Life Support

 
 
By Tony Kontzer  |  Posted 2009-09-29
 
 
 

Few businesses have as specialized a set of technology needs as those in the life sciences sector. The combination of large amounts of data, huge product development costs, patient safety requirements and intense regulatory control makes it critical for these companies to have the IT resources needed to meet a varied and closely monitored set of business processes.

To ensure that they can make the most of their data, produce safe medicines and devices that conform to regulations, and maintain a feedback loop with the doctors and hospitals using their products, life sciences companies have been taking some important steps to shore up their technology.

Business intelligence applications, for example, enable companies to wade through vast reservoirs of data on everything from drug discovery and safety analysis to prescribing habits. BI is proving especially useful in pharmaceutical companies’ efforts to determine how best to target physicians—a process that requires pulling data on doctors’ historical prescription trends (what they prescribe and how they prescribe)—and how to most effectively influence them.

“It’s way too complex to do without a good BI application,” says Eric Newmark, research manager at Health Industry Insights, a unit of research firm IDC.

Life sciences companies are adapting key business applications to fit their very specific business process environments, ensuring that these general technologies are configured to enable staff and regulators to easily investigate issues and how they were addressed. “It’s an industry that takes what’s been proven and adapts it to its needs,” says Jim Macdonell, vice president of solutions delivery for consulting firm Patni’s life sciences unit.

Here’s how two life sciences companies are reaping the benefits of such IT efforts.

Data on Drugs

Once a drug has hit the market, the pharmaceutical company that’s producing it needs data. Lots of it. This “postmarket surveillance,” as it’s known, includes data on how and when drugs are being prescribed, what diagnoses are being matched to those prescriptions and what the lab results show after the drug has taken effect. This information enables the company to determine the impact its drugs are having on the patients taking them.

The informatics division of Premier, a Charlotte, N.C.-based research firm owned by some 200 hospitals and health systems across the United States, provides just such data to a host of pharmaceutical companies through its ClinicalAdvisor product, which provides users with a Web-based interface that allows them to slice and dice the information being collected and disseminated by Premier’s research team.

The only problem was, as the quantity of data exposed via ClinicalAdvisor grew, it became increasingly challenging to organize and present it in the way pharmaceutical companies needed. Researchers at Premier had to spend more time entering, analyzing and manipulating the data, and that meant slower responses to customer queries.

“We found that people want to [get and use] the data the way they want to,” says Chris Stewart, senior architect for the informatics division. “We couldn’t structure the data in a way that would [provide] it in all the ways our customers wanted to get it.”

Whatever Premier initially did to address the situation didn’t seem to help. Buying faster servers, deploying faster storage systems, hiring more database administrators—nothing worked, because Premier’s researchers and their pharmaceutical customers aren’t always sure exactly what they’re looking for, so their queries can be worded in unusual ways.

The answer, Premier found, was to deploy a more effective data warehouse and layer a more powerful business intelligence engine over it. The company chose a data warehousing appliance from Netezza that was designed for rapid analysis of large data volumes, and it coupled that with a front-end reporting tool from MicroStrategy.

The result, Stewart says, “was like night and day.” But even that wasn’t enough. Because the amount of data continues to grow exponentially each year, Premier has had to upgrade its Netezza appliance at every opportunity, with the most recent upgrade implemented in August.

The research team has seen a surge in productivity, and customers are getting better results, no matter how they word their queries. The company hasn’t measured the impact lately, but Stewart says even the first iteration of the Netezza appliance resulted in slashing the time needed to answer several common queries from as long as five hours to three minutes or less.

“We’re letting the data drive our analyses, instead of needing to [know beforehand which] data we need,” says Stewart. “It’s really helped our analysts get the data back to customers faster, with no indexing or tuning of queries.”

A Speedier Process

In the world of contract pharmaceutical manufacturing, success hinges on two things: the ability to produce quality drugs that meet all the necessary requirements and the ability to do so quickly. More often than not, the two are inextricably connected. This explains why, in March 2008, Catalent Pharma Solutions decided to sell off its sterile injectables unit: It wanted to shed the drag that the much slower injectables business had on its bottom line.

