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 “The greatest threat before humanity today is the possibility of secret and sudden attack with chemical, or biological, or nuclear weapons” President George W. Bush Remarks at the National Defense University 11 February 2004

3. BioDefense for the 21st Century:Presidential 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 Defense’s 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 StrategyToday’s 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 • 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) • Disruptive • International competitors developing and possessing breakthrough technological capabilities intended to supplant U.S. advantages in particular operational domains. (capsize 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 Traditional Nuclear Asymmetric Weapons Nuclear Bombs Nuclear Missiles Tactical Nukes Radiological Dispersion Devices Improvised Nuclear Devices Nuclear Power Plants

7. Looking Across Challenges -- CBDP Illustrative Example Alt #1: CBDP (POM 06-11) Traditional Irregular Catastrophic Disruptive 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 RDT&E / 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; RDT&E 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 Joint Requirements Office Joint Science & Technology Office Joint Program Executive Office Joint Test & Evaluation Executive Joint Combat Developer 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 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) Risk Pre 9/11 POM 06-11 Today’s 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 • 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 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 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 Industry, Academia DOD DHHS Product Discovery Product TransitionCivilian 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 HHS funds to NIAID Bioshield No national strategy, clear responsibility or federal funding to shorten this cycle Basic Research Prototype Design or Discovery Preclinical Development Clinical Development FDA Approval Production Methods Production 2 years 2 years 3 years 4 years 1 year 1 year 10 years - $800M Economicand Social Catastrophe Attack with New Threat Safe & Effective Countermeasure

24. The SolutionDramatically reduce the time to develop countermeasures1 14 12 10 8 Current Cumulative Years New 6 4 2 0 Basic Research Discovery Pre- Clinical Clinical FDA Pre-Production Steps to Countermeasure 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 improvementto 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 Clinical Pre-clinical Biology Chemistry Pharmacology I II III Drug Testing Human Trials Human Trials Human Trials Small Molecules Genome Targets Assays Leads Safety Early clinical Pharma- cology Clinical Efficacy & Safety Full scale DB trial with controls Diagnostics Animal Studies ADME / Tox Pharmacogenomics Genomics CombiChem HTS HTS Proteomics Microfluidics Cellular Assays Detection Platforms Sequencing Systems Geno & Phenotyping,SNP’s Structural Drug Design Bioinformatics Positional cloning Parallel sequencing Knock-outs Transgenics Expression arrays 2-D gels Mass Spec Structure-/ Function Detection Platforms Cellular Assays Lead optimization, ADME, Tox Process Chemistry Formulation Chemistry Manufacturing Scale-up Bioinformatics Molecular Informatics Clinical Informatics Automation, Robotics, Informatics, CAD Sensitive & Selective Detection Supply Chain Large Scale Testing / Higher Densities + +/- + + +/- +/- + - - +/- + +

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 RDT&E) 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 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. New Technology-New Approaches Modeling & Simulation Protection Decontamination Detection Non-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. • 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 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 warfighter’s 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 modeling–more 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 S&T Bio Point Det Chem Standoff S&T SST S&T 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) 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   - S&T PROTECTION Col Prot S&T Level 2

39. Option 1 – Security Challenge Remediation 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) 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 DISRUPTIVE Gen Engineered Threats Col Prot S&T Level 2 Resuscitative Intervention Chem Standoff S&T IRREGULAR Radioprotectants - S&T

40. Option 2 – Future Threat Prioritization DETECTION SST S&T Level 1 JBSDS JCAD JSLSCAD JBTDS JCBAWM MEDICAL COUNTERMEASURES Protectant Plague SDD Level 1 Multiagent Vaccine Diagnostics JBAIDS 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) BATTLESPACE MANAGEMENT JEM JWARN JOEF DECONTAMINATION JSSED JSPDS JSTDS (Large/Small/ Scale) M17A3 JSMPDS Level 2 - S&T FORCE PROTECTION ALS UCS

41. Option 2 – Security Challenge Remediation CATASTROPHIC Plague Vaccine Level 1 Multiagent Vaccine JBAIDS Dryvax Vaccine JBSDS JBTDS 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 DISRUPTIVE Col Prot S&T Level 1 CBDEPMEDS CBPS Level 3 JECP (Mobile/Trans/Facility) JSLSCAD - 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