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ELNs and first-to-file
WALTHAM, Mass.—Introduced about 10 years ago, electronic lab notebooks (ELNs) may be the only electronic platforms that have emerged as strategic players across the market. That's the opinion of Michael Stapleton, general manager of informatics at PerkinElmer, who estimates the market penetration is still only 30 to 40 percent, leaving massive growth opportunities for companies that are the survivors of the latest round of mergers and acquisition, including Sapio Sciences, Agilent, Rescentris, Accelrys and IDBS.
The promised benefits? Ken Rapp, managing director for analytical, development, quality and manufacturing at Accelrys, explains: "Electronic lab notebooks go far beyond simply replacing paper notebooks. They support process efficiency from start to finish—turning information into a knowledge base that combines the thoughts and intellectual property (IP) from multiple different sources including research, business and legal teams.
Automation within the software can effectively route content and materials into the next project phase immediately upon completion. In-line data checking can provide feedback immediately to researchers when unexpected results or trends in the data indicate the need for a deeper review. And when compiling the necessary information and data required by regulatory submissions, the organization and search tags included in the electronic records eliminate the months of retrieval and data custody reviews currently required by manual reporting."
As to first-to-file patent concerns that are on many minds, Dr. Amy E. Kallmerten, programs manager of enterprise R&D at PerkinElmer Informatics, quickly counters a common misperception.
"Because the new patent system in the U.S. is actually the first inventor to file, rather than first 'anyone' to file as is commonly misconstrued, the ELN is as effective as ever in safeguarding intellectual property," she says. "It allows you to prove the author, date and time the research was performed through an audit trail. Use of an ELN will also speed the process of filing patent applications, and for that matter, filing patent infringement cases. Because all records are stored in a secure, traceable and searchable manner, data is quickly found, and relevant reports printed so valuable time is saved. Further, via sub-structure searching, you can find not only exact matches for molecules of interest, but also similar molecules, which can be enormously beneficial when ensuring full coverage when applying for a patent, or arguing that a newly patented molecule is too close to—i.e., infringes upon—a molecule covered by one of your patents."
"Security is of the utmost importance, particularly as trends towards externalization and globalization continue to grow," states Rapp. "An ELN based on an open platform gives corporations better control of the data faster than manual data aggregation. When all work records reside in a compliant format and location, records are secure if and when employees leave the company or project. With proper controls in place through electronic data, risks are minimized in terms of which employees and contractors can access records, and companies protect their IP with proper audit trails. Data is more accessible—moving from secure storage systems to PDFs that demonstrate who created records and when. Restricted access to records minimizes risks, but allows data retrieval when appropriate."
Most of PerkinElmer's customers are large pharma and diversified companies, says Stapleton, where at the next level of integration, the combination of ELN and LIMS makes perfect sense. These companies need to derive knowledge from data and know where the data resides, how much of it there is and how diverse it is in terms of bioinformatics, biology, chemistry and toxicology studies, all the way into clinical trials and the market.
"PerkinElmer's next ELN version will provide out-of-the-box capabilities to load data from common biological assays, and conduct analysis using our built-in templates," says Chris Strassel, product manager at PerkinElmer Informatics. "In addition, our integration with TIBCO Spotfire [an analytics package] allows users to quickly load their experimental data to monitor results as they are captured."