Tony Bou Kheir

Company: Purespring Therapeutics

Job title: Head of Analytical Development & Quality Control

Seminars:

Industry Leader’s Fireside Chat: Navigating the Current & Future Landscape of Gene Therapy Analytical Development with Industry Veterans 9:00 am

Delve into a discussion on the latest developments in gene therapy analytical methods, focusing on the unique challenges and regulatory frameworks specific to the European market Examine how analytical strategies in Europe are evolving to balance scientific rigour with regulatory alignment, ensuring assays meet both local and international standards Gain insights into new technologies transforming…Read more

day: Day One

Tackling Key Considerations of Platform Assays & Methods According to Recent Guidance 9:50 am

Understand how platform assays ensure standardised methods for reliable and reproducible results across various formulations and batches Learn how minor formulation tweaks may stay within the same platform, but significant changes could require validation and regulatory re-submission Discuss how modifications to critical quality attributes or biological outcomes often trigger the need for new validation and…Read more

day: Day One