Accelerate Phase Appropriate Assay Development with Advanced Analytics to Demonstrate Safety, Efficacy, & Consistency of Gene Therapies to Regulators
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. Addressing these critical needs, the 7th Gene Therapy Analytical Development Summit returned to Boston in October 2025. With increased pressure for analytical rigor, potency relevance, and product consistency, the need for robust, forward-thinking solutions was more urgent than ever.
The 2025 summit delivered practical, data-driven insights on validating potency assays and genome integrity analytics across diverse delivery platforms to ensure consistency, safety, and regulatory compliance. Attendees explored 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:
- How companies are aligning assay strategies with IND, BLA, and RMAT requirements to meet regulatory expectations and speed up development timelines
- The integration of tools like long-read sequencing, mass photometry, analytical ultracentrifugation, and digital PCR into GMP-ready, QC-compatible workflows
- Real-world strategies to overcome limitations of under-validated techniques that are slowing next-generation programs
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
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2025 Speaker Faculty Included:
Official Partners
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Expertise Partners
Exhibition Partners
Innovation Partner
Companies that Attended in 2025:
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