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

Howard Lee, MD, PhD

Practice Area Focus

  • Clinical Pharmacology
  • Pharmacometrics
  • PKPD Modeling
  • Clinical Trial Simulation
  • Regulatory Strategy (US and Asia)
  • Epidemiology


Howard Lee, MD, PhD is a Professor and head of the Clinical Trials Center, Seoul National University Hospital, Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine. He has formerly held positions as Associate Director for Research and Director of the Center for Drug Development Science (CDDS) at UCSF and was Guest Medical Reviewer, Division of Cardio-Renal Products and Guest Researcher, Office of Clinical Pharmacology and Biopharmaceutics, FDA CDER. Additionally Dr Lee was Associate Director and Fellowship Director for the Center for Clinical Pharmacology, University of Pittsburg and Director of the Diagnostic and Therapeutic Regulatory Consultative Service at UCSF. Dr Lee is a board certified Family Practice physician and holds a PhD in Epidemiology. He completed a fellowship in Clinical Pharmacology at Center for Drug Development Science, Department of Pharmacology at the Georgetown University School of Medicine where he subsequently served as an Assistant Professor of Medicine.