6th Gene Therapy Analytical Development Summit Europe

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6th Gene Therapy Analytical Development Summit Europe

The 6th Gene Therapy Analytical Development Summit Europe, taking place from 20th – 22nd May 2025 in London, returns as the only European forum solely dedicated to tackling the analytical and quality control (QC) challenges across the gene therapy lifecycle from Pre-IND/IMPD to BLA.

This year’s summit arrives at a critical moment for the field. With approvals like LYFGENIA and BEQVEZ raising the bar for analytics, and setbacks such as Rocket Pharma’s KRESLADI rejection exposing CMC vulnerabilities, the need for precise, validated, and regulatory-aligned analytics has never been more urgent.

Join 24+ expert speakers and over 90 industry stakeholders to unlock analytical strategies that elevate your development programmes, streamline regulatory approvals, and safeguard therapeutic efficacy.

This year’s expanded agenda dives deep into critical content areas, including method validation, characterisation, comparability, QC readiness, and potency assays—all tailored to meet European regulatory expectations and harmonise with global frameworks like the FDA and EMA. Whether navigating early development or preparing for commercial scale, you’ll gain the practical tools and regulatory foresight needed to meet evolving standards.

Key speakers include:

  • Uditha De Alwis, VP Analytical Sciences, Sarepta Therapeutics
  • Claire Kerridge, Head of Gene Therapy, MHRA
  • Alicja Fiedorowicz, ATMP Scientific Lead, British Pharmacopoeia
  • Lisa Kirkwood, Associate Director, Analytical, AAVantgarde Bio
  • Simon Briggs, Director, Advanced Analytics, Orchard Therapeutics
  • Karine Gelats, Associate Director, GenSight Bio

 

This year’s programme also features hands-on workshops on PCR strategy, potency assay challenges, and QC/CMC synchronisation, offering actionable tools for both early-stage developers and those preparing for late-stage filings. Roundtables and fireside chats further enhance peer-to-peer learning and real-world application.

What sets this summit apart is its focus on real solutions: how to adapt and validate assays under evolving regulations, scale up with analytical integrity, and navigate tech transfer without compromising consistency. It’s also your chance to engage with leading service providers such as SGS, Intertek, Sartorius, Abselion, QuTEM and Quatre Lab, showcasing cutting-edge innovations in analytics and testing services.

Whether you’re tackling assay validation, seeking clarity on regulatory expectations, or exploring automated solutions to scale up with confidence, this is the community where the top gene therapy analytical minds converge.

Find out more about what this event has to offer in the full agenda: https://ter.li/qf1w8h

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