It's official: NCI Director Ned Sharpless will take on the role of acting commissioner of the FDA. But what does the appointment mean for interagency cooperation between the federal government’s main medical research and innovation arm and its industry regulator?
Outgoing FDA Commissioner Scott Gottlieb, who is expected to step down in early April, tweeted his approval of the pick, writing: “Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”
And in a letter to FDA staff—and perhaps something of an early example of interagency teamwork—Gottlieb described how some may already be personally familiar with Sharpless, who plays on a weekly basketball team with members of the agency’s medical review staff.
But they're no strangers, regardless. In a NCI blog post late last year, Sharpless described strategic partnerships with the FDA as a “win-win for making progress against cancer,” including efforts to solve tissue sample mislabeling and human errors through genomic and proteomic sequencing, as well as working against tobacco use.
In addition, the FDA and NCI have maintained a long-running Interagency Oncology Task Force fellowship program, to develop scientists with skill sets bridging research and regulatory science.
In his more recent work as NCI director, he has helped to broaden the eligibility criteria for institute-sponsored clinical trials to make it easier to recruit patients and speed up R&D.
As part of a multiyear effort with the American Society of Clinical Oncology and Friends of Cancer Research, as well as the FDA, the NCI has adopted new language expanding four areas of criteria that were common obstacles to patients looking to join a clinical trial: the presence of brain metastases, prior or concurrent unrelated cancers, HIV or AIDS status, and dysfunction of the kidneys and other organs.
Other main areas that Sharpless has named as essential to his vision for the institute include a focus on developing the NCI’s scientific workforce—a perennial issue for the FDA—as well as employing big data to better inform research.
Whether Sharpless will stay on as a permanent commissioner remains to be seen. However, Politico reported that Gottlieb has recommended for Sharpless to be officially named for the position going forward.
Outside of the government—and in addition to previously serving as director of the University of North Carolina’s cancer center—Sharpless has co-founded at least two biotech companies: G1 Therapeutics and Sapere Bio, formerly known as HealthSpan Diagnostics. Last December, G1’s stock took a dive after its phase 2 cancer drug trilaciclib failed to outperform placebo in progression-free survival and rates of objective response in small cell lung cancer patients.
Still, drugmakers are likely relieved to have someone with industry experience fill the post, at least temporarily. Indeed, biotech stock indexes on the Nasdaq and the S&P 500 rose at least 1% on the news of Sharpless' appointment, which was revealed by HHS Secretary Alex Azar while testifying before a House health subcommittee on the Trump administration’s annual budget request.
NCI Deputy Director Douglas Lowy will once again fill in to lead the institute during Sharpless’ absence; Lowy previously served as acting director for two-and-a-half years, spanning the transition between the Obama and Trump administrations.