1. Chemical and Biological Defense Program (CBDP) Briefing CDR Franca R. Jones, Ph.D. Principal Director and Director of Medical Programs Office of the Assistant Secretary of Defense for Chemical and Biological Defense July 23, 2015 UNCLASSIFIED

2. Chemical and Biological Defense Program Established by 50 USC 1522 (PL 103-160) to integrate research, development, and acquisition of capabilities to provide all Services with effective and integrated chemical and biological (CB) defense detection, protection, and response capabilities. Remains relevant today as fiscal environment causes Services to cut perceived lower priority efforts. One of the main factors for establishing this program in 1993 was Services were not adequately funding this area. Must consider National, Departmental, and Service priorities – Responds to strategic National priorities outlined in the 2014 Quadrennial Defense Review, the National Strategy for Countering Biological Threats (November 2009), and the National Strategy for Biosurveillance (July 2012) 2 Priorities Biosurveillance Diagnostics Medical Countermeasures Non-Traditional Agents and Emerging Threats

3. Chemical Biological Defense Program (CBDP) Overview The CBDP supports comprehensive DoD efforts to:  Research, develop, and acquire capabilities for a layered, integrated defense focused on CB threats  Better understand potential threats – Further develop capabilities to respond to current and traditional threats – Respond to natural and emerging infectious diseases – Counter advanced threats (engineered pathogens, Non-traditional agents, etc.)  Secure and reduce dangerous materials whenever possible – Proponent for DoD biosecurity and biosafety – Working with Threat Reduction and Arms Control: Cooperative Threat Reduction/Cooperative Biological Engagement Program (CBEP) efforts Global CWMD Situational Awareness System (GCAS)  Leverage industry and interagency partnerships This program is a key part of a comprehensive, national strategy to prevent, protect, and respond to an ever-evolving spectrum of emerging 21st century chemical and biological threats DoD has unique operational requirements, a global presence, and significant current and emerging threats 3

4. Chemical and Biological Defense Program Vision, Mission, and Priorities CBD Vision A Department of Defense that addresses chemical, biological, radiological, and nuclear (CBRN) threats and minimizes their effects CBD Mission Enable the Warfighter to deter, prevent, protect, mitigate, respond, and recover from CBRN threats and effects as part of a layered, integrated defense The CBDP is a key part of a comprehensive national strategy to prevent, protect, and respond to an evolving spectrum of 21 st Century CBRN threats 4 NCB Mission Drive the capability to prevent, protect against, and respond to weapons of mass destruction threats NCB Vision A world safe from nuclear, chemical, and biological threats

5. CBDP Enterprise Organization 5 SCIENCE AND TECHNOLOGY REQUIREMENTS Chairman, Joint Chiefs of Staff Director, J-8 Joint Requirements Office CBRN Defense Under Secretary of Defense (Acquisition, Technology, and Logistics) OVERSIGHT Assistant to the Secretary of Defense (Nuclear, Chemical, and Biological Defense Programs) Deputy Assistant to the Secretary of Defense for Chemical Biological Defense and Chemical Demilitarization Programs Joint Science and Technology Office (Chemical and Biological Defense) Director, Defense Threat Reduction Agency (DTRA) DARPA Overarching Integrated Product Team (OIPT) Under Secretary of Defense (Policy) Ass’t Secretary of Defense (Health Affairs) DoD General Counsel Under Secretary of Defense (Comptroller) Services Other Stakeholders Joint Program Executive Office Chemical and Biological Defense Joint Program Executive Office Chemical and Biological Defense CBDP Test and Evaluation Executive CBDP Test and Evaluation Executive Program Analysis and Integration Office Program Analysis and Integration Office Army Chief of Staff Secretary of the Army Deputy Under Secretary Army Army Acquisition Executive SCIENCE AND TECHNOLOGY REQUIREMENTS Chairman, Joint Chiefs of Staff Director, J-8 Joint Requirements Office CBRN Defense Under Secretary of Defense (Acquisition, Technology and Logistics) OVERSIGHT Assistant Secretary of Defense (Nuclear, Chemical, and Biological Defense Programs) Deputy Assistant Secretary of Defense for Chemical and Biological Defense Joint Science and Technology Office (Chemical and Biological Defense) Director, Defense Threat Reduction Agency (DTRA) DARPA Overarching Integrated Product Team (OIPT) Under Secretary of Defense (Policy) Ass’t Secretary of Defense (Health Affairs) DoD General Counsel Under Secretary of Defense (Comptroller) Services Other Stakeholders Joint Program Executive Office CBRN Defense CBDP Test and Evaluation Executive Program Analysis and Integration Office Army Chief of Staff Secretary of the Army Deputy Under Secretary ArmyArmy Acquisition Executive ADV DEVELOPMENT & ACQUISITIONPROGRAM INTEGRATIONTEST AND EVALUATION 12-S-3080

6. Biological Threats Traditional Threats Bacterial pathogens (anthrax, plague) Viral pathogens (WEE, VEE, Ebola) Toxins (botulinum, ricin) Emerging Threats Current infectious diseases (Influenza, Brucellosis) Emerging infectious disease (zoonotic pathogens) Threat Environment 6 Chemical Threats Traditional Threats Chemical warfare agents (nerve, blood, blister, and pulmonary) Agents designed for military operations/applications Toxic Industrial Materials (TIMs)/Toxic Industrial Chemicals (TICs) Advanced Threats Non-traditional Agents (NTA) Asymmetric applications and/or engagements Enhanced Threats Strains enhanced for environmental survivability Selection or creation of hypervirulent strains and pathogens with increased resistance to preventatives and treatments Advanced Threats Pathogens with altered targets or symptoms to confound diagnosis and treatment Creating viruses de novo 15-S-1229

