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Armed Forces Epidemiological Board. 20 May 2003 Medical Chemical Biological Defense Research Program U.S. Army Medical Research and Materiel Command. LTC John P. Skvorak Director Medical Biological Defense Research Program U.S. Army Medical Research and Materiel Command Phone: 301-619-7889

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armed forces epidemiological board
Armed Forces Epidemiological Board

20 May 2003

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

LTC John P. Skvorak

Director Medical Biological Defense Research Program

U.S. Army Medical Research and Materiel Command

Phone: 301-619-7889

organizational management execution
Organizational Management & Execution
  • On 22 April 2003, USD(AT&L) approved the implementation plan for management of the DoD Chemical & Biological Defense Program (CBDP)
    • Management and integration of CB Defense Science & Technology (S&T) efforts assigned to the Defense Threat Reduction Agency (DTRA)
    • Establishment of a Joint Program Executive Office (JPEO) for the CBDP that reports through the Army Acquisition Executive (AAE) to the Defense Acquisition Executive (DAE)
protecting warfighters through integration and teamwork


  • Agent
  • Delivery System
  • Organization
  • Time

Medical Countermeasures

  • Vaccines & Prophylaxes
  • Diagnostics
  • Therapeutics

Chem/Bio Defense Doctrine

Education & Training

  • Military and Civilian Health Care Providers
  • Electronic Communication
  • Distance Learning

Physical Countermeasures

  • Detection
  • Physical Protection
  • Decontamination
Protecting Warfighters Through Integration and Teamwork
medical chemical and biological defense research program mission vision
Provide medical solutions for military requirements to protect and sustain the force in a Chemical and/or Biological Warfare environment

To Preserve Total Warfighter Effectiveness on a CW/BW Battlefield

Prevent casualties

Provide effective treatment of casualties for rapid return to duty

Provide rapid, far-forward diagnosis of CW/BW disease

Medical Chemical and Biological Defense Research Program Mission & Vision
intelligence requirements process

TEP, STARs, Regional , Proliferation, Technology, and other Assessments

RDA and Modernization Plans, Budget

Intelligence Requirements Process


  • Prepared in discrete, tailored packages
  • Evaluate impact on users
  • Define mission needs


  • Joint Requirements Office for Chemical, Biological, Radiological and Nuclear Defense (JRO-CBRN)
  • Joint Requirements Oversight Council (JROC)


  • Joint Service Materiel Group (JSMG)
  • Defense Threat Reduction Agency (DTRA)/Joint Program Executive Office (JPEO)
  • OSD coordinates/integrates funding requests

ICDs/CDDs/CPDs, CPR, Integrated Priority Lists

All programs driven by validated threats and defined mission needs


Medical Biological Defense

Business Area Taxonomy

Medical Biological Defense

Countermeasures (CMs)





DTO CB.47 (ImmunoDx)

DTO CB.31 (Brucella)

Diagnostic Technologies


DTO CB.32 (Alt. Delivery)

DTO CB.46 (Ricin)

DTO CB.34 (Plague)

DTO CB.54 (Pox Tx)

DARPA Transition









Genetically Engineered Threats Medical CMs



mcbdrp locations


Fort Detrick, MD

Washington, D.C.

MCBDRP Locations
  • Fort Detrick, MD
    • MCBDRP
    • U.S. Army Medical Research Institute of Infectious Diseases
  • Forest Glen Annex, MD
    • Walter Reed Army Institute of Research
    • Naval Medical Research Center
  • Washington D.C.
    • Armed Forces Institute of Pathology
  • Aberdeen Proving Ground, MD
    • U.S. Army Medical Research Institute of Chemical Defense
  • Natick, MA
    • U.S. Army Medical Research Institute of Environmental Medicine
integration of dod acquisition and fda licensure

Research Labs/CBMS Cooperative Management

Research Laboratories






Milestone A

Milestone B


Follow-on Production IPR

Component Advanced Development IPR

Basic Research

Applied Research

Production & Deployment

Sustainment & Disposal

Concept & Technology Development

System Development & Demonstration






Consolidated PDT

Proof of Concept

Baseline Product


Characterize ThreatAgent

Identify Vaccine Antigens


Evaluate Vaccine Technical Approaches


Define Manufacturing Process

Phase 1 Clinical Trials

FDA Licensure

Pre-IND Activities

IND Application to FDA

ManufactureConsistency Lots

Produce, Store andMaintainVaccineStockpile


Formulate Multivalent Vaccine (if required)

