CTR Orientation Biological Threat Reduction Program BTRP

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CTR OrientationBiological Threat Reduction
Program (BTRP)

• Shawn Cali, Program Manager
• 12 April 2007

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BTRP Mission, Goals and History
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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

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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).

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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)

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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)

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BTRP Functional Areas
I.
II.
III.
IV.
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Current Scope of Activities
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Cooperative Biological Research (CBR)
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Cooperative Biological Research (CBR)

• Goal Engage scientists with biological weapons
  related expertise in mutually beneficial research
  and enhance their diagnostic and epidemiological
  capabilities

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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)

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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

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CBR Program Scientific Disciplines and Studies
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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

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Biosafety Biosecurity/Threat Agent Detection
and Response (BSS/TADR) Project
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Bio-SafetyBio-Security/Threat Agent Detection
and Response (BSS/TADR)
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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

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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

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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
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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

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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

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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

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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

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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

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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

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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

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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

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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

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BTRP Integrated Logistics Support
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BTRP Integrated Logistics Support

• In each recipient state, sustain efforts for no
  more than five years after reaching full
  operational capability

Integrated Logistics System
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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

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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

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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

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Conclusion
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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.

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Current and Potential Future Countries
Moldova
Current
Future
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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