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Lean Compliant Operations in Life Science

WCI’s Marty Boom reviews the background of lean principles and looks at some of the practical ways of achieving the world-class performance capabilities within the life science industry

Increasingly beleaguered, pharma in general and biopharma in particular still shiver at the edge of the pool of lean operations, watching wistfully as the top performers from other sectors splash happily about. Lean principles have transformed operational and compliance performance wherever they have been fully applied.

There is general recognition in the life science sector of the need to change and obstacles to overcome, but not much action. The lean principles are by now well proven and, with effective adaptation to the specific requirements of the pharmaceutical industry, they can be applied with the same successes. Nothing should stop pharma and biopharma from jumping into the pool. Now, the regulators themselves are applying the very principles that underlie ‘lean’ to their own regulatory approach. The options are rapidly closing!

WHY NOT PHARMA?

Pharma in general has been a late and slow adopter of lean technology – and biopharma is also well behind other sectors in improving operational performance. Automotive is just one example in which the lean approach goes back decades. In this sector, current best practice is used everywhere and improvement nevertheless continues. So why are pharma and biopharma such late entrants? It is no revelation to say that the traditional and rigid ‘silo’ structure of pharma poses a significant practical barrier to progress. Changes, inherent both to achieving competitive performance and compliance, require the full co-operation and involvement of all those silos. That is difficult, even when the problem is recognised. The late start can be explained by the fact that pharmacos were focused on R&D on the one side and sales and marketing on the other. They saw manufacturing and the supply chain as a cost, not as a source of competitive advantage.

Pharma companies have taken a while to wake up to the realities of global competition and have been slow to change their classic structures in response. But the pressure is mounting: new blockbusters are thin on the ground, patents are running out and competition from generics is rising. In response to these trends, and to regain competitive advantage, products and manufacturing processes are becoming more complex. Complexity and the risk of non-compliance go hand in hand and could ultimately threaten the capability to supply. Operations has, at last, been put on the Board’s agenda.


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Marty Boom is a Principal with WCI and has been with the organisation for the past 10 years. In his role, Marty has managed and led global business improvement assignments in the life science industry. Marty is an expert manager of change in strictly regulated environments. He holds a degree in Mechanical Engineering and Manufacturing Automation from the Technical Institute of Arnhem and a degree in Business Administration.
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