U.S. Army Medical Research and Materiel Command Medical Chemical Biological Defense Research Capabilities

1. U.S. Army Medical Research and Materiel CommandMedical Chemical Biological Defense Research Capabilities Dr. John F. Glenn Technical Director, USAMRMC

2. Outline • Organizational Overview • Laboratory Capabilities • Working with USAMRMC • Points of Contact 0403051F.ppt

3. OrganizationUSAMRMC and the Chemical Biological Defense Program Assistant to the Secretary of Defense (Nuclear and Chemical and Biological Defense Programs) Defense Acquisition Executive Oversight & Coordination Army Acquisition Executive Dep Asst to SecDef (Chemical Biological Defense) Defense Threat Reduction Agency – CB Directorate [Joint Science & Technology Office] Joint Program Executive Office - Chemical Biological Defense Program Management HQ USAMRMC Frederick, MD Execution U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) Edgewood, MD U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Frederick, MD Walter Reed Army Institute of Research (WRAIR) Silver Spring, MD 0403051F.ppt

4. USAMRMC Functions CG, MEDCOM CG, USAMRMC Support the Warfighter on Point for the Nation Medical Research, Development and Acquisition (RDA) Medical Logistics Medical IM/IT Medical Facilities Cradle-to-Grave Medical Materiel Acquisition Transforming Army Medicine 0403051F.ppt

5. Science and Technology USAMRMC Chem-Bio Focus: Medical Product Lifecycle Technology Readiness Assessment Novel Concepts and Emerging Technologies Prototype Maturation and Demonstration Production and Distribution Applied Research Translate Research to Solutions for Military Problems System Development and Production • cGMP pilot lot production • GLP safety and efficacy studies • Endpoints of clinical or surrogate efficacy • Stability studies initiated • Pre-IDE meeting and IDE prepared and submitted for Class III device • 510(k) – preliminary data suggest substantial equivalency to predicate device • Pre-IND meeting • IND prepared and submitted • Phase 1 clinical trials • Investigation of Class III device in clinical trials • Safety demonstrated • Production technology demonstrated • 510(k) - data demonstrate substantial equivalency to predicate device • Phase 2 clinical trials • Investigation of • Class III prototype in clinical trials • Safety and evidence of efficacy demonstrated • Final dose, dose range, and schedule established • Pre-Phase 3 meeting • Phase 3 clinical study plan or surrogate test plan approved • Class III device design validated and final prototypes produced • 510(k) – final prototype produced and tested • Phase 3 clinical trials • Investigation of final Class III prototype in clinical trials • Safety and efficacy demonstrated • Process validation completed • Facility PAI completed • Pre-NDA/BLA/PMA meeting • NDA/BLA/PMA/510(k) prepared, submitted, and approved • Marketing and distribution • Postmarketing studies • Postmarketing surveillance • Technological assessment requirements identified • Non-GLP formulation, dose, and pharmacokinetic studies • Non-GLP safety and efficacy studies • Assays/procedures for GLP/GCP studies identified • Device design history file/review initiated • Generate/test hypotheses and experimental designs • Synthesize candidate countermeasures • Identify sites and mechanisms of action • Device components and design identified • Initial proof of concept TRL 1-3 TRL 4 TRL 5 TRL 6 TRL 7 TRL 8 TRL 9 *TRLs-Technology Readiness Levels. 0403051F.ppt

6. USAMRMC Partners • National Institute of Allergy and Infectious Diseases (NIAID) • Cooperate on biodefense research and development • Evaluate NIAID-developed products • Department of Homeland Security • Management assistance to National Biosecurity Analysis and Countermeasures Center (NBACC) • Defense Advanced Research Projects Agency • Transition technologies from Unconventional Pathogen Countermeasures and Tissue-Based Biosensors program • Cooperate with DARPA Defense Sciences Office as agent for execution of militarily relevant research • Department of Agriculture • Support for analysis of agriculture threats and emerging animal and crop diseases • Federal Bureau of Investigation • Support to Hazardous Materials Response Unit for analysis of suspected biological materials • Pentagon Force Protection Agency (PFPA) Laboratory • Analysis of suspected biological threat materials 0403051F.ppt

