Former UNC-CH Researcher Ned Sharpless Named Acting FDA Chief

For the second time in three years, one of the Research Triangle’s own has been put in charge of the U.S. Food And Drug Administration (FDA).

Norman E. “Ned” Sharpless, M.D., who is currently director of the National Cancer Institute (NCI), was named acting commissioner Tuesday to replace FDA Commissioner Scott Gottlieb, M.D. Gottlieb unexpectedly announced his resignation March 5. 

Health and Human Services Secretary Alex Azar, who made the appointment, said “Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA.” He will take over early next month and lead the agency until a permanent replacement is named.

Sharpless joined the NCI in October 2017 after serving as director of the University of North Carolina’s Lineberger Comprehensive Cancer Center. He also founded or co-founded two Research Triangle-based biotechnology startup companies, Sapere Bio (formerly Healthspan Diagnostics) and G1 Therapeutics (formerly G-Zero Therapeutics).

NCBiotech supports Sharpless' science

The North Carolina Biotechnology Center made two loans to G-Zero Therapeutics (now G1 Therapeutics), co-founded by Sharpless. They were in 2011 and 2012, totaling $475,000, and were subsequently repaid.

NCBiotech also awarded a 2014 Technology Enhancement Grant to UNC’s tech transfer office for a project for which Sharpless was the principal investigator.

“It will be an honor to advance the FDA’s critical public health mission and build on its progress toward the priorities laid out by President Trump, Secretary Azar, and Commissioner Gottlieb,” Sharpless said in a statement.

Gottleib -- who has made lowering drug costs and spurring pharmaceutical innovation top priorities during his two years at the FDA –said in an email to employees that Sharpless “shares our mission and I know he will be embraced warmly by the Agency’s professional staff.” 

Sharpless closely follows another highly respected physician and medical researcher from the Research Triangle -- Robert Califf, M.D. -- who served as acting FDA commissioner during the final year of the Obama Administration. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University at the time of his appointment in February 2016. He has since returned to Duke, where he is the Donald F. Fortin, M.D. Professor of Cardiology in the School of Medicine and a member of the Duke Clinical Research Institute.

Many Triangle health professionals gain prominence

Sharpless and Califf aren’t the only Triangle area health professionals to make good on state, national and international stages.

• Bill Roper, M.D., Ph.D., recently was named interim president of the UNC System. Roper also serves as vice-chancellor for medical affairs at the University of North Carolina at Chapel Hill. He is a former director of the Centers for Disease Control and Prevention, an administrator in the Health Care Financing Administration, and previously held positions in the White House for both Presidents Ronald Regan and George H. W. Bush.
• Victor Dzau, M.D., left his position as president and CEO of the Duke University Medical Center in 2014 to become president of the prestigious National Academy of Medicine in Washington, D.C. Dzau, who maintains a home in Durham, has also served on the NCBiotech board of directors.
• Former FDA Commissioner Mark McClellan, M.D., Ph.D., served under President George W. Bush from 2002 to 2004. McClellan is now director of the Duke-Margolis Center for Health Policy and the Robert J. Margolis Professor of Business, Medicine, and Policy at Duke. He is a doctor and an economist whose work has addressed a wide range of strategies and policy reforms to improve health care, including payment reforms to promote better outcomes and lower costs, methods for development and use of real-world evidence, and approaches for more effective drug and device innovation.

Nobel Laureates who remain active in North Carolina life science research include:

• Robert Lefkowitz, Ph.D., of Duke University, who won the chemistry prize in 2012; and
• Duke researcher Paul Modrich, Ph.D., and Aziz Sancar, M.D., Ph.D. of the University of North Carolina at Chapel Hill, who shared the prize in chemistry in 2015 with Swedish scientist Tomas Lindahl.