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    PRINCIPAL INVESTIGATOR

    Howard Lee, MD, PhD

    Dr. Howard Lee is the founder and director of the Center for Convergence Approaches in Drug Development (CCADD). Dr. Lee is a tenured professor at the Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology (GSCST), Seoul National University, and the Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital (SNUH). Dr. Lee is also a member of the Senate, Seoul National University, for which Dr. Lee has served since November, 2023. Previously, Dr. Lee was a professor of Transdisciplinary Studies at GSCST and was appointed as Head of Global Strategy and Planning, Clinical Trials Center at SNUH. From August 2017 to July 2021, Dr. Lee served as Chair of the Interdisciplinary Graduate Program in Clinical Pharmacology, Seoul National University, 2017-2021 and as head professor for the Advanced Course in Pharmaceutical Medicine at SNUH since 2017.

    Dr. Lee is a board-certified physician in Family Medicine and Clinical Pharmacology and holds a Ph.D. in Epidemiology. Dr. Lee completed a fellowship in Clinical Pharmacology at the Center for Drug Development Science (CDDS) at the Department of Pharmacology, Georgetown University School of Medicine. After fellowship, he became an assistant professor of Medicine and, later, director of CDDS. Dr. Lee also taught at the University of California San Francisco and the University of Pittsburgh.

    Dr. Lee’s professional career extends beyond academia to industry and government. In South Korea, Dr. Lee worked for two pharmaceutical companies as Medical Director overseeing clinical drug development. Moreover, Dr. Lee won a Merck Foundation Grant, through which he published a study entitled “A Systematic Policy Analysis to Identify Key Strategies for Implementing Good Review Practices into the Korea Food and Drug Administration.” In the US, Dr. Lee conducted research as a guest researcher at the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration. Moreover, Dr. Lee received research grants from the National Institutes of Health (NIH)—the Washington Obstetric Pharmacology Research Unit Network grant (NIH HD-03-017) and the Collaborative Pediatric Pharmacology Research Unit Network grant (NIH HD-03-001)—and led the projects as a co-principal investigator and a co-investigator, respectively.

    Since 2012, Dr. Lee has been the principal investigator for 47 clinical studies and investigations, including 17 first-in-human clinical trials. Furthermore, Dr. Lee pioneered the application of Accelerator Mass Spectrometry (AMS) to early exploratory clinical studies run by the Korean biopharmaceutical R&D sector, a feat that helped him secure two government grants.

    Dr. Lee has expertise in pharmacometrics, clinical trials design, drug development science, and drug regulations (in South Korea and the US). Dr. Lee’s research areas include first-in-human studies of new drugs, including biologics, AMS-enabled microdosing and microtracer studies, pharmacokinetic-pharmacodynamic modeling, and regulatory issues related to biosimilar products. Recently, Dr. Lee has expanded his research field to the application of artificial intelligence (AI) to clinical drug development. For example, Dr. Lee spearheaded the application of AI technology to improve the efficiency of patient enrollment into clinical trials. Based on this technology, Dr. Lee founded a tech startup called PMATCH in early 2022, which has developed Battery, a smart phone application that recommends individualized health supplements based on AI. Moreover, Dr. Lee built a natural language processing (NLP) model that extracts information on drug-drug interaction and adverse drug reactions from clinical notes.

    CCADD

    Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University

    Room C-208, 145 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16229, SOUTH KOREA (Gwanggyo)

    Room 406, Building 17, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, SOUTH KOREA (Yeon-gun)

    Tel: +82-31-888-9189 (Gwanggyo); +82-2-3668-7381 (Yeon-gun)

    Fax: +82-31-888-9575

    Email: ccadd.snu@gmail.com