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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: nancy.vause@amedd.army.mil Ft. Detrick Business Development Office (Web Site: www.fdbdo.com)

Mr. Darryl Rekemeyer Phone: 301-620-7071E-mail: darryl.rekemeyer@fdbdo.com

Mr. John GreggPhone: (301) 620-7071 E-mail: John.Gregg@fdbdo.com 

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Points of Contact (cont.)

Office of Research and Technology Applications

HQ USAMRMCDr. Paul Mele Phone: (301) 619-6975E-mail: paul.mele@us.army.mil

Ms. Sara BaragonaPhone: (301) 619-6975E-mail: sara.baragona@us.army.mil

USAMRICDMr. John BlischePhone: (410) 436-3628E-mail: johnny.blische@us.army.mil 

USAMRIIDDr. Dan Coffman Phone: (301) 619-6886E-mail: james.coffman@amedd.army.mil

WRAIRDr. Claudia Golenda Phone: (301) 319-9736E-mail: claudia.golenda@us.army.mil

 

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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