7. U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Unique Expertise • 34 years of experience safely handling the world’s deadliest pathogens in biocontainment • Most of the Nation’s experts in infectious aerosols work at USAMRIID • Most of the Nation’s subject matter experts on biological threats Facilities • Aerobiology labs • Biosafety Level (BSL)-4 labs • The “Slammer” – The only BSL-4 patient care suite in the Nation Capabilities • Large-scale testing and evaluation of medical product evaluation in animal models • Aerobiology • Animal Models and Pathogenesis • Outbreak investigation/support • Definitive I.D. of new threats/bioforensic analysis Part of a national system of medical countermeasure development 0403051F.ppt

8. USAMRIIDKey Role in Interagency Research and Development Research Product Testing Development • NIAID • Universities Vaccines Pharma Industry • Industry Efficacy Testing Drugs • DHS • DOE • USAMRIID’s Unique Strengths • Large-scale medical product testing capability • High-containment labs and animal facilities • Aerosol challenge for large studies • FDA-regulated safety and efficacy • DoD 0403051F.ppt

9. USAMRIID Activities Recent/Pending Transitions • Recombinant staphylococcal enterotoxin A and B (SEA/SEB) vaccine candidates • Vaccine candidate V3526 (multivalent VEE vaccine candidate) • Recombinant protective antigen (rPA) anthrax vaccine candidate • Immunologically and nucleic-acid-based medical diagnostics (reagents, protocols and devices) for JBAIDS Current Efforts • Recombinant ricin vaccine candidate • Alternative vaccine delivery methods for application with rPA, SEB, and F1-V plague vaccine candidates • Oral form of cidofovir for smallpox pre-/post-exposure treatment Partnering • 126 active CRADAs • 377 active Material Transfer Agreements 0403051F.ppt

10. National Interagency Biodefense Campus at Fort Detrick USAMRIID Planned Expansion Existing USDA DHS NBACC Joint and Interagency NIBC Partners • DoD, USAMRIID • DHHS, National Institute of Allergy and Infectious Diseases – Integrated Research Facility • DHHS, Centers for Disease Control and Prevention • USDA, Agricultural Research Service • DHS, National Biological Assessment Countermeasures Centers (NBACC) Research Confederation Members • DHHS, National Cancer Institute • DoD, Armed Forces Medical Intelligence Center Planned New Construction • NIAID • NBACC • USAMRIID Replacement and Test & Evaluation Facility Existing USAMRIID NIAID Integrated Research Facility Scientific Expertise, Security & Synergy 0403051F.ppt

11. U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) Unique Expertise • Neurotoxicology • Skin protection and decontamination • Medical management of chemical casualties Facilities • Chemical surety facility • Neurophore electrocorticographic recording system • Nerve/muscle physiology testing facilities • Molecular modeling and genomic analysis systems Capabilities • Drug discovery and preclinical development • Nerve agent pretreatments and therapies • Vesicating agent therapies • Non-traditional chemical threats • Biological neurotoxins • Biomedical sample analysis for CW agent exposure 0403051F.ppt

12. CH NOH + N Cl- CH 3 Improved Oxime USAMRICD Activities Recent Transitions • Plasma-derived nerve agent bioscavenger • Oxime Replacement for 2-PAM Current Efforts • Recombinant nerve agent bioscavenger • Vesicant countermeasure candidates • Chemical scavengers • Anti-inflammatories 0403051F.ppt

13. USAMRICD Collaborative Research Facility Resources Allows principal investigators external to USAMRICD to conduct research related to XCSM exposure, facilitating successful external collaborative efforts COLLABORATIVE RESEARCH PROGRAM Resources COLLABORATIVE RESEARCH FACILITY (CRF, Bldg 3156) ICD RESOURCES (on a case-by-case basis) Neat agent Dilute agent Small animals Non-human primates Select large animals Core research technologies Blood sample collection (in vivo) RBC AChE analysis Visiting PI lab available 0403051F.ppt

