The Chemical and Biological Defense Program: An Update Dr. Klaus Schafer, DATSD(CBD) WWCC 12 October...
Transcript of The Chemical and Biological Defense Program: An Update Dr. Klaus Schafer, DATSD(CBD) WWCC 12 October...
The Chemical and Biological Defense Program: An Update
Dr. Klaus Schafer, DATSD(CBD)
WWCC
12 October 2004
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Threat: At Home and Abroad
“The greatest threat before humanity today is the possibility of secret and sudden attack with chemical, or
biological, or nuclear weapons”
President George W. BushRemarks at the National Defense University
11 February 2004
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BioDefense for the 21st Century:Presidential Pillars
Prevention and ProtectionPrevention and Protection– Proactive Prevention– Critical Infrastructure Protection
Threat AwarenessThreat Awareness– Biological Warfare Related
Intelligence– Assessments– Anticipation of Future Threats
Surveillance and DetectionSurveillance and Detection– Attack Warning– Attribution
Response and RecoveryResponse and Recovery– Response Planning– Mass Casualty– Risk Communication– Medical Countermeasures– Decontamination
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Successfully Pursue The Global War On TerrorismSuccessfully Pursue The Global War On Terrorism Strengthen Combined/Joint Warfighting CapabilitiesStrengthen Combined/Joint Warfighting Capabilities Transform The Joint ForceTransform The Joint Force Optimize Intelligence CapabilitiesOptimize Intelligence Capabilities Counter Proliferation Of Weapons Of Mass DestructionCounter Proliferation Of Weapons Of Mass Destruction Improve Force ManningImprove Force Manning New Concepts Of Global EngagementNew Concepts Of Global Engagement Homeland SecurityHomeland Security Streamline DOD ProcessesStreamline DOD Processes Reorganize DOD And U.S. Government To Deal With Reorganize DOD And U.S. Government To Deal With
Pre-war Opportunities And Post-war ResponsibilitiesPre-war Opportunities And Post-war Responsibilities
Secretary of Defense’s Priorities for 2005Secretary of Defense’s Priorities for 2005
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Irregular Unconventional methods adopted and
employed by non-state and state actors to counter stronger state opponents. (erode our power)
Disruptive International competitors developing and
possessing breakthrough technological capabilities intended to supplant U.S. advantages in particular operational domains. (capsize our power)
Traditional States employing legacy and advanced
military capabilities and recognizable military forces, in long-established, well-known forms of military competition and conflict. (challenge our power)
Catastrophic Acquisition, possession, and possible
employment of WMD or methods producing WMD-like effects against vulnerable, high-profile targets by terrorists and rogue states. (paralyze our power)
LIKELIHOOD
VU
LN
ER
AB
ILIT
Y
Lower Higher
Higher
Lower
(e.g., terrorism, insurgency, civil war, and emerging concepts like “unrestricted warfare”)
(e.g., conventional air, sea, land forces, and nuclear forces of established nuclear powers)
(e.g., sensors, information, bio or cyber war, ultra miniaturization, space, directed-energy, etc)
(e.g., homeland missile attack, proliferation from a state to a non-state actor, devastating WMD attack on ally)
Defense Strategy
Today’s Security Environment
No hard boundaries distinguishing one category from another
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CBRN Agent Threat Spectrum
CLASSIC
CHEMICAL
BLOOD
VESICANT
NERVE
PSYCHOLOGICALINCAPACITANT
(BZ)
CHOKING
CLASSIC
CHEMICAL
BLOOD
VESICANT
NERVE
PSYCHOLOGICALINCAPACITANT
(BZ)
CHOKING
EMERGING
CHEMICALBIOREGULATOR TOXIN
PROTECTIONDEFEATING
PHYSICALINCAPACITANT
TOXICINDUSTRIALCHEMICAL ANDMATERIAL
PAIN
SLEEP
BLOODPRESSURE
MOODENHANCERS
PLANT
BACTERIAL
VENOM
MARINE
FUNGAL
ALGAL
EMERGING
CHEMICALBIOREGULATOR TOXIN
