(Ivanhoe Newswire) – The number of drugs approved has risen in the last three years, but roughly the same number of drugs have been FDA approved each year since 1950 while the estimated cost has exploded.  Now, researchers are suggesting that the current drug-development system in the United States is in need of change.

 

Garret Fitzgerald, MD, FRS, chair of the Department of Pharmacology and Director of the Institute for Translational Medicine & Therapeutics, Perelman School of Medicine at the University of Pennsylvania, was quoted as saying, “the drug-development system in the United States represents an unsustainable model.”

 

The dominance of large pharma is lessening and the process of drug discovery and development moves to a more modular approach.  The NIH’s Clinical and Translational Science Awards, for example, is an initiative designed to enhance the academia’s ability to interfere.  Approaches to raise capital and distribute intellectual property are also emerging.  

 

Most drug development failures occur during phase 2 clinical trials, where the mechanism of drug action is discovered.  The challenge is coming from a scarcity of those individuals who integrate knowledge of preclinical science with an understanding of the complexity of drug action in humans.  It is apparent in big pharma, academia, and at the FDA.

 

An uncontroversial role for NIH’s National Center for Advancing Translational Sciences would be to address the problem.  This would give academia incentives to couple initiatives in translational medicine and therapeutics.  This multi-disciplinary group could catalyze drug development by including strategies with a focus on a personalized approach, improving the prediction of safety and efficiency, and becoming a source of information about therapy for prescribers and consumers.

 

SOURCE:  American Association for the Advancement of Science, February 2013

 

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