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FDA Compliance, IP Protection Drive Growth In Biologists’ Adoption of E-Lab Notebooks

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According to a recent market research report and industry observers, electronic laboratory notebooks aren’t just for chemists anymore.
 
The report, published last month by informatics market research firm Atrium Research, indicates a marked rise in the rate of adoption of ELNs among biologists — a segment of the market that has long lagged far behind chemistry.
 
Michael Elliott, CEO of Atrium and author of the report, told BioInform this week that biologists currently account for around 7 percent of the ELN market, up from 2 percent to 3 percent of the market about a year ago. This compares to a 25-percent penetration for synthetic chemistry, he said.
 
The report, Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management, pegs the market potential for ELNs at more than $1.7 billion, with a growth rate of more than 30 percent per year.
 
Atrium said that there are currently more than 30 ELN suppliers, and that these companies sold around $43 million worth of products and services in 2006.
 
Elliott said that CambridgeSoft is currently the leader in the ELN market in terms of units and volume. In the biology market, he said that IDBS is currently ahead of its competitors, “but it’s not a huge lead because biology is relatively small.”
 
According to Adel Mikhail, CEO of ELN vendor Rescentris, the overall market is “exploding.”
 
Rescentris was founded in 2003 by former employees of LabBook, an early mover in the ELN sector that did not see much commercial success. Mikhail said that as recently as three years ago, the market was “very nascent.”
 
He noted that since that time, the cost of research and governmental requirements — such as the US Food and Drug Administration’s 21 CFR part 11 rule on electronic records and electronic signatures — have compelled researchers to embrace the new technology.
 
He said that the company’s Collaborative Electronic Research Framework product is one example of the trend.
 
CERF “is really a place for [our users] to work on a daily basis. It’s no longer an access into a database, an experiment manager when you only run an experiment. It’s also for high throughput as well. Some solutions out there claim to be ELNs … but do not offer a document-management system or semantics built in.”
 
Mikhail estimated that 35 percent to 65 percent of scientists’ time is spent managing information rather than doing experiments. An ELN, he said, can cut that time by 25 percent.
 
Something for Everyone?
 
The concept of an ELN could mean different things to different people, but most electronic lab notebooks are client-server systems. For academic and government researchers, ELNs are usually Mac-compatible because that suits their needs, according to Mikhail, who added that pharma is more PC-oriented.
 
For discovery informatics provider Tripos, which moved into the ELN market two years ago with the launch of Benchware Notebook, an ELN is designed to support discovery operations at global pharmaceutical research organizations and single-site biotechnology companies alike.
 
Richard Coxon, Tripos’ business development director, told BioInform that while its ELNs have traditionally been deployed on the chemistry side, he’s definitely seeing an uptick amongst biologists. “On the biology side, we’ve had some customers who are interested in storing [data] like protein sequences [and] peptide sequences,“ he said.
 
The attraction for biologists, he said, depends on what type of biology they are doing. “If you are doing tests of compounds against a biology target, that generates a huge amount of data, so you still need a biology data-management system, [which is not] an ELN.”
 
He said, too, that when ELNs first gained popularity, there was some confusion around what the product actually did. “The way we position it [then] is as a ‘binder’ that allows you to bind a summary of experimental information into an easy-to-access format.”
 
Some of the company’s customers request a system that covers multiple scientific disciplines, he said.
 

“Since most records are electronic, most records from a litigation standpoint are [now] electronic. ELNs have risen to help people organize their data in such a way that they can better address the needs of the court.”

Glyn Williams, vice president of product and marketing at IDBS, described the company’s BioBook ELN — a biology-specific module of its E-WorkBook Suite that it launched last year — as a “generic” lab notebook with “many extensions.” The most recent version of the software, released in early June, added functionality for the “discrete disciplines within pharma,” he said, offering the same interface but for specialist-type needs.
 
The latest release of BioBook includes advanced statistical capabilities, such as ANOVA and t-tests, as well as graphing support and reporting features that are specifically targeted toward biologists.
 
FDA Regs and IP Protection
 
One of the most popular features of ELNs is their ability to record data in a way they otherwise can’t by scribbling on a yellow pad.
 
Williams echoed Mikhail’s claim that the FDA’s 21 CFR part 11 regulation is a key driver behind ELN adoption among biologists.
 
“A lot of areas in biology” require CFR-compliance, he said. “When one signs off on a report you have to give the reason … it’s the auditing control [that] is very important in a lot of the animal studies, for example.”
 
IDBS also claims that BioBook offers intellectual property protection, a feature that Williams said is of interest to a growing number of potential customers.
 
Using the system’s audit trail capabilities, Williams said, “if you’ve developed a molecule and it’s effective for, say, Alzheimer’s, you can prove it was [discovered, say,] in 2002.”
 
Williams said that ELNs also enable data integration — a longstanding challenge in the life science informatics market.. For example, he said, Biologists may perform the majority of their analyses via web services, but can use the ELN to access data from an internal registration database or patent database.
 
Elliot agreed that IP infringement concerns have been one driver behind ELN adoption, noting that a few years ago people were worried about what he called a “hybrid” ELN.
 
“They would print out data, sign it, and the belief was [that] just having the paper record was good enough for the courts.”
 
However, he noted, since then, “Everything has really changed; not only in several court cases, but the Federal Rules of Civil Procedure have changed.”
 
Specifically, he cited the Supreme Court’s decision last April to approve amendments to the FRCP concerning discovery of electronically stored information. The amendments, which alter how federal courts treat electronically stored information, went into effect on Dec. 1, 2006.
 
“Since most records are electronic, most records from a litigation standpoint are [now] electronic,” he said. “ELNs have risen to help people organize their data in such a way that they can better address the needs of the court.”
 
Mikhail noted, however, that despite the advantages of ELNs for biological researchers, the technology is still far from perfect.
”I hope people appreciate that just getting a software system to be as diverse as a piece of paper is a technological challenge,” Mikhail said. “People have [historically] been able to tell the story on a piece of paper — and sometimes the blankness of a computer screen is just not as flexible.”

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