PROTECTIONDEFEATING
PHYSICALINCAPACITANT
TOXICINDUSTRIALCHEMICAL ANDMATERIAL
PAIN
SLEEP
BLOODPRESSURE
MOODENHANCERS
PLANT
BACTERIAL
VENOM
MARINE
FUNGAL
ALGAL
PATHOGEN
BACTERIA
VIRUSES
RICKETTSIAE
GENETICENGINEEREDMICRO-ORGANISMS
PATHOGEN
BACTERIA
VIRUSES
RICKETTSIAE
GENETICENGINEEREDMICRO-ORGANISMS
BWBWBWCWCW
CLEARLY CHEMICAL CLEARLY BIOLOGICAL
Traditional Nuclear
Nuclear BombsNuclear MissilesTactical Nukes
Radiological Dispersion DevicesImprovised Nuclear DevicesNuclear Power Plants
Asymmetric Weapons
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Planning Measures
• Procure masks, suits, sensors for total force
• Civil Support Teams, Installation Protection
• Nuke • Next Chem/GenEng Bio
Traditional Irregular Catastrophic Disruptive
OperationalFuture (FY2011+)
Force ManagementInstitutional
OperationalFuture (FY2011+)
Force ManagementInstitutional
OperationalFuture (FY2011+)
Force ManagementInstitutional
Risk: Risk: Risk:
Alt #1: CBDP (POM 06-11)
Operational
Future (FY2011+)Force Management
Institutional
OperationalFuture (FY2011+)
Force ManagementInstitutional
OperationalFuture (FY2011+)
Force ManagementInstitutional
Alt #2: +$3B RDT&E / Infrastructure & $2B Procurement Across Challenges Accept Risk: Traditional Challenge
Complete 1-4-2-1 procurement only
Reduce Risk: Irregular, Catastrophic, Disruptive ChallengesFund research on emerging threats; RDT&E on 9 new capabilities; USAMRIID Phase 1 (Fort Detrick); accelerate chemical countermeasures
OperationalFuture (FY2011+)
Force ManagementInstitutional
Risk:
OperationalFuture (FY2011+)
Force ManagementInstitutional
Looking Across Challenges -- CBDP Illustrative Example
Tradeoff
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CBRN Defense Program
VISION
Combat Weapons of Mass Destruction through a Strong Chemical, Biological, Radiological, and Nuclear Defense Program
MISSION
Provide CBRN defense capabilities to effectively execute the National Strategy for Combating WMD. Ensure all capabilities are integrated
and coordinated within the Interagency community
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Program Organization
Joint Requirements Office
Joint Science &Technology
Office
Joint ProgramExecutive Office
Joint Test &Evaluation Executive
Joint CombatDeveloper
Delivering Joint Warfighting Capabilities
Program Oversight by the Office of the Secretary of Defense
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Background
Chemical, Biological Defense Program (CBDP)
• Single OSD Office Responsible For CB Warfare Defense And CB Medical Defense Programs (50 USC 1522)
– Coordinate/Integrate RDT&E And Acquisition Using Defense Acquisition Board Process.– Services Responsible For O&M And Integration.
• CBDP & Its Infrastructure Historically Focused On Traditional Threats
– Provides Basic Force Readiness -- Limits Our Ability To Pursue Novel Technologies.
• CBDP Funding Increases As A Result Of 9/11 Have Not Provided Technology Break-throughs Anticipated In All Capability Gaps.
• National Strategy To Combat WMD -- Published In Sept 2002
• 2004 SPG Directed Department To Reduce Gaps/Risk
– OSD/PAE Combating WMD Enhanced Planning Process (EPP) Study Team • Options On 18 Oct.• Inadequate Funding And Not Focused
• 2005 A Transformational Acquisition Approach Is Necessary
– Accepts Increased Risk In Return For High Payoffs.– Weighs Options Vs. Resource Constraints Across The Spectrum Of Challenges.
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CBDP: Current Status
• Underfunded for Years• Old Lab Infrastructure• Difficult to Maintain Intellectual Property • Industrial Base Strong, but…• Slow Movement From Tech Base to Production• Inability to Aggressively Adopt New Biotech Capabilities• Need for Alternatives in S&T base (Stand OFF, etc.)
• Led to EPP Efforts
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Transformational Acquisition Approach
Additional Funding Is Required To Undertake True Transformation Of CBDP!
