Is CBER heading for a risk tolerance swing under Prasad?

A more risk-averse environment at FDA under new CBER Director Vinay Prasad is unlikely to derail the progress that cell and gene therapies have made in rare diseases over the past decade. But what the outspoken FDA critic’s appointment suggests about the application of the modalities to more prevalent indications — and about FDA Commissioner Marty Makary’s broader objectives at the agency — will be closely watched by drug developers and investors alike.

Prasad, who became director of FDA’s Center for Biologics Evaluation and Research (CBER) last week, replaces Peter Marks, who was ousted in March after nine years in the role. ...