Phase 2a


Design Surrogate End-point of Clinical Efficacy

Phase 2b ClinicalTrials

Validate Assays

Qualify Assays


Manufacture cGMP Pilot Lots

Test in Animal Models

Prepare andSubmit BLA

Perform Non-clinical Tests

Characterize Candidates

Manufacture Small-Scale Pilot Lots

Integration of DoD Acquisition and FDA Licensure
medical biological defense potential threats

Bacillus anthracis (Anthrax)

Yersinia pestis (Plague)

Francisella Tularensis (Tularemia)

Brucella sp. (Brucellosis)

Burkholderia maellei (Glanders)

Coxiella burnetii (Q Fever)



Encephalomyelitis viruses




Botulinum Toxins (Types A – G)

Staphylococcal Enterotoxins (SEA/B)

Ricin Toxin

Marine Neurotoxins


Clostridium perfringens

Medical Biological Defense Potential Threats


Task Areas

Objective:Explore the development of candidate prophylactic and therapeutic medical countermeasures (i.e., vaccines, antibiotics and biologics) against validated BW threat agents, using laboratory and appropriate animal models, and to demonstrate their capability for reducing mortality or incapacitation in animal models exposed to predicted or presumed battlefield doses of aerosolized bacterial BW agents.

JFOC(s) addressed:Medical Prophylaxis (OC) – Individual Protection (PC)

Medical Treatment (OC) – Restoration (PC)

*Note: DTO CB.33 Recombinant Protective Antigen (rPA) Anthrax Vaccine Candidate completed in FY02

cb 33 recombinant protective antigen rpa anthrax vaccine candidate dto completed in fy02
CB.33 Recombinant Protective Antigen (rPA) Anthrax Vaccine Candidate(DTO completed in FY02)
  • Requirement for transition of rPA vaccine candidate out of the tech base and into Technology Development pre-acquisition phase have been met
  • National Institute of Allergy and Infectious Diseases (NIAID) selected USAMRIID rPA candidate for Phase 1 clinical trials
    • IND submitted in 2QFY03 in support of Phase I and II clinical trials
    • Phase I trial to be initiated 2/3Q FY03
  • USAMRIID rPA candidate and UK rPA candidate also part of long-term NIAID strategy for 25M dose stockpile

Assembly and action of anthrax toxin

cb 31 medical countermeasures for brucella continuing dto
CB.31 Medical Countermeasures for Brucella(Continuing DTO)

Brucellae in murine macrophage

  • Brucellosis
    • Nonspecific febrile illness
    • Low infectious dose, highly infectious by aerosol
    • Antibiotic resistance may limit treatment options
  • Vaccine Candidate
    • MNPH1 – live attenuated deletion mutant
    • Orally administered
    • Demonstrated proof of concept for protective efficacy in NHPs
cb 34 recombinant plague vaccine continuing dto
CB.34 Recombinant Plague Vaccine(Continuing DTO)
  • Plague: Tech base research generated two recombinant vaccine candidates
    • Both rely on F1 and V antigens
    • U.S. candidate is a recombinantly produced fusion protein
    • UK candidate is a combination of the two individually produced proteins
  • Technical progress:
    • Demonstrated 80% efficacy in non-human primates against 2.8 x 104 colony forming units (CFU)
    • Transitioned F1-V vaccine candidate to technology development pre-acquisition phase
non dto supporting efforts bacterial vaccines
Non-DTO Supporting Efforts(Bacterial Vaccines)
  • Anthrax
    • Further define pathogenesis of anthrax infection
    • Evaluate other known antigens, new adjuvants, and delivery systems
    • Employ functional genomics effort to identify new virulence determinants
  • Plague
    • Characterize the host immune response
    • Plan and develop the next-generation plague vaccine through identification of new protective immunogens
    • Define the genetic diversity and pathogenesis of natural plague isolates
non dto supporting efforts bacterial vaccines16
Non-DTO Supporting Efforts(Bacterial Vaccines)
  • Glanders and Melioidosis
    • Develop an animal model of aerosolized glanders infection
    • Determine the mechanisms of immunity and establish correlates of immunity
    • Identify new virulence determinants
      • Potential vaccine candidates for protection against glanders
      • Evaluate the basis for virulence of Burkholderia mallei and B.pseudomallei by genetic and molecular methods
non dto supporting efforts bacterial therapeutics
Non-DTO Supporting Efforts(Bacterial Therapeutics)
  • Licensed antibiotics/novel antimicrobials
    • Primary focus is evaluation of licensed and investigational antibiotics for efficacy against BW bacterial threats
    • Specific effort to evaluate a series of licensed antibiotics as a post-exposure treatment for plague
    • Demonstrated proof-of-concept for small molecule inhibitors of anthrax toxin
  • Immunotherapy/Immunomodulators
    • Passive prophylactic antibody treatment protects animals against aerosolized plague or anthrax
    • Evaluating compounds capable of priming the immune response