Risk Reduction
(Traditional RDT&E)
Transformational Acquisition
(Leap Ahead/Technologies)
Pre 9/11 POM 06-11 Today’s Request
Risk
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CBRN Defense Program A Shift
• The current shift directs both a broadening and deepening of the CBRNDP.
– CBRN consequence management (about 1997)
– Force protection (in 1999)
– Homeland Defense (in 2002)
– Visibility of “radiological and nuclear” aspects of the program (2003)
– Inclusion of the US Coast Guard (2004)
– Transition from Threat Based to Capabilities Based Process (2004)
– Systems Biology Approach to Medical Issues (2004-2005)
• This broadening requires a carefully developed program strategy to ensure that warfighter capabilities are maintained and advanced concurrently with these added missions.
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DoD Strengths vs. Other Agencies
• DoD has the demonstrated capacity for…
– Solid tech base – Key to DHHS development
– Fielding Systems
– Experimentation with threat agents
– Established Infrastructure (Personnel and Laboratories)
– Crisis and Operational Response
• Schafer’s View: Not Viewed by Congress as a serious player in the Homeland Defense Arena
– Example: HHS Billions for Development of Biologics
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We are Collaborating and Cooperating
• DARPA
• Department of Homeland Security
• Department of Health and Human Services
• International
• Intelligence community
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DoD Strengths vs. Other Agencies
• DoD has the demonstrated capacity for…
– Solid tech base – Key to DHHS development
– Fielding Systems
– Experimentation with threat agents
– Established Infrastructure (Personnel and Laboratories)
– Crisis and Operational Response
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Program Evolving Challenges
• Maintaining current programs to respond to warfighter requirements
Balance of competing priorities within current budget authority
• Enhancing CB installation force protection
• DoD CBDP transforming to provide support for emerging domestic preparedness and consequence RDA requirements
• DoD supports broader efforts of federal domestic agencies and state and local governments, as coordinated by and in cooperation with the Department of Homeland Security under emergency conditions for special purposes.
In accordance with the National Response Plan
• Acceleration of CB defense technologies
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CBD: Where the Program Needs to Go
• Integration of detection systems and medical diagnostics
• Broader intervention through immune system manipulation
• Computational Biology for detection analysis and drug development
• Accelerating product transition
– Process and clinical development
• Transformational management of the programs
– Rapid Development And Insertion Of New Technologies– Program Re-direction
• Darpa-like Authority At DTRA (JSTO-CBD)– Authority To Rapidly Cancel S&T Projects And To Incorporate Rapidly Emerging
Technologies
• Interagency/International cooperation to leverage S&T
• Expand competitive basis for S&T
– Industry, Academia, Interagency
• Address Institute Of Medicine Recommendations
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Where the Program Needs to Go in S&T
Classical Threats Emerging Threats
Medical Non-Medical
Chemical Biological
Evolutionary Revolutionary
Requirements Pull Technology Push
Service Labs Outside Performer
∆ Current Old
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CBD: Efforts
• Improve Industrial Base (Bio/NTAs)
• Consider Intellectual Property Needs
• Transition Many Existing Capabilities to Production for Warfighters
• Incorporate New Science And Technological Approaches:
– Develop NTA countermeasures and detection– Biotech Base for Rapid Detection/Analysis of Genetically Engineered Bio
Threat Agents– Move In-House Development Bias To Best Of Breed Nationally and
Internationally– Move Radiation Therapies out of Tech Base
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CBD: Program Direction
• Near-Term• Win the EPP Battle (JRO Kudos)• Continue Interagency Cooperation
– DoD-DHHS Interagency Medical Countermeasures Development
– Similar Efforts DoD-DHS– Agreements on Standardization– NBAC and NCAC
