Monica Shah, MD, IQVIA, Washington, D.C., discusses ongoing hurdles that need to be overcome in manufacturing cell and gene therapies. Companies must be able to mass-produce products to ensure clinical trials can be conducted and for commercial use. Dr Shah additionally emphasizes the need for careful planning to ensure a robust supply is maintained, especially when treating prevalent diseases as a large patient population can put pressure on current manufacturing capabilities. This interview took place at Meeting on the Mesa 2021.