NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Howard Lee, MD, PhD

Practice Area Focus

  • Drugs
  • Biologics
  • Clinical Pharmacology
  • Pharmacometrics
  • PKPD
  • Modeling and Simulation
  • Clinical Trial Design
  • First-in-human Clinical Trials


Howard Lee, MD, PhD joined NDA Partners as an Expert Consultant in 2013. Dr. Lee was formerly a Guest Medical Reviewer, Division of Cardio-Renal Products and a Guest Researcher in the Office of Clinical Pharmacology and Biopharmaceutics at FDA in the Center for Drug Evaluation and Research (CDER). He is an expert in pharmacometrics, clinical trial design, and drug regulations in the US and Korea.

Dr. Lee is a Professor in the Department of Clinical Pharmacology and Therapeutics at Seoul National University Hospital and College of Medicine and in the Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University. Dr. Lee is also Chair, Interdisciplinary Program in Clinical Pharmacology, Seoul National University. He was formerly Head of Global Strategy and Planning at the Clinical Trials Center at Seoul National University Hospital.

In addition, Dr. Lee was formerly Associate Director for Research and Director of the Center for Drug Development Science (CDDS) at the University of California at San Francisco (UCSF); Director of the Diagnostic and Therapeutic Regulatory Consultative Service at UCSF; and Associate Director and Fellowship Director for the Center for Clinical Pharmacology, University of Pittsburg. In his early career, he was a research fellow at the Center for Drug Development Science at Georgetown University School of Medicine, where he subsequently served as Director of the Medical Department.