Abstract
Abstract A major step in targeted cancer drug discovery is demonstrating ‘proof of mechanism’. Tissue samples are an integral part of current drug development. At the Biotherapy Development Association Meeting in March 2007, the benefits and problems of tissue related endpoint inclusion in clinical drug development were discussed; Academic, Regulatory Authority and Pharmaceutical Industry representation being present. It was agreed that the public supports the use of human tissue in research; cooperation and collaboration are essential to ensure that tissue samples are collected and available for research; tissue sampling should be mandatory for clinical trials; and that tissue remaining from diagnostic, surgical and clinical trial based sampling should be made available for research. Until existing or new technologies provide utility for alternative sampling, access to human tissue samples of consistent quality will underpin the success of cancer drug pipelines in the era of molecular biological biomarkers and personalised medicine.
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