STAT+: Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field

ROME — When Tim Hunt, who leads an organization for cell and gene therapy makers, reached for some reasons for optimism for the jittery field at a conference here last week, he highlighted the recent approvals of rare disease treatments from the likes of Rocket Pharmaceuticals and Regeneron Pharmaceuticals. There was one other headline he touted as potentially promising: “FDA vaccine chief to leave the agency again.” The allusion to Vinay Prasad — the Food and Drug Administration’s top regulator of gene and cell therapies as well as vaccines until his departure from the agency last week — was an indication that even at this event, designed to emphasize the opportunities and roadblocks the sector faces in Europe, it couldn’t escape the decisions that are coming from 4,500 miles away.Continue to STAT+ to read the full story…