New software could curb drug failures

By Kirsty Barnes

- Last updated on GMT

Related tags Drug Clinical trial

New software has been launched that its developers say will help
companies to spot drug candidate safety failures at an earlier
clinical stage.

According to the firm this will allow faster and more accurate drug development decisions. Spotfire said its Clinical Trials Analysis software lets its users interact with and analyse drug data from various sources to identify patterns and trends, outliers and exceptions and thus adapt the information to the specific needs of a trial. "This [software] provides a better understanding of data and helps accelerate analysis throughout every phase of product development,"​ said Spotfire. Accelerating drug development is a high priority amongst all biopharma firms operating in today's industry climate. Pharmaceutical companies are also under intense pressure to reduce late-phase attrition and potential market recalls by discovering problems at earlier stages of development. While more compounds are now going in to Phase I and II clinical trials there is no evidence that the number of compounds entering Phase III is increasing - in fact there seems to be a bottleneck in Phase II where more and more drugs are seeming to fail. As a result, the cost of bringing a new drug to market is escalating and estimated to cost at least $1bn (€0.75bn). At the same time there have been a number of high-profile product withdrawls of late, such as in the case of Vioxx, costing the drug manufacturers involved millions of dollars and causing them endless headaches. Therefore faster a company can identify products to "fail early"​ in the testing cycle, the quicker it can decide on which drugs to continue investing in - saving millions of dollars and countless staff hours. "Competitive advantage in this industry depends upon the ability to quickly make strategic decisions about drug candidates,"​ said Christian Marcazzo, senior director of Life Sciences Analytics at Spotfire. However, an industry expert does not appear to agree and has recently suggested that the 'fail faster' approach taken by drug designers to avoid expensive late stage failures is harming the industry, allowing drugs with higher solubility and kinetic profiles but lower efficacies into the pipeline. This stark warning about the direction the pharmaceutical industry is heading in was delivered at the Drug Discovery and Technology summit in London last week by Dr Simon Campbell, the former president of the Royal Society of Chemistry and ex-senior vice president of worldwide discovery at Pfizer. He believes that "all new compounds can make it to Phase II trials,"​ where issues such as solubility and kinetics (but not efficacy) can be easily fixed and called for companies to stop abandoning new compounds in the early stages of development to avoid the expense of a potential late-stage failure. The validity of metrics-based evaluation was also questioned by Campbell, who said it does not matter how many drug candidates you screen for efficacy, but how many make it along the pipeline.

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