Monrovia, CA -- (SBWire) -- 08/27/2009 -- Allen Rose, Director of The Deane Drug Discovery Institute – Duke University, is to give a keynote presentation entitled, "Modern validation studies for companion diagnostics in Pharmacovigilance and new Drug Development", at GTCbio’s 5th Modern Drug Discovery & Development Summit, on October 14th-16th, 2009, in San Diego, CA.

Companion diagnostics can be developed for efficacy or safety during drug development for targeting the use of prescription drugs. Other companion diagnostics have direct diagnostic implications with regard to prediction of disease risk. In the latter case, prior validation of the data for disease prediction will likely be required by regulators for its use during the development of drugs for prevention, or delay of disease onset. Two examples of companion diagnostics will be presented. The first involves a test for an adverse event that can be applied before prescribing a drug to increase the benefit to risk ratio. The second involves the use of a predictive test used for enrolling individuals into clinical trials of therapeutics for disease prevention/delay of onset.

Allen D. Roses has established an international reputation for his work in pharmacogenetics, exploratory drug discovery, and clinical neuroscience. Dr. Roses founded Cabernet Pharmaceuticals in 2008 to provide pharmacogenetics (PGx) and project-management services to pharmaceutical and biotechnology companies, clinical-research and managed-healthcare organizations, and academic institutions. He has formed a team of consultants with deep experience in the practical application of PGx to drug development. Dr. Roses also serves in several capacities at Duke University: as Jefferson-Pilot Professor of Neurobiology, and Genetics, as Professor of Medicine (Neurology) as Director of the Deane Drug Discovery Institute, and as Senior Scholar at the Fuqua School of Business. He recently returned to Duke after a decade-long career as a Senior Vice President at GlaxoSmithKline (GSK) and its corporate predecessor Glaxo Wellcome (GW).