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CTR Orientation Biological Threat Reduction Program BTRP

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Title: CTR Orientation Biological Threat Reduction Program BTRP


1
CTR OrientationBiological Threat Reduction
Program (BTRP)
  • Shawn Cali, Program Manager
  • 12 April 2007

2
BTRP Mission, Goals and History
3
Program Purpose and Objectives
  • BTR Program 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
Program History
  • 1995Defense Special Weapons Agency (DSWA) begins
    work to eliminate the BW Production Facility at
    Stepnogorsk, Kazakhstan.
  • 1996DoD, 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.
  • 1997National 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.
  • 1998The Defense Threat Reduction Agency (DTRA)
    is established
  • 1998The Biological Weapons Proliferation
    Prevention (BWPP) Program initiates Biosecurity
    and Biosafety (BSS) and Cooperative Biological
    Research (CBR) projects in Russia and BSS in
    Kazakhstan.
  • 2001Uzbekistan is added to BWPP portfolio BSS
    and CBR projects are initiated.
  • 2002Georgia is added to BWPP portfolio new
    project area of Threat Agent Detection and
    Response (TADR) begins in Kazakhstan, Uzbekistan,
    and Georgia.
  • 2005Ukraine and Azerbaijan are added to the BWPP
    portfolio following the signature of Implementing
    Agreements. BSS and TADR are integrated into a
    single project area.
  • 2006BWPP Program becomes Biological Threat
    Reduction Program Area (BTRP).

5
BTRP USG Partners
  • 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)
  • Future USG
  • US Department of Agriculture (USDA)
  • Naval Medical Research Center (NMRC)
  • Army Corps of Engineers
  • Medical Research and Material Command (MRMC)

6
BTRP International/Non-Governmental Organizations
and Contractors
  • 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)
  • National Academies of Science (NAS)
  • Civilian Research and Development Foundation
    (CRDF)
  • Joint University Partnership (Penn State and U
    of New Mexico)

7
BTRP Functional Areas
I.
II.
III.
IV.
8
Current Scope of Activities
9
Cooperative Biological Research (CBR)
10
Cooperative Biological Research (CBR)
  • Goal Engage scientists with biological weapons
    related expertise in mutually beneficial research
    and enhance their diagnostic and epidemiological
    capabilities

11
CBR Background
  • BTRP Strategic Objectives
  • Prevent proliferation of biological weapons (BW)
    related expertise
  • Encourage higher standards of openness, ethics,
    and conduct
  • Integrate former BW scientists and institutes
    into the Western scientific community
  • Transfer pathogen strains to the United States
  • Engage scientists in developing medical
    countermeasures to biological threats
  • Integrate CBR activities with other program
    areas. In non-Russia integrated with the Threat
    Agent Detection and Response (TADR) program (to
    include promotion of strain transfer and
    consolidation efforts)

12
CBR Engagement Strategy
  • BTRP Research Agenda - Identifies key program
    research priorities
  • Surveillance and Epidemiology
  • Diagnostics
  • Biology of the Microbe
  • Host Response
  • Vaccines
  • Therapeutics
  • Country Science Plan - basis for scientific
    investment in recipient state
  • Harmonizes BTRP Research Agenda with country and
    DoD goals
  • Lays out existing research and projects
  • Includes recommendations for future BTRP-funded
    research
  • Based on EDP occurrence (historical and current),
    pathogen collections and BW history (if any)
  • With recipient state buy in, sets out transition
    paths for non-EDP future research for institutes
    and scientists
  • Identifies basis for cooperation with other USG
    entities

13
CBR Program Scientific Disciplines and Studies
14
Keys to Success
  • Improve coordination among the large group of
    USG, NGO and international partners
  • Increase the level of scientific expertise and
    core competencies among host country scientists
  • Change the host nation culture with respect to
    bio safety/security
  • Institute long term plans within universities

15
Biosafety Biosecurity/Threat Agent Detection
and Response (BSS/TADR) Project
16
Bio-SafetyBio-Security/Threat Agent Detection
and Response (BSS/TADR)
17
BSS/TADR Background
  • BTRP Strategic Objectives
  • Consolidate and secure EDPs in centralized
    laboratories
  • Enhance capacity to detect, diagnose and respond
    to bioterror attacks and potential pandemics
  • Improve biosafety and biosecurity
  • Deploy modern diagnostics to eliminate need for
    multiple reference pathogen collections
  • Optimize recipient states existing surveillance
    systems
  • Facilitate transfer of pathogens and data to DOD
    and other USG entities
  • Train mobile epidemiological teams equipped to
    investigate outbreaks of human and veterinary
    especially dangerous infections
  • Provide dedicated transport for samples and
    pathogen consolidation

18
TADR Components
  • 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/Epidemiolo
    gist

19
Threat Agent Detection and Response Network
HS
Transfer Pathogens
HS
CAPACITY
VS
CAPACITY
Shared Information
HS
OS
CAPACITY
OS
HS
OS
OS
CAPACITY
HS
CAPABILITY
MORU is deployed from CRL level to fight outbreak
when Oblast resources not sufficient
20
Central Reference Laboratory (Government
Furnished Design)
  • The CRL will
  • Consolidate EDPs in a secure repository (museum)
  • Shared human and veterinary health facility
  • Confirm pathogen identifications made at the EMSs
  • Analyze epidemiological data at the national
    level and provide associated database management
  • Meet U.S. biosafety and appropriate DoD
    biosecurity standards with biosafety level (BSL)
    2 and 3 laboratories for diagnosis and research

