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

TL;DR

This study examines how external sources of innovation, especially academia, influence the success rate of new drug approvals, highlighting the importance of collaborative research ecosystems.

Contribution

It provides a detailed analysis of publication histories to link external innovation sources with successful drug approvals and terminations.

Findings

Academic institutions contribute most to pre-approval publications.

Approved drugs are associated with more extensive literature datasets.

Collaborative environments across academia, industry, and government enhance approval success.

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.