Cell And Gene Therapy Commercialization Handbook

Cell and gene therapies (CGTs) are expanding into broader indications, requiring manufacturers to adapt their strategies for scale and wider patient access. This commercialization handbook outlines the critical pivot from scientific innovation to operational execution, focusing on five essential pillars: market access, regulatory compliance, distribution, logistics, and patient support. Success depends on early coordination, such as engaging payers with economic data pre-approval to secure coverage and establishing robust cryogenic supply chains that can handle increased volume.

By navigating FDA special programs like RMAT to managing complex patient journeys, manufacturers can avoid costly bottlenecks and delays. Explore these actionable recommendations to build a resilient commercial infrastructure that supports long-term viability.