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Suggested Citation:"References." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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References

ASPR (Assistant Secretary for Preparedness and Response). 2010. The public health emergency medical countermeasures enterprise review: Transforming the enterprise to meet long-range national needs. https://www.medicalcountermeasures.gov/documents/MCMReviewFinalcover-508.pdf (accessed April 7, 2011).

Basch, E. 2010. The missing voice of patients in drug-safety reporting. New England Journal of Medicine 362(10):865-869.

FDA (Food and Drug Administration). 2007. FDA science and mission at risk. Report of the Subcommittee on Science and Technology. http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf (accessed April 7, 2011).

FDA. 2010. Advancing regulatory science for public health. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM228444.pdf (accessed April 7, 2011).

IOM (Institute of Medicine). 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval:Workshop Summary. Washington, DC: The National Academies Press.

Mandl, K. D., and I. S. Kohane. 2009. No small change for the health information economy. New England Journal of Medicine 360(13):1278-1281.

NBSB (National Biodefense Science Board). 2010. Where are the countermeasures? Protecting America’s health from CBRN threats. http://www.phe.gov/Preparedness/legal/boards/nbsb/meetings/Documents/nbsb-mcmreport.pdf (accessed April 7, 2011).

NRC (National Research Council). 2010. The prevention and treatment of missing data in clinical trials. Washington, DC: The National Academies Press.

PCAST (The President’s Council of Advisors on Science and Technology). 2010. Report to the President on reengineering the influenza vaccine production enterprise to meet the challenges of pandemic influenza. http://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST-Influenza-Vaccinology-Report.pdf (accessed April 18, 2011).

Suggested Citation:"References." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Poulin, P., H. M. Jones, R. D. Jones, J. W. T. Yates, C. R. Gibson, J. Y. Chien, B. J. Ring, K. K. Adkison, H. He, R. Vuppugalla, P. Marathe, V. Fischer, S. Dutta, V. K. Sinha, T. Björnsson, T. Lavé, and M. S. Ku. 2011a. PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 1: Goals, properties of the PhRMA dataset, and comparison with literature datasets. Journal of Pharmaceutical Sciences 100: n/a. doi: 10.1002/jps.22554

Poulin, P., R. D. O. Jones, H. M. Jones, H. M. Gibson, M. Rowland, J. Y. Chien, B. J. Ring, K. K. Adkison, M. S. Ku, H. He, R. Vuppugalla, P. Marathe, V. Fischer, S. Dutta, V. K. Sinha, T. Björnsson, T. Lavé, and J. W. T. Yates. 2011b. PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration–time profiles in human by using the physiologically-based pharmacokinetic modeling approach. Journal of Pharmaceutical Sciences 100: n/a. doi: 10.1002/jps.22550.

Querec, T. D., R. S. Akondy, E. K. Lee, W. Cao, H. I. Nakaya, D. Teuwen, A. Pirani, K. Gernert, J. Deng, B. Marzolf, K. Kennedy, H. Wu, S. Bennouna, H. Oluoch, J. Miller, R. Z. Vencio, M. Mulligan, A. Aderem, R. Ahmed, and B. Pulendran. 2009. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nature Immunology10(1):116-125.

Ring, B. J., J. Y. Chien, K. K. Adkison, H. M. Jones, M. Rowland, R. D. Jones, J. W. T. Yates, M. S. Ku, C. R. Gibson, H. He, R. Vuppugalla, P. Marathe, V. Fischer, S. Dutta, V. K. Sinha, T. Björnsson, T. Lavé, and P. Poulin. 2011. PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: Comparative assessement of prediction methods of human clearance. Journal of Pharmaceutical Sciences 100:n/a. doi: 10.1002/jps.22552.

Suggested Citation:"References." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Page 81
Suggested Citation:"References." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Page 82
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Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.

During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools.

Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

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