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FDA’s Lesko Says It Could Be Time to 'Rethink' Voluntary Genomic Submission Guidelines

PHILADELPHIA (GenomeWeb News) - With two years of experience under its belt, it may be time for the US Food and Drug Administration to "rethink" its Voluntary Genomic Submission Guidelines program, according to Larry Lesko, director of the Office of Clinical Pharmacology at FDA's Center for Drug Evaluation and Research.

Speaking at the annual meeting of the Drug Information Association in Philadelphia, Lesko suggested that the program be expanded to include proteomic, metabolomic, and other kinds of biomarker data. He took care to note that these views were his, and that he was not speaking for the agency.

Since it began in March 2004, the VGDS program has had 25 data submissions that have resulted in 15 industry meetings, Lesko said. Other notes on the program, according to Lesko:

- The rate of VGDS submissions -- about one per month -- has remained stable.
- Only a few pharmas have submitted more than once, and they have found the most benefit from their first submission.
- With one exception, none of the data submitted under the voluntary program has been resubmitted as part of a required review. Lesko noted, however, that given the timelines of drug development, the two-year life of the program is relatively short, so that no conclusions should be drawn yet.
- Recently the submissions have been trending toward the pre-clinical arena.
- Top therapeutic areas include cancer, Alzheimer's, and depression.
- Top technical areas include genotyping, microarrays, and software validation.

Lesko suggested that "VGDS" be replaced by "VXDS," where X equals proteomic, metabolomic, or other biomarker data. This suggestion was originally reported last July in GenomeWeb News sister publication Pharmacogenomics Reporter, which quoted Felix Frueh, associate director of CDER and head of the agency's Interdisciplinary Pharmacogenomics Research Group, saying that the agency is "open-minded" to reviewing proteomic biomarkers.

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