Animal Models for Assessing Countermeasures to Bioterrorism Agents (2011) / Chapter Skim
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1 Introduction
1 Introduction
Pages 7-14
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In addition to advances in medical products (such as drugs and vaccines) to treat or prevent natural infectious agents, multiple voices have argued that current advances in biological research and biotechnology would enable the development of bioengineered pathogens (Lindler et al.
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• The strategy suggested that pathogens that occupy similar "pathogenesis niches", e.g., viruses that produce hemorrhagic responses in hosts, or bacteria that survive by exploiting an intracellular niche, acquired evolutionarily similar mechanisms or biochemical tools to achieve these niche-specific outcomes. The Transformational Medical Technologies Initiative (TMTI)
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, exploit host targets attacked by multiple threat agents, or enhance host defenses by modulating the host's immune response. An example of this approach is the targeting of the human protein TSG101, the product of the tumor susceptibility gene 101 that participates in the intracellular movement of proteins.
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These concepts exploit a particular life-history strategy, thereby achieving protection against unknown pathogens with similar pathogenesis patterns. In this graphic representation, major hemorrhagic fever viruses from different taxa (on the left side represented by two letters)
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However, while the FDA's action to create a pathway for testing the effectiveness of countermeasures without human clinical trials was well received, experience since its promulgation demonstrated that it is not a facile pathway for assessing the efficacy of a countermeasure in humans based on the product's efficacy in animals. This past decade has shown that the Animal Rule presents its own set of challenges, including developing appropriate animal models of pathogenesis and extrapolating results from animals to humans.
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Chapter 2 looks at the adequacy of current animal model systems including an assessment of the data provided by these models versus available human data for filovirus-induced hemorrhagic fevers, anthrax, and tularemia. Chapter 3 discusses the history of the Animal Rule and relevant ethical issues.
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From page 13... ...
:2152-2159. Warren TK, Warfield KL, Wells J, Swenson DL, Donner KS, Van Tongeren SA, Garza NL, Dong L, Mourich DV, Crumley S, Nichols DK, Iversen PL, Bavari S
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