Task Areas

Objective:Explore the development of candidate prophylactic and therapeutic medical countermeasures (i.e., vaccines and antivirals) against validated BW threat agents, using laboratory and appropriate animal models, and to demonstrate their capability for reducing mortality or incapacitation in animal models exposed to predicted or presumed battlefield doses of aerosolized viral BW agents.

JFOC(s) addressed:Medical Prophylaxis (OC) – Individual Protection (PC)

Medical Treatment (OC) – Restoration (PC)

*Note: DTO CB.25 Multiagent Vaccines for Biological Threats completed in FY02

cb 25 multiagent vaccines for biological threats dto completed in fy02

To move away from this…

25 Shots

Plus Boosters

To this…

Marburg Virus



Or this…







“Panfilovirus vaccine”

CB.25 Multiagent Vaccines for Biological Threats(DTO completed in FY02)
  • A vaccine or delivery approach that can concurrently immunize an individual against a range of biological warfare threats.
    • Reduce vaccination schedules
    • Decrease production costs
    • Streamline regulatory requirements
  • RNA Replicon and DNA Vaccine

CB.24 Medical Countermeasures for Multivalent Equine Encephalitis Viruses(Continuing DTO)

Live attenuated VEE vaccines derived by site-directed mutagenesis of a full length infectious cDNA clone

Identification of attenuating


sequence of attenuated variants

Wild-type full-


length cDNA clone

mutagenesis of conserved sequences


Site-directed mutagenesis


Molecularly defined clone

with attenuating mutations



Testing in

animal models

Virus Rescue (V3526 virus)

Multivalent VEE vaccine requirement can be met through the use of a single component vaccine (V3526), eliminating interference issues while greatly simplifying clinical trials and formulation issues

cb 54 therapy for smallpox and other pathogenic orthopoxviruses new dto in fy03
CB.54 Therapy for Smallpox and Other Pathogenic Orthopoxviruses(New DTO in FY03)
  • Cidofovir, sold under the trade name Vistide™, is approved by the FDA for the treatment of cytomegalovirus retinitis in AIDS patients
  • Cidofovir inhibits the viral DNA polymerase, thus stopping the replication of smallpox and other pathogenic orthopoxviruses and disease progression
  • Clinical trials of cidofovir against smallpox are not possible (smallpox has been eradicated)
  • FDA licensure is possible under the new Animal Efficacy Rule
    • Variola and monkeypox primate models are proposed to demonstrate antiviral efficacy

Non-DTO Supporting Efforts(Viral Vaccines)

