CBER Cell/Gene Therapy Office Swamped: Director
CBER’s Office of Tissues and Advanced Therapies (OTAT) is swamped with new product submissions to the extent that the office is considering restructuring and revamping processes to help move products along the regulatory pathways. OTAT regulates cell therapies, gene therapies, as well as plasma derived products, such as immunoglobulins and coagulation factors.
Speaking at a 12/6 online update for the Alliance for a Stronger FDA, OTAT director Wilson Bryan said annual submissions were increasing beyond expectations before the pandemic, and now with increased Covid-19 submissions, it is becoming difficult to properly manage the workload. For example, FDA had projected that at its peak OTAT would see about 200 new INDs submitted each year, but in 2020 it received 354 INDs and so far in 2021, 275 have been received, according to Bryan. And the backlog of active cell based or gene therapy INDs was projected to be around 800, but at the beginning of the month, the backlog had grown to 1,142 active cell therapy INDs and 1,201 active gene therapy INDs.
“We have to think of doing things differently, and one of the things we have to do differently is we have to be thinking about our organizational structure,” Bryan told the Alliance. “Some of our branches have grown so big that they are difficult to manage, and new people coming on, don't get the attention that they need from managers to get appropriately trained and it's hard for the managers to ensure consistency across all applications.”
He said OTAT has a reputation of providing individual attention for all the IND sponsors that come in, but in the years ahead, there is going to be less individual attention for sponsors. “And we've got to find ways to communicate with our sponsors, particularly academic sponsors and small drug companies, so that it doesn’t involve so much individual attention,” he said, adding that OTAT will use more “group communications” and more efficient meetings. OTAT’s Web site is being updated to focus on meetings, such as how to prepare for meetings and the type of questions to ask at meetings, and more Webinars will be added its “OTAT Learn” page.
With an increasing workload comes an increasing need for more guidance, Bryan acknowledged. He said the pandemic has taught the agency how to put out quicker and leaner guidance documents. “Some of those guidances take the form of bulleted guidances, and they're relatively short and very focused on a specific topic, and that paradigm, we think, may be useful going forward to allow us to communicate more quickly and more in depth with our stakeholders,” he said.