The ability to maximise the utility of biological data emerging from pharmaceutical, biopharmaceutical, and biotechnology research and development can significantly improve development timelines, success and project costs. It’s a basic tenet, but one that has traditionally been hard to achieve because of a lack of suitable database solutions for storing the data, explains Andrew Lemon, co-founder and CEO at The Edge Software Consultancy.
The Edge was established in 2005 by four informatics scientists who wanted to develop exactly the sort of platform that would be able to store any kind of biological data in a format that could be searched and interrogated without loss of structure or content. ‘Back in 2005 the life sciences sector was becoming disillusioned by LIMS platforms, which it perceived as being too complicated and inflexible,’ Lemon says. ‘The informatics sector was responding by developing electronic laboratory notebook (ELN) solutions. But R&D departments were still repeating in vitro and in vivo studies that had already been carried out, because there wasn’t a database available for storing those studies and results in such a way that they could easily be found subsequently. We set up The Edge because we could see that what was required was a platform that could retain the structure of biological data, and not just store experimental protocols.’
Biological data management and ELN
Ten years on, The Edge offers its flagship BioRails solution as a web-based, biological data management and ELN platform that can handle any type of biological data – from high throughput screening at the early research stage, through to in vivo studies in late preclinical development – and that can support both highly structured and unstructured data. ‘You can record observations and image data, and you can annotate data and write up your experiments in parallel with storing your results,’ says Lemon.
Combining data management capabilities with an ELN in a single environment means that different groups and departments within or between organisations can communicate and transfer data without loss of meaning and with no contraction, Lemon continues: ‘In today’s R&D environment you need to be able to transfer and store multiple types of structured information. The capability to add workflow and methodology information to that data management infrastructure adds significant context. You can understand who has already done what, pull up all the details as well as the results, and have all this information ready for the next person in the chain.’
Analysing multi-dimensional data
In parallel with developing its BioRails platform, The Edge has developed Morphit, a data analytics solution that has been designed for capturing and analysing multi-dimensional study data. As well as developing Morphit alongside BioRails, the company has responded to customer demand by developing content packs for assays that are considered standard for activities such as DMPK and screening. Other content packs are in development, in areas such as in vitro toxicology and in vivo bioassays. ‘We have prepared Morphit binders and matching workflows in BioRails for commonly used assays,’ Lemon states. ‘All the client needs to do is purchase the solution pack, install it locally, and teach it about the files that they are using. We are also enhancing Morphit to extend its analytical capabilities, so there is now support for pharmacokinetic modelling, for example.’
The BioRails and Morphit platforms are highly configurable and highly flexible, and allow you to store, handle and analyse structured data from just about any source,’ Lemon explains. ‘For example, one of our clients uses BioRails for managing analytical chemistry data, and we use BioRails and Morphit as part of our company expenses and accounting systems’.
Tracking external assay requests
The current, fifth version of BioRails has been built on the back of multiple collaborations with clients to expand capabilities, Lemon adds. ‘Back in 2008 we were tasked by what is now AbbVie to build an enterprise-scale assay requesting solution, which would address the increasing trend for outsourcing activities such as sample testing and compound storage. The software that The Edge developed allows project teams to submit and track assay requests to and from internal departments, collaborators and contract service providers. These capabilities are embodied in the BioRails PTO (project tracking and optimisation) module, which allows users to plan, request and track both in house and outsourced activities, and follow and manage workflows within and between departments and contract or partner organisations.
Hybrid inventory support
BioRails PTO is complemented by BioRails Inventory, a dedicated plate and vial-based inventory module for managing activities from plate registration, to creating plates, transferring materials, and managing inventory for both solids and liquids, between and within CROs and their clients. ‘Traditional inventory systems were struggling because they were only designed to work in house. We have developed BioRails Inventory in collaboration with our clients, and in particular with the animal health company, Zoetis – which had already purchased BioRails for assay requesting – as a hybrid system that enables the ordering of compounds from an externally managed powder store, and then the receipt, handling, dissolution, and dispensing of these compounds, in house.’
BioRails PTO and BioRails Inventory have allowed The Edge to develop close relationships with a number of CROs as well as large pharma. ‘Our aim has been to connect CRO with pharma and biotech clients, and facilitate the seamless storage, transitioning and management of inventory, assay requests and workflow data and results between those parties.’
Connecting with LIMS
BioRails can also connect with an existing informatics infrastructure and bridge the gaps left by systems such as LIMS, Lemon continues. ‘LIMS is very sample orientated, and if it’s not a sample that you are testing then a LIMS doesn’t know what to do with it. In contrast, BioRails doesn’t care what you are testing. It could be a sample, or a compound, or an animal, or a target. You can configure BioRails to store whatever test data you want, and use it to request that test and then track its progress. We could, for example, use a LIMS as a source of sample information, then employ BioRails to request and delegate the execution of an experiment, and run the experiment through an ELN. Some of our clients call BioRails a kind of ‘grout’, because it fills in all the gaps.’
Focus on core disciplines
Since its inception in 2005 The Edge has been totally self-funded, and has grown to a personnel base of 20 ‘brilliant’ scientists and technical experts, Lemon states. ‘We have about 50 clients globally, and among those we are working with four of the world’s top 10 pharmaceutical companies. We aim to continue to focus on our core discipline of biology, and extension into inventory support, assay requesting and planning. What we are not claiming to be is a one-stop-shop. Our growth has been organic, and we aim to build on our achievements and to increase our visibility and sales and marketing activities. Ours is a different business model that is based on innovation born of collaboration with clients. Hopefully that will continue to work well for us as we grow our client base.’
