Subramanyam Meena, Goyal Jaya
Global Biomarker Discovery and Development, Biogen, 300 Binney St., Cambridge, MA 02142, United States.
Value Based Medicine, Biogen, 300 Binney St., Cambridge, MA 02142, United States.
Drug Discov Today Technol. 2016 Sep-Dec;21-22:3-10. doi: 10.1016/j.ddtec.2016.10.001. Epub 2016 Nov 19.
The refinement of disease taxonomy utilizing molecular phenotypes has led to significant improvements in the precision of disease diagnosis and customization of treatment options. This has also spurred efforts to identify novel biomarkers to understand the impact of therapeutically altering the underlying molecular network on disease course, and to support decision-making in drug discovery and development. However, gaps in knowledge regarding disease heterogeneity, combined with the inadequacies of surrogate disease model systems, make it challenging to demonstrate the unequivocal association of molecular and physiological biomarkers to disease pathology. This article will discuss the current landscape in biomarker research and highlight strategies being adopted to increase the likelihood of transitioning biomarkers from discovery to medical practice to enable more objective decision making, and to improve health outcome.
利用分子表型对疾病分类法进行细化，已显著提高了疾病诊断的准确性以及治疗方案的定制性。这也促使人们努力寻找新的生物标志物，以了解治疗性改变潜在分子网络对疾病进程的影响，并为药物研发中的决策提供支持。然而，关于疾病异质性的知识空白，再加上替代疾病模型系统的不足，使得难以证明分子和生理生物标志物与疾病病理之间明确的关联。本文将讨论生物标志物研究的现状，并重点介绍为提高生物标志物从发现到临床应用的转化率而采取的策略，以实现更客观的决策，并改善健康结果。
