November 1, 2005 (Vol. 25, No. 19)
Cross Disciplinary ELNs Help Maximize R&D Efficiency
The breakdown of traditional R&D silos in biotechnology and pharmaceutical companies has accelerated the drug discovery and development process, but it has also led to an increased need for robust communications and data-sharing mechanisms. Paper laboratory notebooks, the simplest and most commonly used method for recording scientific data, are no longer meeting the needs of scientists in the electronic-data and/or intellectual-property (IP) driven biopharmaceutical industry.
The limitations of paper notebooks, coupled with the increased acceptance of electronic records by the FDA, has led to the development of innovative software programs that allow scientists to create electronic records that efficiently capture and store data and supporting information.
Known as electronic laboratory notebooks, or ELNs, these systems offer secure version control and audit trails to capture the flow of the scientific process, promote collaboration among scientists, and help protect intellectual property assets.
Limitations of Paper Notebooks
Paper laboratory notebooks present innumerable challenges to the process of drug discovery and development, the most critical of these being the inability to efficiently locate relevant data for cross-departmental review or use, the potential loss of data, and poor or inconsistent security. Data searches require manual examination of handwritten entries and their supporting computer outputs that are printed and applied with tape.
It is estimated that in labs that employ paper notebooks, approximately 2030% of a scientist’s time is spent managing notebook entries. Much of that time can be attributed to the writing and re-writing of similar protocols.
Yet despite the shortcomings of paper notebooks, ELNs historically couldn’t be widely adopted for drug discovery and development purposes because they were primarily designed to meet the needs of chemists, were unable to integrate with legacy IT systems, and were not compliant with FDA standards for electronic records management. With a widening array of electronic record keeping functions designed to meet the needs of both biologists and chemists, however, ELNs are poised to supplant traditional paper systems in both academic and industrial laboratories.
Enterprise-Wide, Cross-Disciplinary Electronic Laboratory Notebook Solutions
Classified according to how specifically their capabilities cater to a particular group of researchers, ELNs can be divided into two categories. “Specific ELNs” contain features designed to work with specific applications, scientific instrumentation or data types. “Cross-disciplinary ELNs” are designed to support access to all data and information that needs to be recorded in a lab notebook.
An example of a cross-disciplinary electronic laboratory notebook is the Infotrieve (www. infotrieve.com) ELN, a system that can be deployed at large or small organizations to securely store data and protocols, protect intellectual property, enhance security, and facilitate collaboration. It uses industry standards for file types, recording features, formatting, storage, and architecture. It can be adopted across many departments at an organization and meet the diverse needs of researchers. It also provides flexibility to supplement or replace existing discipline-specific toolsets if alternative versions are desired, whether or not they are foreseen at the point in time at which the ELN is initially deployed.
Specifically, Infotrieve’s ELN employs industry-standard technology, Oracle databases and the BEA WebLogic application server, and supports a variety of operating systems and hardware platforms. Cross-disciplinary features allow scientists to search against any data entered into the system. Searches can be conducted using several different parameters, including project or experiment title, text within the experiment, the name of the scientist responsible for the experiment, or user-defined parameters.
The ELN is designed to handle data from multiple experiment types, from high throughput data to other nonstandardized forms of entry, and it allows users to import data from many sources and disciplines. The client architecture is based on the Windows platform, so the user interface is familiar and experimental data may be entered into an ELN entry using drag-and-drop capabilities.
Improving Intellectual Property Protection and Data Security
Intellectual property is an important asset for any drug discovery and development company, large or small. ELNs support an organization’s ability to protect its IP over time and through occurrences of personnel turnover. ELNs also enable organizations to package their IP for future mergers and acquisitions.
The new breed of electronic laboratory notebooks provides key security features that make them far more secure than paper notebooks. These include electronic signature and witnessing capabilities as well as password-protected logins that ensure only authorized personnel will access experimental results and analysis. The ELN also offers a permissions scheme, strict version control, and detailed audit trails that record access and changes to data.
The ELN complies with the FDA’s 21 CFR Part 11 and 21 CFR Part 820 guidelines with respect to digital signatures, electronic-records management, and software quality systems management. In using standard PDF format for data storage, export, and printing, the ELN also complies with the FDA’s requirement that electronic copies be readily available for inspection.
Creating Experimental Efficiencies
To increase the efficiency of experimental record keeping, ELNs enable data to be dragged-and-dropped into an experimental entry, one-click entry cloning that duplicates experiments, and templates that provide consistency among project entries.
The search capabilities of the ELN can also increase collaboration. Scientists can search the ELN network for data pertinent to their own experiments rather than manually tracking down collaborators for the information they need.
Improving drug discovery timelines, maximizing R&D efficiencies, and finding and advancing the most promising lead candidates require cross collaboration among scientists in different disciplines. As competitive and investor pressure to accelerate drug discovery and development continues to increase, paper record-keeping systems will continue to give way to electronic laboratory notebook systems, such as Infotrieve’s ELN, that enable efficient data storage and enterprise-wide communication.