A very wide variety of information is generated during the process of Pharma R&D; this information needs to be captured and stored for intellectual property (IP) purposes, but more importantly, needs to be utilised to drive the future scientific research efforts. Capturing the information generated by research staff by using electronic versions of the paper laboratory notebook is a rapidly evolving application area.
The types of data to be handled, and the means by which the data is to be archived, reported, validated and utilised are also changing very rapidly. In his presentation Robert Scoffin of CambridgeSoft gives an overview of the Electronic Laboratory Notebook (ELN) application area to highlight the advantages of an ELN over a paper-based system.
Scoffin points out that the pharma and biotech industry need ELN solutions that satisfy long-term data archival requirements, improve productivity but maintain controls on costs. Although an estimated 90% of systems currently followed a mixed lab notebook model of paper and electronic, an increased use of electronic-only systems is underway.
ELNs enable knowledge obtained from previous research projects with molecules to be captured and aid decision-making in new projects. Creation of a future-proofed knowledge store provides a valuable long-term asset for the organisation from which they can be seeing returns 10 to 20 years on. ELNs must also cope with increasingly complex regulatory requirements and intellectual property must be captured and protectable from a legal point of view.
Productivity enhancements result from data error entry reduction and the elimination of unnecessary duplicate experiments. GSK has reported that laboratory scientists could save 3 hours/week through the elimination of paper-based data entry.
ELNs must also support a variety of personnel in addition to scientists including supporting administrators and programming staff, decision makers, collaborators and peers.
Scoffin states that the approach of integrating all applications into the ELN currently produces requirements with too much complexity to be practically implementable. Rather he counsels a “Matrix” approach in which an ELN with a key core functionality set accompanied by interfaces to publish data into and out of the ELN from network resources and stores.
An ELN needs to be configurable for multiple disciplines and mutiple workflows, have an open integration platfom and be scalable. Standards for data management are important for successful integration and CambridgeSoft is pursuing the use of XML formats for data exchange wherever possible. It was nevertheless necessary to be backwards-compatible where possible in addition to be forward-looking and future proofing. CambridgeSoft’s current implementation of an enterprise ELN is a component-based 3-tier web architecture supporting an Oracle backend and went into production mode with a pharma customer in late 2003.
Scoffin pointed out that is was unreasonable for one vendor to be expect to offer all things in an ELN and hence third part integration (e.g., with LIMS vendors, inventory systems, biological data management systems) was essential. From his experience, the preferred approach up to now has been a decoupled web servcies approach with data transfer via XML. He did however agree there were scalability issues with XML file exchange, particularly with network transfer of image data. He counselled that decisions on tool integration into the ELN client side should be taken on a case-by-case basis, depending on the expected frequency of use, with common-use functionality (e.g., a combichem chemist conducting both virtual and real experiments from their ELN) integrated and applications involving less frequent use handled by a data exchange publishing approach.
You can listen to the full talk of Robert Scoffin and our discussion with audio on the KM in Pharma & Life Science CoP Web site at innovationwell.net