KEYNOTE: Risk Mitigation of API Supply, Shortages Analysis

Synopsis

There has rarely been a time in the industry where we have had so many forces of this magnitude influencing the trajectory of the operations strategy.  In the midst of firefighting, Operation leaders have found it difficult to take the time necessary to understand how all of these trends work together.  The environment is more complex than before because Operations leaders are facing new or stronger forces on top of normal issues.  These forces pushing industry to add more cost, complexity and risk – with compounding effects.  Each organization has a different level of exposure they will need to grapple with, however all players have one thing in common – the amount of mobilization needed to succeed in the face of these trends is enormous
and will need thoughtful prioritization the slides cover the network of forces impacting the pharmaceutical API supply, as well as looking on the historical data and root cause analysis of the past shortages, so that the next shortage can be predicted. The main findings are highlighted. The other part of slides represents possible risk mitigation activities for the companies to secure API supply. Is second source is always an option? Or will European manufacturer be more reliable than Chinese, if we don’t track the whole node map of API supplier and Tier suppliers’ risks. The experience of Dechra with 9 internal manufacturing sites globally and about 50 CMO managing will be represented in the risk assessment and contingency plan setting up.