Dr Ke Liu | Chief, Oncology Branch, Acting Associate Director for Oncology Cell and Gene Therapy, Oncology Center of Excellence
Food and Drug Administration

Dr Ke Liu, Chief, Oncology Branch, Acting Associate Director for Oncology Cell and Gene Therapy, Oncology Center of Excellence, Food and Drug Administration

Dr. Liu is Chief of Oncology in the Office of Tissues and Advanced Therapies (OTAT, previously known as Office of Cellular, Tissue and Gene Therapies (OCTGT)) in the U.S. FDA’s Center for Biologics Evaluation and Research (CBER). 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 (ABIM). He is also an attending medical oncologist in Washington Veterans Administration Medical Center. He received his M.D. from Henan Medical University in China and his PhD in Molecular Biology from Cornell University Graduate School of Medical Sciences in New York City, NY. He completed his Internal Medicine internship and residency training in Albert Einstein College of Medicine (Long Island campus) in New York City and his Medical Oncology fellowship training at the U.S. National Cancer Institute (NCI).  He also received his cancer immunotherapy training in the Surgery Branch, NCI.  During his fellowship, he served as associate investigators 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, cellular and gene therapies for cancer.
In 2003, Dr. Liu joined U.S. FDA’s CBER as a Medical Officer / Clinical Reviewer and later was selected as a Lead Medical Officer. From 2008 to 2011, he served as a Lead Medical Officer in U.S. FDA’s Center for Drugs Evaluation and Research (CDER). He has received multiple citations at the FDA and Center levels for his contributions to the regulatory science / research / policy, product review and approval, and staff mentoring. Recently, he was selected to serve as the acting associate director of oncology cell and gene therapy for the newly created FDA’s Oncology Center of Excellence (OCE).


Agenda Day 1 @ 3:30

A Regulatory Perspective --- Clinical Considerations for Novel Immunotherapies

  • Brief overview of approval processes
  • Review of cell therapies including; adoptive T-cell’s, CAR- T cells, TCRs
  • A closer look at cancer vaccines and neoantigens

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