September 26, 2007

While Congress celebrates the renewal of the Prescription Drug User Fee Act, the 800 pound gorilla in the room is whether or not the FDA and industry can work together to shorten drug development times in a regulatory and political environment where safety concerns seem to trump all other values.

One mechanism for rebalancing safety and innovation will be new scientific tools that give the FDA more comfort in moving new medicines from the lab bench to the bedside faster, particularly what are known as biomarkers.

Biomarkers should, at least in theory, allow companies and regulators to zero in on promising treatments earlier in the development process, shaving years and millions of dollars off of the normal development process.

This article, from Drug Discovery and Development magazine, describes how the hunt for cancer biomarkers is progressing - and why validating them is the real challenge.

Posted by Paul Howard at September 26, 2007 11:25 AM

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