In this free workshop, we'll discuss the most underestimated drivers of CMC risk: material quality, technical variability, and supply chain fragility.

Deep dive into raw material risks in cell and gene therapy, covering quality, technical variability, supply chain vulnerabilities, and end-to-end material management strategies. Attendees will gain rare FDA-insider insight into DMFs, material controls, comparability expectations, and how to build inspection-ready CMC packages for CGT programs.

• Practical overview of material risks and material management principles.

• What's in a material DMF, how different DMF types are used, and how FDA treats each category during review.

• FDA’s real-world approach to material changes, comparability expectations, and what level of justification is needed depending on change category.

• How implantable device methodology, material-level characterization, and filing conventions can inform better raw material control strategies in CGT.

About Basak Clements:

Founder of biomatria. 15+ years leading CGT, biologics manufacturing, and materials science. Former Global Head/Senior Director of Cell and Gene Therapy Materials Science at Roche/Genetech. Her background spans materials science, process development, and supply chain roles at Johnson & Johnson and Amgen. Elected committee member of US Pharmacopeia CGT Expert Committee.

Virtual event, link provided upon confirmation

FDA Insider Workshop is an interactive workshop series on Regulatory, CMC & Raw material topics that are critical for life sciences teams preparing or in clinical trials.