The FDA is taking genomics seriously and is expanding their staff in this area.  With so many of the new drugs submitted for FDA approval that are

gnomically based, this certainly can’t hurt.  Not only are drugs becoming more expensive to bring to market, they are also more specific in what they treat, oncology especially.  With targeting specific genes and proteins and/or alternating the way a specific gene responds the information available continues to grow with increased variables.  When the correct match and subsequent behavior is found, then hopefully the R and D has been successful, and then of course trials are required to ascertain the results. 

The FDA is working hard to not only staff but also play catch up in areas of technology where top level guidance has perhaps not been available in years past to keep up and maintain global business intelligence as it has been moving at the speed of a rocket, and they are getting help and assistance from industries who have invested heavily in technology and business intelligence, namely the pharmaceutical and health insurance businesses, who are contributing data to be analyzed with the Sentinel Initiative, business intelligence software being installed at the FDA and coordinated to allow the analysis certain drugs with individuals in certain age groups, with chronic diseases, etc. in other words information up front, and in time this should also allow for the agency to perhaps be more on top of other issues, like side effects.  BD 

Food and Drug Administration Acting Director Frank Torti announced Monday in a podcast the creation of a new position in the Office of Chief Scientist: the Senior Genomics Advisor. Dr. Liz Mansfield, a scientist who has worked on scientific policy at both the FDA and in the private sector, will be the first to fill the post. Dr. Mansfield “will focus on the FDA’s goal of providing its physicians and scientists with tools and personnel capable of high level analysis of complex genetic data,” according to a transcript of the podcast. The position is significant because it heralds the FDA’s focus on developing approaches to personalized medicine.

Already, the FDA runs the Critical Path Initiative, which aims to enhance the product development process by incorporating new tools for product evaluation. These include biomarker assessments, which aim to correlate the presence of certain genes or proteins to the likelihood that a patient will respond to a new medical product. And just a few months ago, the FDA entered into a partnership with Medco, a pharmaceutical benefits manager for more than one fifth of the American population, which can give the FDA access to a plethora of de-identified patient information on tests, prescriptions, and clinical outcomes.

FDA Embraces Personalized Medicine

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