Biological Threat Agents: Biological Threat Agents: Larry Kerr, Ph.D. Larry Kerr, Ph.D. Determination and Implication for Life Determination and Implication for Life Sciences Research Sciences Research Office of Science and Office of Science and Technology Policy Technology Policy Larry Kerr, Ph.D. Larry Kerr, Ph.D. Assistant Director for Homeland Assistant Director for Homeland Assistant Director for Homeland Security Assistant Director for Homeland Security Office of Science and Technology Policy Office of Science and Technology Policy Security Security Executive Office of the President Executive Office of the President MIT Security Studies Program MIT Faculty Club Cambridge, MA March 7, 2005
Comprehensive WMD Preparedness Strategy WMD EVENT PRE-EVENT POST-EVENT SURVEILLANCE PREVENTION PROTECTION RESPONSE AND RECOVERY AND DETECTION RESEARCH, DEVELOPMENT AND ACQUISITION Investment Review and Prioritization THREAT ASSESSMENT AND AWARENESS Domestic & International INFORMATION MANAGEMENT AND COMMUNICATIONS FUTURE THREAT INITIATIVE
Pillars of our Biodefense Program Strengthened International Cooperation Biodefense Knowledge Center Biodefense Knowledge Center Plum Island Animal Disease Center Public Preparedness Plum Island Animal Disease Center Bio- Bio -Countermeasures Countermeasures Creation and Maintenance of Infrastructure Testing and Evaluation Center Testing and Evaluation Center Bioforensic Analysis Center Bioforensic Research, Development and Acquisition Analysis Center Biothreat Assessment Support Center Biothreat Assessment Support Center Information Management & Communications Characterization Characterization SURVEILLANCE PROTECTION AWARENESS PREVENTION DETECTION RESPONSE RECOVERY THREAT Bioforensics Bioforensics Biodefense Biodefense terrorism terrorism terrorism terrorism - Agrobio- - Agrobio- Agrobio Agrobio
Biological Threats Contagious non-treatable Contagious non-treatable High “e.g. engineered viruses” “e.g. engineered viruses” Smallpox Smallpox Threat Sophistication Non-contagious, non-treatable Non-contagious, non-treatable Antibiotic-resistant Antibiotic-resistant anthrax anthrax Anthrax Medium Anthrax aerosol aerosol Agro Terror Agro Terror Cutaneous Anthrax Low Salmonella food poisoning Low Medium High Potential Consequence
Is “X” a threat? High Threat Sophistication Medium Low Low Medium High Potential Consequence
The Intelligence Community’s Cycle
The IC’s Collection “Disciplines” Human source intelligence (HUMINT) • the operational use of individuals who know or have access to sensitive information. [CIA, Defense HUMINT Service, DIA] Signals intelligence (SIGINT) • the information obtained from intercepted communications, radars or data transmission. [NSA] Imagery intelligence (IMINT) • the use of space-based, aerial, and ground-based systems to take electro-optical, radar or infrared images. [CIO] Measurement and Signature intelligence (MASINT) • the collection of data that locates, identifies, or describes distinctive characteristics of targets . [DIA]
Is “X” a threat? Subject Matter Experts: public health scientific biosafety veterinary law industry education etc.