• Plus Up DoD Tech Base• Leverage Bioshield For Advanced Development• Build S&T Competition• Build Capability
– Mid-Term• Genomics, Proteomics, Vaccinomics, Metabolics, Immune
Products, Prioritize Accelerated Technologies• Technology Insertion• Skunk Works Plus Up
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Product Life Cycle Focus
DOD DHHS Industry,Academia
Product Transition Civilian and Military
Process DevelopmentClinical Development
GLPGMPPhase 1 Safety trials
BioShieldPhase 2/3 Clinical DevelopmentProduction by Industry
Acquisition
DOD
DHHS
ProductDiscovery
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The Problem
Attack with New Threat
10 years - $800MEconomic and Social Catastrophe
Safe & EffectiveCountermeasure
BasicResearch
PrototypeDesign orDiscovery
PreclinicalDevelopment
Clinical Development
FDAApproval
2 years 3 years 4 years 1 year
HHS funds to NIAID
Production
BioshieldNo national strategy, clear responsibility or federal funding to shorten this cycle
ProductionMethods
1 year2 years
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The SolutionDramatically reduce the time to develop countermeasures1
0
2
4
6
8
10
12
14
BasicResearch
Discovery Pre-Clinical
Clinical FDA Pre-Production
Steps to Countermeasure
Cu
mu
lati
ve Y
ears
Current
New
1 Notional, as decrease in time is not equivalent to total 1 year time
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Proposed Solution - a Horizontally Integrated “Bio-Incubator”
BasicResearch
PrototypeDesign orDiscovery
PreclinicalDevelopment
Clinical Development
FDAApproval
Production
Senior Advisory Group
Translational Infrastructure
Project 1
Project 2
Infrastructure 1
DoD Acquisition Process
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The Rapid Production ApproachRevolutionary approaches plus systematic improvement to reduce the time for drug development
• Combine existing and emerging technologies from computer science, chemistry, and biology in a focused, coherent strategy
• Provide immediate results with ever-greater pay-off over time
Near term Impact:Cut current process 2.5 times
•Genomics•Process Focus and Efficiency •Drug to IND in 9 months•Vertically Integrated Teams•Preclinical Testing Paradigm•Computer-aided Drug Design
Mid-Term Impact:Cut another factor of 4
•Proteomics•Humanized Polyclonal Antibodies•Predictive Computational Biology•Transgenic Animal Models•Automated Protein Crystallography•Computer Drug Design
Longer term Impact:Cut process to 3 months
•Systems Biology•Automated Computational Biology•Automated Computer Drug Design
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Pharmaceutical R&D Process The Virtual Pharma
Diagnostics CombiChemHTS
Genomics
ProteomicsHTS
Animal StudiesADME / Tox
Pharmacogenomics
Bioinformatics Molecular Informatics Clinical Informatics
MicrofluidicsCellular AssaysDetection PlatformsSequencingSystems
BioinformaticsPositional cloningParallel sequencingKnock-outs TransgenicsExpression arrays
2-D gelsMass SpecStructure-/Function
Structural Drug Design
Detection PlatformsCellular AssaysLead optimization, ADME, ToxProcess Chemistry
Geno & Phenotyping,SNP’s
Formulation ChemistryManufacturing Scale-up
ClinicalPre-clinical
Genome AssaysTargets
Biology
Drug Testing
Pharmacology
LeadsSmall
Molecules
Chemistry
Human Trials
Human Trials
Human Trials
I II III
Automation, Robotics, Informatics, CADSensitive & Selective DetectionSupply ChainLarge Scale Testing / Higher Densities
++/-++
+/-+/-+-
-+/-++
SafetyEarly clinical Pharma-cology
ClinicalEfficacy &Safety
Full scale DB trial with controls
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Other Approaches
Risk Reduction
(Traditional RDT&E)
Transformational Acquisition
(Leap Ahead/Technologies)
Apply New Concepts to Existing Program – Stand Off/Med
Establish Biologics Technical Senior Advisory Group
Creation of New Biologics Rapid Throughput Mechanism
Renewed Cooperative Effort: Govt, Industry, Academia
Tighter Integration of Combat Development Into Joint Exercise and Doctrinal Efforts
End to End View of Chem Bio Portfolio
Growth Opportunities Aggressively Sought Out & Taken!
This is a Business!
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$ Get Money!
Expand the Program!
Improve the Perceptions Among the Congress of What We Are Capable of Doing!
$ Get More Money!
