Driving Analytical Excellence from Pre-IND Through BLA for Next-Generation Gene Therapies

Returning to Boston this October, the 7th Gene Therapy Analytical Development Summit is the industry’s definitive meeting for advancing assay development and analytical strategy across the gene therapy lifecycle. As gene therapy platforms expand beyond AAV to encompass mRNA, CRISPR-based modalities, LNPs, and novel capsids, analytical teams must evolve in parallel to meet growing regulatory scrutiny and technical complexity.

This summit brings together analytical development, QC, and regulatory experts to share practical insights on validating potency assays, genome integrity, and advanced characterization tools to ensure product consistency, safety, and regulatory readiness from early development through to BLA and commercial launch.

With expert contributions from leaders at Beam Therapeutics, Sarepta, Astellas, Spark Therapeutics, Adverum, REGENXBIO, and GenSight Biologics, attendees will explore real-world solutions to persistent challenges in full or empty capsid quantification, aggregation profiling, stability assay design, and assay transfer into GMP environments.

Featured speakers include Johnson Varghese, Vice President of Analytical Sciences at Beam Therapeutics, sharing phase-appropriate validation strategies, and Sue Duan, Head of Analytical Development at Astellas, who will discuss genome integrity testing across multiple vector platforms. Also presenting are Uditha DeAlwis of Sarepta Therapeutics and Vanessa Strings-Ufombah from Adverum Biotechnologies, offering unique perspectives on aligning assay strategies with global regulatory expectations.

Attendees will gain exposure to cutting-edge techniques including long-read sequencing, digital PCR, analytical ultracentrifugation, and mass photometry, with a focus on integrating these tools into QC-ready workflows that meet IND, BLA, and RMAT requirements.

With two technical tracks, this event delivers unmatched depth across bioassays, molecular analytics, and physicochemical characterization, empowering you to optimize existing platforms or develop robust analytics for new therapeutic modalities.

Whether refining potency assays, reducing batch variability, or preparing for regulatory submission, this is your opportunity to benchmark with peers and shape the future of gene therapy analytics in 2025 and beyond.

Download the Brochure Here for More Information: https://ter.li/wld1o2