Translational medicine - A paradigm shift in modern drug discoveryand development: The role of biomarkers

Abstract

The success rate of novel medical entities that are submitted for registration by the regulatory agencies and followed successful marketing hasbeen stagnating for the past decade. Failure in efficacy and safety continue to be the prime hurdles and causes of failure. Translational medicine is a new function within the pharmaceutical industry R & D organization aimed to improve the predictability and success of drug discovery anddevelopment. Biomarkers are the essence of the translational medicine strategy focus on disease biomarker, patient selection, pharmacodynamic responses (efficacy and safety) target validation, compound-target interaction). Successful deployment of biomarkers research, validation and implementation is adopted and embraced as key strategy to improved the drug discovery and development towards new medical entities. © 2009 Landes Bioscience and Springer Sciences-Business Media.