My Simple Goals for the Program
The End
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Scope of the Chemical and Biological Defense Program
• Integrates and controls funding for:– Chemical and biological defense programs within DoD– All research, development, and acquisition funds– Medical and non-medical funds
• …but not– Operations & Maintenance funds (Retained by Services)
Logistics, sustainment, training, doctrine– Defense Advanced Research Projects Agency (DARPA) Biological
Warfare Defense projects– Technical Support Working Group programs
• Emerging requirements– Consequence management– Force Protection/Installation Protection– Homeland Security
CBDP Support to Homeland Security
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Consequence Management: WMD – Civil Support Teams
• Funding in the DoD CBDP provides resources to complete fielding and modernization of:
• 55 WMD- Civil Support Teams
• Reserve Component (RC) Recon and Decon Teams
• Program provides full funding for
• Type-classified protection, detection, and training equipment
• Development and fielding of upgraded analytical platforms for the detection, identification, and characterization of CB and radiological agents used by terrorists in a civilian environment
• Development and fielding of communication capabilities that are interoperable with other federal, state, and local agencies
• Testing and evaluation to ensure that the systems are safe and effective
• Program management funds to successfully execute the CBDP Consequence Management RDA program
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Other DoD Assets Available
• Specialized Task Forces for Civil Support
• Provide command and control for DoD assets
• USA Chemical/Biological Rapid Response Teams
• Provides chemical and biological incident response command and control of Army SBCCOM resident assets, Navy technical assets, and attachment of the USMC Chemical and Biological Incident Response Force
• USMC Chemical and Biological Incident Response Force (CBIRF)
• Provides chemical and biological incident response and urban search and rescue
• USA Reserve Recon and Decon Teams
• Traditional Army Reserve Chemical Companies
BACK UP
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New Technology-New Approaches
Medical S&T Program
New medical S&T philosophy involves the adoption of a systems biology approach: use of genomics, proteomics, computational chemistry and bioinformatics. This new approach will yield novel solutions to CB threats that were impossible to imagine using older approaches. This is an overarching change that affects all capability areas.
Pretreatments Therapeutics Diagnostics Emerging Threats
New approaches to vaccine development:
• Deemphasize historic approach using live, attenuated pathogens: safety and efficacy issues
• Design of new, non-living vectors for multi-valent and multi-agent pretreatments
• Chemical agent pretreatment based on molecular physiology of cell injury and death
•Non-injection methods of vaccine delivery
New opportunities for intervention:
• Specific remedies for specific effects still needed but….
• Identification of common mech-anisms of agent-mediated injury and design of non-specific and broad spectrum therapeutics effective against whole classes of threat agents
Novel indicators of exposure:
• Continue to develop and improve immunodiagnostic assays and platforms, but also…
• Use DNA arrays and proteomic analysis to identify very early, pre-symptomatic host responses to exposure
• Molecular (nano) fabrication methods to make ultra-miniaturized “lab-on-chip” applications
Anticipating the unknown:
• Genetically engineered threats: rapid re-sequencing capability and bio-informatics for discovery and exploitation of common elements of pathogenesis and virulence
• Novel chemical agents: under-standing underlying mechanisms of cell injury and death to produce non-specific and broad spectrum countermeasures
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Decontamination DetectionModeling & Simulation Protection
New Technology-New ApproachesNon-Medical S&T Program
Non-Med S&T planning emphasizes alignment with JPEO Programs of Record with an focus on the science needed. Projects for 6.2/6.3 target only current technologies that promise substantial improvements—orders of magnitude beyond current capabilities. Projects for 6.1/6.2 seek new innovative solutions.
