The PI System helps Shire find the single source of truth in R&D
- ChallengeR&D scientists need data to quickly analyze experiments.
- SolutionBring data from more than 300 sources into a single location and eliminate redundancies.
- Benefits50% increase in research programs from 2013 to 2015 without any changes in staffing.
In the pharmaceutical world, R&D can sometimes mean “redundancy and duplication” instead of “research and development.” Shire, a biopharmaceutical company that focuses on rare diseases and specialty conditions, used the PI System to increase efficiency and improve the bottom line by eliminating the need for researchers to keep data in individual spreadsheets. As a result, the company was able to conduct more research without increasing staffing—putting it one step closer to cures that could help people around the world. “You have these highly trained, highly educated employees that you’re paying hundreds of thousands of dollars, and they’re sitting at their computer wondering what the pH value for a reactor was,” said Brad Ebel, manager of pilot plant operations at Shire. “It’s ludicrous to be doing that.” Thanks to the PI System, these workers can now put their time to better use.
Clearing a path through the data jungle
More than 300 data sources feed into Shire’s data architecture, each with its own life span. New sources come in as old sources are phased out. The plant’s data-management system must not only be robust enough to handle a diverse array of existing data sources from different vendors, each with their own operating software. It also needs to integrate with future sources that will replace equipment as it becomes obsolete. The PI System helped Shire tame this jungle of data so the R&D team could get the information it needed quickly and efficiently. “We want to enable any scientist to analyze an experiment in 10 minutes or less,” said Paul Turvey, Shire’s associate director of laboratory operations.
PI Vision allows plant operators to pull up a rich and easy-to-read information screen showing the data output of a bioreactor over a full 24-hour time period. By looking at a full day’s worth of data at once—rather than, for instance, spot-checking to see what the pH of the reactor was at one point in time—an operator can spot potential problems or unusual variations even if they don’t rise to the level of triggering a system alarm. The interface also allows plant operators to explore data without worrying about interfering with plant operations. “This was a very happy moment for me when I realized I no longer had to worry about people making changes to my reactor,” Ebel said.
Learning to drive a Ferrari
When Turvey introduced Ebel to the PI System in 2008, he described it as receiving a Ferrari when he didn’t know how to drive a car. However, he found the system to be very user-friendly, and he quickly saw the potential it could have for his unit. Ebel also appreciates how easy the PI System is to understand for everyone in the organization, regardless of technical experience. “I could send this all the way up to the CEO and he would be able to understand it without any additional explanation,” Ebel said. In addition to giving operators a holistic view of their work, the PI System allowed Shire to remove human error from batch processes. Event Frames tracked each batch’s movement from one phase to the next, taking operators out of the equation. However, just because operators aren’t responsible for controlling the data around the clock doesn’t mean that they can’t see it. PI Vision dashboards are available through mobile apps, and Notifications proved to be more effective than Shire’s previous alert system for tracking activity at bioreactors. The PI System also helped operators escalate issues quickly without having to first go into the lab to investigate.
Putting more options on the table
It didn’t take long for the changes Shire made with the PI System to begin having an impact at the company. In 2013, the plant was completing an average of four research programs per year. By 2015, that number increased to six programs completed from start to finish with no change in staffing. The more programs Shire completes, the more chances it has of seeing a drug make it all the way through to production and helping in the fight to treat rare diseases and conditions. “Every drug has a low probability of making it all the way to a success, but you’ve got to get shots on the goal,” Turvey said. “Going from four to six in a few years . . . I think that’s a reflection of the investment in PI and some of our other partners.”
For more information about Shire and the PI System, watch the full presentation here.