Threat Agent Detection and Response (TADR) Program

1. Threat Agent Detection and Response (TADR) Program

2. Objectives • Background • Partner Countries • Focus Areas • Laboratory Diagnostics Training Project • Challenges

3. Program Purpose andObjectives • Biological Threat Reduction Program (BTRP) Purpose: • To counter bioterrorism and prevent proliferation of biological weapons (BW) related technology, pathogens and expertise at the source • BTR Program Objectives: • Prevent the sale, theft, diversion or accidental release of BW materials, technology and expertise • Consolidate especially dangerous pathogens (EDPs) into safe, secure central reference laboratories • Improve Eurasian states’ capabilities to detect and respondto EDP disease outbreaks • Integrate Eurasian scientists into the international scientific community • Eliminate BW infrastructure and technologies

4. Program History 1995—Defense Special Weapons Agency (DSWA) begins work to eliminate the BW Production Facility at Stepnogorsk, Kazakhstan. 1996—DoD, the Russian Federation, and the International Science and Technology Center (ISTC) sign an agreement to fund nonproliferation projects approved by both the United States and Russia. 1997—National Academies of Science report, Controlling Dangerous Pathogens, recommends that DoD establish a program to engage former Soviet Union BW scientists in collaborative research - approved by the Defense Science Board. 1998—The Defense Threat Reduction Agency (DTRA) is established 1998—The Biological Weapons Proliferation Prevention (BWPP) Program initiates Biosecurity and Biosafety (BS&S) and Cooperative Biological Research (CBR) projects in Russia and BS&S in Kazakhstan. 2001—Uzbekistan is added to BWPP portfolio; BS&S and CBR projects are initiated. 2002—Georgia is added to BWPP portfolio; new project area of Threat Agent Detection and Response (TADR) begins in Kazakhstan, Uzbekistan, and Georgia. 2005—Ukraine and Azerbaijan are added to the BWPP portfolio following the signature of Implementing Agreements. BS&S and TADR are integrated into a single project area. 2006—BWPP Program becomes Biological Threat Reduction Program Area (BTRP). ** BTRP will now be known as Cooperative Biological Engagement Program (CBEP)

5. BTRP Partners (US Govt) • USG Partners: • Walter Reed Army Institute of Research (WRAIR) • Armed Forces Institute of Pathology (AFIP) • U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) • Centers for Disease Control and Prevention (CDC) • Naval Medical Research Unit (NAMRU-3) • DOS Bio Industry Initiative (BII) • DHHS Bio Technology Engagement Program (BTEP) • DTRA (CB, ASCO, OS) • US Department of Agriculture (USDA) • Naval Medical Research Center (NMRC) • Army Corps of Engineers • Medical Research and Material Command (MRMC)

6. Other BTRP Partners • International/NGOs : • World Health Organization (WHO) • Food and Agriculture Organization of the United Nations (FAO) • International Office of Epizoonotics (OIE) • International Atomic Energy Agency (IAEA) • World Bank • Canadian Global Partnership (GPP) • American Biosafety Association (ABSA) • Contractors: • Science Applications International Corporation (SAIC) – Threat Reduction Support Center (TRSC) • Cooperative Threat Reduction Integrating Contractors (CTRIC) (Bechtel, Raytheon, Black & Veatch, etc.) • National Academies of Science (NAS) • Civilian Research and Development Foundation (CRDF) • Joint University Partnership (Penn State and U of New Mexico)

7. Current Scope of Activities

8. BTRP Functional Areas I. II. III. IV.

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10. TADR Objectives • Enhance capacity to detect, diagnose and respond to bioterror attacks and potential pandemics • Deploy modern diagnostics to eliminate need for multiple reference pathogen collections • Consolidate and secure EDPs in centralized laboratories • Facilitate transfer of pathogens and data to DOD, USG • Improve biosafety and biosecurity • Optimize recipient state’s existing surveillance systems • Train mobile epidemiological teams equipped to investigate outbreaks of human and veterinary infections

11. National Level Oblast Level Raion Level TADR Template • Central Reference Laboratory (CRL) • Human and veterinary facilities combined where feasible • Mobile Outbreak Response Unit(s) • Epidemiological Monitoring Stations (EMS) at existing Human and Veterinary Laboratories • Disease surveillance and epidemiologic analysis • Case investigation and sample transport capabilities • Disease diagnostics by molecular methods • Oblast Disease Surveillance Enhancement • Disease surveillance and epidemiologic analysis • Case investigation and sample transport capabilities • Disease reporting by Raion Veterinarian/Epidemiologist

