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communities with skilled advanced developers from the larger pharmaceutical organizations appears to be the best strategy to accomplishing this end goal. Opportunities to enhance successful delivery of approved products through advanced development will require:  Fostering broader spectrum indications to increase market attractiveness  Offering long-term (> 10 years) product acquisition contracts with minimum warm-base manufacturing to guarantee markets  Establishing government/private sector-sponsored facilities for advanced development, and domestic pilot lot and commercial scale manufacturing;  Creating more domestic fill-finish capability  Building more flexible and robust high-level biocontainment facilities to conduct regulated animal challenge studies for safety and efficacy testing. 3 . REGULATORY SCIENCE, LAWS AND REGULATIONS There is an urgent need to invest in applied regulatory science (ARS) and to strengthen the underlying research contributing to a more robust and agile regulatory process. This is necessary to ensure that the potential benefits of these public health medical countermeasure candidates translate into approved products. Such science is distinct from basic discovery research, typically done in 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