U.S.%20Army%20Medical%20Research%20and%20Materiel%20Command%20%20Medical%20Chemical%20Biological%20Defense%20Research%20Capabilities

1
U.S. Army Medical Research and Materiel Command
Medical Chemical Biological Defense Research
Capabilities

• Dr. John F. Glenn
• Technical Director, USAMRMC

2
Outline

• Organizational Overview
• Laboratory Capabilities
• Working with USAMRMC
• Points of Contact

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
Infectious Diseases (USAMRIID) Frederick, MD
U.S. Army Medical Research Institute of Chemical
Defense (USAMRICD) Edgewood, MD
Walter Reed Army Institute of Research
(WRAIR) Silver Spring, MD
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
5
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

• 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

• 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

• 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.
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

7
U.S. Army Medical Research Institute of
Infectious Diseases (USAMRIID)

• Unique Expertise
• 34 years of experience safely handling the
  worlds deadliest pathogens in biocontainment
• Most of the Nations experts in infectious
  aerosols work at USAMRIID
• Most of the Nations 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
8
USAMRIIDKey Role in Interagency Research and
Development
Development
Research
Product Testing

• NIAID

• Universities

Vaccines
Pharma Industry

• Industry

Efficacy Testing
Drugs

• DHS

• DOE

• USAMRIIDs 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

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

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
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

12
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

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
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

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

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

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

18
Points of Contact

• USAMRMC Strategic Partnership Office
• COL Nancy Vause
• Phone [phone]
• E-mail nancy.vause_at_amedd.army.mil
• Ft. Detrick Business Development Office
• (Web Site www.fdbdo.com)
• Mr. Darryl Rekemeyer
• Phone [phone]
• E-mail darryl.rekemeyer_at_fdbdo.com
• Mr. John Gregg
• Phone [phone]
• E-mail John.Gregg_at_fdbdo.com
•  

19
Points of Contact (cont.)

• Office of Research and Technology Applications
• HQ USAMRMC
• Dr. Paul Mele
• Phone [phone]
• E-mail paul.mele_at_us.army.mil
• Ms. Sara Baragona
• Phone [phone]
• E-mail sara.baragona_at_us.army.mil
• USAMRICD
• Mr. John Blische
• Phone [phone]
• E-mail johnny.blische_at_us.army.mil
•  

USAMRIID Dr. Dan Coffman Phone (301)
619-6886 E-mail james.coffman_at_amedd.army.mil WR
AIR Dr. Claudia Golenda Phone (301)
319-9736 E-mail claudia.golenda_at_us.army.mil  
20
BACKUP SLIDES
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
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