Wyeth Research, 500 Arcola Road, COL S2307, Collegeville, Pennsylvania 19426, USA.
Adv Exp Med Biol. 2009;655:1-12. doi: 10.1007/978-1-4419-1132-2_1.
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.
过去十年，监管机构注册并成功推向市场的新型医药实体的成功率一直停滞不前。疗效和安全性的失败仍然是主要的障碍和失败原因。转化医学是制药行业研发组织中的一个新功能，旨在提高药物发现和开发的可预测性和成功率。生物标志物是转化医学策略的核心，重点关注疾病生物标志物、患者选择、药效学反应（疗效和安全性）、靶标验证、化合物-靶标相互作用）。成功采用和采用生物标志物研究、验证和实施作为改善新药发现和开发的关键策略。
