Shiew-Mei Huang, PhD, FCP is Acting Director at the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation Research (CDER), Food and Drug Administration (FDA) in Silver Spring, MD. She is also an Adjunct Professor in the Department of Pharmaceutical Sciences at the University of Maryland, School of Pharmacy, in Baltimore, MD. Since joining OCP, she has assumed responsibility for a wide variety of scientific activities relating to review, policy development, research and scientific communications. She has also managed several extramural research projects in the areas of drug metabolism, drug-drug and drug-herb interactions, and pharmacogenetics. She has published numerous peer-reviewed articles and book chapters focusing on the topics of clinical pharmacology, drug metabolism/transport and drug interactions, pharmacogenetics and biomarker areas. Dr. Huang is currently an Associate Editor for Clinical Pharmacology and Therapeutics and is on the editorial board of several additional journals. Juan Lertora, MD, PhD, is Adjunct Professor in the Department of Medicine, Duke University, Durham, NC. He was previously director of the Clinical Pharmacology Program at the NIH Clinical Center. He attended the Faculty of Medicine, National University of the Northeast, Argentina (M.D.) and Tulane University, New Orleans, Louisiana (Ph.D. in Pharmacology). He received the 2013 PhRMA Foundation Award in Excellence in Clinical Pharmacology from the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Lertora was awarded a PhRMA Foundation Faculty Development Award in Clinical Pharmacology while teaching pharmacology at Northwestern University. He received a PMA Foundation Clinical Pharmacology Unit Award as an Associate Professor of Medicine and Pharmacology and Section Head of Clinical Pharmacology at the Tulane University School of Medicine. He received the NIH Clinical Center Director's Award for Teaching and Training in 2008. Paolo Vicini, PhD, is Vice President, Development Sciences, Kymab Ltd., MedImmune Limited, Cambridge, Department of Clinical Pharmacology, Cambridge. He has in-depth leadership and scientific experience in pharmaceutical and academic R&D, teaching and training, consulting and business education. He has more than 130 scholarly publications in diverse areas such as: oncology targeted agents, diabetes, immunotherapy and immunogenicity, dose optimization, maternal-fetal and pediatric pharmacology. Dr. Vicini has direct experience in translational and clinical sciences through all phases of drug discovery and development. Arthur J. Atkinson Jr. was the lead editor to the previous two editions and on the editorial board of the first edition. He was in the Department of Molecular Pharmacology & Biochemistry, Feinberg School of Medicine, Northwestern University, Chicago, IL
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