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European Biopharmaceutical Review

Operational Effectiveness

In much of our work with large and mid-sized pharma/biotech companies, there is a theme that consistently emerges – the requirement for efficiency and effectiveness in operations. Whether it is research and development, commercial or manufacturing, there is no doubt about the increasing focus that companies are placing upon ‘getting it right first time’. In the ever more costly and complex environment of drug development, the cost of getting it right is high, but necessary if the commercial rewards are to be realised. The cost of not getting it right is higher, not only due to the material cost which can amount to millions of dollars of lost revenue from a delayed launch, but also the loss of creditability in the face of investors and regulators.

The head of R&D of a global pharmaceutical company approached us with the following question: are we effective and efficient, and do we use industry best practice?

The company, at that time, was one of the fastest growing in the pharmaceutical industry. Growth and success, while highly desirable, had brought challenges – how to manage the growth and ensure it was sustainable.


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Catherine D’Arcy is a Managing Consultant at PA’s life science and healthcare practice. Catherine has worked for over 16 years in pharmaceutical R&D with a variety of life science companies. She specialises in working with client teams to improve efficiency, particularly in the areas of clinical, regulatory, medical and pharmacovigilance. Much of Catherine’s work has resulted in more streamlined and efficient processes, thus laying the foundations for consistency, quality and reliability – critical requirements for R&D as it rises to the challenges currently facing the industry.
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Catherine D’Arcy
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