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The outsourcing of bioanalytical work in drug development projects is a unique and challenging activity. Development of analytical methods requires considerable technical and scientific expertise, and the application of these methods requires diligence and attention to detail. The increasing need for biomarker analyses also means that the range of scientific expertise and knowledge required may cover a number of different disciplines which may not necessarily be found within one laboratory.
It is therefore surprising that many companies take less care with the management of bioanalytical outsourcing than they do with other disciplines. Larger pharma companies often have technical resources allocated to bioanalytical and biomarker outsourcing, either as a dedicated technical outsourcing function, or built into the responsibilities of their internal bioanalytical laboratory. Smaller companies often do not have access to these resources internally, and may not consider this important. No doubt this is largely due to the relatively small expenditure on bioanalytical activities in comparison to other disciplines, and the fact that bioanalysis is seen as a supporting function to studies managed under toxicology, pharmacology or clinical development. However, the resource costs substantially underestimate the importance of good bioanalytical data to the development project, and the problems that poor data can cause. Moreover, since there is a growing impetus to use biomarker data for early go/no go decisions, it is even more important that these decisions are based on good quality and meaningful data if drug developers are to ensure that the right decision is made. |
