Despite the range of sophisticated software in use in the pharmaceutical industry, it may be surprising to many people that the vast majority of research scientists still record their experiments the same way Leonardo da Vinci did hundreds of years ago--by scribbling the results in a paper notebook they carry around with them.
Electronic lab notebook (ELN) software, which lets scientists access, search and share results of their experiments, has been available for more than 10 years, but due to legal, technological and especially cultural issues, the transition from paper notebooks to ELNs has been slow, with several well-publicized failed implementation attempts along the way.
Yet as the knowledge management benefits of capturing and sharing scientists' work electronically become clearer, the tide appears to be turning. Sales in the fledgling market are increasing 30 percent per year, according to life science informatics industry research firm Atrium Research (atriumresearch.com). With market penetration inching toward 15 percent, more and more scientists are describing the transition as a paradigm shift.
"It enables the possibility of looking at your workflow in a new way and making changes in how you interact with other scientists," says Philip Skinner, a medicinal chemist at Arena Pharmaceuticals (arenapharm.com) in San Diego, which implemented an ELN in 2005. "It's given us a new way to record and present our work. It gives you flexibility to think about what piece of information you might record and in what format."
Others in the industry argue that ELNs should be seen as more than document repositories, that they offer a way for the industry to re-examine how it thinks about knowledge management.
"The knowledge management practices in the pharmaceutical industry are pretty immature compared to other industries," says Jeff Spitzner, founder and chief science officer of Rescentris (rescentris.com), a Columbus, Ohio-based ELN vendor. The industry is "not nearly as collaborative as it needs to be," he adds.
Pharmaceutical companies have complex research and development issues and a tremendous volume of content to manage, according to Spitzner. Bringing new drugs to market takes so much time and money that even a small inefficiency can have a tremendous cost. The lab notebook that contains critical annotations and puts data in a useful context has largely been paper and "paper is a bad interface," he says. To Spitzner, ELNs should not just replace paper with electronic records; they should also be major enablers of information exchange and organizational memory.
In the beginning
Early implementations of electronic lab notebook software in the late 1990s didn't gain much traction.
Like some other KM systems that promised to magically transform how people worked, they over-promised and under-delivered, says Atrium Research President Michael Elliot. "They were very generic and didn't solve any specific problems. They were seen by the scientists as a burden to use without enough benefit."
For the next few years, Y2K issues and U.S. Food and Drug Administration regulatory requirements surrounding electronic archiving of research and development diverted pharmaceutical companies' IT efforts from ELNs. Meanwhile research chemists continued to use anywhere from six to eight specific software applications with no way to integrate them.
"The integration point is the paper notebook," Elliot says. Scientists take data from several places and enter it in their paper notebook and often it's never looked at again.
That leads to people repeating failed experiments or duplicating successful experiments. Rescentris' Spitzner says one pharmaceutical client told him that it did an assessment of paper notebooks and found that 60 percent to 70 percent of experiments were duplications of effort within the company. "Think of the cost of that!" he says. "It's because the compounds and methods that occur to one scientist are just as likely to occur to another, and without any good way to check what's already been done within the company, you're doomed to repeat those mistakes."
In medicinal chemistry, this problem has become particularly acute. "They are trying to synthesize a large number of compounds, and the paper notebook is a huge throughput bottleneck," Elliot says. "It's a brick wall in lead optimization."
So medicinal chemistry groups have started on a departmental level to implement ELNs, and they have invigorated the market.
ELNs have many obvious attributes, according to both vendors and bench chemists. They have the potential to create a searchable repository of data, improve scientists' efficiency and offer better control of procedures for patent filings.
"We all intrinsically know that an ELN can deliver dramatic knowledge management benefits," says Simon Coles, CTO of Amphora Research Systems. "It can increase collaboration, not only among peers but over space and time as well. You can look at what a former employee did 10 years ago."
Yet proving a return on investment to senior management can be difficult. To do so, some vendors and their customers focus on measuring how scientists spend their time. Using paper notebooks, as much as a third of their time is spent on routine data management tasks, shuffling data between system A and B and printing things out, says Dave Dorsett, senior VP and general manager of ELN vendor Symyx Software. "So we can do time and motion studies or surveys to demonstrate the shift with the ELN to spending more time thinking, inferring and using information to make decisions," he says.
They could also measure the time spent in support functions, such as the legal department "on mundane issues such as just trying to read a scientist's illegible handwriting," Dorsett adds.
Reluctance to change
Although convincing legal departments that they can defend patents based on completely electronic records has been an uphill battle, those issues are resolving themselves, say users and vendors. A bigger struggle is overcoming the users' reluctance to change how they work.
The bound notebook is seen as a private artifact, explained Amphora's Coles, and some researchers are offended that their employers are creating mandatory systems that open up that notebook to colleagues and supervisors before they are ready to present their results. "A paper notebook is private and flexible. They can do whatever they want with it," Coles says. "With an ELN, all of a sudden their work is public, so they have the feeling of working in a goldfish bowl."
If you ask the supervisors of scientists using paper notebooks how many experiments each scientist does per day, they'd have no idea. "With an ELN, you can see that information," Atrium's Elliot says. "Scientists are not used to someone looking over their shoulder in the early stage of experimentation, and it's an issue that has to be dealt with."