Xtalks — The Life Science Community™, Online webinar
2026-09-28
Changing a critical starting material, whether driven by supply chain risk, a new supplier, process improvement or obsolescence, can be the most consequential decision a manufacturer can make. It touches everything from analytical comparability to stability data, regulatory strategy and timelines. Therefore, these changes require robust scientific justification and a well-planned CMC strategy. In this webinar hosted by 4basebio, Sandeep Yadav, VP CMC Technical Development at Sangamo Therapeutics, explore what's really involved in preparing a regulatory submission to support a critical starting material change. Drawing on real-world experience, they'll discuss how to build a scientifically sound, risk-based justification that satisfies regulators while keeping development programs on track. Whether responding to an imposed supplier change, planning for commercial scale-up or simply to understand how regulators assess these changes, this webinar will provide practical insights and a clear framework to help navigate critical starting material changes with confidence. Register for this webinar to learn how to strengthen CMC submissions for critical starting material changes, understand regulatory expectations and develop a practical, risk-based approach that supports successful regulatory outcomes.
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