The presentation will include an overview of the FDA’s Animal Rule followed by an example end-user case study.

The format of the presentation is intended to be informative, keeping the audience abreast of key areas that need to be addressed when developing medical countermeasures (MCM) intended for FDA approval for diseases where human clinical trials are not feasible or ethical.

Critical success factors are addressed including choice of an appropriate animal model, developing a study design that will provide adequate data in the absence of a clinical trial, validation of in vitro biological assays, and key statistical analysis performed.

The case-study will highlight examples of application of the rule to both vaccine and compound efficacy studies in non-human primate and small animal efficacy studies conducted under FDA GLP regulations. Specifically, studies involving orthopoxvirus models, their development and use under the animal rule will be covered, however these principles are applicable to other countermeasures as well. The speakers will address the complexity of study design, realistic timelines from direct experience, ways timelines can be compressed, factors influencing cost, and funding agency priority lists.

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