| 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. |
