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European Pharmaceutical Contractor

Taking the Danger Out of Risk

Faced with the apparent chaos of drug development set-up, implementing risk based management strategies can bring much-needed control and confidence, believes Hein Smit Sibinga of PA Consulting Group

Development programmes are becoming more complex than ever before: advancing process technology, consolidation, regulatory change and an increase in pressure to reduce time to market all contribute. It is a level of complexity that too often compromises the ability of an organisation to deliver the programme as planned. Experience indicates that few programmes are running in the ‘safe zone’ where corporate capability is aligned with the complexity of the programme (see Figure 1). Delivery of programmes in the pharmaceutical space has both avoidable risks and unavoidable risks that are manageable. Avoidable risks are typically associated with programme delivery; the unavoidable are associated with compound formulation and clinical outcome.

COMPLEXITY IS CHALLENGING CAPABILITY

Fundamentally, programme complexity is driven by the nature and complexity of the process under development. We can deal with base-line complexity by identifying clear and well-defined deliverables; whilst adherence to well-defined specifications helps constrain ‘scope creep’. Nevertheless, programme delivery can be daunting, not least because successful execution requires the entire organisation to work in a coherent and co-ordinated manner, usually within a commercially demanding environment. The consequence is that even the most experienced and skilled organisations are likely to encounter problems.


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Hein Smit Sibinga is one of a team of engineers, consultants and scientists who have pioneered pragmatic approaches to delivering complex programmes for pharmaceutical, biotech and medical device companies. He focuses on reducing programmes down to basic elements and driving these cross-functional decisions which allow organisations to move forward. As a Mechanical Engineer, his 17 years of experience includes development, operations regulatory and quality support, marketing, CMC, program management and technology transfer. Actively using Six Sigma, he directs teams to minimise rework and block risks from turning into problems. He has taken multiple products from inception through to qualification and validation through to commercialisation.
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