1 u.s. army medical research and materiel command medical chemical biological defense research...
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U.S. Army Medical Research and Materiel Command
Medical Chemical Biological Defense Research Capabilities
Dr. John F. Glenn Technical Director, USAMRMC
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Outline
Organizational Overview Laboratory Capabilities Working with USAMRMC Points of Contact
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HQ USAMRMCFrederick, MDHQ USAMRMCFrederick, MD
OrganizationUSAMRMC and the Chemical Biological Defense Program
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
Frederick, MD
U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
Frederick, MD
U.S. Army Medical Research Institute of Chemical Defense
(USAMRICD)Edgewood, MD
U.S. Army Medical Research Institute of Chemical Defense
(USAMRICD)Edgewood, MD
Walter Reed Army Institute of Research
(WRAIR)Silver Spring, MD
Walter Reed Army Institute of Research
(WRAIR)Silver Spring, MD
Defense Threat Reduction Agency – CB Directorate
[Joint Science & Technology Office]
Defense Threat Reduction Agency – CB Directorate
[Joint Science & Technology Office]
Program Management
Execution
Joint Program Executive Office -
Chemical Biological Defense
Joint Program Executive Office -
Chemical Biological Defense
Assistant to the Secretary of Defense(Nuclear and Chemical and Biological
Defense Programs)
Assistant to the Secretary of Defense(Nuclear and Chemical and Biological
Defense Programs)Oversight & Coordination
Defense Acquisition Executive
Defense Acquisition Executive
Army Acquisition Executive
Army Acquisition Executive
Dep Asst to SecDef(Chemical Biological Defense)
Dep Asst to SecDef(Chemical Biological Defense)
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MedicalResearch,
Development and
Acquisition(RDA)
MedicalLogistics
MedicalIM/IT
MedicalFacilities
Support the Warfighter on Point for the Nation
CG, USAMRMCCG, MEDCOM
Cradle-to-Grave Medical Materiel Acquisition
USAMRMC Functions
Transforming Army Medicine
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TRL 1-3 TRL 4 TRL 5 TRL 6 TRL 7 TRL 8 TRL 9
USAMRMC Chem-Bio Focus: Medical Product Lifecycle
• 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
• Generate/test hypotheses and experimental designs
• Synthesize candidate countermeasures
• Identify sites and mechanisms of action
• Device components and design identified
• Initial proof of concept
• 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
Science and Technology
System Development and Production
Technology Readiness AssessmentTechnology Readiness Assessment
• 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
Novel Concepts and EmergingTechnologies
Prototype Maturation and DemonstrationProduction and
Distribution
*TRLs-Technology Readiness Levels.
Applied Research Translate Research to Solutions for Military Problems
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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
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U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
Facilities Aerobiology labs Biosafety Level (BSL)-4 labs The “Slammer” – The only BSL-4 patient care suite in the Nation
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
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
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USAMRIIDKey Role in Interagency Research and Development
Drugs
Vaccines
Development
Industry
Universities
PharmaIndustry
NIAID
Research
DOE
DHS
Product Testing
DoD 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
EfficacyTesting
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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
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National Interagency Biodefense Campus at Fort Detrick
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
Scientific Expertise, Security & Synergy
Existing USAMRIID
USAMRIIDPlanned Expansion
NIAID Integrated Research Facility
DHSNBACC
Existing USDA
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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
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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
Cl-N
NOH
CH3
+
Improved Oxime
CH
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COLLABORATIVE RESEARCH PROGRAMResources
COLLABORATIVE RESEARCH FACILITY(CRF, Bldg 3156)
ICD RESOURCES(on a case-by-case basis)
Small animals
Select large animals
Blood sample collection (in vivo)
Visiting PI lab available
RBC AChE analysis
Dilute agent
Non-human primates
Neat agent
Core research technologies
USAMRICD Collaborative Research Facility Resources
Allows principal investigators external to USAMRICD to conduct research related to XCSM exposure, facilitating successful external collaborative efforts
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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
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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
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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
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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
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Points of Contact
USAMRMC Strategic Partnership Office
COL Nancy VausePhone: (301) 619-3451E-mail: [email protected] Ft. Detrick Business Development Office (Web Site: www.fdbdo.com)
Mr. Darryl Rekemeyer Phone: 301-620-7071E-mail: [email protected]
Mr. John GreggPhone: (301) 620-7071 E-mail: [email protected]
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Points of Contact (cont.)
Office of Research and Technology Applications
HQ USAMRMCDr. Paul Mele Phone: (301) 619-6975E-mail: [email protected]
Ms. Sara BaragonaPhone: (301) 619-6975E-mail: [email protected]
USAMRICDMr. John BlischePhone: (410) 436-3628E-mail: [email protected]
USAMRIIDDr. Dan Coffman Phone: (301) 619-6886E-mail: [email protected]
WRAIRDr. Claudia Golenda Phone: (301) 319-9736E-mail: [email protected]
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BACKUP SLIDES
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HQ Army Medical Command (MEDCOM)Army Surgeon General
HQ Army Medical Command (MEDCOM)Army Surgeon General
OrganizationUSAMRMC is part of the Military Health Service System
Army Medical
Department Center & School
Army Medical
Department Center & School
Army Center for Health
Promotion & Preventive Medicine
Army Center for Health
Promotion & Preventive Medicine
Army Dental Command
Army Dental Command
Army Veterinary Command
Army Veterinary Command
Army Medical
Research & Materiel
Command
Army Medical
Research & Materiel
Command
Global Health Care
Delivery
Education& Training
Medical Surveillance, Readiness & Operational
Support
Research, Development, Acquisition &
Logistics
Army Regional Medical
Commands• Europe• Great Plains• North Atlantic• Pacific• Southeast• Western
Army Regional Medical
Commands• Europe• Great Plains• North Atlantic• Pacific• Southeast• Western
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Scientific & Feasibility Review Cost Estimate Generated
Decision Point
Agreement Completed/Funds Transferred
Conduct Collaborative Studies
External PI Expresses Interest
PI Submits Proposal
USAMRICD Collaborative Research Facility Access