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A plan for sustainable funding for US biomedical research

Nature Reviews Drug Discovery volume 14, pages 147–149 (2015)Cite this article

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Over the same period, the private sector research and development (R&D) ecosystem in the United States has changed3. With increased globalization have come increased competition, pressure for short-term advantage and a shift in industry from early-stage research to later-stage development. This has resulted in increased offshoring of early- and late-stage research efforts, with potential long-term negative consequences. Additionally, universities, research institutes and research hospitals have become more translationally focused and some have become proof-of-concept centres for new drug discovery ideas. These events have changed the dialogue between those who create biological knowledge and those who apply it, and suggest that successful drug R&D in the future will require new modes of interaction among academic, industrial and governmental organizations. Here, we propose a plan to help provide the funding needed to address the associated challenges: extending patents on drugs by one year and using the additional revenue to support biomedical R&D.

This resource would not be used for profit, or for business as usual on either side. For the NIH, it could be directed towards innovative programmes like the recently announced Accelerating Medicines Partnership (AMP), which focuses on the identification of new drug discovery targets and biomarkers, or the Toxicology in the 21st century (Tox21) collaboration between the NIH, the Environmental Protection Agency and the US Food and Drug Administration (FDA), which is focused on drug safety. Other programmes could focus on the discovery of diagnostics for patient stratification; threats where potential crises (such as Ebola and drug-resistant bacteria) loom; neglected diseases; and drug repurposing. From 2011 and 2012 alone, there were 148 clinical-trial failures between Phase II and FDA submission4. The rescue or repurposing of just one high-value failed drug candidate would have a positive impact on healthcare and could potentially create billions of dollars of market value.

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Figure 1: Actual and projected NIH spending 2002–2020.
Figure 2: Estimated annual drug sales in the United States at risk due to loss of patent exclusivity from 2006 to 2017.

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Acknowledgements

The authors thank a number of colleagues, including E. Anthony, L. Hood, J. Arrowsmith, P. Miller, K. Kuhrt, B. Corb, C. Pickett, R. Aurora, J. Swen, S. Lederer, G. Carlson, P. Fleming, E. Eisenstein and J. Barber for their reviews and useful suggestions and to a reviewer for raising issues around biosimilars.

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  1. SystaMedic, 1084 Shennecossett Road, 456 North-West Corner Road, Groton, North Stonington, 06340, 06359, Connecticut, Connecticut, USA, USA

    Preston Hensley

  2. PureTech, 127 Wamphassuc Point Road, Boston, Stonington, 02116, 06378, Massachusetts, Connecticut, USA, USA

    John L. LaMattina

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  1. Preston Hensley
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  2. John L. LaMattina
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Correspondence to Preston Hensley or John L. LaMattina.

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The authors declare no competing financial interests.

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Hensley, P., LaMattina, J. A plan for sustainable funding for US biomedical research. Nat Rev Drug Discov 14, 147–149 (2015). https://doi.org/10.1038/nrd4454-c1

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