As gene therapy regains momentum across Europe, analytical strategy has become a critical focus for programs progressing into late-stage development and regulatory review.
Recent milestones, including Vyjuvek’s European approval for dystrophic epidermolysis bullosa, Genethon’s pivotal GNT00004 program for muscular dystrophy, and positive EMA scientific advice for retinal gene therapies, underscore the growing need for robust, regulator-ready analytical frameworks.
With more gene therapies approaching commercialization, the pressure to demonstrate product consistency, safety, and potency has never been greater. Returning to London for its 7th edition, the Gene Therapy Analytical Development Summit Europe brings together 60+ senior leaders from biotech, pharma, and regulatory agencies for focused, peer-led discussions on advancing analytical development, quality control, and potency assurance.
Join experts from Complement Therapeutics, MeiraGTx, PureSpring Therapeutics, Orchard Therapeutics, UCB, and more as they share practical insights to strengthen analytical readiness, de-risk regulatory submissions, and accelerate your path from clinic to market.
Key themes include:
- Analytical strategy to support late-stage development and commercial readiness
- Potency assay development and validation for gene therapies
- Ensuring product consistency and comparability
- Regulatory expectations and alignment with EMA guidance
- Risk mitigation across analytical development and QC
About Hanson Wade Group - 7th Gene Therapy Analytical Development Europe
Optimising the Development of Analytical Tools to Drive Efficiency & Demonstrate Product Consistency to Meet Regulatory Expectations for the Safety & Potency of Gene Therapies.
As gene therapy regains momentum in Europe, analytical strategy remains under the spotlight. Over the past 18 months, multiple programmes have advanced into late-stage development and regulatory review; including Vyjuvek receiving European approval for dystrophic epidermolysis bullosa, Genethon’s launch of the pivotal GNT00004 programme for muscular dystrophy, and positive EMA scientific advice for retinal gene therapy programmes from Ocugen and Complement Therapeutics.
As more therapies move closer to commercialisation, the need for robust analytical strategies that meet evolving regulatory expectations has never been greater. Reinforcing the importance of focused, peer-led discussion.
Returning to London for its 7th iteration, the Gene Therapy Analytical Development Summit Europe remains the premier European forum for 60+ senior leaders from biotech, pharma, and regulatory agencies to have dedicated discussions towards advancing analytical development, QC, and potency assurance for gene therapies.
Join experts from Complement Therapeutics, Meira GTx, PureSpring Therapeutics, Orchard Therapeutics, UCB, and more as they share practical insights to strengthen analytical readiness and risk mitigation to accelerate your path to clinic and market.
Download the Event Guide
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