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Cost/success projections for US biodefense countermeasure development

Nature Biotechnology volume 26, pages 981–983 (2008)Cite this article

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To the Editor:

To protect civilians against biological weapons and bioterrorism, the US Department of Health and Human Services (HHS) has developed a list of essential medical countermeasure requirements. We performed a survey of candidate biodefense countermeasures in development and estimated their future clinical development costs, based on historical drug and vaccine development data. The cost of supporting existing candidates through clinical development is estimated to be $4.1 billion over the next seven years, with costs of $817 million in fiscal year 2009, alone. Given the high failure rate of biopharmaceutical development, the probability of developing approved products from the existing pipeline is between 12% and 85% per HHS requirement. To increase the probability to 90%, two to nine additional candidates will be needed per requirement, at a total seven-year clinical development cost of $14.0 billion. To date, the primary government program tasked with supporting clinical development of medical countermeasures has received only $201 million.

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References

  1. US Department of Health and Human Services. Public Health Emergency Medical Countermeasure Enterprise, Implementation Plan for Chemical, Biological, Radiological, and Nuclear Threats. April 2007. <http://www.hhs.gov/aspr/barda/documents/phemce_implplan_041607final.pdf>; accessed August 22, 2008.

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Acknowledgements

The authors are grateful to Luciana Borio, Gigi Gronvall, Dawn Myscofski and four anonymous reviewers for comments on an earlier draft.

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Authors and Affiliations

  1. Center for Biosecurity of the University of Pittsburgh Medical Center, 621 E. Pratt Street, Suite 210, Baltimore, 21202, Maryland, USA

    Jason Matheny, Michael Mair & Bradley Smith

  2. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, 21205, Maryland, USA

    Jason Matheny

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  1. Jason Matheny
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  2. Michael Mair
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  3. Bradley Smith
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Matheny, J., Mair, M. & Smith, B. Cost/success projections for US biodefense countermeasure development. Nat Biotechnol 26, 981–983 (2008). https://doi.org/10.1038/nbt0908-981

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