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.
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.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.