ABOUT EVENT
The 2nd Gene Therapy Potency Assay Summit – What You Missed in 2024:
In 2024, it was predicted that up to 17 gene therapies could be approved across the US & EU. Despite this clinical momentum, increasing regulatory scrutiny highlighted, 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 was 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.
2024's program ensured 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 was your opportunity to stay on top of the latest and greatest analytical techniques and potency assay strategy and demonstrate your product efficacy to regulators.
In 2024 You Joined Your Peers To:
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
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
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
Who You Met?
The 2nd Gene Therapy Potency Assay Summit was 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 was 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 united at a summit that combines both strategic and technical content to provide actional insights for assay developers working across all drug development stages.