14. Walter Reed Army Institute of Research (WRAIR) Expertise • Vaccine and drug discovery and development • Molecular biology of bacterial, viral, and parasitic pathogens • Neuroscience Facilities • Vaccine Pilot-Scale Production Facility • Current Good Manufacturing Practice/Good Laboratory Practice-compliant operations • Viral, bacterial, and recombinant vaccines • De Novo Microarray Laboratory • Production of custom cDNA print microarrays for analysis of gene expression and translation Capabilities • CW drug discovery and preclinical development • Vaccine scale-up 0403051F.ppt

15. WRAIR Activities Recent Transitions • Plasma-derived nerve agent bioscavenger Current Efforts • Host gene expression responses to biothreat agents • Botulinum neurotoxin therapeutics • Prophylactic skin patch vaccine for ricin • Recombinant nerve agent bioscavenger Partners Needed • Skin/wound decontamination 0403051F.ppt

16. Working with USAMRMC Partnership Mechanisms • Cooperative Research and Development Agreements • Material Transfer Agreements • Patent License Agreements • Clinical Trial Agreements • Test and Evaluation Agreements • Technical Assistance Agreements • Partnership Intermediaries 0403051F.ppt

17. Working with USAMRMC (cont.) Strategic Partnership Office (HQ USAMRMC) • Facilitates USAMRMC interactions with industry, academia, and other DoD and Federal agencies • Assistance in establishing formal programmatic collaborations Fort Detrick Business Development Office • Information on procurement opportunities and resources (Broad Agency Announcements, SBIR, etc.) • Support for access to emerging technologies • Assistance in developing opportunities for business, business collaboration, and small business subcontracting prospects Office of Research and Technology Applications (ORTA) • ORTAs exist at HQ USAMRMC and each laboratory • Development of CRADAs, Patent License agreements 0403051F.ppt

18. Points of Contact USAMRMC Strategic Partnership Office COL Nancy Vause Phone: (301) 619-3451 E-mail: nancy.vause@amedd.army.mil Ft. Detrick Business Development Office (Web Site: www.fdbdo.com) Mr. Darryl Rekemeyer Phone: 301-620-7071 E-mail: darryl.rekemeyer@fdbdo.com Mr. John Gregg Phone: (301) 620-7071 E-mail: John.Gregg@fdbdo.com 0403051F.ppt

19. Points of Contact (cont.) Office of Research and Technology Applications HQ USAMRMC Dr. Paul Mele Phone: (301) 619-6975 E-mail: paul.mele@us.army.mil Ms. Sara Baragona Phone: (301) 619-6975 E-mail: sara.baragona@us.army.mil USAMRICD Mr. John Blische Phone: (410) 436-3628 E-mail: johnny.blische@us.army.mil USAMRIID Dr. Dan Coffman Phone: (301) 619-6886 E-mail: james.coffman@amedd.army.mil WRAIR Dr. Claudia Golenda Phone: (301) 319-9736 E-mail: claudia.golenda@us.army.mil 0403051F.ppt

20. BACKUP SLIDES 0403051F.ppt

21. OrganizationUSAMRMC is part of the Military Health Service System HQ Army Medical Command (MEDCOM) Army Surgeon General Army Medical Department Center & School • Army Regional • Medical Commands • Europe • Great Plains • North Atlantic • Pacific • Southeast • Western Army Center for Health Promotion & Preventive Medicine Army Medical Research & Materiel Command Army Dental Command Army Veterinary Command Medical Surveillance, Readiness & Operational Support Research, Development, Acquisition & Logistics Global Health Care Delivery Education & Training 0403051F.ppt

22. USAMRICD Collaborative Research Facility Access External PI Expresses Interest PI Submits Proposal Scientific & Feasibility Review Cost Estimate Generated Decision Point Agreement Completed/Funds Transferred Conduct Collaborative Studies 0403051F.ppt