外部创新对新药批准的影响：一项回顾性分析
The impact of external innovation on new drug approvals: A retrospective analysis
摘要：
制药公司越来越多地依赖外部创新来源来提高其发现研究生产力。然而，仍然需要更深入地了解外部创新如何转化为成功的产品发布，以便更好地了解如何最好地利用创新生态系统。我们分析了FDA批准的新分子实体（NME）和新生物实体（NBE）在过去十年（2006-2016）中由13家顶级研究制药公司推出的批准前出版历史。我们发现，学术机构贡献了大部分预先批准的出版物，出版物的主题与各自创新者的优势密切相关。我们发现这也适用于在3期终止的候选药物，但这些分子的文献量大大低于批准的药物。这可能表明，批准的药物通常与大量机构提供的更强大的数据集相关。总的来说，我们的分析结果支持这样一个假设，即跨越学术界、工业界和政府的合作研究创新环境非常有利于药物的成功批准。
英文摘要：
Pharmaceutical companies are relying more often on external sources of innovation to boost their discovery research productivity. However, more in-depth knowledge about how external innovation may translate to successful product launches is still required in order to better understand how to best leverage the innovation ecosystem. We analyzed the pre-approval publication histories for FDA-approved new molecular entities (NMEs) and new biologic entities (NBEs) launched by 13 top research pharma companies during the last decade (2006-2016). We found that academic institutions contributed the majority of pre-approval publications and that publication subject matter is closely aligned with the strengths of the respective innovator. We found this to also be true for candidate drugs terminated in Phase 3, but the volume of literature on these molecules is substantially less than for approved drugs. This may suggest that approved drugs are often associated with a more robust dataset provided by a large number of institutes. Collectively, the results of our analysis support the hypothesis that a collaborative research innovation environment spanning across academia, industry and government is highly conducive to successful drug approvals.
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