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Felix Frueh, Head of FDA s IPRG, on Drug Relabeling, Education, and the ICH

Felix Frueh
Associate Director
for Genomics

Name: Felix Frueh

Position: Associate Director for Genomics, FDA/CDER; Chair of the FDA Interdisciplinary Pharmacogenomics Review Group

Background: Founder and Managing Partner, Stepoutside Consulting — 2002-2004; Pharmacogenetics Research Director, Transgenomic — 2001-2002; Assistant Director, Protogene Laboratories — 1999-2000

Education: PhD in Biochemistry from the University of Basel, Switzerland — 1995; MS in Biology from the University of Basel, Switzerland — 1991

Felix Frueh, head of the FDA's Interdisciplinary Pharmacogenomics Review Group, spoke this week at the Drug Information Association annual meeting in Philadelphia on the status of the drug-diagnostic concept paper, which is a document intended to precede a more formal guidance on producing "theranostic" products, and other topics of interest to the field.

A physician education program that the FDA and the American Medical Association was also presented at the meeting by FDA, AMA, and industry representatives.

Pharmacogenomics Reporter spoke to Frueh this week to get up recent International Harmonization Committee meeting Frueh attended in Yokohama, Japan, as part of a formal pharmacogenomics working group.

Can you tell me about the status of the concept paper on drug-diagnostic companion products? Will it be completely rewritten?

Yes. We're in the process of revising it and issuing a draft guidance. I can't tell you when it's coming out — we haven't spoken about it in a while, but we hope that it will come out in the middle to the end of this year.

What will change the most from the concept paper?

What we're going to be focusing on more is the clinical perspective of co-development. So the concept paper right now is heavy on statistics, and what we hope to talk more about in the draft guidance is the clinical aspects, such as clinical trial design and the integration of it into the clinical development phase — so what needs to happen ideally, I would think.

We've gotten a lot of industry feedback on the co-development concept paper, in that respect, so we want to make sure that we address the concerns and the feedback that we got, but also make sure that what we have learned over the last year or so — the concept paper has been out for a little bit over a year — is that we make sure that we capture all that information that we got, and also the thinking at the FDA that this is what is going to be part of this draft guidance.

Can you tell me about the online pharmacogenomics course that the FDA and the American Medical Association are planning?

We started a few months ago, and we're in the process of putting together the educational material as we speak.

I don't know when, exactly, the course will be available, but again, I hope that it's going to be around the third quarter of this year sometime.

The idea there is that if you go to the AMA website, it will be available there, and it will give you continuing medical education credit, and so forth. But it's an effort that's been initiated by the FDA and we're working with the AMA experts in the field of pharmacogenomics to create the content for this course.

Will it have any particular focus?

Well, it's going to be sort of a very general 'Pharmacogenomics 101,' so we'll talk about what pharmacogenomics is, where it's being used, how it's being used. It's a very introductory course.

Is there a precedent? I've looked, and I haven't seen one.

That's the reason we're doing it. We did the same thing. We were searching for it, and we couldn't find it. I mean, we talk about education, so we felt it was very necessary to put something out there that physicians, particularly, are going to be able to use.

We're also working on a second iteration of that that goes into more details from a technical perspective. That's a follow-on course, and we don't know exactly with whom we'll be working with, but we see it as an evolving project — it's not going to stop at just this one course.

Can you tell me what happened at the recent International Conference on Harmonization meeting concerning pharmacogenomics?

The [pharmacogenomics working group] met as an informal working group for the first time in Chicago at the ICH meeting at the end of last year.

Since then, we've been writing what we call a concept paper, and a business plan for pharmacogenomics, and that has been accepted by the steering committee in a teleconference held in April.

So, the informal working group has been elevated to an expert working group, and we're now developing ICH guidelines on definitions in the area of pharmacogenomics.

So, this was the subject of the meeting … definitions for what is pharmacogenetics, what is pharmacogenomics, what are genomic biomarkers, and sample coding — for example, what is an anonymous sample, what is an anonymized sample, an identified sample, a single-coded sample, and a double-coded sample. These are the five categories that we've been talking about, and also the implications of using those samples, for example, in a drug-development context.

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