“Lists” of Biological Threat Agents CDC “Select Agent” List • Sec. 551 The Antiterrorism and Effective Death Penalty Act of 1996 • “biological agents and toxins that have the potential to pose a severe threat to public health and safety” • CDC formed an interagency group of SMEs to develop the list • 10-26-01 USA Patriot Act – requirements for appropriate use of BTAs and imposes criminal and civil penalties for inappropriate use • Public Health Security and Bioterrorism Preparedness and Response Act 02 • Requires the list to be reviewed at least biennially USDA “ High Consequence Pathogens ” • Agricultural Bioterrorism Protection Act of 2002 “USDA Sec. to establish and maintain a list of biological agents and • toxins that have the potential to pose a severe threat to animal or plant health…”
CDC Select Agent List “Category A” •Anthrax ( Bacillus anthracis ) •Botulism ( Clostridium botulinum toxin) •Plague ( Yersinia pestis ) •Smallpox ( Variola major ) •Tularemia ( Francisella tularensis ) •Viral hemorrhagic fevers (filoviruses [e.g. Ebola, Marburg] and arenaviruses [e.g. Lassa, Machupol]) “Category B” •Brucellosis ( Brucella species) •Epsilon toxin of Clostridium perfringens •Food safety threats (e.g. Salmonella species, Escherichia coli 0157:H7, Shigella ) •Glanders ( Burholderia mallei ) •Melioidosis ( Burkholderia pseudomallei ) •Psittacosis ( Chlamydia psittaci ) •Q fever ( Coxiella burnetti ) •Ricin toxin from Ricinus communis (castor beans) • Staphylococcal entertoxin B •Typhus fever ( Rickettsia prowazekii ) •Viral encephalitis (alphaviruses [e.g Venezuelan equine, eastern equine, western equine]) •Water safety threats (e.g. Vibrio cholera , Cryptosporidium parvum ) “Category C” – emerging infectious diseases
Biological Threat Agent X High Potential Consequence Medium Low High Medium Low Threat Sophistication
Types of Threats / Means of Attack Nuclear Weapon/Explosive Radiological Dispersal Device Biological Weapon/Material Chemical Weapon/Material Conventional Explosive Complex Interdependencies Physical Force Cyber Means Banking & Finance Info & Telecomm Insider Transportation Public Health Emerging Threats Energy … Water Food “Targets” … and Vulnerabilities Prevent Attacks Reduce Vulnerability Minimize Damage & Recover Homeland Security Strategic Objectives
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Factors Influencing Biodefense R&D � Factors include: • (1) threat information; • (2) potential for major public health impact, such as large outbreaks of disease; • (3) anticipated morbidity and mortality; • (4) availability of safe and effective vaccine, drugs and other countermeasures; • (5) impact on health care infrastructure, economy and national security. � Promising products are accelerated in research & development.
Presidential Biosecurity Initiatives BioWatch Environmental Surveillance in Cities BioSurveillance Traditional and Non-traditional Clinical Symptom tracking BioShield Medical Countermeasures
Defending communities from biological attacks requires timely detection and warning BioSense Epidemic Epidemic Infections (Symptoms) 30000 Outcomes Outcomes Number Affected (Casualties/ Fatalities) 20000 Cities Preparedness BioShield 10000 Incubation Mass Casualty Care 0 0 2 4 6 8 10 12 5 10 15 20 25 BioWatch Days Hours Prevent Warn Protect Contain / Decon Treat Intel Facilities Wide area Restoration Early diagnostics Transport monitoring Portable detection Intel/Law Bldg. Mayor First responders Public Health Org. PHO owner Hazmat lead Forensics
PROJECT BIOSHIELD Project BioShield was announced by President Bush in his State of the Union address on January 28, 2003. $5.6 Billion over 10 years was appropriated to DHS in FY04. $890 million for the FY04, $2.5 billion for FY05-07 under DHS appropriations for “Project BioShield.” Project BioShield Act of 2004 (P.L. 108-276) was signed by President Bush on July 21, 2004 to develop and accelerate acquisition of medical countermeasures to CBRN threats.
BIOSHIELD 1. Establishes a new spending authority to spur development and procurement of “next generation” medical countermeasures (vaccines, therapeutics, and diagnostics) against biological, chemical, radiological, or nuclear agents . - This authority is granted to the Secretaries of DHHS and DHS to present to the President and OMB Director recommendations for procurement. 2. Authorizes the NIH/NIAID to speed research & development in promising areas of medical countermeasures to the agents. - Grants increased flexibility and authority to award contracts and grants under expedited peer review procedures; and - Allows more rapid hiring of technical experts deemed necessary for R&D. 3. Establishes new FDA “emergency-use” authorization for medical countermeasures - The authorization requires a finding by the Secretary of DHHS that the treatment in question is expected to have benefits in the emergency situation that outweight its expected risks. Authorization lasts one year.
WMD Medical Countermeasures RADIOLOGICAL BIOLOGICAL CHEMICAL NUCLEAR “Operational” R&D Components Components R&D T&E Vaccines Therapeutics Standards Acquisition Procurement Manufacture Diagnostics Deployment CONOPS
WMD Medical CM Committee • Prioritize federal initiatives • Address immediate and long-term needs • Recommend national requirements for vaccines, drugs, antitoxins, diagnostics • Represent needs of civilian and military • Coordinate research, development, and acquisition efforts of key federal agencies: HHS, DHS, and DoD • Accelerate development via public-private partnership
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