Nature Reviews Drug Discovery's (NRDD) Bethan Hughes reports on a joint FDA/industry effort to develop a common perspective on stratified medicine.
As reported in the NRDD article, the FDA's experiences with Voluntary Exploratory Data Submissions (VXDS) raised awareness at the agency that the complexity and cost of clinical development with biomarkers was a concern for industry. Reaching outside the Beltway to industry and academia, the FDA hosted a workshop at its White Oak, Maryland campus on October 21 and 22, 2009. Adaptive Pharmacogenomics's Michael Palmer organized and chaired the White Oak workshop. Adaptive Pharmacogenomics has been working with the FDA on methods to assess the complexity and cost of clinical development with biomarkers since 2005.
Michael Palmer will conduct one day courses in New Jersey, Boston, San Diego and San Francisco in February to relate the key findings of the workshop for drug development.