Early Phase Adaptive Designs in biological product Development -- Regulatory perspective and experience
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC