Human-based Systems for Translational Research
Chapter 2: Functional Studies with Human Isolated Tissues to Better Predict Clinical Safety and Efficacy
Published:08 Dec 2014
David C. Bunton, 2014. "Functional Studies with Human Isolated Tissues to Better Predict Clinical Safety and Efficacy", Human-based Systems for Translational Research, Robert Coleman
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Research using human fresh tissue represents one of the fastest growing areas of drug discovery and development. There are two key drivers in the use of human tissue: firstly, the failure of the current approach to drug development which demands new approaches to reduce clinical attrition, and secondly, the drive towards biomarkers for personalised medicine.
The dominant approach to drug development, based on primary screening in high-throughput models and secondary screening in animals, has previously produced numerous ‘blockbuster’ drugs, but clinical attrition rates of 95% are no longer viewed as sustainable. Human disease-relevant tissue is increasingly viewed as a way to decrease clinical failures, particularly during phase II and III where poor efficacy has been partly attributed to an over-reliance on animal models. The second major factor is the drive towards the use of biomarkers and personalised medicines; as the search for blockbusters diminishes, the need for targeted therapies based on predictive non-clinical and clinical human data increases (Table 2.1).