RE:RE:RE:RE:RE:RE:FDA's Head of CBER wants faster approvals with SE/biomarkers As part of Operation Warp Speed, the famed federal effort (PDF) to rapidly develop and progress these vaccines in 2020, the regulator maintained a consistent dialogue between sponsors and manufacturers leading up to regulatory submission.
While such detailed and sustained dialogue couldn’t currently be instituted agencywide, it could make for a valuable pilot project to prove its worth to Congress, said Peter Marks, M.D., Ph.D., director of the agency’s Center for Biologics Evaluation and Research (CBER).
“Parents of patients, of kids who have severe diseases, they don't want to hear about Type A, Type B and Type C meeting timelines,” he said. “They want to know what we're doing to truly make a difference in trying to bring something better to their children's lives.”
The solution is, painfully, both simple and difficult to accomplish: hiring and retaining more staff. The agency needs more permanent full-time employees across all disciplines, Marks said.
Marks' comments came the same day that CBER's sister unit the Center for Drug Evaluation and Research (CDER) announced the launch of its Accelerating Rare disease Cures program. The initiative is designed to speed up and increase the development of effective and safe treatment options to address the unmet needs of patients with rare diseases.