Molder Center for Drug Discovery Research, Temple University School of Pharmacy , 3307 N. Broad Street, Philadelphia, Pennsylvania 18938, United States.
J Med Chem. 2013 Jul 25;56(14):5659-72. doi: 10.1021/jm400330j. Epub 2013 Apr 29.
The pharmaceutical industry is facing enormous challenges, including reduced efficiency, declining innovation, key patent expirations, fierce price competition from generics, high regulatory hurdles, and a tarnished image. There is a clear need for change in the paradigms designed to address these challenges. Pharma has responded by embarking on a range of initiatives. However, along the way the industry has accrued critics whose accusations have tainted its reputation. The first part of this two-part series will discuss the criticisms that have been leveled at the pharmaceutical industry and summarize the supporting data for and against these criticisms. The second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses to address these challenges. It will describe the industry's changing perspective and new business models for coping with the recent loss of talent and declining clinical pipelines as well as present some examples of recent drug discovery successes.
制药行业正面临着巨大的挑战,包括效率降低、创新能力下降、关键专利到期、仿制药的激烈价格竞争、高监管障碍以及形象受损。显然需要改变应对这些挑战的模式。制药业已采取了一系列举措来应对,但在此过程中,该行业积累了批评者,他们的指责玷污了其声誉。本系列的两部分中的第一部分将讨论针对制药业的批评,并总结支持和反对这些批评的相关数据。第二部分将重点关注制药业当前面临的挑战以及制药业为应对这些挑战而采取的措施。它将描述行业正在变化的视角和新的商业模式,以应对最近人才流失和临床管道下滑的问题,并介绍一些最近药物发现成功的例子。