. "Appendix D: Case Studies of HHS Chemical, Biological, Radiological, and Nuclear Medical Countermeasure Development Programs, Executive Summary." The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press, 2010.
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The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary
technical expertise, there appears to be limited experience with the regulatory and licensure process. The simple summation of these individual risks may not entirely reflect the cumulative risk that these companies face. The risk of less experienced companies are perceived to exceed the “ordinary and expected” risks associated with commercial drug and vaccine development by large, experienced pharmaceutical companies.
Commercial drug and vaccine development is challenging. It requires managing the scientific, technical, and regulatory risks to produce a profitable outcome. The US government’s effort to successfully develop, procure, stockpile, and effectively use CBRN medical countermeasures is even more challenging. The pressing national security risks should compel all stakeholders to maximize resources, coordinate efficiently, and pursue all possible avenues to ensure that medical countermeasures are available to protect the public from the catastrophic outcomes of a potential CBRN event.