FDA, People

NCI’s Ned Sharpless gets the nod to run the FDA in wake of Scott Gottlieb’s surprise exit

The head of the National Cancer Institute, UNC alum Norman “Ned” Sharpless, has been tapped as the acting head of the FDA.

The news follows a few different stories pointing to Sharpless as the likely next helmsman of the agency, where the popular commissioner Scott Gottlieb announced his surprise resignation less than 2 years after taking the post. And Gottlieb was quick to offer a thumb’s up.

While not formally nominated, the move positions Sharpless as Gottlieb’s likely successor. If so, Sharpless won’t encounter much, if any, opposition in the biopharma industry. But execs will be waiting to see if he can come close to matching Gottlieb’s zeal for speeding up agency reviews and hastening approvals at a time of record new drug OKs — including the initial launches for the first in a whole new generation of cell and gene therapies.

Sharpless has a solid resume that resonates well with industry execs. He graduated from UNC School of Medicine and did his residency at Mass General. Following a 2-year stint at Harvard Med he went back to UNC, where he became the Wellcome Professor of Cancer Research in 2012. He was tapped to run the NCI in 2017.

That all translates into instant respect in biopharma, but not necessarily unbridled enthusiasm.

Respect, though, will go a long way in setting the stage for Sharpless, particularly as earlier candidates pitched to President Donald Trump includes at least one with an odd libertarian streak that didn’t sit well with drug developers devoted to maintaining a gold standard for new drug approvals — even if that standard has proven increasingly flexible.

Piper Jaffray’s Christopher Raymond put himself down for an enthusiastic endorsement.

Sharpless was clearly Gottlieb’s top choice, and in that he is a long time insider and physician/scientist, we think investors should expect FDA to continue on its current path of increased regulatory efficiency with an industry-friendly lean. We expect the biopharma space to be up sharply on this news.

 


Image: Ned Sharpless. AP IMAGES


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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