  • Multivalent Equine Encephalitis (VEE/EEE/WEE) Vaccine (MEEV)
    • Use infectious cDNA clone & site-directed mutagenesis technology from DTO CB.24 to rationally derive live-attenuated eastern & western equine encephalitis (EEE & WEE) vaccine components to be combined with V3526 candidate into a MEEV
    • Investigate and assess alternative vaccine technologies
  • Recent Accomplishments
    • Developed an EEE vaccine component based on the cleavage deletion mutation
    • Successfully tested one WEE vaccine component in mouse model for:
      • Protective response within 30 days of vaccination
      • Duration of immunity of 1 year
non dto supporting efforts viral vaccines
Non-DTO Supporting Efforts(Viral Vaccines)
  • Filovirus Vaccine
    • Develop a multiagent vaccine capable of protecting against various Ebola (EBOV) and Marburg (MARV) viruses (panfilovirus vaccine)
    • Leverage vaccine platform technology from Multiagent Vaccine DTO (CB.25) & from outside collaboration
  • Next Generation Smallpox Vaccine
    • Leverage DNA vaccine approach from DTO CB.25 to identify orthopoxvirus immunogens that contribute to protective immunity
    • Test if a gene-based vaccine technology can serve as an alternative to the live-vaccinia virus vaccine, or as a prime to a vaccinia boost

FDA-Approved Compounds





NCI-DTP library

Commercial Sources

Combinatorial Lib.


Mouse Model

Commercial Sources


Cell-Based Assay

In Vitro Evaluation


Lead optimization


Lead Identification

In Vitro Evaluation

Assay Development

Target Identification

Target Validation

Non-DTO Supporting Efforts(Viral Therapeutics)


Non-DTO Supporting Efforts(Viral Therapeutics)

  • Antivirals for Smallpox
    • Develop an oral therapeutic antiviral drug based on cidofovir to treat smallpox and other naturally occurring or genetically modified pathogenic orthopoxviruses
    • Develop a second therapeutic antiviral drug based on non-DNA polymerase target (recommendation from IOM)
  • Antivirals for Filoviruses
    • Identified filovirus targets
    • Develop high thorough-put screening assays
    • Identify lead compounds for filoviruses
    • Develop therapeutic antiviral drugs based on lead compounds

Non-DTO Supporting Efforts(Viral Therapeutics)

  • Immunotherapies for Filoviruses
    • Objectives
      • Develop immunotherapies for treatment for infection with the various filoviruses
      • Test therapeutic intervention in combination with immunotherapy
    • Technology
      • Murine monoclonals  humanized antibodies  production in plants (leverage ongoing DARPA transition effort)
      • Combinatorial library from survivor monkey/human  humanized antibodies
      • anti-EBOV equine IgG
      • Test intervention strategies to prevent and treat shock and hemorrhage


Task Areas

Objective:Explore the development of candidate prophylactic and therapeutic medical countermeasures (i.e., vaccines, pretreatments, drugs and immunotherapies) against validated BW threat agents, using laboratory and appropriate animal models, and to demonstrate their capability for reducing mortality or incapacitation in animal models exposed to predicted or presumed battlefield doses of aerosolized toxin BW agents.

JFOC(s) addressed:Medical Prophylaxis (OC) – Individual Protection (PC)

Medical Treatment (OC) – Restoration (PC)

cb 32 alternative vaccine delivery methods continuing dto


MicromedicaTM micro-needles

OnVaxTM “swipe and go”

V. J. Sullivan, Ph.D.

Copyright BDT 2000

CB.32 Alternative Vaccine Delivery Methods(Continuing DTO)

BD Technologies Proprietary Alternate Vaccine Delivery Devices Currently Under Evaluation

  • Respiratory, transdermal, oral immunization that is safe, efficacious & expedient for stimulating mucosal and systemic immunity.
  • Simplify administration of the multiple vaccines.
  • Evaluation of multiple novel adjuvants in combination with alternate deliveries
cb 46 recombinant ricin vaccine new dto in fy03
CB.46 Recombinant Ricin Vaccine(New DTO in FY03)

Ricin: Classical approaches to producing a ricin toxoid vaccine proved unsuitable

    • Recombinant expression vectors will be used to produce mutated A-chain immunogens capable of protecting against ricin toxicity
  • Technical progress:
    • Designed, expressed, purified and partly characterized ricin vacine candidates
    • Lead candidate lacks enzyme activity and protects mice against ricin lethality
    • Lead candidate is stable, monodisperse monomer under physiological conditions with a reduced tendency to self-aggregate

Non-DTO Supporting Efforts(Toxin Vaccines)

  • Toxin vaccines
    • Recombinant candidates for BoNT serotypes A, B, C1, E, and F

