Natalie Palmer-Deverill

Company: MeiraGTx

Job title: Senior Scientist, MSAT Analytical Cell Development

Seminars:

COLLABORATIVE SESSION: Sharing Stories About the Implementation of the New Potency Guidance 12:00 pm

A series of mini case studies outlining the implementation of the new draft FDA guidance into analytical strategies. Attend for discussions and recommendations on how the new guidelines should be interpreted and implemented to guide novel assay design approaches.Read more

day: Regulatory Focus Day

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