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Impact of personalised medicine increasing

Personalised medicine is changing the way the pharma industry develops drugs and makes decisions according to a new report from Tufts University

Personalised medicine is changing the way the pharmaceutical industry develops new drugs and makes decisions about whether to continue or discontinue development of drug candidates, according to a new report from the Tufts Center for the Study of Drug Development (CSDD) at Tufts University.

The study, authored by Tufts CSDD associate director Christopher-Paul Milne, was based on interviews and a survey of nearly two dozen companies that have been active in making use of the new science. 

The report found that between 2006 and 2010, pharma company investment in personalised medicine research increased by a mean of 75 per cent, with an additional increase of 53 per cent predicted by 2015.

More than 90 per cent of the surveyed pharma companies are investing in developing personalised medicines, with companies reporting that up to half of their current pipelines involve personalised medicines. In addition, all of the surveyed companies are using personalised medicine approaches in evaluating compounds during the discovery phase.

Oncology is the therapeutic area with the highest number of personalised medicines on the market and in the pipeline, according to the report. Other areas of significant focus for personalised medicine include cardiovascular, central nervous system, and immunologic therapies. Early progress is also being made in metabolic therapies, respiratory therapies and virology.

The survey found that development of personalised medicine involves some new challenges. The research often necessitates that drug developers partner with a number of external collaborators to ensure sufficient resources and expertise. These multiple partnerships can create challenges surrounding stewardship and can also muddy the waters surrounding intellectual property rights, according to the report.

In addition, the report notes that the US Food and Drug Administration (FDA) does not yet have the expertise it needs in personalised medicine, meaning that companies cannot yet use biomarker data to support marketing approval because the regulators do not have the expertise or procedures in place to properly evaluate the information.

Commenting on the report, Pharmaceutical Research and Manufacturers of America (PhRMA) noted that, while personalised medicine research is promising, it is also resource-intensive. "Importantly, the report makes clear that personalised medicine represents a dramatically new field in biopharmaceutical research,” PhRMA said. "It requires significant investment beyond the traditional R&D process – itself costly and lengthy – such as technologies associated with target validation, early toxicology markers, and micro-sequencing."

19th November 2010

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