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

According to the FDA, 2024 will be the ’breakout year’ for gene therapies. For these therapies to gain regulatory approval, it's crucial to have robust potency assays in place, making it paramount that an effective potency design is incorporated into every drug developer’s analytical strategy. As gene therapy biopharma continues to try to link an often-unclear mechanism of action to potency, increasing regulatory scrutiny means potency data packages must be more robust than ever before.

This year’s agenda has expanded to cover advancing CQA assessment, emerging non-cell-based potency strategies (including HPLC and Mass-spec), and potency assays for a wider range of delivery modalities. This is an unmissable industry event to stay on top of the latest analytical techniques to optimize your own potency strategy and ultimately prove product efficacy to regulators.

Don’t miss out on the opportunity to join 100+ experts this July from Sarpeta Therapeutics, J & J, Sanofi, Beacon Therapeutics, BMS and many other leading gene therapy biopharma.

Join Your Peers This July To:


Navigate the New FDA Gene Therapy Potency Guidelines through a dedicated 3h workshop session to elevate and refine your potency assay strategies


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


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


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


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

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. Uniting 60+ Analytical, Bioassay, Quality Control, Regulatory and CMC experts, the summit will combine both strategic and technical content to provide actional insights for assay developers working across all drug development stages.