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European Biopharmaceutical Review

How to Include Genetic Analysis in Clinical Trials

The demand for genetic analysis in clinical trials is increasing. This is partly due to the growing realisation that understanding the genetic variation within a clinical trial population can improve the design, safety and outcome of the trial. A second major driver is the encouragement that the regulatory authorities, in particular the FDA, are giving to the inclusion of a pharmacogenomic element. For the pharmaceutical company or CRO wishing to incorporate a genetic analysis component there are now a number of service providers who have both the technical ability and appropriate quality systems to provide clinical trial grade genotyping.

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By Dr Stephen Little, CEO of DxS Ltd

Dr Stephen Little is Chief Executive and Co-Founder of DxS Ltd, a UK biotech company providing pharmacogenomic services to the health care industry. Prior to forming DxS, he was a Board and Executive Team Member at AstraZeneca Diagnostics with overall responsibility for R&D within the business.

Dr Little has extensive experience in the development of nucleic acid-based diagnostic technology, products and services for human genetic analysis gained from over 20 years working in the biotechnology industry.

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Dr Stephen Little
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