March 12, 2019

Shuffling the chairs: NCI director is chosen as interim US FDA head

If there is one thing that can be said about the incoming interim commissioner of the US FDA it is that he knows a bit about the nuts and bolts of early-stage drug and diagnostics development. The National Cancer Institute director, Ned Sharpless, who will take the reins from Scott Gottlieb on a caretaker basis, was the founder of the North Carolina-based biotech startups G1 Therapeutics and Sapere Bio, formerly Healthspan Diagnostics. Both companies were founded on Mr Sharpless’s discoveries as associate director of translational medicine at the Lineberger Comprehensive Cancer Center at the University of North Carolina. Today, G1 has a CDK4/6 inhibitor, trilaciclib, in phase II development, while Sapere is developing a blood test to predict which patients are at risk of acute kidney injury following cardiac revascularisation procedures. Presumably Mr Sharpless will need to recuse himself from any decisions regarding either company. Mr Gottlieb surprised the sector last week when he announced his resignation, but investors seem to approve of his likely permanent replacement: the Nasdaq biotechnology index jumped on the news of Mr Sharpless's appointment.