Interoperability a Concern in 82.4% of Laboratories Progressing Toward the 'Paperless' Ideal

Pharma IQ



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While the vast majority of companies are keen to adopt Electronic Laboratory Notebooks (ELNs) in areas ranging from formulation, bioanalytics and R&D, there remain a number of challenging aspects preventing many from achieving the 'paperless lab' ideal. Perhaps the biggest obstacle for firms to overcome is the integration and interoperability between the new system and existing lab infrastructure.

Growing use of ELNs

Over the past few years, the industry has increasingly adopted the ELN, a software application that eliminates paper from laboratories during analytical procedures. In a recent Pharma IQ survey, conducted with key members of the community on behalf of the forthcoming ELNS & Advanced Laboratory Solutions Conference, 91.2 percent of respondents claimed to be at least in the planning phase of ELN adoption and usage. Most participants in the study were pharma or biopharma companies, though almost a quarter were CROs or vendors.

Unsurprisingly, the survey revealed that research and development work was the key focus of companies' ELN usage. In fact, 61.8 percent of companies are using their ELNs to enhance R&D processes, though many have applied them to help maintain a GMP environment, as well as in formulation, chemistry, biologics and bioanalytics.

Challenges in ELN adoption and usage

Aside from the difficulties surrounding protection of intellectual property and displaying ROI to senior management, there are numerous operational hurdles for companies to overcome, particularly in terms of convergence and interoperability. The Pharma IQ study found that 41.9 percent of firms saw integration with other laboratory systems as the most challenging area of ELN adoption. Similarly, 25.8 per cent named the continued integration of ELNs with existing lab infrastructure as a key obstacle in the long term.

More than three-quarters of firms questioned in the survey described interoperability as a "concern" going forward. While 47.1 percent admitted that there were other more pressing obstacles to overcome, 35.3 percent ranked interoperability between their ELN and other lab equipment as a primary concern. Companies must also know how to integrate the semantic capabilities of their ELNs.

In a recent interview with John Trigg, director of phaseFour Informatics, Jeremy Frey, professor of physical chemistry at the University of Southampton, discussed how these capabilities could be harnessed to help researchers capture more complete data. Explaining his interest in ELNs, Professor Frey said: "I joined in with the UK e-Science Research team that started about ten years ago, where the whole desire was to use modern technology, the web, semantics and many other aspects of digital technology to improve the reliability and the reusability of research and research data.

"For chemists, the starting point of this is often the laboratory. No books, so this becomes an ELN and Ive been interested to see just what we could do with that and what the future will bring and what advantages it will bring," he added.

The role of semantics in ELNs and information management

The word 'semantics' has gradually crept into the community's vocabulary in recent years, as companies increasingly get to grips with the term's meaning in the context of ELNs and the coordination of laboratory information. Professor Frey commented: "In some ways, semantics has just become technical jargon for what we all know we all ought to have done, and that is keeping a proper record in context, and it is this context that is important. Sometimes that gets referred to as metadata, and if that metadata gets properly structured in a way that can be readily understood by an automatic computational process, rather than just by humans, that becomes called semantics. At one level, what we really should be talking about is keeping a proper record with all this information in there.

"I often quote, when we are teaching, that if you ask a student to keep a record of something in the laboratory, the first thing they will write down is something like 25, meaning the temperature of the room, but they will not necessarily include the units and they will not include a description of what the temperature is or what was being measured, and as they learn to make better and better records, that context will be more and more complete," he explained.

The professor added: "If you define some guidelines for that context, so we get the meanings of words in there, things like the temperature, what scale does it refer to and what are you expecting, then we start to get more and more formal semantics which can lead, in the limit, to a whole community-agreed anthology which means that those concepts are referenceable back to a defined, more than just a dictionary, and that means that the automatic processes can go looking for specific things and to some extent, in quote, understand the information that is there because the context is so much more complete".

Challenges in harnessing the ELN's semantic capabilities

There are certainly implications when looking at the use of semantics in a wider context. One of Mr Trigg's questions touched on the importance of a common laboratory language. Professor Frey responded: "I think it is a really serious problem because we often do not mean the same thing and the word itself has to be in a context, so in an organic chemistry laboratory the word may have one context and even in an analytical laboratory it may have a different context."

He added: "The problem is if you are now trying to search automatically other peoples records and experiments, it is much more difficult to create that search. And we have the whole problem of an attempt at natural language searching which is really very difficult for computer scientists in the whole artificial intelligence. If we can agree on the vocabulary of the context, then we cut through some of that and actually seriously understand what we were trying to say and be very explicit.

The importance of community-wide progress

In order to move past the issues facing individual organisations in this area, there would perhaps need to be a community effort across the entire industry. Professor Frey agreed with this suggestion, explaining how the time when companies could afford to solve such matters alone was well and truly in the past. "I think the cost of setting up this type of infrastructure, just in the sheer time needed to agree on things, makes this prohibitive. If we can agree on all the terminology and the semantics and structure and so on, then writing the software on top of that is still an immense task but you do not want to build it on shifting sand so you really need this agreement. And I think we all would benefit by having that basis sorted out," he said.