REPORT HIGHLIGHTS


HIGHLIGHTS FROM THE BIOANALYSIS ZONE ROUNDTABLE REPORT


Click here to watch Part 1 of the Round Table Discussion OUTSOURCING STRATEGIES


The CRO participants were keen to understand the outsourcing strategy of Pharma to help them put together their business plans. The consensus was that for small molecules, the bioanalytical work is considered more routine and hence has, to some extent, become commoditized. Therefore, the strategy for most Pharma companies is to outsource the majority of small-molecule regulated preclinical and clinical work, with some degree of support from internal Pharma bioanalytical groups. However, for the increasing numbers of biopharmaceuticals and the novel constructs that are coming through different company pipelines, outsourcing by Pharma depends on the ability of CROs to invest in the equipment and staff required to support the analytical challenges and more complex assays that are arising from these molecules.


It was noted that smaller biopharmaceutical companies and large Pharma may have quite different requirements for bioanalytical outsourcing. Small companies may have little capability in this area and so are more reliant on the CROs for all aspects of method development, validation and study support, using them as a virtual laboratory. Whereas larger Pharma are likely to have some in-house bioanalytical capability that is capable of supporting some, if not all of these aspects. In addition, it was observed that smaller biopharmaceutical companies tend to place the support of a larger proportion of their early phase (discovery) studies out to contract. These studies often tend to be on the critical path for project progression and so the timelines for delivery of analytical data are often more aggressive than those for later development phase studies.


The panelists held the opinion that there is an increasing requirement and value in being able to work with CROs who offer an integrated approach, particularly for preclinical studies where the hand-offs between study directors and principle investigators for the in-life and bioanalytical aspects can become very complex, particularly when they are on different sites, or are part of different companies.


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