These are billed as being exciting times for cell and gene therapies, but seasoned observers of the pharmaceutical industry would be forgiven for taking that billing with a pinch of salt.
One such observer is Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), who recalls the same sort of hype – and questions from the doubters – coming up when he made the move from academia to industry two decades ago.
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