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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