The founders of the new business that resulted, Albuquerque, N.M.-based Oso BioPharmaceutical Manu-facturing LLC, knew that it would have to be as efficient as possible if it wanted to stand out as a contract manufacturer of injectables. The company started with a strategic IT investment, purchasing Sparta Systems’ TrackWise quality management software and configuring it to speed up the investigation of deviations found while manufacturing batches of injectables, called “lots.”

Oso’s TrackWise deployment essentially provides a template for performing those investigations. It gives staff the ability to survey information from the company’s document management and training systems, all from within TrackWise. This makes it easier to access the critical information the company needs to determine what led to the deviation.

As a result, Oso is able to identify and correct deviations in lots much quicker than it could before. When a production line worker forgets to turn on a probe that removes airborne particulates such as dirt and dust from the air, or when an operator doesn’t record how much active ingredient was added to a compound, the system streamlines the investigatory process by requesting and discovering all the needed information via one template.

“It’s basically a timing thing—it streamlines the business process from a quality assurance [standpoint],” says Brian Board, director of quality systems. The impact, according to Board, is “immeasurable. It makes our lives easier on a daily basis.”

As immeasurable as it may be, TrackWise has actually had a very measurable impact on Oso’s business. Since it was deployed, the software has not only provided that unified interface, but it has also enabled Oso to further reduce IT costs by eliminating about 60 percent of the custom functionality that had been built into its document management system.

Even more important is the fact that this streamlining of business processes allowed Oso to reduce the time needed for releasing injectable lots from as long as 90 days to just 30 days. That’s the kind of difference that can mean beating out the competition forcontracts to produce everything ranging from infertility injectables to vaccines.

Whether the objective is to crunch and disseminate data more effectively or to be more efficient in investigating deviations during the drug development process, strategic IT investments are helping life sciences companies speed up their responses to the demands of a fast-moving market.

That’s no easy feat for an industry that is characterized by complex development formulas and unwieldy regulations. However, a business-as-usual approach no longer works in a world of real-time decision making.

Medicine on the Go

It’s not just life sciences companies that are looking to technology for the ability to deliver better results. Even techno-skeptic doctors such as Dr. Amos Johnson have gotten into the act.

Johnson, a primary care physician in Farmington Hills, Mich., is a self-described computer lover who, nonetheless, had been utterly disappointed in the lack of positive impact technology has had on health care. He does acknowledge that electronic medical records have contributed something: “They actually make my work harder,” he says.

But that negative perception has been challenged by, of all things, his iPhone. Johnson is one of 30 physicians in the country who have been beta testing an iPhone application called Care360 Mobile Companion, from Quest Diagnostics. The secure, HIPAA-compliant app allows Johnson to manage all of his patients’ medication needs while on the go. He uses the phone to check everything from what medications do or do not work together to a patient’s medication history to lab test results, with abnormal findings highlighted in red. “The whole layout is really user-friendly,” he says. “It operates a lot like I do with a paper chart.”

What’s more, Johnson also is testing an add-on e-prescription function that allows him to submit prescriptions from his phone, or resubmit prescriptions that patients have lost.

A Collaborative Approach

The commercialization center recently opened by Beaumont Hospitals, a three-hospital system in Southeast Michigan, could prove to be a technical boon to the region’s medical device makers and struggling automotive manufacturers at once.

Part of Oakland County’s new Medical Main Street initiative to connect doctors and med-tech companies, the collaborative environment created in Beaumont’s commercialization center enables medical device makers to tap into a simulated hospital environment, getting hospital staff directly involved in designing and tweaking products based on how they’re used in prototype operating rooms.

The effort is having the additional effect of providing a much-needed potential revenue stream for automobile parts makers. For example, Delphi’s five-year-old Delphi Medical Systems unit is among those working to adapt electronics, sensors, pumps and other automotive technologies for use in medical devices that move fluids or take pressure readings.

Like their more established med-tech counterparts, these companies are benefiting from having direct access to a hospital environment and the valuable research data that those tests yield. “The ability to transfer that technical know-how to our industry presents a lot of opportunities,” says John Shallman, director at the commercialization center.