Threat Agent Detection and Response (TADR) Program.

Threat Agent Detection and Response (TADR) Program

Objectives

• Background

• Partner Countries

• Focus Areas

• Laboratory Diagnostics Training Project

• Challenges

3

Program Purpose and Objectives

• 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 respond to EDP

disease outbreaks• Integrate Eurasian scientists into the international scientific

community• Eliminate BW infrastructure and technologies

4

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).

Program History

** BTRP will now be known as Cooperative Biological Engagement Program (CBEP)

5

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)

BTRP Partners (US Govt)

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

I. II.

III. IV.

BTRP Functional Areas

9

10

• 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

TADR Objectives

11

• 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

Nat

ion

al

Lev

elO

bla

st L

evel

Rai

on

L

evel

TADR Template

12

TADR Network Schematic

CAPACITY

CAPACITY

Shared Information

Transfer Pathogens

HSHS

HSHS

HSHSHSHS

HSHSVSVS CAPACITY

OSOS

OSOS

OSOS

OSOSCAPACITY

CAPABILITY

Epidemiological Monitoring Station

OSSOSS Oblast)

Mobile Outbreak Response Unit (MORU)

Electronic Integrated Disease Surveillance System (EIDSS)

HSSHSS

Transportation by TADR Response Vehicle

VSSVSS Veterinary Sentinel Site

Epidemiological Monitoring Station

OSSOS Oblast Surveillance

Mobile Outbreak Response Unit (MORU)

Electronic Integrated Disease Surveillance System (EIDSS)

HSSHS Human Surveillance

Transportation by TADR Response Vehicle

VSSVS

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?

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

Challenges

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

Challenges

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

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???

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!)

Challenges

• Existing infrastructure• Existing culture and practices• Recipient state regulations• Safety or security requirements• Schedule delays• Sustainability

– People– Equipment– Supplies

QMS training in Ukraine

Renovated lab space in Azerbaijan

RT-PCR training in Georgia

Questions?