The U.S. Department of Health and Human Services has selected four senior leaders for positions at the Food and Drug Administration, including the agency’s first deputy commissioner for technology and artificial intelligence.
Jared Seehafer, M.S., was selected for the newly created deputy commissioner role. He will lead FDA-wide strategy and priorities involving technology, software and artificial intelligence. HHS said Seehafer has about two decades of experience in software, AI and FDA-regulated medical technology.
Michael Davis, M.D., Ph.D., was selected as director of the Center for Drug Evaluation and Research, or CDER. Davis had been acting director of the center and previously served as its deputy center director. CDER is responsible for the regulation and review of drugs.
Karim Mikhail, B.Pharm, MSc, was selected as director of the Center for Biologics Evaluation and Research, or CBER, after serving as acting director. CBER regulates biologic products, including vaccines, blood and blood products, and cell and gene therapies.
Bret Koplow, Ph.D., J.D., was selected to lead the Center for Tobacco Products, or CTP. He had been acting director of the center and has held FDA legal, policy and leadership positions since 2011. Before becoming CTP acting director, Koplow served as senior counselor to the FDA commissioner, focusing on regulatory, policy and operational matters involving tobacco products.
HHS said the appointments are intended to support FDA priorities involving medical innovation, national health security, access to medicines and medical products, and health and wellness.
Davis will oversee CDER’s work on drug development and evaluation, patient access to medicines, and drug supply chains. Mikhail will lead CBER’s oversight of biologics and efforts related to clinical development, biopharmaceutical manufacturing and regulatory frameworks. Koplow will oversee tobacco-product regulation, including efforts involving adult smokers and youth nicotine use.
The selections were announced Sept. 8 by HHS and FDA Acting Commissioner Kyle Diamantas.
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