Challenges, Opportunities, and Evolving Landscapes in Pharmacogenomics and Personalized Medicine: An Industry Perspective

Pharmacogenomics (PGx) is the study of the genetic basis of variability among individuals in response to drugs. It is the newest discipline of medicine and is becoming a very active area of research, with the pharmaceutical industry gaining experience applying it, integrating it into the drug development process, and also learning to better manage the expectations of the medical community. Personalized medicine (PM), based on the genetic makeup of a patient, may result in not only an improved therapeutic response but also a clinically important reduction in adverse drug reactions. The experience to date is mixed, with a few successes but many frustrations. This chapter provides an industry perspective on the emergence of the field of PGx focusing on the more mature DNA technologies. Specifically, the chapter will: (1) give a brief description of the history of PGx, (2) provide definitions of key terms, (3) look at the elements in the current healthcare and commercial environment that are driving us to personalized medicine, (4) consider the challenges (strategic/commercial, scientific, regulatory, implementation) that need to be addressed to make PGx and personalized medicine (PM) a reality, and finally, (4) provide a few practical recommendations from an industry perspective for improved success in this area.