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.
“Currently, there are more than 1,300 active investigational new drug (IND) applications for gene therapies, and over 1,200 active IND applications for cell therapies,” Marks said.
Wilson BryanAdding salt to the wounds of their employment needs (of at least 100 new positions), FDA’s director of the Office of Tissues and Advanced Therapies, now known as the Office of Therapeutic Products, Wilson Bryan, will retire in March, CBER’s chief of consumer affairs Paul Richards confirmed yesterday. The news was first reported yesterday by the Pink Sheet’s Derrick Gingery.
Bryan will depart with more than 20 years of FDA experience, after coming to the FDA from the neurology faculty of the University of Texas Southwestern Medical School for more than a decade. More recently, he’s been up close and personal with this growing cell/gene therapy pipeline, having served since 2016 as the office director.
“The reviewers and project managers in cell and gene therapies are really stretched,” he said at the American Society of Gene and Cell Therapy’s policy summit last September, noting that the meeting workload, in particular, has grown at a pace that far exceeds personnel increases, “and that creates a stressful situation.”
He also noted some key personnel departures from OTAT, and the fact that the industry can quickly poach people from his office for much higher salaries.
“As OTAT has grown, the organizational structure has been a bit of a problem,” Bryan said. “We have some branches that grew to where a branch chief was supervising over 20 people…I’m very worried about turnover due to workload and reimbursement due to salaries not being competitive. We lost some really good people because they can go somewhere else and make a lot of money.”
And this crunch on staff has been going on for a while.
“We are meeting most PDUFA UF [user fee] deadlines, but at the expense of staff working considerable overtime and facing significant burnout,” noted 30-year FDA vet Christopher Joneckis, CBER’s associate director for review management, in April 2021.
Even still, the latest user fee deal infuses significant new sums of money (i.e. millions of dollars) to try to recruit top new talent into the cell/gene therapy office.
