There is a need for tissue-based tools to drive drug development both in the pre-clinical and clinical phase to improve the success rate of drug development. Drug development is a long, complex, and expensive process. On average, it takes about 10 years to get from idea to an approved drug. Additionally, it costs billions of dollars to develop a drug, including developing drugs that are not approved.
Consequently, it is important to improve the probability of success, so innovation will not be attenuated. In accordance with this, FDA and EMA have expressed a view that biomarker-based drug development strategies in combination with translational research could potentially provide a biology targeted approach, which will decrease time and cost and give an overall increased probability of success
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