Conclusion

The global community has developed effective processes and steps to respond to a pandemic outbreak. However, the industry's ability to respond effectively remains to be seen. Unless experts accurately anticipate the final form of the H5N1 virus, conventional manufacturing using embryonated eggs will probably not satisfy international demand. For development and approval cycles to meet the needs of a pandemic response plan, innovative vaccines using cell-culture and recombinant techniques, equipped with integrated biomarkers, will be required. The current plan requires industry collaboration in the face of a global threat—collaboration both through allocation of available or allocated manufacturing capacity, and through shared investment in technology transfer and scale-up. Assuming that compensation and intellectual property issues can be managed or set aside, the biopharmaceutical industry must not delay in developing the necessary business contingencies and technology roadmaps. Although this threat may seem less imminent today than a year ago, the potential for and the consequences of pandemic outbreak remain very real, and they will require cooperation on a global scale.

BIKASH CHATTERJEE is president of Pharmatech Associates, Hayward, CA, 510.732.0177, bchatterjee@pharmatechassociates.com

1. The global financial and economic impact of an avian flu pandemic and the role of the IMF. Avian Flu Working Group. International Monetary Fund. Washington, DC; 2006. Available from: http:// http://www.imf.org/external/pubs/ft/afp/2006/eng/022806.pdf

2. Epidemic and pandemic alert and response. Cumulative number of confirmed human cases of avian influenza A reported to WHO. World Health Organization. Geneva, Switzerland; 2008. Available from: http://www.who.int/csr/disease/avian_influenza/country/cases_table_2008_06_19/en/index.html

3. WHO global influenza preparedness plan: The role of WHO and recommendations for national measures before and during pandemics. Department of Communicable Disease, Surveillance and Response, Global Influenza Programme. World Health Organization, Geneva, Switzerland; 2005. Available from: http://www.who.int/csr/resources/publications/influenza/GIP_2005_5Eweb.pdf

4. Global pandemic influenza action plan to increase vaccine supply: Immunization, vaccines, and biologicals—epidemic and pandemic alert and response. Department of Immunization, Vaccines, and Biologicals—Family and Community Health. World Health Organization. Geneva, Switzerland; 2006. Available from: URL: http://www.who.int/vaccines-documents/DocsPDF06/863.pdf

5. Honour D. Defining business continuity. Continuity Central (serial online) 2006 Sep 29 (cited 2008 Sep 5). Available from: http://www.continuitycentral.com/feature0398.htm

6. Code of practice for British standard for business continuity management. London: British Standards Institute Group; 2006. Report No.: BS25999–1.

7. FY 2006 annual report: innovative technology advancing public health. Center for Biologics Evaluation and Research. US Food and Drug Administration. Washington, DC; 2006. Available from: http://www.fda.gov/cber/inside/annrpt.htm