New Acting Chief of FDA Has Roots in Oncology, Biotech

The new acting chief of the FDA, Ned Sharpless, MD, has a track record with the biotechnology industry and a friendly relationship with the man he is replacing, Scott Gottlieb, MD.

Sharpless, an oncologist, co-founded 2 clinical-stage biotech companies, which he sold his shares in before becoming head of the National Cancer Institute (NCI) in 2017. The companies, G1 Therapeutics, which has a pipeline of breast cancer and non—small cell lung cancer drugs, and Sapere Bio, which studies the science of aging, reflect his interests.

Before joining the NCI, he was director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center. He also received his medical degree from the UNC School of Medicine and completed his internal medicine residency at the Massachusetts General Hospital and a hematology/oncology fellowship at Dana-Farber/Partners Cancer Care, both of Harvard Medical School.

Given his interests, as well as his efforts to streamline the work of the NCI, some observers believe Sharpless will be friendly to the biotech sector.

Writing in Barron’s this week, Kevin Hrusovsky, founder and chairman of Powering Precision Health, noted his background and said, “investors in biotech should be buoyed by his nomination to be the next FDA Commissioner. Based on what we know of him, he will be as friendly to the sector as his predecessor.”

How he feels about biosimilars is a little less clear, but one stakeholder expressed optimism.

In a statement emailed to The Center for Biosimilars^®, The Biosimilars Forum said it “looks forward” to working with Sharpless to strengthen the US biosimilars program, improve guidelines to combat misinformation, and optimize approval processes. These areas will improve patient access to biosimilars and help realize billions of savings to the US healthcare system, said the forum.

In a statement about his appointment to the FDA, Sharpless said he will “build on its progress toward the priorities laid out by President Trump, Secretary Azar, and Commissioner Gottlieb alongside the leadership and staff of the agency.”

Sharpless is also said to have been supportive of Gottlieb’s 2 other priorities: cracking down on teen vaping with increased regulation of e-cigarettes, as well as tobacco.

In addition, Sharpless pushed for greater collaboration between the FDA and NCI, including in oncology, workforce development, and pediatric cancer.

Sharpless became head of the NCI in 2017. He is also chief of the Aging Biology and Cancer Section in the National Institute on Aging’s Laboratory of Genetics and Genomics, where he continues his research on the biology of the aging process that promotes the conversion of normal self-renewing cells into dysfunctional cancer cells.