The Chemical and Biological Defense Program: An Update

1
The Chemical and Biological Defense Program An
Update

• Dr. Klaus Schafer, DATSD(CBD)
• WWCC
• 12 October 2004

2
Threat At Home and Abroad
3
BioDefense for the 21st CenturyPresidential
Pillars

• Prevention and Protection
• Proactive Prevention
• Critical Infrastructure Protection
• Threat Awareness
• Biological Warfare Related Intelligence
• Assessments
• Anticipation of Future Threats

• Surveillance and Detection
• Attack Warning
• Attribution
• Response and Recovery
• Response Planning
• Mass Casualty
• Risk Communication
• Medical Countermeasures
• Decontamination

4
Secretary of Defenses Priorities for 2005

• Successfully Pursue The Global War On Terrorism
• Strengthen Combined/Joint Warfighting
  Capabilities
• Transform The Joint Force
• Optimize Intelligence Capabilities
• Counter Proliferation Of Weapons Of Mass
  Destruction
• Improve Force Manning
• New Concepts Of Global Engagement
• Homeland Security
• Streamline DOD Processes
• Reorganize DOD And U.S. Government To Deal With
  Pre-war Opportunities And Post-war
  Responsibilities

5
Defense StrategyTodays Security Environment

• Irregular
• Unconventional methods adopted and employed by
  non-state and state actors to counter stronger
  state opponents. (erode 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)

Higher

• (e.g., terrorism, insurgency, civil war, and
  emerging concepts like unrestricted warfare)

(e.g., homeland missile attack, proliferation
from a state to a non-state actor, devastating
WMD attack on ally)
VULNERABILITY
Lower

• 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)

Higher

• (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)

Lower
LIKELIHOOD
No hard boundaries distinguishing one category
from another
6
CBRN Agent Threat Spectrum
7
Looking Across Challenges -- CBDP Illustrative
Example
Alt 1 CBDP (POM 06-11)
Traditional
Irregular
Catastrophic
Disruptive

Procure masks, suits, sensors for total force Civil Support Teams, Installation Protection Nuke Next Chem/GenEng Bio
Planning Measures
Risk
Risk
Risk
Risk
OperationalFuture (FY2011)Force
ManagementInstitutional
OperationalFuture (FY2011)Force
ManagementInstitutional
OperationalFuture (FY2011)Force
ManagementInstitutional
OperationalFuture (FY2011)Force
ManagementInstitutional
Alt 2 3B RDTE / Infrastructure 2B
Procurement Across Challenges

• Accept Risk Traditional Challenge
• Complete 1-4-2-1 procurement only
• Reduce Risk Irregular, Catastrophic,
  Disruptive Challenges
• Fund research on emerging threats RDTE on 9 new
  capabilities USAMRIID
  Phase 1 (Fort Detrick) accelerate chemical
  countermeasures

Tradeoff

OperationalFuture (FY2011)Force
ManagementInstitutional
OperationalFuture (FY2011)Force
ManagementInstitutional
OperationalFuture (FY2011)Force
ManagementInstitutional
OperationalFuture (FY2011)Force
ManagementInstitutional
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
Program Oversight by the Office of the Secretary
of Defense
Delivering Joint Warfighting Capabilities
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 RDTE And Acquisition Using
  Defense Acquisition Board Process.
• Services Responsible For OM 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 ST 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 RDTE)
Transformational Acquisition (Leap
Ahead/Technologies)
Risk
Pre 9/11
POM 06-11
Todays Request
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
• Schafers 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 ST Projects And To
  Incorporate Rapidly Emerging Technologies
• Interagency/International cooperation to leverage
  ST
• Expand competitive basis for ST
• Industry, Academia, Interagency
• Address Institute Of Medicine Recommendations

19
Where the Program Needs to Go in ST

• Classical Threats Emerging Threats
• Medical Non-Medical
• Chemical Biological
• Evolutionary Revolutionary
• Requirements Pull Technology Push
• Service Labs Outside Performer

