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Brian Booth, PhD

Division Director
US Food & Drug Administration

Brian Booth, Ph.D. is the Director of the Division of Cancer Pharmacology I (DCP I), in the Office of Clinical Pharmacology at the U.S. Food and Drug Administration. Dr. Booth obtained a Bachelor of Science in Physiology at McGill University in 1988, and subsequently pursued a Doctorate in Pharmacology and Toxicology at Queen’s University (1993) in Canada. Following a Post-Doctoral Fellowship in the Department of Pharmaceutics at the State University of New York at Buffalo, where he studied the interaction between nitric oxide donors and the neuropeptide calcitonin gene-related peptide, Dr. Booth joined the Office of Clinical Pharmacology and Biopharmaceutics, FDA, in 1998. In 2004, he became the Acting Team Leader in the Division of Oncology Drug Products, after serving as a reviewer/pharmacometrician in this division. In November 2006, Dr. Booth was appointed as Deputy Director of the Division of Clinical Pharmacology V, until he was selected as Director of DCP I in 2019. At the FDA, Dr. Booth has been involved with the clinical pharmacology development of several hundred new oncology drugs, ranging from phase 1 to phase 4. In addition to IND and NDA/BLA reviews, Dr. Booth has been involved with teaching and development of new clinical pharmacology reviewers and medical officers, development of the analytical method validation, food effects, ARA drug-drug interactions, ADC- drugs, liposome drug product, PD-1/PD-L1 and studies in hepatic impairment Guidances for Industry, and clinical pharmacology modeling and simulation projects. He has authored or co-authored 85 peer reviewed articles and book chapters.

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