Pharma/Diagnostic Partnerships in Companion Diagnostic Development

The development of CDx assays minimally requires a partnership between a pharmaceutical and a diagnostic company. It is not uncommon for the drug to be developed through an alliance of two pharmaceutical companies, and diagnostic assay development programs may include separate companies for design of the assay and development of the platform. To ensure effective delivery of the CDx within this complex environment, highly matrixed teams must be formed to address strategic and technical issues, and to deliver a quality product coordinated with the drug development schedule.