Larry Kerr, Ph.D. Larry Kerr, Ph.D. Determination and Implication - - PowerPoint PPT Presentation

Larry Kerr, Ph.D. Larry Kerr, Ph.D.

Office of Science and Office of Science and Technology Policy Technology Policy

Assistant Director for Homeland Assistant Director for Homeland Security Security

Biological Threat Agents: Biological Threat Agents: Determination and Implication for Life Determination and Implication for Life Sciences Research Sciences Research

MIT Security Studies Program MIT Faculty Club Cambridge, MA March 7, 2005

Larry Kerr, Ph.D. Larry Kerr, Ph.D.

Assistant Director for Homeland Security Assistant Director for Homeland Security Office of Science and Technology Policy Office of Science and Technology Policy Executive Office of the President Executive Office of the President

PRE-EVENT POST-EVENT

PREVENTION PROTECTION SURVEILLANCE AND DETECTION RESPONSE AND RECOVERY

THREAT ASSESSMENT AND AWARENESS

Domestic & International

FUTURE THREAT INITIATIVE INFORMATION MANAGEMENT AND COMMUNICATIONS RESEARCH, DEVELOPMENT AND ACQUISITION

Investment Review and Prioritization

Comprehensive WMD Preparedness Strategy

WMD EVENT

Pillars of our Biodefense Program

Biodefense Biodefense Characterization Characterization Bioforensics Bioforensics Agrobio Agrobio-

• terrorism

terrorism Biothreat Biothreat Assessment Support Center Assessment Support Center Bio Bio-

• Countermeasures

Countermeasures Testing and Evaluation Center Testing and Evaluation Center Biodefense Biodefense Knowledge Center Knowledge Center Plum Island Animal Disease Center Plum Island Animal Disease Center Bioforensic Bioforensic Analysis Center Analysis Center THREAT AWARENESS

Public Preparedness

Agrobio Agrobio-

• terrorism

terrorism PREVENTION PROTECTION SURVEILLANCE DETECTION RESPONSE RECOVERY

Information Management & Communications Research, Development and Acquisition

Creation and Maintenance of Infrastructure

Strengthened International Cooperation

Biological Threats

Low High Salmonella food poisoning Cutaneous Anthrax Medium Low Medium High

Threat Sophistication Potential Consequence

Agro Terror Agro Terror Contagious non-treatable “e.g. engineered viruses” Contagious non-treatable “e.g. engineered viruses” Smallpox Smallpox Non-contagious, non-treatable Antibiotic-resistant anthrax Non-contagious, non-treatable Antibiotic-resistant anthrax Anthrax aerosol Anthrax aerosol

Low Medium High Low Medium High

Threat Sophistication Potential Consequence

Is “X” a threat?

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

Low Medium High Low Medium High

Threat Sophistication Potential Consequence

Types of Threats / Means of Attack “Targets” and Vulnerabilities Homeland Security Strategic Objectives

Nuclear Weapon/Explosive Radiological Dispersal Device Biological Weapon/Material Chemical Weapon/Material Conventional Explosive Physical Force Cyber Means Insider Emerging Threats … Prevent Attacks Reduce Vulnerability Minimize Damage & Recover Energy Info & Telecomm Public Health Transportation Water Food Banking & Finance

…

Complex Interdependencies

Arrow

Factors Influencing Biodefense R&D

Factors include:

• (1) threat information;
• (2) potential for major public health impact, such as large
• utbreaks of disease;
• (3) anticipated morbidity and mortality;
• (4) availability of safe and effective vaccine, drugs and
• ther 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

Prevent Protect Contain / Decon Treat 10000 20000 30000

Infections

5 10 15 20 25 Days 2 4 6 8 10 12 Hours Number Affected

Incubation Epidemic Epidemic (Symptoms) Outcomes Outcomes (Casualties/ Fatalities)

Warn

BioShield BioWatch BioSense

Wide area monitoring Intel Facilities Transport Restoration Portable detection Early diagnostics Intel/Law PHO Bldg.

• wner

Mayor First responders Hazmat lead Forensics Public Health Org.

Defending communities from biological attacks requires timely detection and warning

Mass Casualty Care Cities Preparedness

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

• n 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
• f 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

BIOLOGICAL CHEMICAL

RADIOLOGICAL NUCLEAR R&D Components “Operational” Components Vaccines Diagnostics Therapeutics R&D T&E Standards Acquisition Procurement Manufacture Deployment CONOPS

• 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

WMD Medical CM Committee

• Credibility and immediacy of threat
• Target population

– Who is targeted (civilian, military, high risk groups, other)? – In what settings would the countermeasure be used?

• Availability of alternative countermeasures

– Current and projected

• Dosing schedule for prevention or treatment
• Feasibility of deployment in a public health emergency
• Product shelf-life and ongoing requirements

How to spend $5.6 billion wisely?

