Howard Lee
Howard Lee, MD, PhD, an expert on the science underlying drug regulation, has been appointed director of the UCSF School of Pharmacy's Washington, DC-based Center for Drug Development Science (CDDS).
The 12-year-old center is highly regarded for modernizing drug development and regulation with advanced scientific methods to forecast and improve clinical trial outcomes. It has been administered by the UCSF pharmacy school's Biopharmaceutical Sciences department since 2004.
In his new role, Lee will strengthen the center's continuing work with UCSF programs in fields essential to modern drug development, such as modeling, simulation, pharmacometrics and pharmacogenomics. Collaborative research among these fields aims to make better, safer drugs available to patients as quickly as possible.
Lee will lead an international initiative to establish a CDDS-based Center for Asian-Pacific Drug Regulation Studies that will prepare regulatory scientists with the knowledge needed to improve drug development and drug regulatory systems in China, India, Japan, South Korea, Taiwan and other countries.
He also will oversee development and implementation of a new Diagnostics and Therapeutics Regulatory Consulting Service (DTRCS) as part of UCSF's new Clinical and Translational Science Institute, funded by the National Institutes of Health. The core concept of the DTRCS is to provide development and regulatory advice to UCSF translational and clinical scientists, both before the scientists develop research proposals and as they carry out their research.
"CDDS has an international reputation for pioneering powerful computational methods for modeling and simulation of clinical trials - information that is crucial to successful trials and individualizing drug therapy," said Kathleen Giacomini, PhD, professor and chair of UCSF's Biopharmaceutical Sciences department. "Howard's experience will add great leadership as we work to advance the personalization of drug therapy."
Lee is a graduate of the Seoul National University College of Medicine. He completed a two-year postdoctoral drug development and regulatory science fellowship at the CDDS and subsequently served as an assistant professor of pharmacology at the CDDS during the center's pre-UCSF affiliation with Georgetown University. He has been a guest researcher in the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research. For the past two years, he has been a research assistant professor of medicine in the Center for Clinical Pharmacology at the University of Pittsburgh School of Medicine.
In South Korea, Lee served as secretary-general and director of general affairs of the Korean Academy of Pharmaceutical Medicine, and on advisory committees where he was credited with helping the South Korean FDA modernize clinical trial regulations. In addition to having written more than two dozen scientific papers, he is a recognized expert on Asian drug regulatory systems and author of a book on the Korean system.
Lee succeeds Carl Peck, MD, as CDDS director. Peck co-founded CDDS and is the former director of the FDA's Center for Drug Evaluation and Research. Peck will continue in CDDS as adjunct professor.
"We are thrilled to welcome Howard as the newest member of our school and the larger UCSF community," said Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy. "I am confident that he will maintain the momentum inspired by Carl's leadership as he pioneers the kinds of new collaborations in the drug development sciences we need today to ensure improved drugs for tomorrow."
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