Analyze This

Dr. Alain Meller, Director Electronic Laboratory Notebook Solutions at Agilent Technologies takes a look at electronic lab notebooks (ELN) and the associated benefits.

NGP. The number of bioanalytical measurements performed in life science research is increasing dramatically. What is driving this increase?
AM. Many factors determine this growth:

The more science progresses and knowledge is made available through globally accessible databases, the more experiments should be conducted to test hypotheses and discriminate between different assumptions.

More techniques than ever before are now available to the scientist, augmenting the number of experiments: HTS, combinatorial technologies, higher array densities in genomics, etc.

Increasing regulatory and safety constraints impose more testing throughout the entire R&D cycle.

NGP. To a great extent, scientists still gather their experiment data by handwritten notes rather than in electronic form. What are the advantages of electronic lab notebooks (ELN)?
AM. ELN increases overall R&D productivity – some effects are short term and others more long terms (among the cited drivers):

They improve individual as well as organization-level efficienc y for individuals, by providing an integrated environment with workflow support and with features that accelerate information entry and automate calculations. On an organizational level , they allo w people to share and search for information.

The quality of experiment documentation is improved. ELN achieves this by making experiments visible to the community and by providing templates that reflects local or global way of operating.

Traceability is improved by being able to link experiments to authors, by being able to follow different paths in navigating through the knowledge base – by project, compounds, laboratories, etc.

A further advantage is that repeat experiments can be avoided . One of the most important factors cited by companies is that people do not know which experiments have already been conducted in the past and whether or not they were successful; the ELN allows mining the experiment database using complex searches.

One axis for increasing R&D efficiency is the ability to have different disciplines collaborate on projects, for example, chemists with analysts. The ELN is a perfect place to implement these processes – on the same example, both the chemist and analyst can be involved in the cycle of Analytical Request.

ELN is able to ease multi-site collaboratio n. The scalability of an ELN like Kalabie allows deployment across sites, thus extending the benefits to global organizations.

ELN can be an efficient change management vehicle. Companies in this sector are experiencing merger and acquisitions, and the ELN can help achieve integration faster . (For example, when Solvay Pharmaceuticals acquired Laboratoires Fournier, the Kalabie ELN was the pioneer application to align the organization in Discovery.)

Even though the implementation of a paperless organization in the context of Intellectual Property protection may not be a necessary short -term objective for many companies, the ELN at least provides easy to read printouts so researchers can avoid cutting and pasting experimental data into lab notebooks.

NGP. What is key to the design principles of ELN?
AM. From a user interface perspective, the ELN should be simple and straightforward to avoid unnecessary complexities and minimize the learning curve.

From an architectural perspective, it should allow plug-in, discipline-oriented workflows onto a common shareable knowledge base. This approach is known as ‘broad and deep ’. We do not believe that a single generic ELN can provide enough value to the various disciplines.

We also recognize that it is not possible to have multiple ELN implementations for different disciplines in a single company for obvious reasons. So the architecture should support common needs (“broad”), as well as ability to adapt to discipline specificities (“deep”) in a single architecture.

From an IT perspective, zero client PC installation and high scalability are fundamental requirements. Response time should be high otherwise user adoption will not be gained.

Taking into account regulatory compliance to GLPs and 21CFR Part 11 as well as IP protection mechanisms are also desirable.

NGP. What are the benefits of combining an ELN with a content management system?
AM. For over five years, Kalabie ELN has been implemented as a central repository of experimental data by numerous clients. This includes raw data from instruments as well as various documents that are linked to the experiment. Kalabie ELN provides mechanisms for uploading and securing these documents into its database.

However, other benefits could be gained in medium to large pharma companies by separating the management of raw data, for example, to outside the ELN. Benefits are the following:

At a conceptual level, it makes sense to reserve the ELN to document experiment goal, protocol and final insights, and to not mix in the raw data; of course, the ELN should be able to reference the data at the data management level.

The ELN may not be the only application that needs to access raw data, and other kind of documents not related to experiment s which could benefit from a content management system. This would permit a uniform and centralized way to address problems such as the archiving strategy of raw data and documents.

Systems like OpenLAB ECM are providing instrument-level management capabilities that are not part of the primary ELN requirements, thus avoiding reinventing the wheel when the need to link to instruments becomes important.

ELN tends to be globally accessible system, while raw data management are predominantly local. Therefore, a two level architecture provides the best performance and scalability particularly for multi-sites implementation.

That is why, in the strategic view of its portfolio, Agilent has made the ELN to ECM integration one of its priorit ies. This integration is already available and allows Kalabie ELN to refer to analytical data stored in ECM.

NGP. In the battle between an open or proprietary approach, which side do you take?
AM. Agilent is committed to an Open System Architecture and strongly believes that serving the R&D life science space requires the collaboration of different vendors to provide the best IT solutions. Kalabie ELN, for example, allows the customer to choose from different vendors for supporting the chemistry capabilities. 

This is also the reason why Agilent is partnering with Accelrys to enhance the interoperability of our solutions. As mentioned earlier, the ELN is a natural place to implement processes therefore allowing a customer to use a product like Accelrys’ SciTegic Pipeline Pilot to process information from the ELN or to capture information into the ELN brings a lot of new possibilities for integration and consolidation of information. This kind of integration, made possible by the openness of our respective architectures, is finally providing exciting potential applications to our customers.

NGP. Is data preservation and storage an issue? And how do you address it?
AM. Yes, this is a key problem particularly if information may need to be archived in some cases for more than 30 years. That is one of the reasons why we avoided proprietary formats like Microsoft in favour of ASCII-based formats (XML).

As mentioned earlier, when you centralize raw data and documents in a content management layer, you can then think about the subject in a global manner. OpenLAB ECM allows the management of document archiving and retention policies, thereby facilitating the preservation and storage of data.

NGP. What are your predictions for the future of the ELNS? Will they become as widespread and popular as LIMS software?
AM. I have no doubt that ELNs will continue to grow and spread over the full spectrum of experimental sciences. However, this field is still pretty much in its infancy and what an ELN will look like will certainly evolve considerably in the future. In Pharma, I see ELNs as the place for supporting experimental activities with some degree of specificity according to disciplines, implementing inter-discipline workflows to support research processes and a valuable source of information for R&D management.

About Dr. Alain Meller
Dr. Alain Meller, Director Electronic Laboratory Notebook Solutions at Agilent Technologies, is a seasoned informatics business manager with both independent software vendors and professional services organizations. He joined Klee Group in late 2004 to manage the Kalabie ELN business, where over two years he consolidated all areas of the business. Since Agilent’s acquisition of Kalabie in June 2007, he has lead the integration and development of ELN solutions into the Agilent lab informatics portfolio.