Determination of Threat

Under Project Bioshield, DHS is responsible for Material Threat Determinations (MTDs)

• Material threat: any agent whose introduction into the U.S.

population is sufficient to affect national security

• Material Threat Determination (MTD): letter from the Sec DHS

that an agent constitutes a material threat

• Material Threat Assessment (MTA): a risk assessment (threat x

vulnerability x consequence) that: * forms the basis of an MTD decision * provides a “plausible worse case” for sizing the amounts

• f required countermeasures

Determination of Threat

MTAs focus on “plausible worse cases” and address:

• Intel information on capabilities and intent (DHS/IAIP + IC)

– Intelligence information not necessary for analysis but included

• Scientific feasibility (DHS/S&T + broad range of SMEs)
• acquiring material: finished product or seed stock
• production techniques: equipment, protocols, skills
• material produced: amounts, quality (wet/dry), shelf life
• dissemination: efficiency; viability etc.
• Representative scenarios
• urban aerosol release; food contamination; water
• vulnerabilities; release points, mechanisms; “natural”

attenuation

• consequences: exposure, morbidity, mortality estimates;

reload concerns

BIOSECURITY

Today and Tomorrow’s Fears…

1949 WWII 1980

Korean War Space Race Viet Nam

1985 2001 9/11 Soviet Threat

“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 “Category B”

• Brucellosis (Brucella species)
• Epsilon toxin of Clostridium perfringens
• Food safety threats (e.g. Salmonella species, Escherichia coli 0157:H7)
• 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)
• Water safety threats (e.g. Vibrio cholera, Cryptosporidium parvum)

CDC Select Agents

2010 1980 2000

T H R E A T

Traditional Threat Agents Pre-Genomic Era rDNA technologies Physiology Immunology Neurosciences Genomics Bioinformatics Proteomics Post-Genomic Era Modified Pathogens/Toxins Nanotechnology Engineered viruses siRNA Chimeric agents Biofilms Advanced Biological Agents Modified Biological or Biochemical Agents

2004

The Unknown

Dual-Use Biological Research

“Biological research with legitimate scientific purpose that may be misused to pose a biological threat to public health and/or national security “

7 Areas of Concern

Would proceeding with the experiment…

• 1. Render a vaccine to a pathogen ineffective;
• 2. Confer antibiotic resistance to a pathogen so as to decrease

the effectiveness of a countermeasure;

• 3. Increase the virulence of a pathogen;
• 4. Increase the transmissibility of a pathogen;
• 5. Increase the host range/tropism of a pathogen;
• 6. Enable evasion of diagnostic/detection capabilities; or
• 7. Demonstrate weaponization of a pathogen.

National Science Advisory Board for Biosecurity

• 1. Develop guidelines for oversight of “Experiments of Concern”

and provide ongoing evaluation and modification of these guidelines as needed.

• 2. Work with journal editors and other stakeholders to ensure

the development of guidelines for the publication, public presentation, and public communication of potentially sensitive research, and encourage the adoption of these guidelines by international organizations.

• 3. Provide guidance on the development of a code of conduct for

scientists and laboratory workers.

Opportunities arise from the Opportunities arise from the “ “Complexity Complexity” ” of the R&D enterprise

• f the R&D enterprise

Opportunities arise from the Opportunities arise from the “ “Flexibility Flexibility” ” of the R&D enterprise

• f the R&D enterprise

Science is global Science is global

Larry Kerr, Ph.D. Larry Kerr, Ph.D.

Office of Science and Office of Science and Technology Policy Technology Policy

Assistant Director for Homeland Assistant Director for Homeland Security Security

Back-up slides

• On March 4, 2004 Secretary Tommy Thompson announced the creation of

the NSABB

– Provide advice to Federal Departments and agencies on ways to minimize misuse of knowledge and technologies emanating from essential biological research – Create a system of research review (through the Institutional Biosafety Committees) – Provide guidelines for the identification of research that may require special attention – Promote professional codes of conduct – Create educational materials for the research community about effective biosecurity

• 25 voting members with expertise in the following areas: molecular biology,

microbiology, infectious diseases, biosafety, public health, veterinary medicine, plant health, national security, biodefense, law enforcement, scientific publishing

• Ex officio members from 15 Federal agencies and departments

National Science Advisory Board for Biosecurity

Protect public health, both the rare as well as the commonplace

A typical MTA/MTD takes several months

• Draft an initial MTA
• extensive one-on-one interactions with SMEs
• “Vet” in broad interagency/SME forum
• typically day and a half meeting, 30-40 participants
• Do additional homework and revise/refine MTA as needed
• Draft MTD recommendations and presentation for Sec DHS
• Obtain IAIP formal concurrence
• Brief Sec DHS
• Secretary signs out an MTD

MTD Schedule

• Already done:
• Smallpox
• Botulinum toxin

In progress:

• Anthrax (MTA Dec 04)
• Radionuclides (MTA Jan 04)
• Nerve agent (MTA Feb 04)
• By the end of FY05
• Plague
• Tularemia
• Major viral hemorrhagic fevers
• Any major new concern from on-going HSPD-10 risk assessments