Monica Shah, MD, IQVIA, Washington, D.C., considers some issues in developing cell and gene therapies for cardiovascular diseases that need to be addressed, including administrating advanced therapies directly to the heart and large-scale manufacturing cell and gene therapies. Trial design is an additional barrier to overcome, as defining the right target population and specific endpoints are necessary. Dr Shah also highlights how future cell and gene therapies need to show value and superior efficacy compared to existing treatments for them to be commercially viable. This interview took place at Meeting on the Mesa 2021.