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laboratory informatics multi-tasking Masters of

Contract research organisations are using HPC to get the best out of pharmaceutical

data. Sophia Ktori investigates


he pharmaceutical industry’s drive to tighten its R&D belt and outsource aspects of its drug discovery, preclinical, and clinical development has spawned

a multibillion dollar, global contract research market. It’s a highly competitive environment where pharma is looking for maximum value from dwindling budgets. Contract research organisations (CROs) are vying for the business, and are heavily reliant on cutting-edge informatics to manage the inevitable multi- tasking, and ensure that clients get maximum value from the resulting data – fast, securely, and according to the contract specifications. While pharma has traditionally outsourced

preclinical development and clinical trials management to CROs, the industry is now increasingly partnering upstream research and drug discovery, including high-throughput screening (HTS), suggests Andy Vines, product manager at IDBS: ‘Rather than just providing off-the-shelf ADME, DMPK or profiling services, for example, some CROs, particularly those in the BRIC regions, are offering early discovery screening services underpinned by their own domain expertise and specialist knowledge. Tese organisations are establishing long-term partnerships with pharma.’

The three ‘ilities’ Such partnerships require a robust, flexible mechanism to deliver three ‘ilities’ – portability, incorporability, and reproducibility, Vines says. ‘Te issue of portability is centred on ensuring that the data packages generated by the CRO can be transferred seamlessly to the pharma client, in a form that ensures the depth and quality of information is the same as if it had been generated


ActivityBase allows every aspect of workflow, assay, data management and transfer, quality control and custody chain to be customised to requirements

by pharma in house,’ he explains. ‘Portability then has to be coupled with incorporability, to ensure that the pharma client can utilise the data within their own informatics systems. Te CRO must also ensure that the entire workflow is carried out to exact specifications, and that it is reproducible. Te client may only be outsourcing a portion of its screening workflow, so the procedures carried out by its contract research partner must exactly mirror those carried out in house.’ IDBS has developed its ActivityBase screening

data management system as a highly adaptable and flexible solution that pharma and CROs can use to optimise and facilitate these three ‘ilities’, whilst maintaining data richness and security of plate-based screening assays. ActivityBase allows every aspect of workflow, assay, data management and transfer, quality control and custody chain to be customised to requirements, down to the definition of any container-type dimensions. ‘What we provide is a solution that offers the

ability to create a data analysis template that encodes the entire data analysis process, such that putting raw data into the system will generate results according to the precise data analysis methods specified,’ Vines says. Te pharma company or CRO can develop workflows for the screening assay, results presentation and data analysis, along with supporting methodology and

reagents, to exact specifications, and then transfer that whole package of information between partners, where it can easily be imported into an in-house system. ‘In an ideal world, both the CRO and pharma client would have ActivityBase installed in house, to make the transportation of data totally straightforward. However, the flexibility of the system means that information can be transferred in the correct format to other informatics platforms, without loss of relevance.’

A strategic imperative CROs need to address a number of emerging issues in today’s dynamic environment: increasing emphasis on precision medicine, rapid deployment, flexibility, interoperability and scalability, says Rick Mandahl, VP for business development at UNIConnect. Te firm’s soſtware platform, UNIFlow, is a web-based solution that is designed to support the depth and complexity of genomic science, which Mandahl describes as ‘a strategic imperative as blockbuster approaches yield to more targeted, nimble, fast moving frameworks, supporting adaptive clinical trials.’ UNIConnect’s UNIFlow system is also ideally

suited to the high throughput screening (HTS environment), and particularly for CROs that may have to implement new assays rapidly, from multiple clients with differing requirements,

@scwmagazine l

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