ELNs and first-to-file

Electronic lab notebooks are no longer just replacing paper, but enabling collaboration around the globe with IP protection

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WALTHAM, Mass.—Introduced about 10 years ago, electronic labnotebooks (ELNs) may be the only electronic platforms that have emerged asstrategic players across the market. That's the opinion of Michael Stapleton,general manager of informatics at PerkinElmer, who estimates the market penetrationis still only 30 to 40 percent, leaving massive growth opportunities forcompanies that are the survivors of the latest round of mergers andacquisition, including Sapio Sciences, Agilent, Rescentris, Accelrys and IDBS.
The promised benefits? Ken Rapp, managing director foranalytical, development, quality and manufacturing at Accelrys, explains:"Electronic lab notebooks go far beyond simply replacing paper notebooks. Theysupport process efficiency from start to finish—turning information into aknowledge base that combines the thoughts and intellectual property (IP) frommultiple different sources including research, business and legal teams.
Automation within the software can effectively route contentand materials into the next project phase immediately upon completion. In-linedata checking can provide feedback immediately to researchers when unexpectedresults or trends in the data indicate the need for a deeper review. And whencompiling the necessary information and data required by regulatorysubmissions, the organization and search tags included in the electronicrecords eliminate the months of retrieval and data custody reviews currentlyrequired 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 PerkinElmerInformatics, quickly counters a common misperception.
"Because the new patent system in the U.S. is actually thefirst inventor to file, rather than first 'anyone' to file as is commonlymisconstrued, the ELN is as effective as ever in safeguarding intellectualproperty," she says. "It allows you to prove the author, date and time theresearch was performed through an audit trail. Use of an ELN will also speedthe process of filing patent applications, and for that matter, filing patentinfringement cases. Because all records are stored in a secure, traceable andsearchable manner, data is quickly found, and relevant reports printed sovaluable time is saved. Further, via sub-structure searching, you can find notonly exact matches for molecules of interest, but also similar molecules, whichcan be enormously beneficial when ensuring full coverage when applying for apatent, or arguing that a newly patented molecule is too close to—i.e., infringes upon—a molecule covered by one of yourpatents."
"Security is of the utmost importance, particularly astrends towards externalization and globalization continue to grow," statesRapp. "An ELN based on an open platform gives corporations better control ofthe data faster than manual data aggregation. When all work records reside in acompliant format and location, records are secure if and when employees leavethe company or project. With proper controls in place through electronic data,risks are minimized in terms of which employees and contractors can accessrecords, and companies protect their IP with proper audit trails. Data is moreaccessible—moving from secure storage systems to PDFs that demonstrate whocreated records and when. Restricted access to records minimizes risks, butallows data retrieval when appropriate."
Most of PerkinElmer's customers are large pharma anddiversified companies, says Stapleton, where at the next level of integration,the combination of ELN and LIMS makes perfect sense. These companies need toderive knowledge from data and know where the data resides, how much of itthere is and how diverse it is in terms of bioinformatics, biology, chemistryand toxicology studies, all the way into clinical trials and the market.
"PerkinElmer's next ELN version will provide out-of-the-boxcapabilities to load data from common biological assays, and conduct analysisusing our built-in templates," says Chris Strassel, product manager atPerkinElmer Informatics. "In addition, our integration with TIBCO Spotfire [ananalytics package] allows users to quickly load their experimental data tomonitor results as they are captured."

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