Biomarkers help drive growth of personalized med programs

That personalized medicine trend you've been hearing so much about isn't just a bunch of hype. A new study from the Tufts Center for the Study of Drug Development concludes that the personalized drug development strategy is a key feature among biopharma companies. And an increased use of biomarkers to gauge patient response to these drugs is a common feature--even though stiff regulatory challenges remain.

"Early indications show that development of personalized medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry," says Christopher-Paul Milne, associate director at Tufts CSDD and author of the study.

None of that, though, is making it easier to stitch together a development program for a personalized medicine, which typically try to deliver just the right therapy at the right time tailored for the right individual patient. A bigger demand for development resources required a greater reliance on broader groups of partners, including added diagnostics help. And while developers are using biomarkers to track just how successful these new drugs are, they're having to wait for regulators to catch up on the science before it becomes a part of the approval process.

Cancer drugs are the most common type of personalized drug in the pipeline, with a common expectation than in coming years all new oncology treatments will be paired with a diagnostic test to identify patients most likely to respond. Cardiovascular, central nervous system, and immunologic drugs are next in line for the personalized treatment, says Milne, while metabolic and respiratory therapies, along with virology, are just getting started.

- here's the Tufts release
- read the story from the New York Times

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