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KM infrastructure for the life sciences virtual organization

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Like other large life sciences companies, Merck & Co. outsources many aspects of the drug development cycle, working with small biotech companies on drug compounds and clinical research organizations (CROs) on clinical trials. But as the number of its strategic partnerships grew exponentially every year, Merck used to struggle with how to connect with them more efficiently.

“When researchers wanted to work with us, they had to fill out a 40-page risk assessment document before we even started to give them access to our virtual private network. It was a long process that took up to three months,” says Andrea Kirby, Merck’s IT director for enterprise capabilities and solutions. “We had to figure out how to bring them very rapidly into our environment and start collaborating almost immediately.”

Content management systems developed for life sciences have traditionally been internally focused. They are on-premise, behind a firewall and difficult to externalize. But there has been business model pressure to allow for collaboration between different parties and still maintain a secure, regulated environment.

“I speak for a lot of big pharma companies when I say we have a lot of technology dinosaurs behind the firewall that are not really ready from a security and compliance standpoint,” Kirby says.

In 2011, by creating its own collaboration platform called EngageZone and connecting to a cloud-based identity management hub called Secure Access Manager provided by Exostar, the access provisioning process has been reduced to days instead of weeks or months.

Although EngageZone started as a project for clinical research, it soon spread throughout the company. “It became clear that this was not just a research problem,” Kirby says. “When I went to our manufacturing division, for instance, they had the same problems connecting to external partners. We knew we had to make it a more enterprisewide effort.”

Closer look at the cloud

The life sciences industry is seeing an increasing number of “virtual organizations” made up of several companies, each with its own specialty. For instance, in a recent survey, 80 percent of companies said they were outsourcing regulatory submissions, says Steve Gens, managing partner of the consulting firm Gens & Associates. That development is leading to a shift in thinking about the information technology infrastructure required to support it, including a closer look at cloud computing platforms and services.

Gens says there was some innovation around managing regulated clinical research content in the 1990s and early 2000s. Most of those solutions were built to work within a company’s firewall. But since then, there’s been a gap in technology innovation, and things have remained somewhat static. “Our surveys suggest that in the next few years we will see a move to next-generation content management systems,” Gen says. “There has not been much use of cloud-based solutions in this area yet, but there is a lot of interest and investigation.”

Globalization is another huge factor as life sciences companies think about collaboration in the cloud. A company like Johnson & Johnson has local affiliates in 150 countries. “Fifteen years ago, the information systems of those local affiliates were fairly siloed,” Gens says. Good communication mechanisms and transparency were lacking between corporate offices and local affiliates submitting regulatory information in their countries. Now companies are using private clouds to extend their systems to those affiliates, and seeing improvements in terms of the amount of time it takes to deploy, as well as performance and cost containment.

Relatively new multitenant cloud-based content management platforms are allowing life science startups to avoid large investments in software, hardware and IT staff, while still gaining access to sophisticated systems and the ability to scale up as needed.

The advantages

“It makes zero sense to follow the old model of bringing a document management system in house and to put the servers together and put all the security around it,” says Michael Hughes, executive director of IT at Kythera Biopharmaceuticals, which is focused on the development of prescription products in the aesthetic medicine market.

“When Kythera was a 30-person company, it had one IT guy one day a week,” Hughes adds. “Even as it has grown to over 100 employees, it still makes no sense to put a server room together or for our IT department to worry about IT security.”

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