Fred Larimore’s (Cook Pharmica) presentation at Interphex 2008 covered continous improvement and the role QbD and quality risk management play. He gave great examples of how a pharma company can increase througput and capacity, while saving time and reducing costs. As part of his talk, he defined “continuous improvement” as “reducing cost,” and pointed out that industry needs to realize our endgame is all about fixed costs in today’s environment and economy.

Whomever ends up in the White House next January may or may not have an impact on how the pharma industry and FDA operate, but one topic that will continue to come up among the new leadership is cost reduction and for us, pharma spending.

Larimore spoke about companies’ typical “fixed costs” such as staff, utilities, and facilities as well as “variable costs” such as raw materials. Going forward, however, certain percentages of staff and utilities will need to be considered variable (that is to say, subject to cutting or letting go).

Given the growing agenda and demands on industry (especially FDA), is cost reduction the way to go? Are we thinking about the patients when we tie “continuous improvement” to spending? What are your thoughts?