Regulatory Focus™ > News Articles > C-Path Initiative's Work on Personalized Medicine Starts to Get Results

C-Path Initiative's Work on Personalized Medicine Starts to Get Results

Posted 20 April 2012 | By Alexander Gaffney, RAC 

The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star.

C-Path, now under the leadership of President and CEO Dr. Carolyn Compton, is working with numerous private companies to create technologies to develop safer, more effective drugs.

"The idea here is, through the creation of new tools, new measurement standards, models for progression of diseases, we're going to be able to accelerate the approval process and get these therapies to patients as soon as possible," Compton said.

That work has already led to results, said Compton. Seven brand new biomarkers for drug-induced renal toxicity were approved for use by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

An additional 66 biomarkers are being developed at the agency in addition to patient databases and disease progression models, reports The Arizona Star.

The initiative has unique access to FDA, whose regulators are allowed to share data and interact with regulators in ways that private companies cannot, reports The Arizona Star.

Read more:

The Arizona Star - Tucson tech: Changing the way disease is treated

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