NCI Director Ned Sharpless to Be Named Acting FDA Commissioner

Norman (Ned) E. Sharpless, MD

National Cancer Institute (NCI) director Norman (Ned) E. Sharpless, MD, has been named as acting commissioner of the FDA once Scott Gottlieb, MD, leaves the regulatory agency in April 2019, according to an announcement by the Health and Human Services Secretary (HSS).¹

The news was released at a House Energy and Commerce Health Subcommittee Hearing one week after Gottlieb announced his plan to resign in early April after nearly 2 years of service.

“Dr Sharpless’ deep scientific background and expertise will make him a strong leader for the FDA,” said HHSS secretary Alex Azar in a statement. “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

Sharpless was sworn in as the 15th director of the NCI on October 17, 2017. Prior to the appointment, Sharpless served as the director of the University of North Carolina (UNC) at Chapel Hill’s Lineberger Comprehensive Cancer Center since January 2014.²

Described as a visionary leader as well as a gifted scientist and clinician by UNC-Chapel Hill chancellor Carol L. Folt, Sharpless was a Morehead Scholar at UNC-Chapel Hill where he received his undergraduate degree in mathematics. From there, Sharpless went on to obtain his medical degree from the UNC School of Medicine.

After completing his internal medicine residency at the Massachusetts General Hospital as well as a hematology/oncology fellowship at Dana-Farber/Partners of Cancer Care, Sharpless served as a faculty member at Harvard Medical School for the duration of 2 years. In 2002, he returned to the UNC School of Medicine as a faculty member in the Departments of Medicine and Genetics. A decade later, he was named the Wellcome Professor of Cancer Research at UNC.

During his time at UNC, Sharpless also codirected a large clinical trial referred to as UNCseq, which used next-generation sequencing of tumor DNA as a way to define optimal chemotherapy in patients with advanced cancer in real-time.³ Beyond this work, he has authored over 150 scientific papers, reviews, and book chapters.

Sharpless has continued to participate in research efforts as chief of the Aging Biology and Cancer Section in the National Institute on Aging’s Laboratory of Genetics and Genomics, where he has worked to further the collective understanding of the relationship between aging and cancer.

No stranger to the drug development process, Sharpless has contributed to the preclinical development process of several therapeutic agents in melanoma, breast cancer, and lung cancer, in addition to cofounding 2 early-stage biotechnology companies.

“Change is good, but bittersweet,” wrote Sharpless on Twitter. “It is difficult for me to say goodbye to the NCI family as I head to the FDA to serve as acting commissioner. Rest assured that our goals for patients and the public’s health will translate into my new duties.”

In subsequent tweets, Sharpless thanked President Donald Trump, Azar, and Gottlieb for their “support and encouragement” as well as his team at the NCI for their “professionalism and passion.” He also shared that with this move, Douglas R. Lowy, MD, prior deputy director of the NCI will now serve as acting director for the institute in his stead.

References

1. Ned Sharpless, director of the National Cancer Institute, to be named acting FDA commissioner [news release]. Washington, DC: Stat News; Published March 12, 2019. https://bit.ly/2XV9mQH. Accessed March 12, 2019.
2. NCI director Dr. Norman E. Sharpless. National Cancer Institute. Updated March 11, 2019. https://bit.ly/2yLZ5Jj. Accessed March 12, 2019.
3. Sharpless Tapped as NCI Director. OncLive. Published June 12, 2017. https://bit.ly/2F1SMX0. Accessed March 12, 2019.