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Clinical Translation
Clinical pharmacology, modeling and simulation in drug development, artificial intelligence for drug development, drug regulatory science, drug development science, microtracing and microdosing studies, pharmacoepigenomics
Howard Lee, MD, PhD
Current Research Interests
Dr. Howard Lee is the Founder and Director of the Center for Convergence Approaches in Drug Development (CCADD). Dr. Lee serves a Professor at the Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University. Dr. Lee is also appointed at Seoul National University College of Medicine and Hospital, affiliated with the Department of Clinical Pharmacology and Therapeutics. Dr. Lee formerly was Professor, Department of Transdisciplinary Studies, GSCST.

Dr. Lee has served as Chair, Interdisciplinary Program of Clinical Pharmacology, SNU. Dr. Lee previously served as Head of Global Strategy and Planning, Clinical Trials Center, SNUH.

Dr. Lee is a board-certified physician in Family Medicine and Clinical Pharmacology and holds a PhD in Epidemiology. He completed a fellowship in Clinical Pharmacology at the Center for Drug Development Science (CDDS), Department of Pharmacology at the Georgetown University School of Medicine where he subsequently served as an Assistant Professor of Medicine and eventually became Director after CDDS has joined the University of California San Francisco in association with the School of Pharmacy. Dr. Lee also had served as faculty in two other US-based universities including the University of California San Francisco and the University of Pittsburgh.

Dr. Lee’s professional career consists of an interesting mix of academia, industry, and government. Before he went to the US, Dr. Lee had a 5-year real-world experience in clinical drug development at two pharmaceutical companies as Medical Director. Dr. Lee also was a Guest Researcher at the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration.

Dr. Lee was the co-principal investigator for clinical pharmacology of the Washington Obstetric Pharmacology Research Unit Network grant (NIH HD-03-017) affiliated with Georgetown University Medical Center. Dr. Lee also served as a co-investigator of the Collaborative Pediatric Pharmacology Research Unit Network grant (NIH HD-03-001). Dr. Lee was the principal investigator of the Merck Foundation Grant, entitled “A Systematic Policy Analysis to Identify Key Strategies for Implementing Good Review Practices into the Korea Food and Drug Administration”.

Since returning to Korea in late 2012, Dr. Lee has served as the principal investigator in >21 clinical pharmacology studies including eight first-in-human studies. Furthermore, Dr. Lee has spearhead the introduction of Accelerator Mass Spectrometry (AMS)-enabled exploratory early clinical drug development studies to the Korean biopharmaceutical R&D sector, which has awarded Dr. Lee two government grants. Starting 2017, Dr. Lee has expanded his research areas, particularly to application of artificial intelligence to clinical drug development and optimal use of drugs, for which Dr. Lee has four government grants.

Dr. Lee is well-versed in pharmacometrics, clinical trials design, drug development science, and drug regulations (Korea and the US). Dr. Lee’s current research interests are first-in-human studies of new drugs including biologics, AMS-based microdosing and microtracer studies, pharmacokinetic-pharmacodynamic modeling, regulatory issues related to biosimilar products, and, lastly but not the least, artificial intelligence to streamline clinical drug development practices.

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