NEW YORK — It’s not really a stretch of the imagination to think that microbiome companies should care deeply about who will lead the Food and Drug Administration after the current commissioner, Scott Gottlieb, departs in a few weeks. After all, no microbiome-based drug has yet gone through the regulatory process and made it to market and investors are still skittish about how those drugs will be received by the agency.
Yet a five-person panel of microbiome executives on a panel at the inaugural Chardan Microbiome Summit on Thursday didn’t address the shift in leadership until prompted by a member of the audience. And when they did, the response was essentially “meh.”
“I’m not anticipating any change. I think the regulatory flexibility we’ve seen in the last few years has been attributed to Gottlieb,” Aoife Brennan, chief executive officer and chief medical officer of Synlogic (SYBX), said during the panel. “But I think a lot of the science-based regulation we’ve seen is a trend that pre-dated him.”
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