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Suggested Citation:"Appendix A: References." 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. doi: 10.17226/12856.
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A
References

BVGH (BIO Ventures for Global Health). 2006. Advance market commitments to stimulate industry investment in global health product development. http://bvgh.org/LinkClick.aspx?fileticket=W_5VAgleR8k%3d&tabid=91 (accessed March 18, 2010).

Center for Arms Control and Non-Proliferation: Scientists working group on biological and chemical weapons. 2010. Biological Threats: A Matter of Balance. Statement released January 26, 2010. http://www.armscontrolcenter.org/policy/biochem/articles/biological_threats_a_matter_of_balance (accessed March 8, 2010).

FDA (Food and Drug Administration). 2004. Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathIniative/CriticalPathOpportunitiesReports/UCM113411.pdf (accessed March 4, 2010).

FDA. 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 March 9, 2010).

Graham, B., and J. Talent. 2009. Bioterrorism: Redefining prevention. Biosecurity and Bioterrorism: Biodefense strategy, practice, and science. 7(2):125–126. http://www.liebertonline.com/doi/pdfplus/10.1089/bsp.2009.0610?cookieSet=1 (accessed March 15, 2010).

IOM (Institute of Medicine). 2008. The U.S. commitment to global health: Recommendations for the new Administration. Washington, DC: The National Academies Press.

IOM. 2009. Venture philanthropy strategies to support translational research: Workshop summary. Washington, DC: The National Academies Press.

IOM and NRC (National Research Council). 2004. Giving full measure to countermeasures: Addressing problems in the DoD program to develop medical countermeasures against biological warfare agents. Washington, DC: The National Academies Press.

Suggested Citation:"Appendix A: References." 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. doi: 10.17226/12856.
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LSE (The London School of Economics and Political Science). 2010. Policies and incentives for promoting innovation in antibiotic research. http://www2.lse.ac.uk/newsAndMedia/news/archives/2009/09/antibiotics.aspx (accessed March 14, 2010).

Matheny, J., M. Mair, and B. Smith. 2008. Cost/success projections for U.S. biodefense counter-measure development. Nature Biotechnology 26(9):981–983.

Melese, T., S. M. Lin, J. L. Chang, and N. H. Cohen. 2009. Open innovation networks between academia and industry: An imperative for breakthrough therapies. Nature Medicine 15:502–507.

NBSB (National Biodefense Science Board). 2010a. Where are the Countermeasures? Protecting America’s Health From CBRN Threats. http://www.hhs.gov/aspr/barda/documents/phemceimplplan_041607final.pdf (accessed May 17, 2010).

NBSB. 2010b. Optimizing industrial involvement in medical countermeasure development. http://www.hhs.gov/aspr/omsph/nbsb/nbsbrpt-2010.pdf (accessed March 2, 2010).

PhRMA. 2010. R&D investment by U.S. biopharmaceutical companies remains strong despite ongoing economic challenges. http://www.phrma.org/news/news/rd_investment_us_biopharmaceutical_companies_remains_strong_despite_ongoing_economic_chall (accessed March 30, 2010)

Wolf, M. C., A. N. Freiberg, T. Zhang, A. Akyol-Ataman, A. Grock, et al. 2010. A broad-spectrum antiviral targeting entry of enveloped viruses. Proceedings of the National Academy of Sciences 107(7):3157–3162.

Suggested Citation:"Appendix A: References." 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. doi: 10.17226/12856.
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Page 57
Suggested Citation:"Appendix A: References." 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. doi: 10.17226/12856.
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During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)--a partnership among federal, state, and local governments; industry; and academia--is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market.

At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.

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