Old
Current
?
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 ST 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
Industry, Academia
DOD
DHHS
Product Discovery
Product Transition Civilian and Military
DOD
GLP GMP Phase 1 Safety trials
Process Development Clinical Development
DHHS
BioShield
Phase 2/3 Clinical Development Production by
Industry
Acquisition
23
The Problem
10 years - 800M Economic and Social Catastrophe
Attack with New Threat
Safe Effective Countermeasure
24
The SolutionDramatically reduce the time to
develop countermeasures1
1 Notional, as decrease in time is not
equivalent to total 1 year time
25
Proposed Solution - a Horizontally Integrated
Bio-Incubator
Senior Advisory Group
DoD Acquisition Process
BioCooperative
Basic Research
Prototype Design or Discovery
Preclinical Development
Clinical Development
FDA Approval
Production
Translational Infrastructure
Infrastructure 1
Project 1
Project 2
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 RD Process The Virtual Pharma
28
Other Approaches
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!
Risk Reduction (Traditional RDTE)
Transformational Acquisition (Leap
Ahead/Technologies)
29
My Simple Goals for the Program

• Get Money!
• Expand the Program!
• Improve the Perceptions Among the
  Congress of What We Are Capable of Doing!
• Get More Money!

30
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

32
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

35
BACK UP
36
New Technology-New Approaches
Medical ST Program
New medical ST 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
New Technology-New Approaches
Non-Medical ST Program
Non-Med ST 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
improvementsorders of magnitude beyond current
capabilities. Projects for 6.1/6.2 seek new
innovative solutions.

• 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 ST 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 interferents

• 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
  warfighters common operating picture
• Incorporate live weather into predictive
  models--NOWCASTING

Supporting Science and Tech

• Providing the fundamental science
• Agent Fate-research follows a test matrix and
  uses predictive modelingmore data points, faster
  
• Began Bio Agent Fate
• Research Bio Simulants
• Limit low-level Bio work to toxins

38
Option 1 Future Threat Prioritization
DETECTION Additional NTAs Bio Standoff ST Bio
Point Det Chem Standoff ST SST ST
MEDICAL COUNTERMEASURES NTA Animal Models
Bridging Study INATS Bioscavenger Genetically
Engineered Threats Protectant Vaccine
(Brucellosis, Ebola, Marburg, Plague) Neuroprotect
ant Radioprotectants Therapeutics Resuscitative
Intervention Vesicant Agent CM Diagnostics BW
Diagnostics (JBAIDS Blk II)
EARLY WARNING Sensor Integration PT
ST 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  
- ST
PROTECTION Col Prot ST Level 2
39
Option 1 Security Challenge Remediation
CATASTROPHIC Bio Standoff ST Bio Point
Det Additional NTAs Animal Models Bridging
Study INATS Bioscavenger Vaccine (Brucellosis,
Ebola, Marburg, Plague) BW Diagnostics (JBAIDS
Blk II)
TRADITIONAL SST ST 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 Vesi
cant Agent CM
DISRUPTIVE Gen Engineered Threats Col Prot ST
Level 2 Resuscitative Intervention Chem Standoff
ST
IRREGULAR Radioprotectants
- ST
40
Option 2 Future Threat Prioritization
DETECTION SST ST Level 1 JBSDS JCAD JSLSCAD
JBTDS JCBAWM
MEDICAL COUNTERMEASURES Protectant Plague SDD
Level 1 Multiagent Vaccine Diagnostics JBAIDS
PROTECTION Col Prot ST Level 1 Protection Mask
Clothing ST CBDEPMEDS CBPS Level 3 JCESM M41
PATS M20/M20 A-1 Dryvax Vaccine JECP
(Mobile/Trans/Facility)
BATTLESPACE MANAGEMENT JEM JWARN JOEF
DECONTAMINATION JSSED JSPDS JSTDS (Large/Small/
Scale) M17A3 JSMPDS Level 2  
- ST
FORCE PROTECTION ALS UCS
41
Option 2 Security Challenge Remediation
CATASTROPHIC Plague Vaccine Level 1 Multiagent
Vaccine JBAIDS Dryvax Vaccine JBSDS JBTDS
TRADITIONAL SST ST Level 1 Protection Mask
Clothing ST JCESM M41 PATS M20/M20
A-1 JCBAWM JCAD JEM JWARN JOEF JSSED JSPDS
JSTDS (Large/Small/ Scale) M17A3 JSMPDS Level
2 ALS UCS  
DISRUPTIVE Col Prot ST Level 1 CBDEPMEDS CBPS
Level 3 JECP (Mobile/Trans/Facility) JSLSCAD
- ST
42
Option 3 Future Threat Prioritization
DETECTION BIDS JSLNBCRS LAV
PROTECTION CBPS Level 1
DECONTAMINATION JSMPDS Level 1  
- ST
43
Option 3 Security Challenge Remediation
CATASTROPHIC BIDS
DISRUPTIVE CBPS Level 1
TRADITIONAL JSLNBCRS LAV JSMPDS Level 1
- ST