3rd Gene Therapy Potency Assay Summit

The 3rd Gene Therapy Potency Assay Summit is scheduled to take place on May 28–29, 2025, at the Revere Hotel Boston Common in Boston, Massachusetts. This summit is dedicated to advancing the development of robust potency assays essential for the clinical and commercial success of gene therapies. Attendees will engage in in-depth technical discussions on topics such as phase-appropriate assay development, methodology advancements, reducing lot-to-lot variability, and aligning with evolving regulatory guidelines. The event aims to foster collaboration among analytical leads, quality control experts, and regulatory professionals to address shared challenges and explore new technologies enhancing assay predictability.

The summit will feature insights from experts across the biopharma industry, providing perspectives from those who have navigated IND-enabling studies to the commercialization of gene therapy products. Participants will have the opportunity to network with professionals from companies at various stages of development, facilitating the exchange of data, methods, and experiences. The event also offers a platform to connect with partners and solution providers, supporting attendees at every stage of cell and gene therapy development.

Event Highlights:

Dates: May 28–29, 2025

Location: Revere Hotel Boston Common, Boston, MA

Focus Areas:

• Phase-appropriate assay development
• Methodology advancements
• Reducing lot-to-lot variability
• Aligning with evolving regulatory guidelines

Participating Companies:

• Vertex Pharmaceuticals
• Alexion Pharmaceuticals
• Novasenta
• UCB
• GenSight Biologics
• Prime Medicine

Notable Speakers:

• Jie Li – Director, Analytical Development, Vertex Pharmaceuticals
• Jing Li – Associate Director, Analytical Tech Transfer, Alexion Pharmaceuticals
• Melody Dai – Vice President, Novasenta
• Qingwei Deng – Head of Analytical Development, Gene Therapy, UCB
• Scott Jeffers – Chief Technology Officer, GenSight Biologics
• Yonghong Yang – Director, Prime Medicine