FDA to tackle uptick in cell and gene therapy applications with new ‘super office’

Looking to maximize efficiency in anticipation of an impending flood of cell and gene therapy applications, CBER will morph its Office of Tissues and Advanced Therapies into a new FDA “super office” dubbed the Office of Therapeutic Products.

Wilson Bryan, director of the Office of Tissues and Advanced Therapies (OTAT) at FDA’s Center for Biologics Evaluation and Research (CBER), announced the new Office of Therapeutic Products (OTP) at a recent town hall. The virtual town hall was the first in a planned series to answer questions from stakeholders about topics on which OTAT has regulatory oversight, particularly when it comes to addressing CMC-related issues, which was the focus of the event. The rapid proliferation of new modality therapies with unique CMC issues, which has ramped up FDA’s need to provide guidance as well as to review more submissions, is one driver behind the creation of OTP.  ...