Agenda/Scientific Program

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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 theme for 2025 is "Potency Strategy for Cell and Gene Therapy Products". This one-day program features speaker presentations, extended panel discussions, and networking opportunities that give you multiple opportunities to engage in meaningful discussions on the latest challenges with potency strategies for cell and gene therapy products. We look forward to an informative Summit and hope to see you there. Be ready to network, collaborate, and expand your knowledge.

Potency Strategy for Cell and Gene Therapy Products

The CGTP Summit will comprehensively address CMC-related delays in the clinical development of CGT products, with a primary focus on the development of a globally acceptable potency strategy. These delays often arise from several factors, including a lack of clarity on the minimum potency requirements needed to advance into Phase 1 studies, and a lack of alignment on the strategies necessary to proceed to pivotal or late-phase studies. Additionally, the absence of global harmonization on potency requirements poses significant challenges, making it difficult for the industry to advance a unified global product. 

Throughout the Summit, we aim to highlight pressing issues and provide phase-appropriate solutions. By drawing lessons from more established CGT modalities such as AAV and CAR-T, which have successfully reached commercial stages, we can better navigate the path forward for newer modalities. The Summit will also delve into the challenges specific to emerging technologies, such as genome and epigenome editing, and induced pluripotent stem cells (iPSCs), focusing on their strategies for entering early-phase clinical development. 

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