Improving decision making:
• Reduce work in classical modeling to provide for investment in decision support tools for transition in FY07
• Develop algorithms to model transport and diffusion of aerosol agents in urban areas and inside buildings
• Extend models to include NTAs and TICs
• Integrate sensors and decision support tools into warfighter’s common operating picture
• Incorporate live weather into predictive models--NOWCASTING
New technologies for limiting exposure:
• Research monolayered reactive materials or spray-on materials
• Looking for reactive coatings for vehicles, weapons systems
• Investigating materials for self-detoxification and increased aerosol protection
• Improve TIC protection• Deferred selective
permeable membrane to tech watch only
Returning equipment to usable status:
• Focus on interiors and sensitive equipment:
• Terminate S&T on enzymatic decon and phages
• Research technologies for embedded decon
Collecting information, not just detecting:
• Develop new signatures and outsource hardware research
• Increase discrimination• Reduce false alarms• Minimize consumables• Reduce response time
and logistical burden• Improve algorithms for
background and interferentsProviding the fundamental
science:• Agent Fate-research follows
a test matrix and uses predictive modeling–more data points, faster
• Began Bio Agent Fate• Research Bio Simulants• Limit low-level Bio work to
toxins
Supporting Science and Tech
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DETECTION
Additional NTAs
Bio Standoff S&T
Bio Point Det
Chem Standoff S&T
SST S&T
EARLY WARNING
Sensor Integration PT S&T
Integrated EW SDD
Integrated EW Hazard Prediction
Integrated EW Effects of Ops
Battle Space Mgt & Dec Tools
DECONTAMINATION
Solid, Fixed & Equipment Decon
Equipment Decon SDD Level
PROTECTION
Col Prot S&T Level 2
MEDICAL COUNTERMEASURES
NTA
Animal Models & Bridging Study
INATS
Bioscavenger
Genetically Engineered Threats
Protectant
Vaccine (Brucellosis, Ebola, Marburg, Plague)
Neuroprotectant
Radioprotectants
Therapeutics
Resuscitative Intervention
Vesicant Agent CM
Diagnostics
BW Diagnostics (JBAIDS Blk II)
Option 1 – Future Threat Prioritization
- S&T
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CATASTROPHIC
Bio Standoff S&T
Bio Point Det
Additional NTAs
Animal Models & Bridging Study
INATS
Bioscavenger
Vaccine (Brucellosis, Ebola, Marburg, Plague)
BW Diagnostics (JBAIDS Blk II)
DISRUPTIVE
Gen Engineered Threats
Col Prot S&T Level 2
Resuscitative Intervention
Chem Standoff S&T
IRREGULAR
Radioprotectants
TRADITIONAL
SST S&T
Solid, Fixed & Equipment Decon
Equipment Decon SDD
Sensor Integration PT
Integrated EW SDD
Integrated EW Hazard Prediction
Integrated EW Effects of Ops
Battle Space Mgt & Dec Tools Level 3
Neuroprotectant
Vesicant Agent CM
Option 1 – Security Challenge Remediation
- S&T
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Option 2 – Future Threat Prioritization
DETECTION
SST S&T Level 1
JBSDS
JCAD
JSLSCAD
JBTDS
JCBAWM
BATTLESPACE MANAGEMENT
JEM
JWARN
JOEF
DECONTAMINATION
JSSED
JSPDS
JSTDS (Large/Small/ Scale)
M17A3
JSMPDS Level 2
PROTECTION
Col Prot S&T Level 1
Protection Mask & Clothing S&T
CBDEPMEDS
CBPS Level 3
JCESM
M41 PATS
M20/M20 A-1
Dryvax Vaccine
JECP (Mobile/Trans/Facility)
MEDICAL COUNTERMEASURES
Protectant
Plague SDD Level 1
Multiagent Vaccine
Diagnostics
JBAIDS
FORCE PROTECTION
ALS
UCS
- S&T
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Option 2 – Security Challenge Remediation
CATASTROPHIC
Plague Vaccine Level 1
Multiagent Vaccine
JBAIDS
Dryvax Vaccine
JBSDS
JBTDS
DISRUPTIVE
Col Prot S&T Level 1
CBDEPMEDS
CBPS Level 3
JECP (Mobile/Trans/Facility)
JSLSCAD
TRADITIONAL
SST S&T Level 1
Protection Mask & Clothing S&T
JCESM
M41 PATS
M20/M20 A-1
JCBAWM
JCAD
JEM
JWARN
JOEF
JSSED
JSPDS
JSTDS (Large/Small/ Scale)
M17A3
JSMPDS Level 2
ALS
UCS
- S&T
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Option 3 – Future Threat Prioritization
DETECTION
BIDS
JSLNBCRS LAV
PROTECTION
CBPS Level 1
DECONTAMINATION
JSMPDS Level 1
- S&T
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Option 3 – Security Challenge Remediation
CATASTROPHIC
BIDS
DISRUPTIVE
CBPS Level 1
TRADITIONAL
JSLNBCRS LAV
JSMPDS Level 1
- S&T