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Open-access public-private partnerships to enable drug discovery--new approaches.

机译:开放访问的公私合作伙伴关系以实现药物发现-新方法。

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The productivity of the pharmaceutical industry, as assessed by the number of NMEs produced per US dollar spent in R&D, has been in steady decline during the past 40 years. This decline in productivity not only poses a significant challenge to the pharmaceutical industry, but also to society because of the importance of developing drugs for the treatment of unmet medical needs. The major challenge in progressing a new drug to the market is the successful completion of clinical trials. However, the failure rate of drugs entering trials has not decreased, despite various technological and scientific breakthroughs in recent decades, and despite intense target validation efforts. This lack of success suggests limitations in the fundamental understanding of target biology and human pharmacology. One contributing factor may be the traditional secrecy of the pharmaceutical sector, a characteristic that does not promote scientific discovery in an optimal manner. Access to broader knowledge relating to target biology and human pharmacology is difficult to obtain because interactions between researchers in industry and academia are typically restricted to closed collaborations in which the knowledge gained is confidential.However, open-access collaborative partnerships are gaining momentum in industry, and are also favored by funding agencies. Such open-access collaborations may be a powerful alternative to closed collaborations; the sharing of early-stage research data is expected to enable scientific discovery by engaging a broader section of the scientific community in the exploration of new findings. Potentially, the sharing of data could contribute to an increased understanding of biological processes and a decrease in the attrition of clinical programs.
机译:过去40年中,按照每美元研发投入所产生的非营利组织的数量评估,制药行业的生产率一直在稳步下降。生产力的下降不仅对制药业构成重大挑战,而且对社会也构成挑战,因为开发药物来满足未满足的医疗需求非常重要。将新药推向市场的主要挑战是成功完成临床试验。然而,尽管近几十年来在技术和科学上取得了许多突破,并且尽管进行了强有力的靶标验证工作,但药物进入试验的失败率并未降低。缺乏成功表明对靶标生物学和人类药理学的基本理解受到限制。一个促成因素可能是制药业的传统保密性,这一特征并未以最佳方式促进科学发现。很难获得与目标生物学和人类药理学相关的更广泛的知识,因为工业界和学术界之间的研究人员之间的互动通常仅限于封闭的协作,在封闭的协作中所获知识是机密的。然而,开放获取的协作伙伴关系正在行业中获得发展动力,并且也受到资助机构的青睐。此类开放式协作可能是封闭式协作的有力替代方案。期望通过共享早期研究数据,使更多的科学界参与新发现的探索,从而实现科学发现。潜在地,数据共享可能有助于增进对生物学过程的了解并减少临床程序的消耗。

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