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European Pharmaceutical Contractor

All in the Mind

Animal models for CNS disorders have been shown to have limited predictive power for man, which in many cases is due to weaknesses in the animal models themselves. However, these models can often provide the information which is key to ensuring efficacy throughout formal preclinical development and Phase I clinical trials.

So, how can the investigator weigh up the strengths and weaknesses of different models in order for them to be used effectively so as to ensure that efficacy seen in animal studies translates into the clinic? This article will discuss the issues in relation to stroke, where a number of promising therapies have failed in the clinic, identifies broader relevance to other CNS conditions, and considers how to ensure that animal models enhance the prediction of efficacy in patients (1).

DEVELOPMENT OF THERAPIES FOR STROKE

Stroke is described as the rapid loss of brain function due to damage or a blockage of the blood vessels supplying blood to the brain, and can be due to a haemorrhage or ischaemia caused by thrombosis or embolism. Whilst these mechanisms all involve disruption of the blood supply to the brain, the range of mechanisms leading to disruption of blood flow and the extent of damage offers a range of potential therapeutic interventions, whilst making selection of the appropriate preclinical models more difficult (see Figures 2-4).


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Peter Gaskin holds BSc in Biochemistry from the University of Surrey and a PhD from the University of Nottingham, and has worked in pharmaceutical R&D for over 19 years. He began his career working in mechanistic toxicology, drug metabolism and pharmacology at ICIís central toxicology laboratory, followed by a number of posts in research and regulatory toxicology in the pharma and CRO industries. In 1999 Peter joined Quintiles, firstly as a Program Manager and subsequently as Associate Director and Head of Program Management. Following Aptuitís acquisition of Quintiles preclinical business in 2005, Peter became a Principal Consultant in the newly-formed Aptuit Consulting Inc where he advises clients on non-clinical development strategies. He is a member of the British and European Toxicology Societies and a member of TOPRA.
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Peter Gaskin
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