Translational medicine--a paradigm shift in modern drug discovery and 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 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.

journal_name

Adv Exp Med Biol

authors

Day M,Rutkowski JL,Feuerstein GZ

doi

10.1007/978-1-4419-1132-2_1

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

1-12

eissn

0065-2598

issn

2214-8019

journal_volume

655

pub_type

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