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在临床中实现端到端的成功:辉瑞研发生产力的经验教训。

Achieving end-to-end success in the clinic: Pfizer's learnings on R&D productivity.

机构信息

Worldwide Research, Development and Medical, Pfizer Inc, United States.

Worldwide Research, Development and Medical, Pfizer Inc, United States.

出版信息

Drug Discov Today. 2022 Mar;27(3):697-704. doi: 10.1016/j.drudis.2021.12.010. Epub 2021 Dec 15.

DOI:10.1016/j.drudis.2021.12.010
PMID:34922020
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8719639/
Abstract

Over the past decade, Pfizer has focused efforts to improve its research and development (R&D) productivity. By the end of 2020, Pfizer had achieved an industry-leading clinical success rate of 21%, a tenfold increase from 2% in 2010 and well above the industry benchmark of ∼11%. The company had also maintained the quality of innovation, because 75% of its approvals between 2016 and 2020 had at least one expedited regulatory designation (e.g., Breakthrough Therapy). Pfizer's Signs of Clinical Activity (SOCA) paradigm enabled better decision-making and, along with other drivers (biology and modality), contributed to this productivity improvement. These laid a strong foundation for the rapid and effective development of the Coronavirus 2019 (COVID-19) vaccine with BioNTech, as well as the antiviral candidate Paxlovid™, under the company's 'lightspeed' paradigm.

摘要

在过去的十年中,辉瑞(Pfizer)一直致力于提高其研发(R&D)生产力。截至 2020 年底,辉瑞的临床成功率达到了 21%,这是 2010 年的 20 倍,远高于行业约 11%的基准。该公司还保持了创新的质量,因为其在 2016 年至 2020 年期间获得批准的产品中有 75%至少有一个加速监管指定(例如突破性疗法)。辉瑞的临床活动迹象(SOCA)范式使决策更加明智,与其他驱动因素(生物学和模式)一起,推动了这一生产力的提高。这为辉瑞与生物技术公司合作快速有效地开发 2019 年冠状病毒(COVID-19)疫苗以及公司的“光速”范式下的抗病毒候选药物 Paxlovid™奠定了坚实的基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/b0e2f8178fdf/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/424f6a1f3230/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/e6b665989cfc/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/4cad127e528f/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/b0e2f8178fdf/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/424f6a1f3230/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/e6b665989cfc/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/4cad127e528f/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5fc/8719639/b0e2f8178fdf/gr4_lrg.jpg

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