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Two Pharmas Are Better than One

Best Practices Winners: Merck & Co.; Abbott Laboratories
Project: Biological Knowledge Management: Registration, Association, & Sharing
Category: Knowledge Management, Pharma
Nominated by: Accelrys

By Kevin Davies

July 20, 2009
| Following the acquisition of biotechs such as GlycoFi and SiRNA in 2006, Merck management faced a critical challenge to register its biologics—to provide a corporate identifier and tracking attributes. Lori Harmon, manager of information services, says Merck soon ruled out internal inventory applications but couldn’t find a commercial option either. “We could have had a vendor do a custom solution, but that was costly.”

A discussion with Accelrys revealed that the San Diego informatics company had received a similar approach from Abbott Labs. “Chemistry is a field that’s very well developed, with very specific rules, chemical names, and so on,” says Accelrys VP Marketing, Jonathan Usuka. “Biology has nothing similar. We saw a real problem with these global organizations… Biologists hadn’t met each other and yet needed to share information. The nomenclature is not standardized—what do you search on? And the work was so specialized, they couldn’t convey what they need to see to an IT professional to make a database.”

And so two years ago, the parties agreed to explore a consortium approach to building the robust IT infrastructure for registering biological materials. Biological materials require a sophisticated understanding to define them uniquely. Realizing economies of scale and utilizing an extensible SOA architecture and knowledge model, the system developed in conjunction with Accelrys solves a host of challenges related to IP protection and knowledge sharing.

Setting Standards
Much of the intellectual property of pharma companies is locked up in their use of biological materials, but ensuring researchers understand specifics about materials used in complex, reproducible workflows is a major headache. Enterprise-wide standards must be adopted for a company’s crucial biological inventory to be transformed from a confused grab bag into an organized treasure trove. 

For more than 18 months, Merck, Abbott, and Accelrys hammered out biological definitions that could become industry standards. The two pharmas defined the respective challenges using biological entities in their own workflows, while CSO Frank Brown and colleagues at Accelrys developed capabilities for defining, storing, searching, and retrieving the information. The project was divided into phases, with multiple meetings to nail down priorities and understanding which challenges are tractable.

The biological registration system sits on top of Accelrys’ popular workflow platform, which was initially developed for the chemistry world. “The bioregistration solution is not a collection of components and it’s not standalone software either. It’s completely integrated into Pipeline Pilot,” says Usuka. “[Now] as a drug discovery informatics platform, it’s starting to find areas to impact biological discovery as well as intellectual property protection.”

A key lesson, the parties agree, was the use of business rules. By enabling both partners to customize the application, the consortium realized an economy of scale without sacrificing the unique nature of their internal processes.

Another priority was to encourage collaboration across global sites, allowing Merck and Abbott scientists to locate proprietary plasmids, or RNA vectors distributed across the organization. Moreover, patent applications are no longer jeopardized by duplicate registrations or by misreferencing the same material.

The first phase focused on basic biologic resources—cell lines, plasmids, proteins, and antibodies—but will expand to vaccines and small interfering RNA (siRNA). The latter is especially important for Merck in light of its push into RNA interference screening. Usuka says this will be “one of the major areas we want to nail in phase III,” while the partners retain some flexibility. “If a company wants to define special features of viruses or vaccines or RNAi, they can build those themselves.”

Merck found that joining forces in the consortium lowered development costs considerably, to an estimated 25% of the putative cost had they gone it alone.

“It’s been very successful,” says Harmon. “It’s really enabled a sharing, a best practices between companies. Each company has been able to bring requirements from individual scientists.” Harmon says there has been fruitful give and take from both companies. For example, Merck embraced Abbott’s use of the term “moniker” for the sample names.

Harmon adds that, “External collaborations are a key strategy for Merck, and by doing this we feel we share both the risk and the rewards of the collaboration.” Merck is exploring additional pre-competitive alliances with other pharma companies, seeking new ways to share data with external collaborators.

For its part, Abbott said the joint approach “afforded significant savings over the likely cost of developing such a system internally.” Abbott also praised the agile approach to software development that enabled iterative refinements to the requirements following review of prototype systems. Merck and Abbott received 100 perpetual seats, and Lilly recently became the third member of the consortium, which has one year left to run.

Accelrys’ Usuka can’t resist pointing out that the underlying LMQS (List Management and Query Services) registration system was itself an award winner at CHI’s 2009 Molecular Medicine Tri-Conference Best of Show awards. Usuka thinks the Bio-IT World Best Practices Award helped attract Lilly, and has seen a resulting surge of interest since the presentation. As Usuka says, “It’s a great way to start a conversation!” 

This article also appeared in the July-August 2009 issue of Bio-IT World Magazine.
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