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Despite Unanswered Questions, Pharma Views ELNs as Must-Have Technology

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BOSTON — Adoption of electronic laboratory notebooks is on the rise among pharmaceutical firms, but according to speakers at a recent conference, the industry still has some concerns about the technology.
 
At Cambridge Healthtech Institute’s Bridging Pharma and IT conference this week in Boston, several speakers discussed how they are using electronic laboratory notebooks to manage experimental data, and a roundtable discussion on the topic was filled to capacity.
 
Yet according to some conference participants, there are still many unanswered questions about ELNs. "The roundtable was a little disappointing in that most people hadn't done much,” one participant said. “It was sort of like everybody coming to look at everybody else's experience, of which there wasn't much."
 
Nevertheless, the participant, a senior-level staffer from a major pharmaceutical company who spoke to BioInform on condition of anonymity, is planning to implement an ELN.
 
"We are looking specifically at how and where to implement ELNs for our bioanalysis, drug metabolism, and pharmacokinetics area. We have an ELN in our discovery area for chemistry but we are looking to move it into some biology areas," the participant said.
 
The source is looking to invest approximately $2 million in the ELN project and is drawing from a list of between 10 and 15 vendors that will be whittled down to three to five with whom the source will have more serious talks before making a decision for the company.
 
The pharma staffer can afford to pick and choose. As BioInform has reported over the past few months, numerous vendors are entering an already crowded ELN market, so it's no wonder that pharma players can drag their heels a bit before settling on a provider.
 
Earlier this year, market research firm Atrium Research estimated that there were around 30 vendors in the ELN market in 2006. The company estimated that these vendors had sold about $43 million worth of products and services in 2006, and projected the potential ELN market to be greater than $1.7 billion (BioInform, June 15, 2007).
 
Vendors clearly see a growth opportunity for ELNs, particularly in the pharmaceutical market. Last week, for example, Accelrys cited Agilent’s Kalabie ELN as a critical component in the companies’ newly forged resale agreement, which is focused on pharma customers (BioInform Sept. 27, 2007).
 
But despite the activity on the vendor side, some pharma customers remain wary. "I think the technology is immature,” said the pharma participant. “It's not something that is necessarily cost-justified. … I've done a lot of things in IT with systems, and it's still a little hard for me to understand exactly what an ELN does."
 
Control Issues
 
Perhaps it is this uncertainty surrounding ELNs that prompted speaker Julie Hughes, Global Biologics Business IT lead from Pfizer Global Research and Development, to begin her talk with a slide defining the technology.
 
Hughes’ group in Chesterfield, Mo is responsible for the integration of analytical technology with informatics technology to support the development of drug candidates. Currently Hughes' team is working to implement various pharmaceutical IT projects including a data archival system, a chromatography data system, a laboratory information management system, and an ELN system.
 
In her presentation, Hughes said that Pfizer is working on finding an ELN to simplify its informatics processes alongside a LIMS. It was unclear how far along the company is in actually installing the system.
 

“I've done a lot of things in IT with systems, and it's still a little hard for me to understand exactly what an ELN does."

Benefits of ELNs, she said, include the elimination of data transcription, the ability to print specifically to the notebook, and automatic transfer of data. She also cited "trending data" and "collaborative experiments" as drivers for Pfizer's plans to adopt an ELN.
 
"A global ELN is in the process of being developed," Hughes told the crowd of some 100 attendees. Pfizer is using third-party ELN software, she said, but did not disclose the vendor.
 
Pfizer is installing the same system for chemists and biologists, Hughes said, though she acknowledged that the process can drag out when different research groups are sharing a technology .
 
"It takes a long time to arm wrestle, to see how we'll do certain things," she said.
 
The source from the other pharma shares Hughes’ view of control born of so-called "cultural differences."
 
For example, lab scientists are used to paper lab notebooks and may be reluctant to replace them with a software product. In addition, the source said, many scientists don’t want their colleagues to be able to access their data.
 
Why Go with ELNs?
 
For Hughes and Pfizer, an ELN is one solution to the plethora of data spitting out of pharma’s high-throughput technologies. In her talk, Hughes said that while the bottleneck used to be that there were too many samples to be analyzed, today the issue has moved to data analysis.
 
She defined an ELN as a "system that is used as a diary for the replacement of paper laboratory notebooks and batch records, which will allow personnel to enhance organizational efficiency and effectiveness."
 
Hughes pointed out that the Collaborative Electronic Notebook Association defines an ELN as "a system to create, store, retrieve and share full electronic records in ways that meet all legal, regulatory, technical, and scientific requirements."
 
Legal issues in particular, were a hot topic during the ELN roundtable.
 
A primary issue of concern, some said, is the competitive nature of the ELN marketplace, and the very real possibility that many of the 30-plus companies in the market today may not exist five or 10 years down the road.
 
"When you start talking about intellectual property protection and retaining things for decades, are you going to bet that on a company that might not be around in three years?,” the pharma participant asked. “Better not."
 
Another concern, the source said, is the fact that ELNs should only function as a work environment, rather than a true archival system. "Use the notebook to produce the record, to pull in data and do all these different things. But it should not be viewed as an archival system. It does not have the right technology and the vendors aren't stable enough."

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