(previous DTO)

      • Candidates transitioned to advanced development
      • Effort limited to support of advanced developer
    • Staphylococcal enterotoxin (SE) A and B vaccines (previous DTO)
      • Candidates ready to transition
      • Effort limited to stability analysis on pilot lots for use in future clinical studies
non dto supporting efforts toxin therapeutics



(5-10 years out)


(5 years out)




Receptor Antagonists

Scavenge Free Toxin



Protect SNAREs

Rescue SNAREs


(10-15 years out)

Bot Hc Delivery Vehicle


Non-DTO Supporting Efforts(Toxin Therapeutics)
  • Toxin therapeutics
    • Therapeutics for



    • Current major efforts
      • Active site inhibitors
      • Immunotherapy (MAbs)
      • Expand structural biology and high performance computing capabilities and access to compound libraries
non dto supporting efforts toxin therapeutics32
Non-DTO Supporting Efforts(Toxin Therapeutics)
  • Therapeutics for exposure to


    • Block T-cell activation
    • Block SE-stimulated cytokine


  • Therapeutics for exposure to


    • Basic research effort

Diagnostic Technologies

Task Area

Objective:Explore the development of technology candidates (reagents, protocols and devices) for inclusion into a deployable state-of-the-art identification and diagnostic system that integrates multiple methods for the identification of potential BW agents and the diagnosis of diseases they cause. The technology aim is to develop and integrate technologies so they will be capable of identifying multiple independent biomarkers from different agents simultaneously.

JFOC(s) addressed:Medical Diagnostics (OC) – Restoration (PC)

Med and Env Surveillance (OC) – Contamination Avoidance (PC)

*Note: DTO CB.26 Common Diagnostic Systems completed in FY02

cb 26 common diagnostic systems dto completed in fy02
CB.26 Common Diagnostic Systems(DTO completed in FY02)

Common Diagnostic Systems

Delivered by S&T Program

  • Milestone A in FY01
  • Technology Data Package on evaluation of diagnostic technologies in support of JBAIDS
  • Continuing to transition reagents and assays to the Critical Reagents Program
  • Provides capability to rapidly identify exposure to BW and infectious disease agents
  • Portable nucleic acid analysis system:
    • Specimen processing, gene detection device, reagents, protocols
    • Capable of simultaneous detection of multiple agents
cb 47 improved immunodiagnostic platform new dto in fy03
CB.47 Improved Immunodiagnostic Platform(New DTO in FY03)

Technology Options

  • Adjunct to nucleic acid detection
    • Primarily for the detection and identification of toxin threats
    • Also provides confirmatory assay for other medical diagnostic tests

Time-Resolved Fluorescence

Electrochemiluminescence (ECL) Reaction - First Generation Device - ORIGEN®

Magnetic Field Detection



Non-DTO Supporting Efforts(Diagnostics Technologies)

Evolutionary Strategy

  • Strategic Plan
    • Assay development
    • Identification of novel biological targets
    • Testing and evaluation
    • Technology assessment


Portable Rapid Nucleic

Acid Analysis System (Live Agents) Block I (CB.26)

Improved Immunodiagnostic System (Toxins) Block II (CB.47)



Diagnostic Systems

Block III



Genetically Engineered Threats

Countermeasures Task Area

Objective:Identify, group, prioritize, and assess the medical impact of non-traditional toxins, virulence factors, and genetically engineered microbes as BW threat agents. The information generated from research efforts under the thrust area will be used to direct the development of medical countermeasures and diagnostics against the most plausible and dangerous novel or emerging BW threats.

