Kaitin K I
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA.
Clin Pharmacol Ther. 2010 Mar;87(3):356-61. doi: 10.1038/clpt.2009.293. Epub 2010 Feb 3.
Forged in the early 1960s, the paradigm for pharmaceutical innovation has remained virtually unchanged for nearly 50 years. During a period when most other research-based industries have made frequent and often sweeping modifications to their R&D processes, the pharmaceutical sector continues to utilize a drug development process that is slow, inefficient, risky, and expensive. Few who work in or follow the activities of the pharmaceutical industry question whether change is coming. They know that the pharmaceutical sector, as currently structured, is unable to deliver enough new products to market to generate revenues sufficient to sustain its own growth. Nearly all major drug developers are critically examining current R&D practices and, in some cases, considering a radical overhaul of their R&D models. But key questions remain. What will the landscape for pharmaceutical innovation look like in the future? And, who will develop tomorrow’s medicines?
制药创新的模式形成于20世纪60年代初，近50年来几乎一直未变。在这段时间里，大多数其他以研究为基础的行业都对其研发流程进行了频繁且往往是全面的修改，而制药行业仍在继续采用一种缓慢、低效、有风险且成本高昂的药物开发流程。在制药行业工作或关注其活动的人中，很少有人质疑变革是否即将到来。他们知道，按照目前的结构，制药行业无法将足够多的新产品推向市场，以创造足以维持自身增长的收入。几乎所有主要的药物开发商都在严格审视当前的研发实践，在某些情况下，还在考虑对其研发模式进行彻底改革。但关键问题依然存在。未来制药创新的格局会是什么样？还有，谁将研发出明天的药物？
