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A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
A presentation (in powerpoint format) detailing the plan is ...A
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A presentation (in powerpoint format) detailing the plan is ...A

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  • 1. Vanderbilt and Biodefense Research <ul><li>February 26, 2003 </li></ul>An Opportunity and a Responsibility
  • 2. Objectives <ul><ul><li>To discuss initiatives and opportunities in biodefense and emerging infections research </li></ul></ul><ul><ul><li>To discuss Vanderbilt’s participation in a “Regional Centers of Excellence in Biodefense” consortium </li></ul></ul><ul><ul><li>To describe Vanderbilt strengths in research with potential application to biodefense initiatives </li></ul></ul><ul><ul><li>To identify additional programs with possible applicability to biodefense research </li></ul></ul>
  • 3. The National Institute of Allergy and Infectious Diseases (NIAID) supports and carries out biomedical research to understand, prevent, and treat infectious and immunologic human diseases. Infectious diseases include those caused by new, emerging and re-emerging infectious agents, including those infections that are intentionally introduced as an act of bioterrorism. The recent deliberate exposure of U.S. civilians to spores of the anthrax bacterium, Bacillus anthracis , uncovered an unmet need for tests to rapidly diagnose, vaccines and immunotherapies to prevent, and drugs and biologics to cure diseases caused by agents of bioterrorism. NIAID and other federal health agencies are evaluating and accelerating measures to protect the civilian population from the health consequences of such an attack.
  • 4.  
  • 5. Category A <ul><li>Bacillus anthracis (anthrax) </li></ul><ul><li>Clostridium botulinum </li></ul><ul><li>Yersinia pestis </li></ul><ul><li>Variola major (smallpox) and other poxviruses </li></ul><ul><li>Francisella tularensis (tularemia) </li></ul><ul><li>Viral hemorrhagic fevers </li></ul>Arenaviruses LCM, Junin virus, Machup virus, Guanarito virus Lassa Fever Bunyaviruses Hantaviruses Rift Valley Fever Flaviruses Dengue Filoviruses Ebola Marburg
  • 6.  
  • 7. Category B <ul><li>Brucellosis ( Brucella species)--Lab & Health Professionals </li></ul><ul><li>Epsilon toxin of Clostridium perfringens </li></ul><ul><li>Food safety threats ( Salmonella species, Escherichia coli O157:H7, Shigella ) </li></ul><ul><li>Glanders </li></ul><ul><li>Melioidosis </li></ul><ul><li>Psittacosis </li></ul><ul><li>Q fever </li></ul><ul><li>Ricin toxin from Ricinus communis (castor beans) </li></ul><ul><li>Staphylococcal enterotoxin B </li></ul><ul><li>Typhus fever </li></ul><ul><li>Viral encephalitis (Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis) </li></ul><ul><li>Water safety threats ( Cholera , Cryptosporidium ) </li></ul>
  • 8. Category C <ul><li>Emerging infectious disease threats such as Nipah virus and additional hantaviruses. </li></ul><ul><li>NIAID priority areas: </li></ul><ul><li>Tickborne hemorrhagic fever viruses </li></ul><ul><li>Crimean-Congo Hemorrhagic fever virus </li></ul><ul><li>Tickborne encephalitis viruses </li></ul><ul><li>Yellow fever </li></ul><ul><li>Multi-drug resistant TB </li></ul><ul><li>Influenza </li></ul><ul><li>Other Rickettsias </li></ul><ul><li>Rabies </li></ul>
  • 9.  
  • 10. Key Events & Responses 1996-97 Select Agent Program Established Vanderbilt is registered as a Select Agent facility in December 2000.
  • 11. Key Events & Responses 1996-97 9/11/01 Select Agent Program Established WTC & Pentagon Attacks 9/11 emergency response included identifying labora-tories with Select Agents so that extra security could be provided. VEHS sent out memo requesting voluntary disclosure of possession of Select Agents.
