) assay (USAMRIID, Cepheid)

  2.    SMEED™ – Special Medical Emergency Evacuation Device (USAISR, Impact Instrumentation)

  3.    Nerve Agent Sensor (WRAIR, Agentase)

  4.    AeroMP – Aerosol Control System (USAMRIID, Biaera Technologies)

  5.    IAC 1090 – Intelligent Aquatic BioMonitoring System® (USACEHR, Intelligent Automation Corporation)

  6.    Force Sensing Treadmill (USARIEM, Advanced Mechanical Technology)

  7.    ANAM® – Automated Neuropsychological Assessment Metrics (MRMC, University of Oklahoma)

  8.    FEBSS – Field Expedient Bleeding Simulation System (EACH, Skedco)

  9.    Dengue Virus Monoclonal Antibodies (WRAIR, Chemicon/Millipore)

  10.   Antibodies against Type A Botulinum Neurotoxin (USAMRIID, Toxin Technology)

  11.   Bednet – Single Person Portable Bednet for Insect Protection (WRAIR, Iguana and MMI)

  12.   BMIST/AHLTA Mobile – Mobile Medical Record System (TATRC, Vista Partners)

  13.   SAFTE ® – Sleep Model Determines Individual Readiness Levels (MRMC, Fatigue Sciences)

  14.   IXIARO® – Japanese Encephalitis Vaccine (WRAIR, Intercell)

  15.   Diazepam AutoInjector (USAMMDA, Meridian Medical Technologies)

  16. Vaccine reagents and screening system (USAMRIID, Integrated BioTherapeutics)

  17. Biosurety Program Management Software (USAMRIID, Foxspire)

  18. MOES™ – Mobile Obstetrics Emergencies Simulator (CIRO, Gaumard Scientific)

  19. Hepatitis C treatment (FAMC, SciClone)

                                                                  7                                           Barry Datlof
                                                                                                             26 April 2011
  FastCast™ Available for Licensing
                                            Spray foam immobilization cast
                                            for emergency use in the field




- One step: sprayed directly onto skin
- Cures in 30-40 seconds
- Waterproof
- Contours perfectly without pressure point
- Replaces multiple pieces of medical equipment
                                                                        Barry Datlof
                                                                       26 April 2011
              Monitoring Combat Readiness
                            Developed by US Army and Fatigue Sciences
                                        Personnel wear                Wrist movements are
                                      the sleep band that              recorded 24/7 and
Individual fatigue risk levels
                                  measures wrist movements            downloaded over the
  are amalgamated into a
        Group report                                                         internet




 SAFTE evaluates the fatigue                                      Downloaded data are converted
risk and effectiveness of each                                      to daily sleep/wake/work
                                  Daily sleep/wake/work times
       individual person                                                       times
                                  are fed into the SAFTE risk
                                        evaluation model




                                                                                       Barry Datlof
                                                                                      26 April 2011
 Barry Datlof
26 April 2011
                         Solution: AlertCap™ Continuously Monitors EEG Brain Waves and
                          Immediately Sounds An Alarm Before You Lose More Alertness




                                                                                                                                                 Patent Status:
                                                                                                                                                 Application Pending
                                                                                                                                                 USSN 339,864
            High and Low Frequency EEG Bands
                                         Awake                                                                      Neutral                                                                        Drowsy                                                                                 Asleep
                  0.50                                                                                                                                                                                                                                    0.90
                                                                                                                                                                                                                                                                     LFB 1-15 Hz
                  0.45                                                                                                                                                                                                                                               HFB 201-500 Hz
                                                                                                                                                                                                                                                          0.80
                  0.40
                                                                                                                                                                                                                                                          0.70
                  0.35
Relative Energy




                  0.30
                             High frequency                                                                                                                                                                                                               0.60

                                                                                                                                                                                                                                                          0.50
                  0.25
                                                                                                                                                                                                                                                          0.40
                  0.20
                                                                                                                                                                                                                                                          0.30
                  0.15

                  0.10                                                                                                                                                                                                                                    0.20


                  0.05
                                     Low frequency                                                                                                                                                                                                        0.10

                  0.00                                                                                                                                                                                                                                    0.00
                         0   1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16                                                                                                                                                                0    1    2   3      4   5   6   7   8   9   10   11   12   13   14   15   16
                                                                                                    0   1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   0   1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16
                                                 Elapsed Time (sec)                                                         Elapsed Time (sec)                                                                                                                                                Elapsed Time (sec)
                                                                                                                                                                                                       Elapsed Time (sec)

                                                                                                                                                                                                                                                                     Slower
                                                                                                        AlertCap™                                                                  Head Nodding
                                                                                                                                                                                                                                                                     Reactive
                                                                                                           Buzz                                                                Eyelid Closing                                                                        Costlier & more complicated

                                                                                                                                                                                                                                                                                                               Barry Datlof
                                                                                                                                                                                                                                                                                                              26 April 2011
                                       USAMRMC
 Office of Research and Technology Applications




Paul Mele, Ph.D.   Barry Datlof, MBA    Sara Baragona, MBA   Blake Sajonia, JD    Jennifer Rebelez   Amanda Sipple
    Director          Licensing             Technology          Technology            Technology        Intern
                        Officer              Transfer            Transfer              Transfer
                                             Associate          Consultant             Assistant




                                       https://technologytransfer.detrick.army.mil/

                                                     301-619-6664



                                                                                                          Barry Datlof
                                                                                                         26 April 2011

								
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