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.
Speaker
Sandeep Yadav, PhD, VP CMC Technical Development, Sangamo Therapeutics
Sandeep Yadav, PhD, is currently Vice President of Technical Development at Sangamo Therapeutics, advancing genomic medicines from discovery to commercialization. Prior to Sangamo, he held several leadership position at Genentech/Roche and contributed to various clinical and commercial programs including; Tacentriq®, Ocrevus®, Rituxan®, Avastin® and Pulmozyme®. He has led CMC strategy from clinical development and commercialization across biologics, cell and gene therapies and small molecules. Dr. Yadav brings deep expertise in process development, manufacturing and global regulatory submissions. A recognized thought leader with ~30 publications and patents, he actively engages in industry forums and is passionate about building high-performing teams through mentorship, strategic leadership and collaborative execution.
Message PresenterWho Should Attend?
This webinar is ideal for CMC, regulatory and technical professionals involved in the development and manufacture of cell and gene therapies, nucleic acid therapeutics and other next-generation therapeutics, including:
- CMC and Regulatory Affairs professionals
- Process Development and Manufacturing Scientists
- Analytical Development and Quality professionals
- Technical and Project leaders responsible for CMC strategy, process changes and lifecycle management
What You Will Learn
Attendees will gain insight into:
- How to define and justify a critical starting material, and why this classification shapes CMC strategy and regulatory pathways
- What regulators expect in a robust submission, including comparability data, risk assessments and the scientific evidence needed to support a critical starting material change
- How to avoid common regulatory pitfalls by structuring an effective CMC submission, communicating proactively with regulatory agencies and understanding differences in expectations across agencies such as the FDA and EMA
- How to plan for successful implementation, with practical guidance on managing timelines and navigating unavoidable or urgent starting material changes
Xtalks Partner
4basebio
4basebio is a Cambridge-based biotechnology company pioneering the use of synthetic DNA to enable next-generation therapeutics and vaccines. Through its proprietary enzymatic DNA synthesis platform, 4basebio produces GMP-grade synthetic DNA with superior speed, purity, and scalability, overcoming the limitations of plasmid-based systems. These solutions help partners accelerate proof-of-concept studies and reach clinical milestones more efficiently, while maintaining the highest standards of safety and quality. With a focus on innovation, flexibility, and precision, 4basebio equips biopharma and academic partners with the tools to unlock the full potential of genetic medicine.
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