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Ke Liu, MD, PhD

Ke Liu, MD, PhD

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

Ke Liu, MD, PhD, is Senior Vice President, Head of Regulatory Affairs & Strategy at Sana  Biotechnology. 

Ke has more than 20 years of experience and expertise in oncology, cell and gene  therapy, including basic, translational, clinical research, drug development, and  regulation. 

Before joining Sana in December 2020, Dr. Liu spent more than 17 years working at the  U.S. Food and Drug Administration (FDA), including the Center for Biologics Evaluation  and Research (CBER), Center for Drug Evaluation and Research (CDER), and Oncology  Center of Excellence (OCE), most recently serving as OCE Associate Director for Cell and  Gene Therapy, and Chief of Oncology Branch in CBER’s Office of Tissues and Advanced  Therapies. He oversaw the clinical evaluation and approval of many innovative cancer  therapeutics with curative potential [e.g., chimeric antigen receptor (CAR) T cells, T-cell  receptor (TCR)-modified T cells, genome-edited products, neoantigen-based therapies,  adoptive T cell therapies, oncolytic viral therapy, dendritic cell therapy, and  combinations of these immune-oncologic therapeutics with checkpoint inhibitors and  other agents]. He had received many awards, such as FDA honor award for FDA  Guidances writing and reviews for new drug / biologic applications as well as mentoring  award. 

Prior to FDA, Ke served as an associate investigator for multiple clinical trials studying a  variety of new cancer therapeutics at the U.S. National Cancer Institute (NCI). He served  as protocol chairperson responsible for developing and conducting a clinical trial using  genetically modified cells for the treatment of cancer patients.  

Ke has many publications and book chapters elaborating on scientific and regulatory  perspectives on drug development, approval pathways and standards, trial endpoints  and design. He is a co-inventor of a U.S. patent for cancer cell therapy. 

Ke is a medical oncologist and internist, certified by the American Board of Internal  Medicine (ABIM). He is a physician licensed to practice medicine in Maryland and served  as a volunteer attending medical oncologist for more than 15 years at the Veterans  Administration Medical Center in Washington, D.C. 

Ke completed his Internal Medicine internship and residency in Albert Einstein College  of Medicine, his Medical Oncology fellowship at the NCI, and additional cancer  immunotherapy training at the NCI’s Surgery Branch. He obtained his MD from Henan  Medical University in China and his PhD in Molecular Biology from Cornell University  Graduate School of Medical Sciences.