Understanding the factors that promote drug innovation is important both for improvements in health care and for the future of organizations engaged in drug discovery research and development. By identifying the inventors of 252 new drugs approved by the US Food and Drug Administration from 1998 to 2007 and their places of work, and also classifying these drugs according to innovativeness, this study investigates the contribution of different types of organizations and regions to drug innovation during this period. The data indicate that drugs initially discovered in biotechnology companies or universities accounted for approximately half of the scientifically innovative drugs approved, as well as half of those that responded to unmet medical needs, although their contribution to the total number of new drugs was proportionately lower. The biotechnology companies were located mainly in the United States. This article presents a comprehensive analysis of these data and discusses potential contributing factors to the trends observed, with the aim of aiding efforts to promote drug innovation.
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I thank researchers (usually the listed patent inventors) who helped to clarify apparent discrepancies between the patent history and the development information for several drugs. The helpful comments of the referees are also greatly appreciated.
The author received no financial support for this research other than grants-in-aid from the Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT). These grants-in-aid supported research related to the role of start-ups in innovation generally, not specifically in pharmaceuticals. The author consults for two Japanese biotechnology companies, for which his only compensation is equity or stock options. Neither of these companies is mentioned, or specifically alluded to, in this article. He is also an advisor to RIKEN (The Institute of Chemistry and Physics), a basic-research laboratory supported by the Japanese government. Otherwise, he has no interests that might be perceived to influence the results and discussion reported in this article. The author has not shown this paper to, or discussed its contents with, any organization representing biotechnology or pharmaceutical companies.
Additional notes on data sources and analysis methodology (PDF 363 kb)
Lists of all 252 drugs with attributions and other key features (XLS 218 kb)
Notes on the attribution, classification or characteristics of particular drugs or groups of drugs (PDF 717 kb)
Special topic notes (PDF 402 kb)
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Kneller, R. The importance of new companies for drug discovery: origins of a decade of new drugs. Nat Rev Drug Discov 9, 867–882 (2010). https://doi.org/10.1038/nrd3251
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