title: Companion diagnostics: emerging strategies and issues in pharmaceutical development.
abstract: This article summarizes the broad messages from pharmaceutical and diagnostic companies on the collaborations required to support companion diagnostics. Since the groundbreaking herceptin HER2 diagnostic model in 1998, it has taken until 2011 for the US FDA to issue a draft guidance document, which was then immediately followed with approvals for two new drugs and their companion diagnostics. This conference summarized the current state of thinking in new projects and innovative technologies in pharmaceutical and diagnostic codevelopment. Attitudes are slowly changing and collaborations are rapidly ensuing, although the alignment between pharmaceutical and diagnostic understanding of value, timelines, outcomes and impact is difficult and remains a contentious area. The value of this conference has been to address these issues.
authors: Integrated Medicines Ltd, Director of Programmes, Topfield House, Ermine Street, Caxton, Cambridge, CB23 3PQ, UK. janette.thomas@integratedmedicines.co.uk
authors: Janette
authors: J
authors: Thomas
authors: Elyse
authors: E
authors: Stratton
authors: Mieke
authors: M
authors: Keppens
mesh_terms: D019937:Diagnostic Techniques and Procedures / Q000592:standards* / Q000639:trends; D004345:Drug Industry; D006801:Humans; D007221:Industry; D013672:Technology / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards