Clinical pharmacology, biomarkers and personalized medicine: education please.
Over the past decades, the scope of clinical pharmacology within the pharmaceutical industry has widened considerably. Key growth has been in the area of translational science and exploratory medicine, where clinical pharmacologists are nowadays the mediator between basic research and establishment of clinical usefulness. This role has led to and is supported by the rapid developments in pharmacokinetic-pharmacodynamic modeling and simulation, a strong focus on biomarkers for early informed decision-making, and the advent of pharmacogenomics into safety and efficacy predictions and evaluations. The ultimate goal--safer, more efficacious drug prescription--is shared with that of today's drive for more personalized medicine. This article reviews the evolution of clinical pharmacology within the industry, the regulatory, clinical and societal drivers for this evolution, and the analogy with the establishment of personalized medicine in clinical practice. Special attention is given to the integration of biomarkers into clinical practice and the concurrent need for education of clinicians, pharmacists, payers and patients.
de Koning
Paul
P
Exploratory Development Department, Astellas Pharma Global Development-Europe, Elisabethhof 1, 2353 EW Leiderdorp, The Netherlands. paul.dekoning@eu.astellas.com
Keirns
James
J