Informatics
Enterprise ELNs as a foundation for preclinical drug development
To have real business impact within preclinical drug development, Enterprise ELNs (Electronic Laboratory Notebooks) must provide a secure, scalable and searchable data management backbone across all disciplines focused on development of both small and large molecules, in compliant and non-compliant environments. Through more effective capture and reuse of data and knowledge, we discuss how Enterprise ELNs improve inter- and intra-departmental collaboration, and support quality initiatives such as ‘Quality by Design’.
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LNs were originally intended to repro- duce the paper-based lab notebook process that has been the basis of data capture and scientific Intellectual Property (IP) protection for centuries. They have evolved through widespread use into enterprise systems: sophisticated data capture, management and reporting solutions capable of spanning a wide variety of departments/domains1. The resulting Enterprise ELNs are able to support collabora- tion not only within teams, but now between teams as well. Each individual team has a solu- tion based on its specific needs, but there is a common core allowing cross-domain data shar- ing and therefore more effective collaboration. The early ELN systems focused on electronically capturing results from a laboratory with data from Excel®, PowerPoint®, emails and domain-specific applications, and were often in a chemistry- focused environment2. Such systems were only ori- entated towards the documentation and capture of patent-relevant IP and essentially replaced using paper-based notebooks with cutting and pasting information electronically, providing a ‘sticker book’ approach. These early systems had little regard for data and knowledge sharing between
Drug Discovery World Summer 2010
teams, or with reuse of corporate learning, because they were only designed to provide ‘page’-like reports: they did not provide a rich data source that could be easily mined and shared. Over the past five years the use of ELNs has spread into biology-related disciplines such as pharmacology, drug metabolism and pharmacoki- netics (PK), and process-driven disciplines such as bioanalysis, formulations, analytical and pilot manufacturing. To support such diverse needs, ELNs have developed into enterprise systems that provide more flexible and broader data capture and sharing and IP capture. In this context, IP means corporate knowledge or data, ie important historical data and know-how that could be a potentially competitive advantage. Certain ELNs support both contextual and structured fact data capture that enables the creation of a Corporate Knowledge Store – a searchable, mineable resource that can be leveraged across the organisation. The remainder of this paper will look in more detail at how these advanced Enterprise ELNs can deliver significant business impact, and what capabilities are required for their application to both large and small molecule preclinical develop- ment organisations.
By Simon Beaulah, Dr Paul Denny- Gouldson and Dr Scott Weiss
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