A conference report from Rome highlighted how FDA decisions are shaping sentiment for the gene therapy and cell therapy sector, even as industry leaders look for opportunities in Europe. The discussion centered on recent approvals of rare disease treatments and continued concerns about the regulatory roadblocks that can delay programs. The piece also flagged leadership churn inside FDA’s vaccine and gene/cell therapy apparatus, pointing to the departure of Vinay Prasad, who previously served as a top regulator of gene and cell therapies as well as vaccines. That personnel shift is being watched closely by stakeholders as they plan development and regulatory strategy. While the full details of future policy actions were not provided, the immediate takeaway for biotech teams is that FDA is continuing to set the pace for both approval expectations and operational risk in gene therapy development.