March 13, 2019

Meet Ned Sharpless—the next acting FDA commissioner

Daily Briefing

    HHS Secretary Alex Azar announced Tuesday that Ned Sharpless, director of the National Cancer Institute (NCI), will serve as acting commissioner of FDA when FDA commissioner Scott Gottlieb departs.

    Learn more: How to ensure seamless leadership transitions

    Gottlieb announced last week that he would be resigning his post at FDA within the next month to spend more time with his wife and three young children in Connecticut.

    Azar named Sharpless as FDA's next leader during a Tuesday House Energy and Commerce health subcommittee hearing. Azar told committee members that Douglas Lowy, deputy director of the NCI, will serve as acting director of the institute when Sharpless leaves.

    Who is Ned Sharpless?

    Sharpless is an accomplished researcher, oncologist, and administrator, the Washington Post reports.  He has published over 150 original papers according to his official biography. He has served as director of the NCI for roughly 18 months, and according to the Post, has received "good reviews from cancer advocates, patient groups, and academic researchers."

    During his time at the NCI, Sharpless has pushed for increased data sharing, analysis, and aggregation in order to develop new understanding of and treatments for cancer. He has also expressed interest in utilizing artificial intelligence, including IBM Watson, to improve cancer treatments. "It's early days for [NCI] in this area," he said last year, "and most of the regulatory issues are really for … FDA to tackle."

    Sharpless has also advocated for the modernization of clinical trials and worked to boost funding for academic investigators nationwide.

    Ellen Sigal, chair of Friends of Cancer Research, an advocacy group, said Sharpless "has already proven to be an extraordinary leader throughout his career and while running the NCI." She added, "His dynamic style, deep scientific knowledge and passion for helping patients make him an ideal next commissioner during this pivotal time for science and public health."

    Before joining the NCI, Sharpless served as director of the University of North Carolina Lineberger Comprehensive Cancer Center. He has also co-founded two biotech companies: G1 Therapeutics, which develops cancer drugs, and HealthSpan Diagnostics, which develops blood tests.

    Sharpless' vision for FDA

    Following Azar's announcement, Sharpless said he plans to continue the work Gottlieb started at FDA. "We are going to be carrying forward Dr. Gottlieb's vision," he said. "His agenda is my agenda. My agenda is his agenda."

    Gottlieb supported Sharpless' appointment as acting FDA commissioner and said he and Sharpless have a cordial relationship. He added that Sharpless "plays on a weekly basketball team with some of our medical review staff."

    According to the Post, Sharpless could start at FDA quickly and is a potential contender for the permanent commissioner job. While Sharpless has never been confirmed by the Senate, as a presidential appointee, he has been extensively vetted and divested himself of financial holdings that could potentially become conflicts of interest.

    According to Azar, "Sharpless' deep scientific background and expertise will make him a strong leader for FDA." Azar added, "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" (Baker, Axios, 3/12; McGinley/Goldstein, Washington Post, 3/12; Facher, STAT News, 3/12; Owermohle, Politico, 3/12).

    Learn more: How to ensure seamless leadership transitions

    We spoke with an array of HR executives and discovered eight key insights your organization can use to build a strong, diverse executive team ready to meet current and future challenges. To learn more, read our briefing about how to ensure seamless leadership transitions.

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