By Malorye Branca
January 15, 2003
| Emerging biopharmaceutical companies have a lot of budget pressure, but when ILEX Oncology Inc., based in San Antonio, Texas, decided to overhaul its systems, it didn't need to crunch many numbers to decide what to do.
"We had to do it," says Don York, ILEX' senior director of information technology. "It was pretty obvious to all of the management that we had a big problem, and we had to fix it."
The systems weren't bad, just too numerous. From the time ILEX was founded in 1994, new hires brought in their own software from previous jobs. "When I came here three years ago, we had 34 systems in use, and a lot of them did pretty much the same thing," York says.
ILEX started by licensing promising compounds from other companies, then ushering those through clinical trials. That involved numerous steps, including recruiting doctors and patients, monitoring studies, and submitting paperwork to the FDA. But the company's project teams were using different software for each of these tasks, and those systems often didn't speak to each other very well.
This proliferation of IT silos was creating even more bottlenecks in the already cumbersome process of drug development. ILEX' offices and labs around the world — Texas, Massachusetts, England, and Switzerland — were all affected.
To track each project's expenses, for example, the accounting department had to round up the data and integrate a lot of it by hand. "At least most people were using Excel," says Bobby Rios, ILEX' controller for the past few years. "But it was very time consuming."
Mike Dwyer, president and chief operating officer of ILEX at the time, addressed the problem. "The driving force came from sitting down and seeing how people were using technology on a day-to-day basis," says Dwyer, who is now president and CEO of OpTx Corp., in Denver. "There was a tremendous duplication of effort — all kinds of people maintaining the same information in different places."
Re-Engineering Cancer Treatment
That kind of IT system doesn't mesh well with ILEX' scientific goals: to develop new types of cancer drugs that minimize traditional problems of low efficacy and serious side effects.
|ILEX' IT Imperatives
|A look at the major changes within ILEX' IT team.
The company's first drug, the monoclonal antibody Campath, received FDA approval 18 months ago as a treatment for the most common type of adult leukemia: B-cell chronic lymphocytic leukemia. Millennium Pharmaceuticals Inc. partnered with ILEX in late 1990 to co-develop the drug. It's not a "first line" therapy, but since the launch of Campath in June 2001, it has generated about $60 million in sales. ILEX recently bought out Millennium's stake in the partnership and is exploring new markets for the drug, including other cancers and multiple sclerosis.
Campath is not a blockbuster, but it doesn't have to be. ILEX will do well even if it turns out only a few niche products. Of course, the company is hoping for more than that, based on a pipeline of innovative compounds, some of which are now coming out of its own discovery efforts. However, reaching the cutting edge of drug development, ILEX' management realized, is probably easier if you aren't skimming the bottom of IT implementation.
"Researchers couldn't get information and didn't even know where the best information was," York says. "It made sense to create one system, based on one reliable database, and integrate the clinical trial software with accounting and project management."
Changing, and Managing Change
Implementing that change fell to York, who joined ILEX in 1999 from a bioengineering company. His former job was similar in some ways, but the attitude toward systems was quite different. In bioengineering, people took systems integration for granted. In pharma, York discovered, there were a lot of Ph.D.s and M.D.s who "wanted to hang on to their favorite systems."
York proved a fortunate choice for the task. "Don is the consummate IT professional," Dwyer says. "He knows exactly what he's doing, and he can speak to businesspeople without jargoning them to death."
|ILEX' Management Style
|The IT department developed an information structure to centralize the drug development process in a single database system, and then integrated other key components for information sharing and reporting.
Given its location in San Antonio, ILEX could draw on a deep pool of IT talent, thanks partly to Texas Instruments Inc. York created a team consisting of two developers, an Oracle database administrator, and one person in charge of quality assessment testing and technical writing.
One hurdle was agreeing on a reasonable schedule. York's team examined the old systems and the company's goals and proposed a plan. "Of course, [management] said, 'This is great, but we have to do it in half the time,'" York says. So he broke the project into modules, promising to deliver the overhaul in several distinct stages. He realized this goal was a classic case of rapid application development with plenty of code walkthroughs, prototypes, and testing.
He also faced the challenge of managing the reactions of ILEX' 250 or so employees, which required about a year and a half of meetings. First, York's team met with each project group and tried to find areas of "commonality" if their systems overlapped. "We'd ask them, 'How would you like to see this on a computer screen? What types of data fields do you need?'" he says. Next, his team built mockups, and when the system was finally running, they held weekly user forums, receiving constant feedback along the way.
So far it's all on schedule. York's group started the project in April 2000. Within six months, they delivered a "module 1" version client/server system. Six months later, the system had all the necessary working components. They spent another six months making enhancements.
The end product does what they need it to do, and it speaks one language. They have an Intel-based PC network, with a few Unix machines for specialized applications. All the databases are Oracle; the interface is modeled after Microsoft Outlook. "Everyone at ILEX knew how to use Outlook," York explains. "Building it that way shortened the learning curve." The interface was developed using mainly Visual Basic, but the group also used C++ and tools from Sheridan Software Systems (now Infragistics Inc.). "The first goal was to get something out there people could use," York says. Now they are working on making it Web-accessible.
Most importantly, ILEX staffers like the new system. Rios says, "It has reduced the amount of time we spent [amassing financial data on clinical trials] from four to five days to no more than two days, and sometimes it takes even less than that."
Terry Murdock, ILEX' vice president of clinical operations, is also enthusiastic. "Every day, I see more information available to me to make management decisions," he says. "As we are starting up a trial, I can stay in tune with what sites are considered, which ones are qualified, and what their contracts are. Once a site is enrolling patients, I can track patient accrual. Then, I can actually see where that patient is [in terms of his or her progress through the trial] in real time."
ILEX has already won recognition for its new systems. Last summer, it was the only pharmaceutical company on CIO Magazine's prestigious "CIO 100" list. Best of all, the system is helping ILEX implement a new "seamless product flow" commercialization process, in which, York says, "a core team takes the product all the way from bench to bedside." Now those teams have access to the data they need to get those drugs to launch.