MolecularHealth, a leader in clinico-molecular informatics™, today announced that Larry Lesko, Ph.D., F.C.P., former Director of the Office of Clinical Pharmacology within the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), has joined the company as a scientific advisor. Dr. Lesko is currently a Professor in the Department of Pharmaceutics at the University of Florida’s College of Pharmacy and leads the University’s new Center for Pharmacometrics and Systems Pharmacology initiative within the interdisciplinary Institute of Therapeutic Innovation in Lake Nona, Fla.
While at the FDA, Dr. Lesko served as Chair of the Clinical Pharmacology Section of the Medical Policy Coordinating Committee and Co-chair of the Biopharmaceutics Coordinating Committee in the CDER, both of which developed numerous guidances for industry. He was also FDA’s Associate Director of Research, where he was responsible for managing the Product Quality Research Program in the Office of Generic Drugs.
MolecularHealth is preparing a drug safety assessment and prediction technology, Molecular Analysis of Side Effects (MASE), for FDA evaluation. “MASE is a technology solution that takes drug safety science beyond observational assessment by adding the molecular dimension, enabling us to identify, analyze and validate the mechanisms by which drug-related events occur within the body. Understanding the complexity of drug behavior in different patients and populations and alongside other drugs – perhaps even before they reach the market – is an incredible advancement in the understanding of and approach to drug safety” said Lesko.