Overcoming Challenges to Develop Countermeasures Against Aerosolized Bioterrorism Agents Appropriate Use of Animal Models (2006) / Chapter Skim
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6 Resource Issues
6 Resource Issues
Pages 41-50
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From page 41... ...
This chapter will consider these broad structural needs and some possibilities for addressing them, based in large part on discussions at the Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents Workshop. PERSONNEL NEEDS AND TRAINING Development and testing of animal models for countermeasures against aerosolized bioterrorism agents requires collaboration between the several different communities of scientists and clinicians with interests in aerosol models.
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From page 42... ...
Information exchange and community building could be facilitated through a consortium of scientific societies (such as the American Association for Aerosol Research, the American Society for Microbiology, the International Society for Aerosols in Medicine, and the Society of Toxicology, among others) to develop targeted meetings or joint sessions at appropriate professional meetings (such as the Emerging Infectious Diseases or Biodefense Research meetings organized by the American Society for Microbiology)
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From page 43... ...
Aerosol generation and exposure equipment, itself expensive and specialized, when used with the agents needs to be carefully adapted for containment and decontamination, further adding to the costs. Animal Resources The cost of the laboratory animals themselves is another important factor to be taken into account.
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From page 44... ...
Overlap Select Agents and Toxins Variola major virus (Smallpox virus) Bacillus anthracis Variola minor virus (Alastrim)
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From page 45... ...
Though nonhuman primates are widely favored as test subjects in studies of aerosolized bioterrorism agents, they are often difficult to handle in highcontainment laboratories; this description applies especially to macaques (Patterson and Carrion 2005)
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From page 46... ...
The traditional approaches involve calculations from input and chamber samples, or sacrificing some of the animals to determine actual numbers of the agent in the lung. While these approaches are still necessary, recently developed technologies using bacteria with inserted light-emitting genes or other markers are making it possible to determine the number of inhaled bacteria by direct imaging in the living animal (Advance Research Technologies and GE Healthcare 2005; Contag and Bachmann 2002)
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From page 47... ...
Probably no federal agency has a more critical role in the development of new countermeasures against bioterrorism agents than the FDA, the principal U.S. regulatory agency for medical countermeasures.
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From page 48... ...
The power of the Animal Rule is that the efficacy of a countermeasure can be demonstrated in a nonhuman species whose responses mimic and are predictive of the disease process in humans. However, the current lack of animal models is an impediment to gaining FDA approval; few animal models have been established that predict the human disease process associated with Category A select agents.
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From page 49... ...
Without an acceptable animal model, there would be no pathway for achieving FDA approval of these countermeasures through the Animal Rule, thereby discouraging pharmaceutical industry efforts in this area. Already, the market for countermeasures against bioterrorism agents is considered modest, there are product-liability issues, and the cost of research, development, and testing of antibiotics -- which have a 90-percent failure rate during that process -- is high (Cassell 2002)
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From page 50... ...
In addition, collaboration between the research community and the FDA regarding the scientific requirements of the Animal Rule could increase the rate at which new countermeasures are tested and approved. The Committee recognizes that the FDA is in a critical position to help advise researchers involved in countermeasure testing, and the agency appears willing to serve this vital role.
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