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Translational Medicine—A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers

  • Mark Day
  • J. Lynn Rutkowski
  • Giora Z. Feuerstein
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 655)

Abstract

The success rate of novel medical entities that are submitted for registration by the regulatory agencies and followed successful marketing has been 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 and development. 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.

Keywords

Drug Discovery Translational Medicine Target Validation Medical Entity Clinical Drug Development 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Landes Bioscience and Springer Science+Business Media 2009

Authors and Affiliations

  • Mark Day
    • 1
  • J. Lynn Rutkowski
    • 1
  • Giora Z. Feuerstein
    • 1
  1. 1.Wyeth ResearchCollegevilleUSA

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