Implications of pharmacogenomics for drug development.
The use of pharmacogenomics (PGx) today is almost ubiquitous in drug development and is advancing into the practice of medicine as an increasing number of drugs come to market with indications that are related to the presence or absence of a specific genetic biomarker. The authors review the history of PGx and its tools in research, in clinical trials and in clinical medicine. The economic, regulatory, and technological driving forces for adoption of PGx are then considered. Current impediments to a more robust proliferation of the benefits of these technologies are discussed-pharmaceutical companies, clinical education, required statistical methods, and intellectual property landscape.
Kirk
Randal J
RJ
Third Security, LLC, 1881 Grove Avenue, Radford, VA 24141, USA. randal.krk@gmail.com
Hung
Jeffrey L
JL
Horner
Scott R
SR
Perez
Jeffrey T
JT
D002626:Chemistry, Pharmaceutical; D015510:Clinical Medicine; D002986:Clinical Trials as Topic; D015195:Drug Design; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry; D015507:Drugs, Investigational; D023281:Genomics / Q000379:methods; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D010597:Pharmacogenetics / Q000191:economics* / Q000266:history*; D010601:Pharmacology, Clinical; D013678:Technology, Pharmaceutical; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational