The impact of biomarker technology and biomarker strategies in pharmaceutical development is still in its infancy; but the impact is already proving significant. Biomarker strategy forms the basis for personalised medicine, the industry/regulatory focus centres on improving the success rate and reducing the high attrition rate often encountered in early phases of clinical research. The depth and breadth of knowledge required to successfully implement biomarkers into drug development is generating company collaborations and inclusion of professionals that have not traditionally been part of drug product development.