Up to the challenge: Manufacturing’s central role in the cell- and gene-therapy revolution

Pharma took a huge leap from small-molecule drugs to biologics, and now it’s taking another one as the industry beefs up in cell and gene therapies. Some 800 such therapies are moving through the biopharma pipeline, and former FDA commissioner Scott Gottlieb expects 10 to 20 to be approved annually by 2025. Drugmakers, CDMOs, and even hospitals are investing big money in production capacity and the complicated supply-chain infrastructure necessary to make all that happen. The upfront investment is daunting, and the complexity of the production processes themselves are unmatched in the rest of the pharma world. In this session, our experts will describe the state of play in cell and gene therapy manufacturing today, and outline the growth and changes necessary to keep up with demand as the next-generation therapies make their way through pipelines, past regulators and to patients themselves.