Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Shirley K. Seo, PhD
Director
Division of Cardiometabolic and Endocrine Pharmacology (DCEP)
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Shirley Seo is the director of the Division of Cardiometabolic and Endocrine Pharmacology in the Office of Clinical Pharmacology at the FDA. Dr. Seo obtained her Ph.D. in pharmaceutics at the University of Texas at Austin in 2004 where her main areas of research focus were drug metabolism, pharmacokinetics, and immunopharmacology. That same year, she began her FDA career in the Office of Generic Drugs, and in 2007, joined the antivirals teams as a reviewer in the Office of Clinical Pharmacology. In 2012, Dr. Seo became the clinical pharmacology team leader for antiviral products, a position she served in for almost 6 years. In her current role as a division director, she is actively engaged in guiding the development of regulatory policy and overseeing regulatory decision-making for drugs in the following disease areas: cardiology, nephrology, non-malignant hematology, diabetes, dyslipidemia, general endocrinology, bone, reproduction, and urology. Her areas of scientific interest and regulatory expertise include: pediatric clinical pharmacology, complex drug interactions, antiviral drug development, and drugs being developed for medical countermeasures. In 2019, she became an associate editor for the journal, Clinical Pharmacology & Therapeutics. Shirley also has a passion for mentoring.
Abstract
Shirley K. Seo’s presentation provides an in-depth look at clinical pharmacology and its pivotal role in early drug development. She defines clinical pharmacology as the study of pharmacokinetics (PK)—what the body does to the drug, encompassing absorption, distribution, metabolism, and excretion (ADME)—and pharmacodynamics (PD)—what the drug does to the body. Clinical pharmacologists “own the dose,” meaning they help determine the optimal dosing regimen, including how much and how often to administer a drug, and whether adjustments are needed based on various factors. Her talk outlines the design and purpose of crucial early clinical studies, such as first-in-human trials, ADME (mass balance) studies, bioavailability studies, food effect studies, and those assessing hepatic and renal impairment, as well as drug interactions. These studies gather essential data on a drug’s safety, tolerability, and PK characteristics, which is then used to inform subsequent development phases and is communicated in drug labeling. Seo also introduces developing areas in the field, including physiologically based pharmacokinetics (PBPK) and model-informed drug development (MIDD), emphasizing that conducting these studies as early as possible maximizes the chances of success for a new drug.