21
Select Agent Security
  • Repository meets US DOD security standards
  • Select Agent inventory and access controlled by
    BTRP Pathogen Asset Control System (PACS)(GFI), a
    Government Furnished Design, that provides
    electronic database with associated
    infrastructure and equipment
  • Select Agents will be characterized through
    cooperative research projects in the US and
    Recipient State

22
Epidemiological Monitoring Station (EMS)
  • Uses standard microbiological and modern
    molecular techniques (ELISA and PCR) to identify
    EDPs in human and animal samples
  • Reports results to epidemiologist via the
    Electronic Integrated Disease Surveillance System
    (EIDSS)
  • Operates at BSL 2
  • Packages and sends suspect/probable EDP samples
    to the CRL for confirmation

23
Oblast/Regional/Zonal Laboratories
  • Conducts quick screening tests for EDPs
    (dipstick, microscopy)
  • Performs some serological analysis
  • Receives, processes and packages samples for
    transfer to an EMS for further analysis
  • EIDSS to report results to from epidemiologist
  • Operates at BSL1-2

24
Enhanced Disease Surveillance and Reporting under
TADR
  • Receive reports of suspect EDP cases
  • Investigate cases and collect samples
  • Have dedicated transport to facilitate
    investigations
  • Deliver sample to the laboratory
  • Report case investigations by the Electronic
    Integrated Disease Surveillance System
    (EIDSS)(GFI)
  • Perform computer based epidemiological analysis

25
EIDSS
  • EIDSS integrates human and veterinary laboratory
    and surveillance EDP data and sends it in near
    real time to recipient state stakeholders and US
    governmental agencies
  • EIDSS tracks data from the lowest levels of EDP
    reporting, investigating, sampling, testing and
    lab results to the highest national level

26
Mobile Outbreak Response Unit
  • An interdisciplinary team of epidemiologists,
    laboratorians physicians and/or veterinarians
  • Deployed from the National level to provide
    additional surveillance, diagnostic and response
    capacity when local resources are not sufficient
    to control an outbreak
  • The team will have EIDSS connectivity and bring
    equipment for active disease surveillance and
    case investigation and for molecular diagnostics

27
Training in the BTR Program85-95 Government
Developed
  • Biosafety, security, laboratory diagnostics and
    epidemiology practices are trained to ensure the
    success of the BSS/TADR project and the overall
    sustainment of the BTR Program
  • Train-The-Trainer
  • Recipient State
  • Striving towards self-sufficiency
  • Module Based Training
  • Epidemiology
  • Laboratory
  • Communications and Information Technology
  • Pathogen Repository
  • Contaminant Assessment
  • Clinician Training

28
Keys to Success
  • Avoid over-engineering of safety or security
    requirements
  • Conduct prior research towards construction and
    logistic permit requirements to avoid schedule
    delays
  • Eliminate excessive layers of management and
    reduce management costs
  • Optimize in-country presence resulting in better
    subcontractor oversight
  • Develop sound understanding of recipient state
    regulations
  • Ensure system engineering plans provide latest
    technology upon FOC
  • Empower in-country managers to make decisions on
    requests from DTRA leadership
  • Develop innovative approaches to enhance the
    Disease Surveillance System
  • Focus on coordination between major TADR
    requirements construction, IT, training, etc.
  • Provide timely logistical support to the
    laboratory system
  • Implement existing training programs

29
BTRP Integrated Logistics Support
30
BTRP Integrated Logistics Support
  • In each recipient state, sustain efforts for no
    more than five years after reaching full
    operational capability

Integrated Logistics System
31
BTRP Integrated Logistics Support Requirements
  • Support normal and surge operations
  • Provide and maintain warranties and licenses
  • Comply with all USG, international, and recipient
    state import and export regulatory requirements
  • Effectively and efficiently set up operations and
    sustain them
  • Work from outset with recipient states to ensure
    that they can sustain the integrated logistics
    system after USG disengagement
  • Consider integrated logistics support needs
    during project planning/systems engineering

32
Keys to Success
  • Conduct continuous market research
  • Involve recipient state in decision making
  • Include supportability in systems design
  • Develop an efficient re-ordering process
  • Include detailed logistics/maintenance plans
  • Adopt systems approach to logistics support
    planning
  • Include logistics communication between
    scientists and planners

33
Government Furnished Equipment Data
  • Data provided to the Government from previous
    contracts may be used for future contracts
  • Diagnostic Protocols
  • Training curriculum and materials
  • Laboratory operations and quality assurance
    manuals
  • Laboratory blueprints
  • EIDSS, PACS

34
Conclusion
35
Program Summary
  • Well defined.
  • Complex and highly technical.
  • Many USG/NGO partners.
  • Several countries/governments.
  • Long term obligations and policies.
  • Rapidly changing environment, both politically
    and technically.

36
Current and Potential Future Countries
Moldova
Current
Future
37
BTRIC Contractors Must
  • Reduce integration costs and management structure
  • Optimize oversight and control of subcontractors
  • Propose innovative approaches
  • Avoid over-engineering of solutions
  • Synchronize efforts across and throughout the
    program
  • Look for cost savings
  • Adopt an integrated DOTMLPF approach to tasks
  • Facilitate relations with USG partners,
    international/non-Governmental organizations,
    contractors, and Foreign Governments
  • Focus on sustainment efforts
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