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The Current Status of Drug Discovery and Development as Originated in United States United States Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development

机译:目前在美国学术界起源的药物发现和发展现状:工业和学术合作对药物发现和发展的影响

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摘要

Academic drug discovery is a vital component to current drug discovery and development environments. In this study, we investigated 798 drug discovery projects that took place between 1991 and 2015 at 36 academic institutions in the United States . The observed success rates of academic drug discovery and development were 75% at phase I, 50% at phase II, 59% at phase III, and 88% at the new drug application/biologics license application ( NDA / BLA ) phase. These results were similar to the corresponding success rates of the pharmaceutical industry. Collaboration between academic institutions and the pharmaceutical industry seemed more important at later stages than earlier ones; all projects that succeeded at phase III or the NDA / BLA stage involved academic‐industrial collaboration. Many academic research projects involved neoplasms and infectious diseases, and were focused on small molecules and biologics. The success rates and possible effects of academic‐industrial collaboration seemed to vary depending on disease domains and drug modalities.
机译:学术药物发现是目前药物发现和开发环境的重要组成部分。在这项研究中,我们调查了1991年至2015年在美国的36个学术机构之间发生的798个药物发现项目。观察到的学术药物发现和开发的成功率在I期为75%,II期50%,第III期的59%,新药物申请/生物学许可证申请(NDA / BLA)阶段为88%。这些结果与制药行业的相应成功率类似。学术机构与制药业之间的合作似乎比早期的阶段更重要;所有在第三阶段或NDA / BLA阶段成功的项目都涉及学术工业合作。许多学术研究项目涉及肿瘤和传染病,并专注于小分子和生物制剂。学术界合作的成功率和可能的影响似乎因疾病结构域和药物方式而异。

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    Public Affairs and Policy DepartmentMitsubishi Tanabe Pharma CorporationTokyo Japan;

    Institute for Health Economics and PolicyMinato‐ku Tokyo Japan;

    Graduate School of Pharmaceutical SciencesLaboratory of Pharmaceutical Regulatory ScienceTokyo Japan;

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  • 正文语种 eng
  • 中图分类 临床医学;
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