Ke Liu, M.D., Ph.D.
Acting Associate Director for Cell and Gene Therapy, Oncology Center of Excellence
Chief of Oncology, Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Dr. Liu is the acting associate director for cell and gene therapy for the Oncology Center of Excellence and chief of oncology in the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA).This office reviews, evaluates and approves most innovative cancer therapeutics with curative potential. Examples include chimeric antigen receptor (CAR) T-cells, dendritic cells, adoptive T cell therapies, tumor neoantigen-based personalized medicine (vaccine or cell therapy), natural killer cells, oncolytic viruses, therapeutic cancer vaccines, and combinations of these immune-oncologic therapeutics with checkpoint inhibitors and other agents.
Liu is a medical oncologist and internist certified by the American Board of Internal Medicine. He is also an attending medical oncologist at the Washington D.C. Veterans Administration Medical Center. He received his M.D. from Henan Medical University in China and his Ph.D. in molecular biology from Cornell University. He completed his internal medicine internship and residency training at Albert Einstein College of Medicine and his medical oncology fellowship training at the National Cancer Institute, where he also received his cancer immunotherapy training. During his fellowship, Dr. Liu served as associate investigator for multiple phase 1 and 2 clinical trials investigating a variety of new cancer therapeutics. In particular, he served as protocol chairperson and was responsible for developing and conducting a phase 1/2 clinical trial using genetically modified cells for the treatment of patients with cancer that formed a basis for a patent issued by the U.S. Patent and Trademark Office. His primary academic interests include clinical trial design, immunotherapy, and cellular and gene therapies for cancer.
In 2003, Dr. Liu joined the FDA as a CBER medical officer/clinical reviewer, and from 2008 to 2011 as a lead medical officer in the FDA’s Center for Drug Evaluation and Research (CDER). He has received multiple FDA and CDER citations for his contributions to regulatory science and research policy, product review and approval, and staff mentoring. In 2017, he was selected to serve as acting associate director for cell and gene therapy for the FDA’s newly created Oncology Center of Excellence.