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International Clinical Trials

Model Making

“Pharma will need to virtualise much of the research it currently performs in the lab and transform the way in which it designs and manages clinical studies if it is to remain at the forefront of medical research.” That was a key conclusion of the Pharma2020 report published recently by PricewaterhouseCoopers (1).

Research costs have been rising over recent years, yet the number of market approvals has fallen. Only 11 per cent of molecules entering preclinical development will ultimately make it to the market, and significantly more will have failed before that stage. Early indication of the clinical limitations of a candidate compound is crucial to reducing late-stage attrition rates and avoiding the ‘nasty surprises’ that could lead to the demise of a new medicine.

The pharmaceutical industry has already begun to adopt modelling and simulation with the aim of streamlining drug development. Recent estimates suggest that within the next few years, up to 15 per cent of research and development budgets could be spent on in silico approaches, as the industry fully embraces technologies that are widely used as standard in other sectors.

PHARMACOKINETIC MODELLING AND SIMULATION

The pharmacokinetic characteristics of a drug have a fundamental impact on its commercial viability. Following drug administration, the processes of absorption...

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Steve Toon (BPharm, PhD, MRPharmS) is an Executive Director of Simcyp Limited – the leader in providing solutions for the population-based mechanistic in vitro-in vivo extrapolation (IVIVE) of pharmacokinetic properties. Steve is also an Honorary Lecturer at the University of Manchester, UK, and consults for a variety of venture capital and pharmaceutical organisations. Steve was formerly CEO of Medeval Limited, a clinical pharmacology CRO he helped found and develop. Following the acquisition of Medeval by ICON in 2003, he became SVP, Clinical Pharmacology, of ICON plc. A pharmacist by profession, Steve received his degree from the University of Bath and his PhD in pharmacokinetics from the University of Manchester.
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