Cullen Mason

Company: Biogen

Job title: Associate Director

Seminars:

PANEL: When Should We Start Measuring Potency? Navigating Potency Measurement & Assay Setup Considerations 9:00 am

Understanding the implications of the new FDA draft potency guidance on the necessity and implications of potency assays in phase 1 trials Determining best practice for optimizing controls, reference standards, and AAV serotype selection to establish robust potency assays that satisfy regulatory demands Overcoming limited batch size to develop appropriate documentation and address gaps in…Read more

day: Regulatory Focus Day