12. Epidemiological Monitoring Station Epidemiological Monitoring Station Oblast Surveillance Oblast) OSS OS OSS OSS Human Surveillance HSS HS HSS HSS Veterinary Sentinel Site VSS VS VSS VSS Mobile Outbreak Response Unit (MORU) Mobile Outbreak Response Unit (MORU) Electronic Integrated Disease Surveillance System (EIDSS) Electronic Integrated Disease Surveillance System (EIDSS) Transportation by TADR Response Vehicle Transportation by TADR Response Vehicle TADR Network Schematic HS Transfer Pathogens HS CAPACITY CAPACITY VS Shared Information HS OS CAPACITY OS HS OS OS CAPACITY HS CAPABILITY

13. Training in the BTR Program • Biosafety, security, laboratory diagnostics and epidemiology practices are trained to ensure the success of the TADR project • Train-The-Trainer • Goal: Recipient state self-sufficiency • Module Based Training: • Epidemiology • Communications and Information Technology • Clinician Training • Laboratory • Vector surveillance • Pathogen Repository • Contaminant Assessment

14. Laboratory Diagnostics Training • Quality Management Systems (QMS) training • Combination of classical and molecular-based diagnostics for the following agents: • Bacillus anthracis • Francisella tularensis • Yersinia pestis • Brucella abortus • Primarily molecular-based diagnostics for the following agents: • Crimean Congo Hemorrhagic Fever • Tick-borne Encephalitis • (Avian influenza) • (Smallpox)

15. Sample: Diagnostics training for Brucella • Rose-Bengal test (serological testing) • Primary culture from a clinical specimen • Gram stain • Biochemical testing (Oxidase, Catalase, Urease tests) • Acriflavine (Rough v. Smooth surface antigen) test • Dye sensitivity assays • Triple Sugar Iron Test • Hydrogen Sulfide Test • RT-PCR

16. Challenges • Existing infrastructure • Retrofit? • Blow it in place?

17. Challenges • Existing infrastructure • Retrofit? • Blow it in place?

18. Challenges • Existing infrastructure • How old is the equipment? • Does it work?

19. Challenges • Existing infrastructure • Existing culture and practices • Foreign • Unsafe? • How do we reconcile old and new? • How do you teach Quality? • How do you make it “stick” when you leave?

20. Challenges • Existing infrastructure • Existing culture and practices • Recipient state regulations • Permission for lab construction/renovation • Local contracting issues • Lab certification • Import/export (Shipping and receiving of bacterial strains, etc.) • Getting permission to conduct training • Getting a protocol authorized

21. Challenges • Existing infrastructure • Existing culture and practices • Recipient state regulations • Safety or security requirements

22. Challenges • Existing infrastructure • Existing culture and practices • Recipient state regulations • Safety or security requirements

23. Challenges • Existing infrastructure • Existing culture and practices • Recipient state regulations • Safety or security requirements • Schedule delays • Me: Let’s train in November • Them: Suspected H1N1 outbreak, govt doesn’t want you around, your trip is canceled • Me: Let’s train in November • Them: The lab isn’t certified, your trip is canceled • Me: Let’s train in February • Them: We don’t have the control strains, your trip is canceled • Me: Let’s train in March • Them: Your paperwork wasn’t processed correctly, your trip is cancelled • Me: How about April???

24. Challenges • Existing infrastructure • Existing culture and practices • Recipient state regulations • Safety or security requirements • Schedule delays • Sustainability • People • Equipment • Supplies • How do you retain newly-trained employees? • Which equipment do you purchase • The type that works best? • The type that they can get the supplies for? • Identify reagants that are: • Inexpensive • Reliable • Available (from someplace closer than the continental US!)

25. Challenges • Existing infrastructure • Existing culture and practices • Recipient state regulations • Safety or security requirements • Schedule delays • Sustainability • People • Equipment • Supplies

26. QMS training in Ukraine

27. Renovated lab space in Azerbaijan

28. RT-PCR training in Georgia

32. Questions?