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, email@example.com
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