Medical Technology Transfer Product Development and Commercialization Thru

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 Industry Startups & Established Companies Biotech Pharmaceuticals Medical devices Diagnostics Consumer products Military products SBIR/STTR Investors Partnership Intermediaries DOD PIAs • Techlink • Miltech • Techmatch • Firstlink • Springboard • T 2 Bridge Government Federal Laboratory Consortium Not for Profits OSD Tech Transfer • AUTM • LES • T 2 Society HHS Tech Council MD Maryland TEDCO Frederick Innovative Technology Center Frederick Entrepreneur Council University of Maryland Invenio. IP Ft. Detrick Business Development Office UK Research Labs Contract Research Organizations Bio Gates Foundation+ • Path Foundation • MMV • 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 Gas Molecules Poisoning Tafenoquine Dengue Vaccines 18% Hepatitis C Chikungunya IXIARO (Japanese Encephalitis) SMEED Rift Valley Fever Clot Lysis SEA/SEB Malaria Water Biomonitor Actigraph Nerve Agents Anthrax Vaccinia PCR Internal Positive Control Dengue Nerve Agent Sensor Leishmania BMIST Mobile Medical Tissue Adhesive Transdermal Aero. MP Delivery FEBSS RBC Hemostasis Storage FVIIa+Fib Critical Care Inhalation Bednet Tox Exposure Litter Treadmill Diagnostics 23% Meningitis Mosquito Breeding Fibrin Sealant Devices 36% Malaria Botulinum Broad Spectrum Antibacterial Shigella Immunogenic Peptide Alphavirus Vaccine Replicon Fish Hatching Flavivirus Leukosep Detox Sponges 6 Liver Cells Cognitive SAFTE Performance Sleep Performance Raman Spectra Database Personal Water Additive ANAM Traumatic Brain Injury Medical IT 10% 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. Aero. MP – Aerosol Control System (USAMRIID, Biaera Technologies) 5. IAC 1090 – Intelligent Aquatic Bio. Monitoring 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 Auto. Injector (USAMMDA, Meridian Medical Technologies) 16. Vaccine reagents and screening system (USAMRIID, Integrated Bio. Therapeutics) 17. Biosurety Program Management Software (USAMRIID, Foxspire) 18. MOES™ – Mobile Obstetrics Emergencies Simulator (CIRO, Gaumard Scientific) 19. Hepatitis C treatment (FAMC, Sci. Clone) 7 Barry Datlof 26 April 2011

Fast. Cast™ 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 Individual fatigue risk levels are amalgamated into a Group report SAFTE evaluates the fatigue risk and effectiveness of each individual person Personnel wear the sleep band that measures wrist movements Daily sleep/wake/work times are fed into the SAFTE risk evaluation model Wrist movements are recorded 24/7 and downloaded over the internet Downloaded data are converted to daily sleep/wake/work times Barry Datlof 26 April 2011

Barry Datlof 26 April 2011

Solution: Alert. Cap™ 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 0. 50 Neutral Drowsy Asleep 0. 90 0. 45 0. 40 Relative Energy LFB 1 -15 Hz HFB 201 -500 Hz 0. 80 0. 70 0. 35 High frequency 0. 30 0. 60 0. 50 0. 25 0. 40 0. 20 0. 30 0. 15 0. 10 0. 20 Low frequency 0. 05 0. 10 0. 00 0 1 2 3 4 5 6 7 8 9 10 Elapsed Time (sec) 11 12 13 14 15 16 0 1 2 3 4 5 6 7 8 9 10 Elapsed Time (sec) Alert. Cap™ Buzz 11 12 13 14 15 16 0 1 2 3 4 5 6 7 8 9 10 11 Elapsed Time (sec) Head Nodding Eyelid Closing 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) Slower Reactive Costlier & more complicated Barry Datlof 26 April 2011

USAMRMC Office of Research and Technology Applications Paul Mele, Ph. D. Director Barry Datlof, MBA Licensing Officer Sara Baragona, MBA Technology Transfer Associate Blake Sajonia, JD Technology Transfer Consultant Jennifer Rebelez Technology Transfer Assistant Amanda Sipple Intern https: //technologytransfer. detrick. army. mil/ 301 -619 -6664 Barry Datlof 26 April 2011