Former Director of Clinical Pharmacology at CDER Joins Certara’s Simcyp Scientific Advisory Board

August 20, 2015

Dr. Lawrence J. Lesko’s selection underscores biosimulation’s integral role in the drug development process

PRINCETON, NJ – Aug. 20, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that Lawrence J. Lesko, PhD, has joined its Simcyp® Scientific Advisory Board (SAB). Dr. Lesko was Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for 16 years until his retirement in July 2011. He currently serves as Clinical Professor and Director of the Center for Pharmacometrics and Systems Pharmacology in the University of Florida College of Pharmacy at Lake Nona in Orlando, FL.

“We are delighted that Dr. Lesko has joined our Simcyp SAB,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “He is a distinguished scientist with a unique understanding of the powerful role that biosimulation can play in enhancing the drug development process. He shares our mission to get safer, more effective drugs to the patients who need them as quickly as possible.”

Dr. Lesko added, “We are definitely seeing increased use of modeling and simulation in new drug applications (NDAs). They provide valuable insight regarding dose selection in unstudied populations, such as pediatric patients or those with rare diseases. They also allow researchers to study potential drug-drug interactions in virtual populations before new products enter clinical trials. I look forward to working with the Simcyp team and helping them to continue to advance this field.”

“We are proud to have Dr. Lesko join our team. His wisdom, in-depth knowledge of the U.S. regulatory process, and vision for as yet untapped biosimulation applications will help Simcyp to propel this field forward,” said Malcolm Rowland, PhD, DSc, Simcyp SAB chair, Professor Emeritus of the Manchester School of Pharmacy at The University of Manchester, UK, and Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences in the Schools of Pharmacy and Medicine at the University of California San Francisco.

Their fellow SAB members are J Brian Houston, PhD, DSc, Professor of Drug Metabolism and Pharmacokinetics and Director of the Centre for Applied Pharmacokinetic Research at the University of Manchester; Donald Mager, PharmD, PhD, Associate Professor of Pharmaceutical Sciences at the University at Buffalo, SUNY; Geoff Tucker, PhD, Emeritus Professor of Clinical Pharmacology at the University of Sheffield, UK; and Yuichi Sugiyama, PhD, Head of the Sugiyama Laboratory in the RIKEN Innovation Center in Tokyo and Professor Emeritus of the Graduate School of Pharmaceutical Sciences at The University of Tokyo.

Simcyp’s physiologically-based pharmacokinetic/pharmacodynamic (PBPK/PD) simulators use PK/PD modeling and simulation in virtual human and laboratory animal populations to streamline the drug development process. Simcyp has the industry’s most sophisticated platform for predicting drug-drug interactions and PK outcomes in clinical populations. Currently, 70 percent of the top-40 pharma companies (including all of the top 10) are members of the Simcyp Consortium.

At the FDA, Dr. Lesko created a new Division of Pharmacometrics, which is responsible for the quantitative analysis of dose-response, PK-PD relationships, PBPK to support drug labels and NDA approvals, and the development of drug-disease models to support clinical trial simulations. Dr. Lesko led a systems pharmacology program which used mechanistic approaches to investigate drug safety issues and bioinformatics methods to predict off-target effects. He also advanced precision medicine by championing the inclusion of new genetic information in on-market drug labels.

Dr. Lesko has co-authored several industry guidance documents, including “Exposure-Response,” “Clinical Pharmacogenomics: Premarketing Evaluation in Early Clinical Trials” and “Pharmacogenomics Data Submissions.” He has also had more than 200 peer-reviewed papers published.

Dr. Lesko received the 2015 American Conference on Pharmacometrics (ACoP) Leadership Award, the 2015 Agilent Thought Leader Award for Systems Biology, the 2014 American Association of Pharmaceutical Scientists (AAPS) Distinction in Biomarkers Research Award, and the 2011 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT). He was also 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.

He is board certified in clinical pharmacology and is a fellow of the Japanese Society for the Study of Xenobiotics, the American College of Clinical Pharmacology, and the AAPS.

About Certara

Certara is a global biosimulation technology-enabled drug development company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable superior drug development and regulatory decision-making through biosimulation, thus increasing R&D productivity and commercial value. For more information, visit www.certara.com.

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
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