Welcome to the 7th Gene Therapy Analytical Development Summit
Advancing Analytics & QC from Pre-IND to BLA
As gene therapies evolve beyond AAV to include mRNA, CRISPR-based platforms, and novel capsids, analytical strategies must advance in parallel to meet rising complexity and regulatory expectations. With increased pressure for analytical rigor, potency relevance, and product consistency, the need for robust, forward-thinking solutions is more urgent than ever.
The 7th Gene Therapy Analytical Development Summit returns to Boston this October as the industry’s most comprehensive event dedicated to analytical excellence across the gene therapy development lifecycle–from early research through to BLA submission and commercial readiness.
This year’s summit will deliver practical, data-driven insights on validating potency assays and genome integrity analytics across diverse delivery platforms to ensure consistency, safety, and regulatory compliance. Attendees will explore solutions to persistent challenges in full/empty capsid quantification, aggregation profiling, and stability assay design, focusing on enhancing product quality and minimizing batch failures.
With expert insights from Spark Therapeutics, Novartis, Sarepta, Astellas, Beam, Regeneron, Eli Lilly, Bristol Myers Squibb, and more, this is the must-attend meeting for those advancing gene therapy analytics.
Key highlights include:
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How companies are aligning assay strategies with IND, BLA, and RMAT requirements to meet regulatory expectations and speed up development timelines
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The integration of tools like long-read sequencing, mass photometry, analytical ultracentrifugation, and digital PCR into GMP-ready, QC-compatible workflows
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Real-world strategies to overcome limitations of under-validated techniques that are slowing next-generation programs
Previously Attending Companies Include:
World-Class Speaker Faculty Includes:
Vanessa Strings-Ufombah
Executive Director, CMC Assay and Drug Product Development
Adverum Biotechnologies
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The 7th Gene Therapy Analytical Development is a premier forum that provides an invaluable platform for professionals to share knowledge, engage in collaborative learning, and drive innovations in the field. By focusing on analytical development, the summit ensures that gene therapies are meticulously evaluated, leading to safer and more effective treatments for patients worldwide
Prateek Tripathi, PhD, Senior Expert-Science & Technology, Novartis Pharmaceuticals
2025 Speaker
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Our Partners:
Expertise Partner
Program Partners
Hosting Partner
Exhibition Partners
