Agenda September 23, 2026: Main Conference Day OneWednesday, 23 September 2026 - ET (Eastern Time, GMT-05:00)

This interactive workshop will run from 9am – 12:45pm.

Through a series of presentations, case studies, interactive discussion and exercises this workshop will delve deeply into the underlying science of developing potency assays.

Some of the topics to be discussed include:

• Overview of what potency is, and what it is not
• Considerations when qualifying and validating bioassays
• From initial ideas, through characterisation to the final potency method
• Clinical correlation
• Regulator objections and why
• Examples of potency assays for approved products
• Examples of a cell and gene therapy potency assays for various product types

This interactive workshop will run from 9am – 12:45pm.

Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.

Some of the topics to be discussed include:

• CDMO Selection: Models and Process
• Contract and Quality Agreement Negotiation
• Tech Transfer: Best practices and risk management for external tech transfers
• Knowledge Management and Digital Transformation in Tech Transfer
• Quality Assurance and Quality Control
• Life Cycle & Relationship Management

The CGT C-Level Forum provides a unique, powerful and valuable space for candidly sharing ideas and experiences between executives of ~20 CGT therapeutic development companies. The forum is designed to foster new ideas and create new relationships between attendees so that they can leave with tangible outcomes and that will drive their businesses and the sector forward.

An exclusive invite-only session, in a closed room setting, the forum will include 2-3 case studies discussing the right approach to engage and partner with pharma and industry. It will also include general discussion focussed on brainstorming solutions to the most pressing and current challenges of CEO/CSO/CBO/CMOs in the CGT sector.