ABSTRACT
A key element of drug development programs is planning the most
efficient and cost-effective path toward successful registration and
favorable reimbursement. One discipline that has gained consid-
erable attention from regulators, payers, and developers in recent
years [1-7] as a means to achieving this goal is pharmacogenetics
(PGt)—the study of variation in germ-line deoxyribonucleic acid
(DNA) sequence as related to drug response [8]. While PGt has
great potential to positively impact the success of developing a new
medicine, the integration of PGt into the drug development pipeline
has not been implemented effectively in most pharmaceutical
companies. The goal of this chapter is not to review the extensive
literature published on the scientific concept and commercial
opportunity that PGt offers; rather, it is to describe the requirements
and principles of successful PGt application, enabled by integration
of know-how andmethodology into the mainstay drug development
pipeline.
