Electronic Laboratory Notebooks in Pharmaceutical R&D: On the Road to Maturity

Abstract

Laboratory activities in pharmaceutical R&D, including planning, experimental design, execution, data collection, processing, and reporting, rely on computer systems significantly. New computer systems are routinely implemented to increase the efficiency and quality of work in every aspect of R&D. One notable exception is the laboratory notebooks, which have been slow to “go electronic.” Only in the last few years, technology began to improve and more companies started to implement electronic laboratory notebooks (ELNs). Because the laboratory notebook is primary evidence for the ownership of intellectual property, concerns on whether electronic records can be used as evidence for invention is wide spread. Many early adopters of ELN technology took a hybrid approach: entering data electronically but printing and signing the printouts. However, there is very little basis for such concerns as regulatory agencies accept electronic records. What is important is that any records, electronic or paper, should be managed properly to ensure authenticity and trustworthiness. There are many benefits associated with ELNs, the most significant of which is the ability to search records electronically. The use of ELNs significantly increases productivity for scientists, peer reviewers, and supervisors in R&D. Time spent in searching for patent support data in discovery areas and on compliance and procedure-related tasks in regulated areas would be reduced, freeing time for other productive tasks. If integrated with other laboratory information systems, ELNs will also provide ability to directly drill down to hard data such as compound registration, biological assay, drug safety measurements, and pharmaceutical tests. Developing an information architecture that supports the complete spectrum of data will ensure proper interface between ELNs and other systems. The increased acceptance of ELN technology, combined with the maturing of R&D computing environment in the pharmaceutical industry, suggests that ELNs will have a wider acceptance in the near future. (JALA 2007;12:157–65)

Proper Laboratory Notebook Practices: Protecting Your Intellectual Property

“…Typically, in the pharmaceutical industry, lab notebooks are individually numbered and checked out to scientists. Upon completion of the notebook, they are archived and many companies also create microfilm copies (Du and Kofman 2007). However, in many universities, laboratory notebooks are not checked out to researchers and often the storage of the notebooks is There are numerous examples of poor storage and maintenance of university-based research records.…”

“…With this increasing reliance on computers in research, there are concerns that the standard paper laboratory notebook is becoming obsolete. In the pharmaceutical industry, there has been a strong push toward the transition from paper to electronic laboratory notebooks (ELNs) (Du and Kofman 2007). An ELN is a software program that has been created to specifically replace the use of paper-based laboratory notebooks.…”

“…To date, numerous pharmaceutical companies have implemented ELNs to varying extent, including Merck, GlaxoSmithKline, AstraZeneca, and Eli Lilly (Du and Kofman 2007). However, academic laboratories have been slow to move in this direction.…”

“…Two of the major drawbacks have been cost and inflexibility of these programs (Goddard et al 2009). ELNs were originally designed for specialized use in the pharmaceutical industry, being tailored for specific research purposes (Goddard et al 2009;Du and Kofman 2007). However, this is not useful for the academic research community where day-to-day activities can vary greatly.…”

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“…As an example, next-generation sequencing and protein structure 39 determination are generating datasets, which are becoming increasingly prevalent especially in 40 molecular life sciences (Du & Kofman, 2007). The combination and interpretation of these data 41 requires experts from different research areas (Ioannidis et al, 2014), leading to large research 42 consortia.…”