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US FDA Hires Former ProtoGene Scientist, Felix Frueh, as Associate Director of Genomics


BioArray News has learned that the US Food and Drug Administration has hired Felix Frueh for the apparently new position of associate director of genomics within the Center for Drug Evaluation and Research.

Frueh, reached Tuesday by phone, confirmed that he had joined the agency three weeks ago but deferred comment other than to say he was excited about the opportunity.

Prior to joining the FDA, Frueh, 37, founded a Gaithersburg, Md., consultancy, Stepoutside Consulting, whose website describes its mission as “helping small and medium-size European biotechnology companies establish a US market presence.” The company, which offers a variety of services including regulatory consulting, was sold in May to DNA Bridges, a consultancy with offices in San Francisco and Wilmington, Del.

Frueh arrives at the FDA at a time when the agency is preparing to finalize the pharmacogenomics draft guidance document (see BAN 11/19/2003), which was released for comment in November 2003.

He will likely head the Interdisciplinary Pharmacogenomics Review Group, or IPRG, which will oversee voluntary pharmacogenomics data submissions.

The FDA is discussing the pharmacogenomics draft guidance documents this week at the Biotechnology Industry Organization’s annual convention in San Francisco, and next week at the Drug Information Association’s annual meeting in Washington, DC (June 13-17).

FDA officials did not return BioArray News requests for comment in time for the publishing deadline.

Frueh, previously was a senior scientist at ProtoGene Laboratories, a now defunct microarray developer.

Additionally, he has been an assistant professor at Georgetown University Medical Center.


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