The need for a digital laboratory mouse:
The current cost of drug discovery is over $802 million per approved compound. Much of this increase is attributed to the rising costs of clinical trials. Even with significant investment, the failure rate of new drugs is high. It is estimated that only five out of every 5,000 potential new drugs tested on animals reaches clinical trials, and only one out of 5,000 ultimately wins approval by the FDA. In fact, the FDA recently stated that “A new product development toolkit – containing powerful new scientific and technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques – is urgently needed to improve predictability and efficiency along the critical path from laboratory concept to commercial product.” (Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. 2004).
Traditional methods do not allow the crucial "go/no go" tests to be carried out until the product development is well underway. In silico modeling is available to supplement these traditional methods. In silico technology is the study of computerized models of complex biological systems to support drug discovery. It can be used to:
1) Improve compound selection
2) Develop more effective pre-clinical/clinical trial protocols through the following:
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Evaluation of dosage/timing |
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Patient inclusion/exclusion criteria |
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Serum markers |
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Drug interactions |
The power of in silico modeling lies in the ability to test a very large number of parameters without the cost and risk associated with actual subjects.
© 2009 Immunetrics
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