Accelerating the Route to Commercialization with Robust Potency Assay Development

Following a challenging year in the gene therapy field, the 3rd Gene Therapy Potency Assay Summit returns at a crucial time when drug developers increasingly recognize that a robust potency assay is fundamental to both clinical success and commercial viability. As regulatory expectations continue to evolve, it has never been more important to develop assays that are accurate, reproducible, and aligned with regulatory standards.

While many industry meetings touch on potency in a broad or non-technical manner, this summit stands apart as the only event fully dedicated to the complexities of potency assay development. With an emphasis on deep technical discussions, attendees will gain unparalleled insights into phase-appropriate assay development, methodology advancements, reducing lot-to-lot variability, and meeting evolving regulatory expectations. By bringing together a specialized community of Analytical Development, Quality Control, and Regulatory experts, this meeting offers a unique platform to discuss challenges, share strategies, and explore innovative solutions.

One of the key highlights of this year’s agenda is the session “Navigating Regulatory Requirements for Gene Therapy Potency Assays”, presented by Melody Dai, Vice President, Head of Regulatory Affairs & CMC at Novasenta. This session, taking place at 9:00 AM on Day 1, will provide an in-depth exploration of regulatory strategies for potency assays, covering both early and ongoing regulatory engagement. Attendees will learn how to build effective relationships with regulatory agencies, navigate evolving requirements, and prepare for critical regulatory meetings and submissions. By leveraging insights from experts with hands-on experience in clinical-stage gene therapy products, this session will offer practical guidance that extends beyond theoretical discussions.

With a carefully curated agenda and contributions from industry leaders, the 3rd Gene Therapy Potency Assay Summit provides an essential opportunity to advance potency assay strategies, enhance regulatory preparedness, and accelerate the path to commercialization. Whether you are refining your assay methodologies, tackling regulatory complexities, or preparing for the next phase of development, this event will equip you with the expertise and connections needed to drive success in gene therapy.

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