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New FDA Genomics Czar Felix Frueh on Microarrays, Diplomacy

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At A Glance

2004-Present - Associate Director for Genomics, Center for Drug Evaluation and Research, US Food and Drug Administration.

2004-2002 — Managing partner, Stepoutside Consulting, Gaithersburg, Md.

2002-2001 — Research director, pharmacogenomics, Transgenomic, Gaithersburg, Md.

2000-1999 — Assistant director, department of biology; senior scientists, DNA microarray applications, Protogene Laboratories, Menlo Park, Calif.

2001-1999 — Assistant professor, Department of Pharmacology, Georgetown University, Washington, DC.

Education:

1996-1999 —Postdoctoral fellow, Department of Molecular Pharmacology, Stanford University.

1995-1996 - Postdoctoral fellow, Department of Pharmacology, University of Basel, Basel, Switzerland.

1995 — PhD, biochemistry, University of Basel.

1991 — MS, biology, University of Basel.

 

Felix Frueh joins the United States Food and Drug Administration in a newly created position that will put him at the helm of the Interdisciplinary Pharmacogenomics Review Group. This body was put in place by the agency to handle genomics data voluntarily submitted by industry under the “Guidance for Industry: Pharmacogenomics Data Submissions,” which is scheduled for final release this summer. (For details, see article, page 1).

“We wanted to hire somebody with the scientific expertise that would convey the credibility we need as a regulatory agency to the industry,” Larry Lesko, director of the Office of Clinical Pharmacology and Biopharmaceutics at the Center for Drug Evaluation and Research, told BioArray News last week in describing Frueh’s position. “You have to sit across the table from company experts as well as train people in the FDA in this new field. The individual will have to have excellent communications skills to understand the context of those questions coming from the industry. And, they have to understand drug development and the industry.”

For microarrays, Frueh’s resume is long and deep. He has helped create new platforms, and has helped companies apply them. He helped Pat Brown develop the first human cDNA microarrays at Stanford University, and then went to now-defunct Silicon Valley startup Protogene Laboratories to develop a commercial microarray platform, while at the same time holding a position as assistant professor in pharmacology at Georgetown University. From there, he worked as research director for Transgenomic, and then as an independent business consultant, establishing a firm to help Swiss biotechnology companies open in the US market.

BioArray News caught up with Frueh last week to learn how he intends to approach this position, heading up how the agency works with an industry intensely sensitive about its data.

How did you get involved with this effort?

I had started a consulting company and parallel with that, I did two other consulting projects, one with the Centers for Disease Control, a genetics project; and the second was working with Larry Lesko and his team on the revision of the [pharmacogenomics data submission] genomics document. During that time, I got more and more interested in doing this full time, and apparently, the FDA did as well.

How did you first get involved with microarrays?

I got my PhD in biochemistry in Switzerland, working on novel methods for parallel gene expression analyses, and then I moved to Stanford where I got involved with Patrick Brown on cDNA microarrays, the first human microarrays that came out of Pat’s lab at the time. From there, I took an appointment at Georgetown [University] as an assistant professor but stayed in California working at a small startup company, Protogene, to develop applications based on their proprietary microarray technology for gene expression and the genotyping area.

What are your thoughts on microarray technology?

It’s hard to come up with a final answer; it’s still too early to tell. Microarrays for gene expression are a given, it is the only good way to do highly parallel gene expression. For genotyping, [microarray technology] is not quite there yet. Perlegen has an even higher density platform [than Affymetrix] with many SNPs on an array, and maybe that’s the way of moving forward. I’m not sure we have seen a breakthrough in genotyping technology. There are some inherent problems with the types of arrays — there are genotyping by hybridization [arrays], which Affymetrix came up with; single-base extension on the array; and on-array PCR technology. All of that tries to address the issue that comes up with the yes-no answer for genotyping. The determination of homozygous versus heterozygous mutations is an issue; the detection of mutations in a heterogeneous mixture of related sequences is another [e.g. in cancer research] that will be hard to address with microarray technology.

What has your experience been with Affymetrix?

Other than my first boss at Protogene coming out of Affymetrix, I have never been associated with them.

What do you see as your position in working with this voluntarily submitted data?

The role requires a mixed-type of experience between science, organizational skills, and business experience. In many ways, this is a little bit like trying to start an organization within an organization. It's a new paradigm that requires creating an infrastructure that doesn't compromise the processing of required applications such as INDs and NDAs, which need to move forward and move forward quickly. We need to find appropriate resources and a path where we can learn as much as we can. We also have to collaboratively work with industry to get up to speed from an educational point of view, and create a process that allows us to capitalize on the experience and move it back into the [review] divisions.

There is a fine line between making sure that we are getting the information and learning as much as we can while making sure that the regular process is not being jeopardized by this process.

The skill set is mixed — science, interpersonal skill, and organization skills.

You come from Switzerland, a country known for its neutrality, might that serve you best as you come in to the government sector from the private sector?

Yes, this is a whole new culture. It’s different.

 

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