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Center Articles and PublicationsCost/Success Projections for US Biodefense Countermeasure DevelopmentJason Matheny, Michael Mair, and Bradley T. Smith Nature Biotechnology. 2008;26(9):981-983. © 2008 by Nature Publishing Group – partner of AGORA, HINARI, CrossRef and COUNTER. All rights reserved. DOI:10.1038/nbt0908-981 Introduction: "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." |