  • 12. Key Events & Responses 1996-97 9/11/01 Oct ‘01 Select Agent Program Established WTC & Pentagon Attacks Anthrax Letters Vanderbilt EH&S and VUPD responded to >75 suspicious powders, packages, and mail. [4 responses last week!] Conducted several training sessions regarding opening mail, etc.
  • 13. Anthrax Incidence in HAS District (1988-2002) Incidence per 1 million population 18 12 23 18 7 4 6 4 3 1 1 1 3 7 6 0 20 40 60 80 100 1988 1990 1992 1994 1996 1998 2000 2002
  • 14. <ul><li>Presentation </li></ul><ul><ul><li>90% present with edema (often massive) </li></ul></ul><ul><ul><li>20-30% febrile (80-90% complain of fevers) </li></ul></ul><ul><ul><li>Other common complaints – tenderness, abdominal pain, headache </li></ul></ul><ul><li>Location of Lesion </li></ul><ul><ul><li>70% Face and Neck (eyes and mouth) </li></ul></ul><ul><ul><li>15% Arms, 10% Trunk, 5% Legs </li></ul></ul>CLINICAL MANIFESTATIONS
  • 15. Complications of Cutaneous Anthrax Infection Necrosis requiring debridement Persistent secondary infection Death No complications 78% 11% 3% 8%
  • 16.  
  • 17.  
  • 18. Key Events & Responses 1996-97 9/11/01 10/26/01 Oct ‘01 Fall ‘01 Late ‘01 Select Agent Program Established WTC & Pentagon Attacks Anthrax Letters USA PATRIOT Act UConn incident HHS Inspector General visits begin Vanderbilt establishes Lab Security & Accountability Task Group - comprised of faculty, research administrators, security, EH&S, legal counsel, Human Resources, and other stakeholders.
  • 19. Key Events & Responses 1996-97 9/11/01 10/26/01 Oct ‘01 Fall ‘01 Late ‘01 Select Agent Program Established WTC & Pentagon Attacks Anthrax Letters USA PATRIOT Act UConn incident Vanderbilt administration rejected proposal to work with anthrax based potential com-munity concerns. IBC had previously voted approval and established a safety plan. HHS Inspector General visits begin
  • 20. Key Events & Responses 6/12/02 Public Health Security. . .Act Lab Security & Accountability Task Group identifies method by which to obtain CDC/USDA notification from faculty.
  • 21. Key Events & Responses 6/12/02 9/10/02 Public Health Security. . .Act CDC/USDA Notifications due Deans request electronic (via BioWISE) disclosure of non-possession or possession from 700+ faculty members. Three previously undisclosed agents are found; seven investigators with no previous disclosure
  • 22. Key Events & Responses 6/12/02 9/10/02 12/13/02 Public Health Security. . .Act CDC/USDA Notifications due CDC/APHIS rules IBC overseeing development of plans required under the new regulations.
  • 23. Key Events & Responses 6/12/02 9/10/02 12/13/02 Public Health Security. . .Act CDC/USDA Notifications due CDC/APHIS rules Acknowledgement that national security administrators are very interested and involved in how Select Agents are handled in our institutions. 1/15/03 Texas Tech incident
  • 24. The overall goal of the RCE Program is to develop and maintain strong infrastructure and multifaceted research and development activities that will provide the scientific information and translational research capacity to make the next generation of therapeutics, vaccines and diagnostics against the NIAID Category A, B, C agents, with particular emphasis on Category A
  • 25.  
  • 26. RBL program will provide support for building and/or renovating biosafety level (BSL-3) facility and necessary associated BSL-2 laboratories, animal facilities, and research support space.
  • 27.  
  • 28.  
  • 29. We see biodefense as not only a national priority but also an exciting research agenda. Thus, there is a tremendous impetus and opportunity to conduct research with select agents. At the same time in working with select agents there is a substantial obligation imposed for assuring safety and security on the institution and investigators. Summary:

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