What Is The Greatest Insight Gained From Attending The 2015 ISPE/FDA Quality Week?

In discussions with industry and FDA colleagues, it is clear that understanding supply chain risks is the key to understanding risk of drug shortages. Over the past 10-15 years, the pharma industry has done an excellent job of reducing supply chain costs. However, we may have pushed our focus on efficient supply chains too far, contributing to the increase in quality issues and/or drug shortages in this same period. We recognize that, while we can learn much from supply chain structures in other industries like automotive or apparel, our risk tolerance in pharmaceuticals is different. New developments are changing our risk profile (e.g., shift from primary care to specialty care). Our burgeoning small and large molecule pipelines require agility that mature pipelines did not. The explosive growth in biologics demand will challenge our global capability to respond.

ANDREW SKIBO
is the head of global biologics operations and global engineering at MedImmune/AstraZeneca and the 2015 chair for ISPE’s international board of directors.