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.
Ex vivo gene modified ATMPs have been proven time and again to be effective and curative medicines but are exceptionally challenging to bring to market.
Development of a robust QC strategy is as important as the batch manufacture process, and so I’m delighted to speak about how our analytics have evolved. Come to the workshop to learn and share with us because as a community we can help get all ATMPs across the finishing line to treat more patients.
Karen Buckland, Translational Medicine Lead Scientist, University College London (UCL), 2026 speaker
I’m thrilled to join this event and connect with fellow CMC analytics professionals. Bringing the community together to discuss shared challenges and innovative solutions is essential as we advance therapeutic product development.
Alexandre Valancin, Team Leader of Gene Therapy, Chemistry, Manufacturing & Controls Analytics Projects, UCB
I am looking forward to the opportunity to present the latest work from Complement Therapeutics on our potency assurance strategy for our lead asset, CTx001. I am also excited to get the chance to hear from, and speak to, experts in the gene therapy analytical development space, particularly with respect to the analytical challenges they are facing and how they have addressed them.
Peter Emery-Billcliff, Principal Scientist, Complement Therapeutics
Industry News
Encoded Therapeutics Presents Positive Interim Phase 1/2 Clinical Data for ETX101 in Dravet Syndrome
Encoded reported encouraging early efficacy and safety results from its ongoing ETX101 gene therapy trial, supporting continued development and potential clinical benefit.
Regeneron Invests $150M Upfront in Tessera Therapeutics’ In Vivo Gene-Writing Platform
Regeneron has entered a major collaboration with Tessera to support its rare disease gene-writing programmes, signalling strong industry backing for next-gen genetic medicines.
FDA Unveils “Plausible Mechanism” Pathway to Accelerate Custom Gene Editing Therapies
The FDA proposed a new regulatory route that could speed up approval of highly personalised and bespoke gene-editing therapies for rare conditions.
Eli Lilly Acquires Adverum Biotechnologies, Strengthening its Gene Therapy Portfolio
Lilly’s acquisition of Adverum (developer of the Phase 3 ocular gene therapy Ixo-vec) expands pharmaceutical investment and confidence in gene therapy approaches for vision loss.
Cell & Gene Therapy Market Projected to Surpass $105B by 2033
Industry forecasts highlight sustained long-term growth and investment in gene therapy and related advanced medicines.
Explore the Agenda
- 16+ expert speakers from the likes of AAVantgarde, UCB, PureSpring Therapeutics, Regeneron, and UniQure
- 3 days of cutting-edge analytical and QC content addressing the toughest challenges in potency assurance, product characterisation, and analytical readiness across gene therapy platforms
- 6 hours of immersive, case-study led sessions tackling both earlier stage analytical development and later stage QC challenges
- Regulatory-led sessions featuring voices from the Medicines and Healthcare products Regulatory Agency (MHRA) with pharmacopeial insights
Attending Companies Include
Explore the Agenda
Preview regulator-led discussions on analytical strategy, alongside hands-on workshops exploring real-world approaches to assay challenges, QC readiness, and potency assurance.
Partner With Us
Position yourself as the go-to solution provider by showcasing your expertise and value to a room full of biopharma KOLs.
Join Biopharma Experts
Engage with analytical development, QC, CMC, and regulatory leaders through structured networking, roundtables, and small-group discussions to accelerate your gene therapy pipelines.