ABOUT EVENT

The 2nd Gene Therapy Potency Assay Summit – What to Expect in 2024:

In 2024, it is predicted that up to 17 gene therapies could be approved across the US & EU. Despite this clinical momentum, increasing regulatory scrutiny highlights, now more than ever, the importance of robust analytical data packages to support program progression into and through the clinic.

At every step of this process, it is paramount to incorporate effective phase-appropriate potency design and validation data, linking an often unclear mechanism of action to potency to define the therapeutic efficacy of a gene therapy.

This year’s program will ensure you can navigate the path to approval by helping you implement emerging technologies into potency assay approaches, unpick the latest FDA guidance, and leverage key insights from companies with approved products.

Bringing together 70+ leading industry biopharma experts, this is your opportunity to stay on top of the latest and greatest analytical techniques and potency assay strategy and demonstrate your product efficacy to regulators.

Join Your Peers This July To:

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Navigate the New FDA Gene Therapy Potency Guidelines through a discussion-based roundtable, led by the Alliance for Regenerative Medicine, to elevate and refine your potency assay strategies

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Discover How Potency Assay Development for Novel Delivery Modalities differs from conventional AAV approaches to ensure regulatory adherence

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Participate In Roundtable Sessions on the Challenges Surrounding Reference Materials and Cell Line Selection to ascertain novel solutions and better understand industry standards

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Develop Protocols to Optimize Your Resource Management by discussing efficient resource allocation during tech transfer and how to establish collaborative partnerships with CROs

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Enhance Your Assay Precision with Emerging Technologies. Learn how to integrate cutting-edge methodologies to improves specificity, sensitivity, and reproducibility, elevating potency assessment standards and product quality

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Chroma Medicine

Who Will You Meet?

The 2nd Gene Therapy Potency Assay Summit is dedicated to enhancing the quality and diversity of analytical tools for gene therapy products, attracting a niche audience of industry analytical experts to ignite thought-provoking discussions that lead to long-term, mutually beneficial relationships in a rapidly evolving field.

This is the only industry-led event dedicated to covering all challenges associated with potency for gene therapy drug developers specifically. 60+ Analytical, Bioassay, Quality Control, Regulatory and CMC Managers, Directors, VPs, and C-Level executives will be uniting at a summit that combines both strategic and technical content to provide actional insights for assay developers working across all drug development stages.