MolecularHealth Names Drug Safety and Personalized Medicine Expert Lawrence J. Lesko as Scientific Advisor
NEW YORK, March 14, 2012 /PRNewswire/ — MolecularHealth, a leader in clinico-molecular informatics((TM)), 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.
“Larry’s vast knowledge and experience in drug development and regulatory science, particularly in the field of mechanism-based safety assessment within precision medicine, will be invaluable as we advance our drug safety assessment and prediction technology, Molecular Analysis of Side Effects (MASE), for regulatory agencies, pharmaceutical companies and others concerned with drug safety,” said Dr. Friedrich von Bohlen, MolecularHealth’s chief executive officer. “We are particularly delighted that Larry, one of the preeminent drug development and regulatory scientists and a pioneer in personalized medicine, has joined us as we work with the FDA to evaluate and refine MASE.”
Dr. Lesko added, “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.”
Prior to his work with the FDA, Dr. Lesko was Vice President of PharmaKinetics Laboratories and held an appointment in the Laboratory of Neuroscience, National Institute on Aging, National Institutes of Health. He was also a faculty member at the University of Massachusetts Medical Center and the Massachusetts College of Pharmacy. Dr. Lesko is a Fellow of the American College of Clinical Pharmacology, the American Association of Pharmaceutical Sciences and the Japanese Society of Clinical Pharmacology and Therapeutics. In 2011, Dr. Lesko received the Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and, in 2007, the ASCPT Rawls-Palmer Progress in Medicine Award. He holds a bachelor’s degree and a Ph.D. from Temple University Health Science Center and is board certified in clinical pharmacology.
MolecularHealth, Inc., a clinico-molecular informatics company, is advancing precision medicine by translating patient-specific molecular and genomic data, clinical history and published scientific and medical evidence into safer, more effective drug choices for patients. The company’s solutions range from a next generation drug safety assessment and prediction tool that analyzes the molecular basis of adverse events to a treatment decision support system that transforms genome sequences into evidence-based treatment strategies for cancer patients. Backed by the co-founder and former chairman and chief executive officer of SAP, Dietmar Hopp, through dievini Hopp BioTech, MolecularHealth maintains offices in Basel, Switzerland; Heidelberg, Germany; Houston and New York. The company is led by a team of seasoned entrepreneurs, including the founding members of Generation Health, LION Bioscience, Model N Life Sciences and Xapien, and a group of scientists and technologists instrumental in the development of data analysis software for the Human Genome Project and clinical IT systems for leading U.S. health systems. MolecularHealth’s collaborators include the University of Texas MD Anderson Cancer Center and the U.S. Food and Drug Administration (FDA).
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SOURCE MolecularHealth, Inc.