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laboratory informatics

Standardisation bugbear Pharmaceutical companies haven’t traditionally been keen to share their proprietary data, but the industry’s increasing willingness to engage in risk/profit sharing partnerships, coupled with the need to outsource portions of its discovery, preclinical and clinical workflows to the contract research sector, have led to an increased requirement for the transfer of information between organisations. Tis data-sharing requirement has been partially responsible for a call to standardise data from disparate sources. ‘Lack of data standardisation is still an enormous concern throughout the industry,’ Smallmon stresses. ‘Pharma itself has been pressing for data standardisation for years, through initiatives such as the FDA Data Standards Council (DSC) and organisations like the Allotrope Foundation. Vendors of informatics platforms, such as laboratory information management systems (LIMS) and compound/storage management soſtware, have developed solutions that can cope with and convert many different data formats, but ultimately it would be much simpler if there was a common concept of what data should look like, so third party tools could much more easily query that data openly, across different data sources and datasets.’ Smallmon suggests that ongoing

standardisation issues are at least in part due to instrumentation manufacturers, who generally provide their hardware with dedicated data models that aren’t compatible with other systems. ‘Tings are starting to

change, but the situation is far from perfect, and in the meantime, LIMS and other soſtware vendors like LabVantage are having to ensure that systems can sit alongside and integrate with the dedicated instrumentation soſtware.’

Facilitating collaborative R&D Personalised medicine, biologics, and the trend towards externalising services and collaborative R&D models are trends highlighted by Mariana Vaschetto, VP for marketing at Dotmatics. ‘In the pharma research arena, there is a shiſt towards personalised medicine and biologics, and another clear and emerging emphasis is


collaborative research. Externalising services is just one aspect of this collaborative approach, but we are also now seeing increasing numbers of collaborations that span multiple groups, where every stakeholder contributes original ideas and results. Tis concept of collaboration is ideally suited to making optimum use of the vast amount of historical data in pharma’s archives.’ ‘Informatics for R&D needs to adapt

to these changes,’ Vaschetto continues. Te Dotmatics platform, for example, has been designed with this R&D setup in mind, as a true collaborative platform that enables research teams around the globe to collaborate in real time, not only sharing data but discussing ideas and testing hypotheses.’ Te key component for any informatics

system, and independent of the specific vendor, has to be the ability to enable a collaborative research environment in a way that maximises each stakeholder contribution towards the common end. ‘From the technical point of view it is important that the informatics environment can be customised to each company’s workflow and deployed either in the cloud or in house. Because the members of a project may work with multiple technologies, it is important that access to the collaborative environment can be done from a variety of devices, including traditional workstations and mobile devices.

Consolidation Consolidation is one area that has played a major role in shaping the pharma industry, and this brings particular informatics challenges, comments Nick Townsend, director of life sciences at LabWare. ‘Merger and acquisition activity continues to create challenges for pharmaceutical clients who have embarked on global laboratory informatics projects. We have oſten seen how ongoing projects involving centralised, global laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs) have to be reshaped to accommodate newly acquired sites and new businesses. Te project teams have to manage harmonisation of business processes as the new entities are brought on board, and then face the challenge of moving lab informatics systems and data over to the unified, global system.’ Tis typically involves designing processes

for managing the transfer of static data, such as test methods and product specifications, and reworking coding/naming conventions. It might also involve extending functionality to ensure that it’s business as usual for the acquired sites, Townsend notes. ‘It’s a complex, resource-intensive task that has to be very carefully controlled and documented in a pharmaceutical environment.’

Overview of a high throughput combination experiment in Genedata Screener: 586 combinations tested on 147 plates in 384-well format. Left side: overview across all plates (normalised data), each plate carries 4 combinations. Middle: Overlaid dose response curves show the slight shift of IC50s for the A-series of the selected combination. Right side: Tabular view shows numerical and graphical results for each of the 586 combinations: e.g. synergy scores, excess volumes, isobolograms and combination index displays


Merging informatics infrastructures Te biggest challenges are oſten associated with merging infrastructures. ‘Even in an ideal situation when both companies have the same enterprise resource planning (ERP), LIMS, chromatography data system (CDS),

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