The Chemical and Biological Defense Program: An Update

Dr. Klaus Schafer, DATSD(CBD)

WWCC

12 October 2004

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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.

11

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

12

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

13

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.

14

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

15

We are Collaborating and Cooperating

• DARPA

• Department of Homeland Security

• Department of Health and Human Services

• International

• Intelligence community

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

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!

29

$ 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

31

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

33

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

34

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

36

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

37

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

38

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

39

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

40

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

41

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

42

Option 3 – Future Threat Prioritization

DETECTION

BIDS

JSLNBCRS LAV

PROTECTION

CBPS Level 1

DECONTAMINATION

JSMPDS Level 1  

- S&T

43

Option 3 – Security Challenge Remediation

CATASTROPHIC

BIDS

DISRUPTIVE

CBPS Level 1

TRADITIONAL

JSLNBCRS LAV

JSMPDS Level 1

- S&T