The Risk-Reward Of US FDA Leadership Running Offices Below Them
Executive Summary
CBER’s Celia Witten is the latest senior executive to run an office within the center during a leadership transition, a move that can help achieve specific goals, but also create tension.
You may also be interested in...
US FDA Opens OTP Director Search Again
The new job notice offers a top salary, but also invites questions about the candidate pool attracted by the original solicitation.
US FDA Cell/Gene Therapy Office ‘Aggressively Recruiting’ Amid Reorg, Senior Staff Departures
Transformation of former Office of Tissues and Advanced Therapies into a ‘super office’ will provide leadership opportunities for a younger generation, retiring director Wilson Bryan says. CBER head Peter Marks says he is not concerned if agency staff later go to work for industry; suggests increased staffing and reorg could help cut down on gene therapy IND clinical holds.
Gene Therapy: Years After Accelerated Approval, Will US FDA Still Be Asking ‘Does It Work?’
Retiring Office of Tissues and Advanced Therapies’ Director Wilson Bryan expects the expedited pathway will be used more frequently moving forward, but worries that ambiguous confirmatory trial results many years down the line will still leave efficacy questions unanswered.