FDA and Biomarkers
There has been some talk recently of improving the drug development process by including the use of biomarkers. Now, I’ll be the first to admit this is somewhat out of my area of expertise; I’ve always been involved on the manufacturing side, but I wonder if the FDA will really quickly buy into this approach. I know from my experience in developing oncology drugs that the FDA wanted to see an increase in overall survival; that is the gold standard as it should be. The company I worked for suggested several surrogates mainly to get a good idea of who the drug may help and to determine more quickly if development should be discontinued. The feedback was that the FDA would not be considering such data in our filings.
So, maybe biomarkers will work for other areas, but my experience in oncology was that the FDA still wanted to see overall survival. But then maybe it will slowly change as more evidence comes in.
Resources:
• RedOrbit - Health - Research and Markets: The FDA is Encouraging the Use of Biomarkers in Clinical Trials and, in a Few Cases, Requiring the Development of Companion Diagnostics
• The FDA Is Encouraging The Use of Biomarkers In Clinical Trials
• Safety Biomarkers Help to Reduce Drug Attrition
Technorati Tags: biomarkers, FDA
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