Early Phase Adaptive Designs in biological product Development -- Regulatory perspective and experience
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*Boguang Zhen, FDA  

Keywords: Adaptive Designs, early phase, regulatory perspective

Recently, there are an increasing number of protocols with Adaptive Designs in therapeutic biological product development submitted to CBER/FDA for review. Some of these studies are designed for supporting licensing application and many are at the stage of early phase clinical trial development. The presenter will first summarize the types of Adaptive Designs commonly seen in the submissions, and then share the review experience for early phase adaptive design. Issues and challenges in reviewing protocols with early phase adaptive design component will be presented and discussed with some hypothetical examples.