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It’s Like Building the Airplane While Flying it: Biomarker Discovery and Development in Clinical Trials
Session Chair(s)
Lynn Tuan, MS
Senior Specialist, Global Regulatory Affairs , Alexion Pharmaceuticals , United States
To facilitate drug development, both FDA and EMA have established qualification programs for drug development tools and novel methodologies, which include biomarkers. Qualified biomarkers that have gone through these formal qualification processes can be relied upon for making regulatory decisions within the stated Context of Use. This session will inform the common review issues and considerations in the Biomarker Qualification evaluations and provide an example to illustrate how biomarker identification, quantification and integration using a novel methodology can facilitate drug development.
Learning Objective : Describe the common review issues in the Biomarker Qualification evaluations in US and EU; Discuss the importance of integrating continuous cerebrospinal fluid (CSF) sampling in early phase drug development.
Speaker(s)
Lynn Tuan, MS
Senior Specialist, Global Regulatory Affairs , Alexion Pharmaceuticals , United States
Biomarker Development: What Can We Learn from Qualified Biomarkers?
Svetlana Semenova, PHD
Director Scientific Affairs, Parexel International, United States
Targeting Cerebrospinal Fluid (CSF) in Early-Phase CNS Drug Development
Christopher Leptak, MD, PHD
Executive Vice President, Drug and Biological Products, Greenleaf Health, Inc., United States
FDA Update
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