27th March 2025 | 10:00am EDT / 7:00am PDT / 2:00pm GMT / 3:00pm CET | Sarah Thomas, Senior Vice President of Quality at REGENXBIO Inc. |BOOK FREE SEAT FOR THIS WEBINAR
The principles for developing traditional biologics are well established, but do not always translate well to cell and gene therapy products. Creative yet practical adaptations are necessary to advance gene therapy programs toward licensure. During this presentation we will explore three key areas where practical adaptations are required:
Building toward the commercial process: change control and managing product evolution for non-traditional development pathways, comparability challenges, and regulatory expectations
Maturation of analytics – the level of product understanding expected as programs advance, method advancement from early to late phase, ensuring repeatability and robustness in method performance
Finding the right partners – finding the right match in terms complementary capabilities, technical performance, phase-appropriate GMP compliance and client service infrastructure
Presented by Sarah Thomas, Senior Vice President of Quality at REGENXBIO Inc.

Sarah Thomas is the Senior Vice President of Quality at REGENXBIO, responsible for the Quality Assurance, Quality Control and Analytical Development organizations. She has over 30 years’ experience in pharmaceutical, biotech & gene therapy Quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led Quality teams through the transition from clinical to commercial operations, and through multiple product approvals. Ms. Thomas received an MBA from George Washington University and a BS in chemistry from Butler University.
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