The impact of external innovation on new drug approvals: A retrospective
analysis
- URL: http://arxiv.org/abs/2102.01260v1
- Date: Tue, 2 Feb 2021 02:21:34 GMT
- Title: The impact of external innovation on new drug approvals: A retrospective
analysis
- Authors: Xiong Liu, Craig E. Thomas, Christian C. Felder
- Abstract summary: 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.
This may suggest that approved drugs are often associated with a more robust dataset provided by a large number of institutes.
- Score: 0.0
- License: http://arxiv.org/licenses/nonexclusive-distrib/1.0/
- Abstract: 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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