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Getting Together on Genomics

What Wyeth learned about working with the US and European regulatory agencies to mine their pharmacogenomic data.

Fran Hawthorne
<figcaption> Credit: © 3D4MEDICAL.COM/GETTY</figcaption>
Credit: © 3D4MEDICAL.COM/GETTY

In a twist to the usual approach to clinical trials, the pharmaceutical company Wyeth was the guinea pig this time. The company had agreed to a videoconference with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) last winter as part of the process for submitting pharmacogenomics data jointly to the agencies. The data weren't from a particular clinical trial, but were instead part of Wyeth's efforts to lay the groundwork for regularly integrating genomics data into future trials. Before the FDA and EMEA could issue the new guidance this spring, says Allen Rudman, associate director of the FDA's office of clinical pharmacology in Silver Spring, Md., "we had to try it out."

For its part, Wyeth had been collecting genetic samplings from 400 healthy volunteers in the United States, Canada, and Germany over the course of a year, broken into 18 subgroups...

Guiding Principles for Processing Joint FDA EMEA Voluntary Data Submissions: www.emea.eu.int/pdfs/general/direct/pr/FDAEMEA.pdf

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