7th Gene Therapy Analytical Development Summit | Leading AD meeting in the USA!

Accelerate Phase-Appropriate Assay Development with Advanced Analytics to Demonstrate Safety, Efficacy, and Consistency of Gene Therapies to Regulators

As gene therapies advance beyond traditional AAV platforms to include mRNA, CRISPR-based technologies, and novel capsids, analytical development faces rising complexity and stricter global regulatory expectations. The 7th Gene Therapy Analytical Development Summit returns to Boston this October as the premier industry forum dedicated to tackling these challenges and shaping the future of advanced therapies.

Explore the website for more details here: https://ter.li/m28thn

This year’s agenda provides practical, data-driven insights into potency assay validation, genome integrity analytics, and stability testing across diverse platforms. Attendees will explore solutions to persistent bottlenecks in full/empty capsid quantification, aggregation profiling, and method variability, with a clear focus on enhancing product quality, reducing batch failures, and accelerating time to clinic.

Key Program Highlights:

Aligning assay strategies with IND, BLA, and RMAT requirements to meet regulatory expectations and fast-track approvals
Integrating advanced tools such as long-read sequencing, mass photometry, analytical ultracentrifugation, and digital PCR into GMP-ready workflows
Real-world solutions for overcoming immature or under-validated techniques that slow next-generation programs
Exclusive regulatory workshop, “BLA Submission & PPQ Strategies: Navigating the Critical Path to Regulatory Approval” led by Jeanette Young & Sue Duan, Astellas Pharma – one of the most anticipated sessions of 2025

With insights from Novartis, Spark Therapeutics, Sarepta, Astellas, Regeneron, Eli Lilly, Beam Therapeutics, Bristol Myers Squibb, and more, this meeting is the must-attend hub for analytical, QC, CMC, and regulatory leaders driving forward gene therapy innovation.

In addition to 30+ expert speakers, 6 interactive workshops, and two dedicated content tracks, the summit offers unparalleled networking opportunities through poster sessions, speed networking, and informal meet-ups - ensuring valuable collaboration with peers and thought leaders across biotech, pharma, and regulatory organizations.

Confirmed attendance includes REGENXBIO, Adverum Biotechnologies, CSL, Sanofi, Editas Medicine, Voyager Therapeutics, and Alexion, alongside leading academics and service providers.

The 7th Gene Therapy Analytical Development Summit is your opportunity to stay ahead of regulatory expectations, benchmark against industry leaders, and access the analytical insights needed to deliver safe, effective, and consistent gene therapies in 2025 and beyond.

Secure your place in Boston today: https://ter.li/yf9ypj