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academia with NIH support, or industry research intended to develop one specific product. ARS can improve the likelihood of success for a product at all stages from preclinical studies through stockpile, distribution and dispensing. Other areas may include revisiting regulations pertaining to the Animal Rule (AR) and Emergency Use Authorization (EUA). Finally, there may be a benefit to exploring alternate regulatory paradigms and pathways for these specific products for public health emergencies. Applied regulatory science can assist on issues such as:  Using biomarkers and more predictive animal models to increase indicators of efficacy.  Using "adaptive" and other flexible clinical trial designs and current information technology sciences to modernize clinical trial design, performance and analysis, reduce costs, and decrease development time  Facilitating more rapid scale up of production  Improving stability of products  Developing quality measurements, assays and standards for novel technologies such as stem cells and engineered tissues  Developing better or faster testing technologies like rapid microbial testing for vaccines to identify accidental or deliberate contaminants. 4. PRODUCT USE AND IMPROVEMENTS When new threats to population health appear, we must be able to rapidly recognize them from the noise of routine health-related activities. Highly flexible diagnostic technologies, such as the multiarray platforms described above, are needed to optimize detection and speed characterization of