IeLN SUPPLEMENT:


NTRODUCTION


BUT WHICH ONE TO USE?


Electronic lab notebooks (eLNs) are software products designed to replace paper laboratory notebooks. eLNs have been much discussed and often piloted since their inception in the 1990s. Now they have reached a point of sophistication and common use to make them ubiquitous in pharmaceutical industry laboratories.


Scientists and technicians in chemistry, biology and bio-analytical departments use eLNs to exploit the benefits of electronic processing and storage, including increased productivity, improved data quality, enhanced knowledge management of experimental and reaction data, improved IP protection and reduced costs of regulatory-compliance. eLNs have evolved their functional richness


and utility while at the same time have simplified their deployment. Thin, browser-based clients suffice and access backend systems that can either be installed inside the firewall or - for those who need ultimate flexibility and elasticity - they can be hosted. eLNs need the flexibility to support workflow while being able to support up to several thousand users. eLN manufacturers need to focus on the


scientific functionality of their products to meet the rapidly developing scientific disciplines they support. State-of-the-art data and information aggregation technologies must be embraced as must standards such as those encapsulated by the ‘semantic web’. Importantly, eLNs must provide regulatory compliance and business functionality too. For example, they should be able to support compliance with appropriate industry regulations such as 21 CFR Part 11 (computerised system controls in Pharma), as well as 37 CFR (patents and inventions). eLNs are complicated and their domain is both time-consuming for experts to keep


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abreast of and daunting for novices. With a multiplicity of products available on the market, the challenge is to find the best solution to meet the users’ needs. As such, industry conferences provide useful forums for Pharma users to keep in touch with technology developments and eLN vendors to learn of emerging industry requirements. One example of such a meeting was the Third Annual Laboratory Data Management Conference held in London between 21 - 22 June this year. Eleven presentations were delivered by representatives of big and mid-sized pharmaceutical companies and key lab technology companies. A vendor exhibition allowed delegates to


converse with product experts to improve their understanding of the functionality, flexibility and regulatory compliance of their current products. During the second day of the meeting,


several chairman-led, interactive, round-table discussions allowed delegates to actively discuss various ‘hot’ topics such as managing laboratory data and its metadata, providing interoperability and data integration between different systems, the role of open-source software in the laboratory, evaluating next generation eLNs and developing appropriate strategies for their successful implementation. The keynote address was delivered by the


Pistoia Alliance (www.pistoiaalliance.org). The topic was promoting a more innovative and cost-efficient platform for laboratory processes.


The eponymous Pistoia Alliance is well


positioned to provide such an address, for it is a not-for-profit, cross-company organisation created to lower the barriers to innovation in life science R&D. In 2007, a group of senior pharmaceutical industry R&D IT leaders met in Pistoia, Italy and concluded that many of the activities carried out by researchers in their organisations were remarkably similar. They envisaged that much replication of effort might be minimised if they shared thinking about, defined and then documented the best practices for these precompetitive research activities. This would enable expert technology companies to build and deliver such services to be shared by many companies. The money saved by creating economies of scale in the delivery of precompetitive scientific services could be redeployed for company-specific, strategic, transformational, innovative initiatives. If senior management in Pharma R&D were


actively to engage in R&D operational excellence, companies could make rapid progress in overcoming such barriers to innovation. Senior management should direct investment into, and provide active and engaged support for, the work of organisations such as the Pistoia Alliance. For it is these not-for-profit, cross-company organisations that are ideally positioned to establish the opinion-forming working parties of industry-respected practitioners to define and find widely-accepted solutions to the shared problems that, individually tackled, waste money and stifle innovation.


European Pharmaceutical Review 3 Volume 16 | Issue 4 | 2011


John Wise Executive Director, Pistoia Alliance


ELNS – AN ESSENTIAL PRODUCTIVITY TOOL –


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