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May 15, 2008 (Vol. 28, No. 10)

ELNs Ready for Large-Scale Deployment

Even Pen-and-Paper-Type Scientists Are Embracing Electronic Laboratory Notebooks

  • Adoption by Scientists

    “Adoption by scientists is split along experience lines,” Dr. Scoffin reported. Twenty-somethings, fresh from university, have been known to tell their new bosses that the organization is archaic if it’s still using paper notebooks. More experienced scientists generally are more hesitant, simply because they’re unfamiliar with the technology.

    When Lonza implemented ELNs, scientists’ first response was not positive, Dr. Giraud recalled. But, they did agree to test it, and after a two-month pilot, users requested only minor changes. Now, all new projects use the ELN.

    At Eli Lilly (www.lilly.com), attorneys and quality assurance largely drove the decision to use a completely electronic notebook instead of a hybrid notebook, explained Michael Kopach, Ph.D., principal research scientist, chemical product research.

    Legal and quality teams were uncomfortable with hybrid notebooks because they required replicating data, thus allowing the possibility that the electronic and paper records would not be equivalent. Therefore, a fully electronic system was deemed a much lower risk. Validation, he explained, was an important requirement for legal acceptance.

    Rollout began about four years ago, starting in process chemistry with 100 users for a one-year deployment, Dr. Kopach noted. “The results were so positive that we expanded to all of our process and discovery chemists,” he continued. More recently, the company has expanded to formulation development, a contract manufacturing organization, and other areas. Biology departments are in early pilots. Eli Lilly uses one electronic platform with modules developed for each discipline as needed. “The goal is to convert all scientists to the fully electronic format,” he remarked.

    Researchers watched the implementation in process chemistry carefully and decided the ELN had merit. There are still issues in rollouts though. Perhaps the greatest surprise was the need for additional training, particularly among very experienced scientists who weren’t very computer savvy.

    “For deployment of the initial 100 users, we had a mandated 30-day conversion process from paper to fully electronic. We found that many users received their initial training and then waited until day 29.5 before converting to the electronic system, thereby forgetting quite a bit of what they had learned in the training sessions.

    “So for future deployments, we decreased the transition time from paper to electronic to 14 days and assigned all new ELN users a mentor, which greatly facilitated user uptake of the new system,” Dr. Kopach elaborated.

    “We are seeing increases in productivity in those fully deployed departments” because project managers and scientists can easily access previously inaccessible information, using it to create new experiments and add greater value. “It helps project managers see the big picture,” Dr. Kopach said. “In external conference meetings, people tend to quote high-efficiency improvements, but they’re not extremely accurate.” Lilly’s collection of metrics shows “a safe, conservative estimate of return on an investment of 5%, which adds up quickly to a lot of money.”

  • Value in Networking

    “We find that a lot of the value in e-notebooks comes from analyzing the business process,” noted Dr. Scoffin. The process of switching from paper to electronic notebooks helps people rethink the way they conduct research and communicate it throughout the organization, leading to improvements in their own workflow. After implementing ELNs, “the level of communication between research groups within the company has dramatically increased.”

    Traditionally, he explained, research groups have a tree-like structure, with information being pushed from the ground up but not across the branches. Researchers involved in similar work in different geographic locations for different therapeutic areas are unlikely to communicate and so, are generally unaware of the information colleagues have that may affect their projects. With ELNs, cross-disciplinary searches can reveal the work, insights, and cautions of other teams that may have a bearing on a scientist’s own research.

    Likewise, the data can be used to determine future research, Dr. Scoffin added. In the past, tech-savvy companies used Word or Excel templates within research groups to document projects, but the templates usually varied across the company. Because they weren’t coordinated, they weren’t accessible to others.

    “In order to drive research, it is necessary to have the structures in place to access that data,” he stressed. Although scientists can choose to lock data, making it inaccessible to others, most are now making it available. “That’s the biggest change in the past five or six years.”

    Backtracking is also easier with ELNs. “It’s a well-documented phenomenon, especially in clinical development, that going backwards along a decision tree is not easy,” Dr. Scoffin said. ELNs let users flag significant decisions so they can re-evaluate them much later as knowledge is gained.

  • Legal Issues

    Patent evidence creation and preservation has been Amphora Research Systems’ (www.amphora-research.com) focus since creating the first fully electronic ELNs in 1996 for Kodak. The company addresses patent concerns and internal requirements. It’s important to understand that “not all the stuff sloshing around a computer should be kept,” noted Simon Coles, CTO and cofounder of Amphora.

    “You get a patent, primarily, for what happens in someone’s brain,” he continued. “Hopefully, you have a record of that, which you then take into court.” To provide the right information, companies need good patent-evidence systems.

    A good system, he says, “allows scientists to create reliable and reproducible evidence. Keep it simple,” Coles advised.

    For patent purposes, he continued, keeping raw data is not a primary focus. Instead, keeping insights drawn from that data is more important. “Put in whatever somebody skilled in the art needs to reproduce your work and enough information to understand the scientist’s thinking at a given time. It should handle records from all systems, with documents signed by the author and witnessed. The experiment write-ups should have long retention periods. Your records management process should take care of everything else.”

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