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DIA 2021 Global Annual Meeting


It’s Like Building the Airplane While Flying it: Biomarker Discovery and Development in Clinical Trials

Session Chair(s)

Lynn  Tuan, MS

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 continuous CSF sampling procedure and goals of CSF sampling in drug development; Discuss selected illustrative studies to demonstrate applicability and importance of CSF sampling in drug development.

Speaker(s)

Lynn  Tuan, MS

Biomarker Development: What Can We Learn from Qualified Biomarkers?

Lynn Tuan, MS

  • Senior Specialist, Global Regulatory Affairs
  • Alexion Pharmaceuticals , United States
Svetlana  Semenova, PhD

Targeting Cerebrospinal Fluid (CSF) in Early-Phase CNS Drug Development

Svetlana Semenova, PhD

  • Director Scientific Affairs
  • Parexel International, United States
Christopher  Leptak, MD, PhD

FDA Update

Christopher Leptak, MD, PhD

  • Senior Vice President, Drug and Biological Products
  • Greenleaf Health, Inc., United States