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DTSTART;VALUE=DATE:20251021
DTEND;VALUE=DATE:20251024
DTSTAMP:20260515T044155
CREATED:20250620T105534Z
LAST-MODIFIED:20250620T105629Z
UID:41341-1761004800-1761263999@www.pharmajournalist.com
SUMMARY:7th Gene Therapy Analytical Development Summit
DESCRIPTION:Driving Analytical Excellence from Pre-IND Through BLA for Next-Generation Gene Therapies \nReturning 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. \nThis 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. \nWith 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. \nFeatured 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. \nAttendees 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. \nWith 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. \nWhether 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. \nDownload the Brochure Here for More Information: https://ter.li/wld1o2
URL:http://www.pharmajournalist.com/event/7th-gene-therapy-analytical-development-summit/
LOCATION:Hilton Boston Logan Airport\, One Hotel Dr\, Boston\, MA\, 02128\, United States
ORGANIZER;CN="Hanson Wade":MAILTO:info@hansonwade.com
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