Molecular Biomarkers for Personalized Medicine
Huixiao Hong, Roger Perkins, Leming Shi, Hong Fang, Donna L, Mendrick, and Weida Tong · 2014
The views presented in this chapter are those of the authors and do not necessarily reflect those of the US Food and Drug Administration (FDA). No official endorsement is intended nor should be inferred. The term “personalized medicine” was first used some 12 years ago [1] in the context widely understood today of “the right drug for the right patient with the right dose at the right time through the right route.” A more comprehensive definition comes from the President’s Council of Advisors on Science Technology (PCAST): “‘Personalized medicine’ refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not” [2]. The definition does not encompass designing drugs for sensitive subpopulations, a goal that may remain elusive, absent the support and incentives for those who would carry out the requisite research and development.