Grand rounds in proteomics at the FDA white oak, silver spring, MD, USA, april 3, 2007.

The application of proteomics in drug development could be a major source of novel biomarkers to improve the efficacy and safety of new drugs. Training of US Food and Drug Administration (FDA) reviewers on current applications of proteomics is important for the future review of proteomic data. A Grand Rounds in Proteomics was held on April 3, 2007 at the FDA in White Oak, Silver Spring, MD, USA. The goal of this activity was to contribute to reviewer training as well as to generate discussions regarding the readiness of proteomic platforms in drug development, similar in scope to applications in genomics and metabolomics. Several speakers from industry and academia presented data on proteomic applications in drug development (meeting agenda available in the Supporting Information). An additional goal of this meeting was to encourage proteomic data submissions within the Voluntary eXploratory Data Submissions (VXDS) at the FDA. VXDS meetings represent key venues for exchange between the FDA and sponsors of scientific and clinical data on exploratory biomarkers. The FDA has received a limited number of VXDS submissions containing proteomic data. This meeting was an opportunity to identify possible areas in proteomics where future VXDS submissions may be received. Voluntary submissions have been transformed into regulatory submissions in genomics, and a similar path may also be followed by proteomic data in the future. Proteomic biomarkers may also be suitable for submission to the Pilot Process for Biomarker Qualification at the FDA.