Regulatory Workshop Day
Tuesday 28th March 2023

Workshop A – 9:00 – 12:00

Harmonizing the Expectations from Regulators & Setting Up Your Comparability Studies for Gene Therapy

  • Tayler Renshaw Director - Regulatory Affairs, Chemistry, Manufacturing & Controls, Astellas Innovation Management

Synopsis

Hear from regulators and sponsors in this workshop session on what the current expectations are for comparability in IND applications for gene therapy products to help you set up for your comparability assessments.

Key learnings from this workshop:

• Understanding what regulators are looking for in gene therapy comparability studies

• Clarifying what regulators consider ‘comparable’ for gene therapy

• Elucidating lessons learned from applications

Workshop B – 13:00 – 16:00

Developing an Appropriate Potency Assay to Support Comparability & Aid in Regulatory Approvals

Synopsis

Utilizing appropriate potency assays are of utmost importance when attempting to prove comparability to regulators, so the design of these assays should be of consideration when undergoing or planning for comparability studies. This session will delve into the development of these potency studies from the perspective of regulators. Key learnings from this workshop:

• Understanding the importance of correct potency assay design

• How to implement these potency assays into your own comparability studies

• Discussing what regulators require from potency assays in approval applications