Welcome to the CGTP Summit

The annual CASSS CGTP Summit brings together senior-level industry, regulatory, and academic professionals to discuss pertinent challenges in the cell and gene therapy field. The topic for the 2026 Summit is "Specifications for Cell and Gene Therapies". This one-day program features speaker presentations, extended panel discussions, and networking opportunities that allow you to engage with fellow attendees. View the scientific program below or click this link to open the scientific program in a new tab. View the full Summit abstract below.

The Summit will be offered in-person as well as live-streamed to a virtual audience. Extend your in-person stay and maximize your knowledge-sharing experience by attending the back-to-back CGTP Symposium on June 9-11, 2026.

Summit Abstract

Specification setting for advanced therapy medicinal products (ATMPs) remains one of the most persistent and complex challenges across the development lifecycle, particularly in the context of accelerated development timelines, inherent variability, evolving potency strategies, and limited manufacturing experience. Traditional specification frameworks are often poorly suited for non-well-characterized, individualized, or patient-specific therapies, creating uncertainty around clinical relevance, regulatory expectations, and licensure readiness.

This Summit convenes senior industry leaders and regulators from multiple global health authorities to examine practical strategies for defining, evolving, and defending ATMP specifications across the product lifecycle. The sessions will address challenges specific to ATMP modalities, illustrated through case studies, best practices, and thought-provoking panel discussions. The program concludes with a global regulatory panel, where insights will be shared regarding the current and evolving regulatory framework governing ATMP specifications.

Through focused session presentations and open industry–regulatory dialogue, the Summit will address key challenges in ATMP specifications, with the goal of enabling a shared understanding and globally informed, fit-for-purpose approaches to support robust ATMP specifications.

Frequently Asked Questions

"It was very useful especially discussion around analytics which are evolving for cell and gene therapy products."
—Melia Grim, CGTP Summit 2025 Attendee
"The place to be to interact and ask direct questions with regulators/industry peers. A fantastic networking opportunity."
—Gael Debauve, CGTP Summit 2025 Attendee

Past Event Videos

  • The CGTP Experience - Week of Insightful Talks and Discussions

  • The Evolution of CGTP

  • Regulatory Presence at CGTP Symposium

  • CASSS Moments: Game Changing Interactions with Regulators

  • CASSS Moments: How Hot Topics Can Influence a Career

  • CASSS Moments: Active Listening to Understand the Issues

  • Cell & Gene Therapy Products 2023 Keynote: Becky Schweighardt, Grace Science LLC

  • Cell & Gene Therapy Products 2022 Keynote: Peter Marks, CBER, FDA

  • Cell & Gene Therapy Products 2020 Keynote: Simon Frost - Action Potential: A Parent’s Perspective