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And Now, a Word from the FDA

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Felix Frueh was hired by the FDA going on three years ago to serve as the associate director of genomics for the Office of Clinical Pharmacology, which itself is housed within the Office of Translational Sciences.

Frueh sat down with GT's Meredith Salisbury to talk about the growing relevance of genomics, proteomics, and more in the clinical realm. What follows is an excerpted transcript of the discussion.

Genome Technology: Why did FDA find it important to bring in someone to oversee genomics?

Felix Frueh: I started at the FDA to do two things: one is to chair an interdisciplinary pharmacogenomics review group, and secondly to work in the Office of Clinical Pharmacology to build a genomics review group in order to have a place for the review of genetic and genomic information that comes to us through the normal submissions that the FDA receives for drug approvals.

The fact that this has been housed in the Office of Clinical Pharmacology makes perfect sense, because a lot of the impact that we see today for pharmacogenetics is related to pharmacokinetics and pharmacodynamics, which is what we do here.

What has changed over the last few years is that because we learned so much more about genetics and genomics, the submissions, from a genetic and genomic perspective, have gotten a lot more complex. It requires additional expertise above and beyond just a clinical pharmacology type of expertise to appropriately review these submissions.

What we do here in the genomics group is not just the review board -- it's a lot of infrastructure building and a lot of background work in order to make sure that FDA possesses the resources, the expertise, [and the] educational tools which are required to be prepared for reviewing genomics submissions.

[As for] the interdisciplinary pharmacogenomics review group, this is a group that was assembled about two years ago out of the need to have a home for voluntary pharmacogenomics data submission. The idea is that because there is so much cutting-edge research in this area, we wanted to have a venue that is outside of the normal regulatory submission process where we can get access to that data very early on. So it's exploratory data that is not yet used for making a regulatory decision.

GT: Your director, Larry Lesko, spoke at a conference last summer where he suggested that the voluntary data submission process be expanded to include proteomic and metabolomic data. You're already talking about how complex genomic data is -- how realistic is this?

Frueh: This is in fact very realistic. We already have gotten some submissions and are very excited about it. Among all the frenzy about genomics, one thing we have to realize is that genomics is only one of these new [type] of biomarkers. Proteomic, metabolomic, imaging biomarkers -- I think are perhaps a little bit behind what we talk about in genomics, but certainly not far. The use of these biomarkers is something that we have to look at very carefully, and we can only do that if we have the expertise and resources available to do it. What we set out to do in genomics we would like to now translate into these other areas as well.

What's really fascinating is that we have seen a couple of voluntary submissions in which the sponsors actually looked at the ‘pan-omic' type of marker -- in other words, the translation of what you see on a genomic level into the proteomic and metabolomic aspect of biomarkers, which is honestly [among] the most fascinating things that I have seen. It really gives you great insight in the biology of these biomarkers in the context of drug development. This is what this expansion is all about. It is not a pipe dream -- it is reality.

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