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Pharmacogenomics in Drug Development and Regulatory Decision-Making: The Genomic Data Submission Proposal

The FDA Commissioner Mark McClellan opened the recent 'Pharmacogenomics in Drug Development and Regulatory Decision-making' workshop in Washington DC with a clear message to his audience of senior executives from all top 10 pharmaceutical companies. He stated that there is enormous potential for pharmacogenomics to make safer medicines more cheaply, and that we need to speed up pharmacogenomic applications to benefit both consumers and manufacturers. He went on to say that he believed the drug industry and the FDA have a shared interest in "making pharmacogenomics work".

He saw particular benefit in modifying drug risks and benefits in genetically defined sub-groups, and concluded by leaving the audience in no doubt that "the FDA are very interested in using pharmacogenomics to improve the drug development process and to identify more effective medicine". The workshop was jointly organised by the FDA, DIA, PhRMA and BIO. There were over 400 attendees and as further indication of how seriously the FDA is taking this issue, more than 150 of the delegates were from the FDA itself. The primary aim of the meeting was to discuss the FDA's new genomic data submission proposal (1).


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By Dr Stephen Little, Chief Executive and Co-Founder 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. Over the 20 years he has spent working in the biotechnology industry, Dr Little has built up extensive experience in the development of nucleic acid-based diagnostic technology, products and services for human genetic analysis.
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Stephen Little
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