The field of genetics and its applications continue to evolve rapidly with the publication of multiple genome-wide association studies, the availability of new DNA sequencing technologies, and examples of biomarkers that are being used to help define patient response in myriad diseases (e.g., oncology, HIV, autoimmune, cardiovascular). In addition, the increased pressure to demonstrate value of medicines is refocusing efforts and attention on how to effectively and practically define patients who are grouped by biomarkers during and following clinical development.