Mike Lehmicke, Director of Science & Industry Affairs, Alliance for Regenerative Medicine (ARM), Washington, D.C., discusses the challenges faced by the advanced therapy medicinal products (ATMP) field as a result of chemistry, manufacturing and control (CMC) regulations. ARM works with regulatory bodies and stakeholders to overcome CMC issues and aims to improve the clarity with which requirements are communicated to prevent them delaying commercialization. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.