JFOC(s) addressed:Medical Prophylaxis (OC) – Individual Protection (PC)

Medical Treatment (OC) – Restoration (PC)

Medical Diagnostics (OC) – Restoration (PC)


DARPA Transition of BW Defense Programs

Thrust Area

  • Objective:Pursue technological advancement of novel medical countermeasures and diagnostic technologies initially developed through the Defense Advanced Research Projects Agency (DARPA) that will protect the warfighter from BW agents and provide increased operational capabilities.
  • Specifically, these promising initiatives will be developed to demonstrate proof-of-concept in appropriate animal models and include: novel, broad-spectrum therapeutics; the application of gene shuffling technology to DNA vaccine development; plant-based production of vaccine antigens and antibodies by expressing plague antigens and Ebola monoclonal antibodies in transformed plants; and a hand-held, tissue based biosensor through step-wise development of B-cell lines for relevant pathogens and multi-channel sensors.
  • JFOC(s) addressed:Medical Prophylaxis (OC) – Individual Protection (PC)
  • Medical Treatment (OC) – Restoration (PC)
  • Medical Diagnostics (OC) – Restoration (PC)
  • Status: Nine programs selected to date
roadmap vaccines

CB.34 Plague

Licensed Plague

Plague Vaccine

Licensed NGAV


98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13

Vaccine Technologies S&T Program

CB.25 Multiagent

CB.32 Needle-less Delivery

CB.31 Brucella

Brucella Vaccine

CB.24 Multivalent VEE

Multivalent VEE Vaccine

Multivalent VEE Vaccine

CB.33 rPA

Next Gen Anthrax Vaccine (NGAV)

CB.46 Ricin

Ricin Vaccine

FDA Licensed Vaccine Procurement

Tech Base

VEE – Venezuelan Equine Encephalitis

rPA – recombinant Protective Antigen


Un-funded Developmental

Partially funded Developmental

roadmap diagnostics and therapeutics
Roadmap(Diagnostics and Therapeutics)

98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13

Diagnostic Technologies S&T Program


Common Diagnostic System



Improved Immuno-diagnostic Platform

JBAIDS Blk 2&3

JBAIDS Blk 2&3

Therapeutic Technologies S&T Program

Therapy for Smallpox & other Pathogenic Orthopoxviruses


Therapy for Smallpox & other Pathogenic Orthopoxviruses

FDA Approval of Cipro® for use after exposure to inhalation anthrax (Aug 2000)

Tech Base


JBAIDS – Joint Bio Agent Identification & Diagnostic System

CDS – Common Diagnostic Systems for Bio Threats & Endemic Infectious Diseases


Un-funded Developmental

Partially funded Developmental

Unfunded Procurement

fy03 congressional interest medical s t funding increases 20 4m
FY03 Congressional Interest(Medical S&T Funding Increases: +$20.4M)
  • Engineered Pathogen Identification and Countermeasures Program (“Bug to Drug”) (Sarnoff Corporation): +$5.0M
  • Monoclonal Antibody-based Technology “Heteropolymer” (HP) System (EluSys Therapeutics, Inc.): +$1.0M
  • Bioadhesion Research (Ligocyte Pharmaceuticals, Inc.): +$1.8M
  • Mustard Gas Antidote (Mustard Consortium): +$2.1M
  • Needleless Delivery Methods for Recombinant Protein Vaccines (BD Technologies): +$1.0M
  • Vaccine Stabilization (U of Kansas): +$1.5M
  • Organic Vaccine Production (TBD): +$2.5M
  • Portable Biochip Analysis System (Cleveland Clinic): +$1.8M
  • Piezoelectric Dry Powder Inhalation Device (U. of Pitt) : +$1.7M
  • Bioprocessing Initiative (U. of Nebraska Lincoln): +$2.0
cooperation with the department of health and human services dhhs
Cooperation with the Department of Health and Human Services (DHHS)
  • NIAID/CDC/FDA anthrax therapeutics
  • NIAID/USAMRIID/JVAP rPA clinical trials
  • NIAID/USAMRMC/USAMRIID Biodefense Campus
    • Program coordination
    • Program management
    • Infrastructure
    • Smallpox research program
    • Anthrax antibodies
medical biological defense future trends
Medical Biological Defense Future Trends
  • Countermeasures for Genetically Engineered Microbes
    • Genomic sequencing of BW threat agents to identify and understand virulence factors, toxins and drug resistance genes
  • Immunomodulators and Therapies
    • Alternatives to agent-specific vaccines or therapies
  • Multiagent Vaccines
    • Alternative to one vaccine for one BW threat agent
  • Alternative vaccine delivery strategies
    • Immunization via mucosal and transdermal routes
  • Early markers of infection/host response