Workshop
Pre-Conference Regulatory Symposium:
Animal Rule Licensure and Emergency Use Authorization
Monday, June 15, 2009, 9am - noon
This symposium is designed to address some of the unique challenges that relate to achieving licensure of medical countermeasures under the Animal Rule; such as the development of appropriate animal models, designing appropriate pivotal animal efficacy trials and bridging animal data to humans. The symposium will facilitate discussion among government agencies supporting development portfolios, companies engaged in MCM development, and the FDA. Symposium participants will share lessons learned and discuss the practical aspects of biodefense product development, such as managing risk in critical path development activities or delivering products to stockpiles.
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Pre-Conference Technical Symposium:
Developments in Biodefense Technology Platforms
A Briefing from Leading Biodefense Researchers
Monday, June 15, 2009, 9am - 3:45pm
Technology platform projects are intended to impact multiple medical countermeasures (MCM) products. Some technology platforms are designed to array products against multiple threats to quickly address unknown, unmet needs. Other new technologies may be applied to multiple products to address challenges in storage and administration. This symposium will provide an overview of several kinds of technology platform projects that are intended to improve the overall capabilities to meet bioterrorist and emerging infectious disease threats.
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