Amid application tsunami, FDA's top cell and gene therapy leader to retire in March

The FDA is in a bind and what it needs most right now is the expertise necessary to vet a massive pipeline of cell and gene therapies coming down the pike.

Less than 30 of these therapies have so far been approved by the FDA, and Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, told Endpoints News in an emailed statement that there are now 2,500 applications pending, and many of the meetings with sponsors are falling behind.