FDA Seeking New Talent to Handle Gene Therapy Rise
A top priority this year for dealing with the surge in development of new cell and gene therapies (CGTs) is for the Center for Biologics Evaluation and Research (CBER) to attract hundreds of talented and experienced scientists to the agency.
CBER Director Peter Marks recognizes the difficulties in recruiting and retaining staff with limited salary levels and relatively flat funding expected from Congress. CBER increased staff by 126 new hires last year in its CGT office.
A “key need,” Marks explained in a webinar sponsored by the Alliance for a Stronger FDA last week, is to attract more seasoned people, particularly those with expertise in manufacturing, to provide the kind of timely, accurate information that industry needs.1 Such mid-career people with knowledge of manufacturing issues, moreover, are particularly critical for CBER to help train more junior staffers, he explained.
CDER still has a considerable pay gap in hiring compared to the private sector, Cavazzoni said, acknowledging that “everyone is competing for talent.”
Both Marks and Cavazzoni cited the importance of provisions in the 21st Century Cures Act and recently renewed user fee legislation for providing added resources and authority for FDA to offer higher salaries to individuals with needed experience and qualifications. Even so, the agency struggles to compete with the private sector for “really good people,” said Marks.
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