Dr. Lesko, starting in 1995, became the first Director of the Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research at the Food and Drug Administration. His tenure as Office Director was for 16 years until his retirement in 2011. At the FDA, Dr. Lesko formed a pharmacological mechanism-based drug safety assessment team to analyze the root cause of adverse drug events.. This program used mechanistic approaches to understand off-target drug effects using bioinformatics strategies. He also led the advancement of precision medicine through the update of labels of previously approved drugs with new genetic information on safety, dosing and efficacy. Dr. Lesko coauthored numerous Guidance for Industry including “Clinical Pharmacogenomics: Premarketing Evaluation in Early Clinical Trials” and “Pharmacogenomics Data Submissions”. He also started a Division of Pharmacometrics (i.e., Biosimulation) that is responsible for quantitative analysis of dose response and PK-PD (biomarkers) relationships to support optimal dosing in FDA approved drug labels, and the development of drug-disease models to support clinical trial simulations in drug development. Dr. Lesko has published more than 225 peer-reviewed manuscripts and is a frequent invited national and international speaker.
Dr. Lesko was admitted as a Fellow of in the College of Physicians of Philadelphia in 2019. In 2018, Dr. Lesko received the first FDA OCP Distinguished Alumni Lectureship Award for his contributions to clinical pharmacology. Dr. Lesko also received the prestigious UF Global Gator Award in 2017 for his contributions to international drug development. He was the recipient of the 2015 Leadership Award from the International Society of Pharmacometrics, the 2015 Agilent Technologies Thought Leader Award in Integrated Systems Toxicology and the 2014 AAPS Distinction in Biomarker Research Award. In 2011, he received the Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT). Dr. Lesko also was honored with the Rawls Palmer Progress in Medicine award from ASCPT, the Coriell Scientific Leadership Award for Personalized Medicine, the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy Award for Clinical Service, and the Nathanial B. Kwit Distinguished Service Award for Clinical Pharmacology from the American College of Clinical Pharmacology.
Dr. Lesko earned a B.S. in Pharmacy and a Ph.D. in Pharmaceutics at Temple University Health Science Center in Philadelphia. He is board-certified in applied clinical pharmacology.