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How to Optimize Your Drug Label Using Biosimulation Methodology

On-Demand Webinar

While biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than a dozen cases, driving down R&D costs and timelines, and allowing for greater population inclusion within the label. In this webinar, Dr. Steve Toon presented some recent examples of the role of PBPK modelling in the regulatory approvals process.

About Our Speaker

Steve Toon, Managing Director, Simcyp Certara. Dr Steve Toon joined Simcyp as Executive Director in 2006 from ICON Clinical Research where he was Senior Vice President of Clinical Pharmacology. He moved into his current position within Certara in 2014. Dr Toon is also Honorary Lecturer in Experimental Pharmacokinetics at the University of Manchester.

A pharmacist by profession, and a member of the Royal Pharmaceutical Society of Great Britain, Steve received his pharmacy degree from the University of Bath and his PhD in pharmacokinetics from the University of Manchester. Following a two-year period at the University of Washington in Seattle, he returned to Manchester in 1983 to help found Medeval Limited, one of the first clinical pharmacology CROs within the UK. In 1998 he headed a venture capital (3i) backed MBO of Medeval from the University of Manchester and was a founder of Cyprotex Limited in the same year. Having been CEO of Medeval for 10 years, he became Senior Vice-President, Clinical Pharmacology, of ICON plc. following the acquisition of Medeval by ICON in January 2003.

Steve’s scientific interests are in model informed drug development and the molecular-structural and metabolic aspects of pharmacokinetics (especially as they relate to drug-drug interactions). He has published over 50 articles, abstracts and chapters in books, and has lectured widely on his areas of interest.

 

While biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than a dozen cases, driving down R&D costs and timelines, and allowing for greater population inclusion within the label. In this webinar, Dr. Steve Toon presented some recent examples of the role of PBPK modeling in the regulatory approvals process.

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