Systematically identifying risks to product supply and taking the necessary steps to mitigate these risks allows a company
to proactively avoid product shortages. Multiple options to mitigate risk are available. Diversification by establishing backup
manufacturing facilities in geographically distinct areas is one strategic approach to avoid product shortages in the event
of an emergency situation at the primary manufacturing site. By carefully laying out the strategy for and potential challenges
of conducting legacy technology transfers, companies can successfully implement diversification. It remains to be seen how
companies and regulatory agencies such as FDA can work together to move forward in preventing and avoiding such product shortages
and thus ensuring safe treatments for patients.
The author wishes to express sincere thanks to Arleen Paulino, Bill Keefe, Dan Rathman (Amgen), Ali Siahpush (Dendreon), and
David Clark (MedImmune) for their active support and insightful comments in preparation of this paper.
Sushil Abraham is director of technology transfer at MedImmune, 636 Research Drive, Frederick, MD 21703, tel. 301.228.5183, AbrahamS@MedImmune.com
. At time of acceptance of this paper, the author was at Amgen, 4000 Nelson Road, Longmont, CO 80503.
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