ABSTRACT

The costs of developing intellectual property (IP) have been steadily rising particularly in healthcare and especially in pharmaceuticals. Greater rigour and higher levels of clinical proof are now required for medical devices to get their medical claims approved and in order to achieve a CE mark in the European Union, and this is also a costly process. Another output from Tufts University's research in pharmaceuticals is the analysis of the average costs to achieve each of the stages of clinical development leading to an analysis of productivity in the pharmaceutical industry. When a likely structure activity relationship (SAR) has been established a programme is started by moving into the synthesis and testing of the few compounds that might work. One of the most difficult problems is toxicity which is usually the cause of the maximum tolerated dose (MTD). This is the single greatest cause of failure in drug development.