As a year marked with more ground-breaking advanced therapy product approvals and new guidance from regulators comes to an end, David McCall, Senior Editor of Cell & Gene Therapy Insights, talks to Peter Marks, Director of the Center for Biologics Evaluation and Research at the US FDA, about his reflections on talking points and progress made in cell and gene therapy over the course of 2023, and his plans and priorities for the agency’s future activities through 2024 and beyond.