7. Coordination, Cooperation, Integration 7 Department of Defense International Interagency Industry and Academia 15-S-1229

8. Deputy Assistant Secretary of Defense for Chemical and Biological Defense Total Chemical and Biological Protection for the Warfighter 8 Internal External Environmental Detection Individual Protection Collective Protection Decontamination Vaccines Pre-treatments Diagnostics Therapeutics 15-S-1229

9. Deputy Assistant Secretary of Defense for Chemical and Biological Defense CBDP: A Systems Approach 9 Pre-Incident Post-Incident Incident CBDP Capabilities Constructs Sense ShapeShield Sustain Prevent ProtectRespond Recover Pretreatments Surveillance Detection Surveillance Detection Reconnaissance Individual Protection Collective Protection Therapeutics Diagnostics Decontamination Common Technologies

10. Deputy Assistant Secretary of Defense for Chemical and Biological Defense  The DoD’s development and prepositioning of a diagnostic assay for Ebola allowed rapid deployment of this asset when the need arose in West Africa.  The DoD’s EZ-1 assay was used extensively overseas as well as at home. Ebola Diagnostic Assay EZ-1

11. Deputy Assistant Secretary of Defense for Chemical and Biological Defense  The DoD also contributed to the development of the BioFire Filmarray, an improved assay for diagnosing Ebola virus disease, as well as other infectious diseases. BioFire Filmarray Assay 11

12. Deputy Assistant Secretary of Defense for Chemical and Biological Defense  Originally funded by the DoD, ZMAPP is a cocktail of three humanized antibodies that bind to the Ebola glycoprotein.  Production of these antibodies in tobacco plants required extensive biological and process engineering efforts. ZMAPP 12

13. Deputy Assistant Secretary of Defense for Chemical and Biological Defense Transport Isolation System 13  The Transport Isolation System (TIS) provides a patient isolation unit to increase caregiver safety (expands single patient Aeromedical Biological Containment System (ABCS) concept to multiple patient use on military cargo aircraft  The primary goal of the TIS100A is to preserve and enhance the Aeromedical Evacuation (AE) mission by providing an adaptable / modular isolation system  The TIS provides aircraft crew with a system for the effective isolation of exposed / infected personnel during flight operations  The TIS integrates with the C-17 and C-130 transportation aircraft (among others)

14. Deputy Assistant Secretary of Defense for Chemical and Biological Defense  The Field Deployable Hydrolysis System (FDHS) is a system designed to render chemical warfare materiel into compounds not usable as weapons with a resulting destruction efficiency of 99.9 percent.  The FDHS was mounted on the MV Cape Ray and deployed to Syria charged with the destruction of their chemical weapons stockpiles.  Aug. 18, 2014 – Defense Secretary Chuck Hagel has congratulated the crew of the Cape Ray for completing the work of neutralizing Syrian chemical weapons components. Field Deployable Hydrolysis System 14

15. Deputy Assistant Secretary of Defense for Chemical and Biological Defense Chemical Biological Protective Shelter 15 Program Description Mobile, self-contained, rapidly deployable chemical and biological shelter that provides a contamination-free, environmentally-controlled medical treatment area for U.S. Army Medical units

16. Deputy Assistant Secretary of Defense for Chemical and Biological Defense  Provides a set of tools and capabilities that will facilitate the timely identification and detection of biological events in order to minimize operational impacts to the local and global populations.  Provides an integrated suite of web-based components designed to support public health officers, environmental officers, clinicians, physicians, and CBRN personnel as they maintain their situational awareness of local, regional, and global biological threats to the public.  BSP 1.0 leverages existing tools and technologies to provide users across multiple organizations and disciplines with a centralized “one-stop shop” for all of their Biosurveillance resources. The Biosurveillance Portal (BSP) 16

17. Reducing Operational Impacts from Chemical and Biological Threats 17 Operational Impact Prevent Protect RespondRecover Additional Pretreatments Improve Surveillance (Information & Sensors) Additional Vaccines Decontamination DetectionProtection Integrated Protection How can we fill the gap to reduce operational impact? Effectiveness of Countermeasures Therapeutics Bio defense detect / diagnose to treat Biological Window of Treatment Limited Vaccines Biological Window of Treatment TherapeuticsDetection ProtectionDecontamination Chemical Window of Treatment Limited Pretreatments Chem defense detect to warn Biological Window of Treatment Diagnostics 15-S-1229

18. The CBDP is pursuing an approach that provides comprehensive protection to the Warfighter and the Nation against current and future threats. The CBDP is the center of gravity within the U.S. Government for defense against NTA threats. DoD/HHS are indispensable partners in the coordinated development of chemical and biological defense medical countermeasures for the Warfighter and the Nation. The CBDP must maintain critical infrastructure to achieve its strategic goals and objectives. The Bottom Line 18 UNCLASSIFIED

19. Deputy Assistant Secretary of Defense for Chemical and Biological Defense "The level of outbreak [Ebola] is beyond anything we’ve seen—or even imagined." - Dr. Tom Frieden, Centers for Disease Control and Prevention, September 2014 “On that terrible night, the world saw in gruesome detail the terrible nature of chemical weapons, and why the overwhelming majority of humanity has declared them off-limits -- a crime against humanity, and a violation of the laws of war.” - President Obama, September 10, 2013 These Challenges are Relevant Today… 19 15-S-1229

20. Questions? UNCLASSIFIED