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Int J Pharm. 2019 May 30;563:273-281. doi: 10.1016/j.ijpharm.2018.12.093. Epub 2019 Jan 18.

The impact of external innovation on new drug approvals: A retrospective analysis.

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Advanced Analytics and Data Sciences, Eli Lilly and Company, Indianapolis, IN 46285, United States. Electronic address:
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, United States. Electronic address:
Discovery Research, Karuna Pharmaceuticals Inc, Boston, MA 02110, United States. Electronic address:


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.


Approval; Drug discovery; External innovation; Innovation ecosystem; New biologic entities; New molecular entities; Text mining

[Indexed for MEDLINE]

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