Animal Models for Assessing Countermeasures to Bioterrorism Agents (2011) / Chapter Skim
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4 Developing New Animal Models for Biodefense Research
4 Developing New Animal Models for Biodefense Research
Pages 51-60
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From page 51... ...
The Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents concludes that focusing on the creation of new animal models -- that is, continuing to rely exclusively on the use of animals for efficacy studies -- is not warranted at this time. Although new models, such as hamsters, New World nonhuman primates, pigs, or bats, may be useful for basic research purposes, they will eventually encounter the same problems seen in the better-defined animal models currently in use.1 Instead, the Committee suggests that it is more useful to use different approaches that "support the qualification2 of animal models" (DHHS 2010, p 11)
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From page 52... ...
infectious diseases, there may be particular environmental or natural conditions that provide an opportunity to collect human clinical efficacy data under natural exposure. In fact, the Animal Rule treats the use of a product approved under the rule in response to an exposure as a clinical trial from which essential data can be obtained (Walker and King 2011)
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From page 53... ...
. These disease outbreaks represent potential opportunities to collect prophylactic and therapeutic clinical data on the efficacy of drugs and biologics approved under the Animal Rule and to collect data to determine the relevance of the animal models used.
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From page 54... ...
Examples of pertinent issues include the appropriateness of using the Animal Rule regulatory pathway for the specific clinical indications; pilot animal efficacy studies (protocols or data) ; and iterative determinations for the pivotal animal studies, such as the relevant dose level based on prior pilot animal and human studies.
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From page 55... ...
. Such attributes do not apply to animal models and the Animal Rule does not mention "validated" animal studies.
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From page 56... ...
A different set of criteria (Technology Readiness Levels) for medical countermeasures and detailed description 8 of the development stages of animal models to support approval of countermeasures under the Animal Rule have been developed by the working groups of the Public Health Emergency Medical Countermeasures Enterprise for use across the public and private sector; https://www.medicalcountermeasures.gov/TRL_Page.aspx.
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From page 57... ...
OPTIMIZING CURRENT ANIMAL MODELS The production of relevant and effective medical countermeasures to biothreats would greatly improve if the focus were shifted from developing new animal models to improving the extrapolation of animal data from the current models to the human response. This shift can be accomplished by cultivating alternative or underutilized sources of information, such as the data collected from current models and human populations.
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From page 58... ...
validate the animal model. The Committee also recommends the following to improve the usefulness of the information derived from human populations: • To address the dearth of data from human populations, expand the collection of data from patients in outbreak zones and from postmarketing studies.
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From page 59... ...
In: Swearengen JR, ed. Biodefense: Research Methodology and Animal Models.
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