Laboratory information management systems come in off-the-shelf and custom flavors, both of which are aimed at improving productivity
A number of pharmaceutical companies are rethinking their laboratory information management system (LIMS) strategy, migrating away from systems developed in-house and toward vendor developed platforms. R&D groups understand that they aren’t in the business of software development, a technical challenge that can distract their drug development efforts. Nevertheless, when upgrading their LIMS, pharmas and established biotechs must decide between customized solutions and more off-the-shelf products.
Thomas Huggins, PhD, is section head of Procter & Gamble Pharmaceuticals’s bioanalytical chemistry group, Mason, Ohio. His group supports all of P&G Pharmacuticals’ product development initiatives, from phase I through phase IV. “We will support the animal work, which [includes] GLP and non-GLP work, as well as all of the clinical work,” he says.
Since April 2000, Huggins’ group has been using the Watson LIMS platform, originally a product of Pharmaceutical Software Systems Inc., which was acquired by InnaPhase Corp., in turn acquired in 2004 by Thermo Electron Corp., Waltham, Mass. Before using the Watson LIMS, the group used a home-grown platform. “We had an internally developed LIMS database that was built around supporting one specific study. It wasn’t Y2K compliant. It was not 21 CFR Part 11 compliant. It essentially met the needs at the time, but it was not a system that we could evolve or grow with. It was very limited in its capabilities,” he says.
The decision to migrate away from this older system to the Watson LIMS came down to overhead, says Huggins. After looking at several different platforms, P&G decided that the costs involved in maintaining and evolving the Watson LIMS were lower than that of competing solutions. Also, the platform could encompass a bioanalytical workflow and manage sample inventory, as well as facilitate the analysis, reduction, and tabling of data, all in a GLP-compliant environment. “For anything that is GLP or clinical driven, I would say the bulk of the industry is adopting an off-the-shelf product like Watson LIMS,” he says.
Huggins’ group also considered that the system uses a central Oracle database. “We looked at hardware and software to [answer the question] ‘is this an off-the-wall package, or is it something we believe is going to be around long-term?’ ”
As is typical when replacing any well-worn, home-grown data management system, Huggins’ group needed to decide how they were going to handle legacy data. “We decided to draw a line in the sand. Studies that used the old LIMS system [stayed in that system]. For any new efforts, we used the Watson LIMS. And that worked out pretty well,” he says.
By this point, however, the old system is completely shut down, to which Huggins says, “Thank God. But it was a very labor-intensive effort because a couple of studies [in the old system] were phase III clinical studies that dragged on for several years.”
Considering the transitions in ownership that the Watson LIMS system has been through since it was first implemented at P&G, Huggins says that, overall, their relationship with the vendor has been positive and hasn’t changed much since the beginning. “Their customer service is very good, and they are always looking to address outages and add new capabilities,” he says.
The one thing that changed, however, is related to the Watson platform maturing and being acquired by progressively larger companies. “There used to be a lot of things that were done on the side without a cost associated with them. Now, everything comes at a cost. Products have gotten more expensive, and training—you defiantly pay for that. So it has gotten a little less friendly in that there’s always money involved,” he says. He adds, however, that this change is understandable considering Watson started with a very small company but is now owned by a larger entity which is more focused on the bottom line.
In Huggins’ view, the Watson LIMS platform has very little competition in the area it serves. “I would say the bulk of the top pharmaceutical companies and contract research organizations use Watson LIMS; which is good and bad. Good, in that they obviously have a good product.” Bad, in that the product has something of a “stranglehold on the pharmaceutical industry,” he says.
Jo Webber, PhD, general manager of Thermo Electron’s informatics business, credits much of the success of the product to it being designed specifically to follow the processes of bioanalytical studies in drug development. “[Customers] don’t get into lengthy customizations and configurations that you see with a generic LIMS. [That is, something] designed to work in a petrochemical company, an environmental company, and a pharmaceutical company, but it requires a lot of effort to make it work at any one.”
Added to this are regulatory requirements which are far from generic, says Webber. “If you’re making rubber components, you might test a batch of it, and you might keep that data for a few months or a year. But the complexity of testing in a pharmaceutical company, the ability to keep that data for a long period, and the ability to store it securely and provide it easily to the FDA is a burden that no other industry has. I think that is what has caused people to look more strongly at what they’re getting from a LIMS solution,” she says.
As LIMS platforms acquire more features, either through in-house customizations or enhancements added by vendors, they can become one end of a more complex knowledge management and analysis system. P&G Pharmaceuticals isn’t there yet with its Watson LIMS implementation, “but we’re evolving into that, and hopefully we’re evolving as early as this year,” says Huggins. “We’re hoping to use retriever software to mine the database because there’s a lot of information in there that we’d like to use in metrics,” he says.
Other aspects that Huggins is hoping will improve in the future include the system’s ability to handle immunoassays. “It’s very cumbersome [as it is now], and there’s very little flexibility in how you can design your analytical runs,” he says. He says, however, that this is less a problem with the Watson LIMS and more a result of the user community still developing standard practices for analytical batch design.
The custom route
For some areas of drug development, a more custom solution is in order. Informatics provider 3rd Millennium Inc., Waltham, Mass., both develops LIMS systems from the ground up for its pharma and biotech customers and integrates platforms offered by vendors.
Roland Carel, PhD, head of informatics with 3rd Millennium, says that in some situations implementing a commercial product is nearly as much work as creating something that’s of lighter weight, but much more focused on the specific needs of a company. “There are a lot of very custom workflows that companies develop because they have a specific experimental technique. They are [looking to answer] unique research questions,” he says.
Carel describes three phases of 3rd Millennium’s work with its clients. “The first phase is an initial look at the problem. Essentially, [we] examine the business requirements at a high level, talk to the main players who are going manage the process, and try to figure out what are their main goals for the informatics piece,” he says. This phase is generally short, but it gets the customer to think about the project goals in a very detailed way, and helps 3rd Millennium to establish a common language with the customer, he says.
The second phase involves a detailed analysis of a customer’s data management requirements and what integration needs to be done with any existing systems. This analysis is mapped back to the goals established in the first phase. “We talk to all the stakeholders at that point, from senior management all the way down to the technicians who are actually going to do the work in the lab,” Carel says. “Out of that comes a fairly large mass of data of requirements, things that people would like, things that people must have, various preferences in terms of data gathering techniques, and their workflows and the like,” he says.
In the third phase, all this data is analyzed and mapped back either to existing commercial products or a custom development effort. “[The whole process is] really a collaborative effort. I guess we see ourselves as the catalyst of making it happen. But a lot of the ideas and the thinking usually comes directly from the customer,” says Carel.
Filed Under: Drug Discovery