Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA.
Nat Rev Drug Discov. 2010 Mar;9(3):203-14. doi: 10.1038/nrd3078. Epub 2010 Feb 19.
The pharmaceutical industry is under growing pressure from a range of environmental issues, including major losses of revenue owing to patent expirations, increasingly cost-constrained healthcare systems and more demanding regulatory requirements. In our view, the key to tackling the challenges such issues pose to both the future viability of the pharmaceutical industry and advances in healthcare is to substantially increase the number and quality of innovative, cost-effective new medicines, without incurring unsustainable R&D costs. However, it is widely acknowledged that trends in industry R&D productivity have been moving in the opposite direction for a number of years. Here, we present a detailed analysis based on comprehensive, recent, industry-wide data to identify the relative contributions of each of the steps in the drug discovery and development process to overall R&D productivity. We then propose specific strategies that could have the most substantial impact in improving R&D productivity.
制药行业正面临着一系列环境问题的压力,包括由于专利到期导致的收入大幅减少、医疗保健系统成本不断增加以及监管要求越来越高。在我们看来,应对这些问题对制药行业未来生存能力和医疗保健进步带来的挑战的关键是大幅增加创新、具有成本效益的新药的数量和质量,同时又不承担不可持续的研发成本。然而,众所周知,多年来,行业研发生产力的趋势一直在朝着相反的方向发展。在这里,我们根据全面、最新的行业数据进行了详细分析,以确定药物发现和开发过程中各个步骤对整体研发生产力的相对贡献。然后,我们提出了一些具体的策略,这些策略可能会对提高研发生产力产生最重大的影响。