Karim Mikhail

Karim Mikhail serves as the FDA’s Director of the Center for Biologics Evaluation and Research (CBER). He joined the FDA in 2025 as a Senior Advisor in the Office of the Commissioner where he led U.S. competitiveness reforms, spanning multiple disciplines from accelerating early clinical development to on-shoring of biopharmaceutical manufacturing. He brings over two decades of leadership experience in leading both large pharmaceutical companies and small biotechnology startups across therapy areas including cardio-metabolism, respiratory, immunology, neuroscience, oncology, women's health, and anti-infectives.

Mr. Mikhail has lived and worked across eight countries on three continents, with trilingual fluency. He has an unparalleled international perspective and deep understanding of the drug development ecosystem from multiple perspectives—regulatory, commercial, and scientific. His clinical development experience spans a range of therapeutic areas, providing deep understanding of the drug development lifecycle from bench to bedside to market.

Mr. Mikhail holds a Master of Science in Biopharmaceutical Management from École supérieure de commerce de Paris (ESCP Business School) and a Bachelor of Pharmacy & Pharmaceutical Sciences from Cairo University. His Six Sigma Executive Belt certification reflects his commitment to operational excellence. Mr. Mikhail is a distinguished thought leader in pharmaceutical innovation and entrepreneurial business strategy.