Data Management Fills The PrescriptionData Management Fills The Prescription

The escalating costs of drug development are making it tougher for biotechnology and pharmaceutical companies to invest time and money in clinical trials. But the lengthy, expensive clinical trial phase of drug development is critical to ensuring a drug's safety and compliance with Food & Drug Administration regulations. For many such companies, the answer is to make greater use of clinical data and simulated drug trials, which reduce the need for human participants and cut costs by millions of dollars. Two recent alliances may make that task easier.

Wednesday, Oracle, PricewaterhouseCoopers, and Pharsight revealed they'll begin working on a clinical data repository solution that uses data-management and query technology to help drug makers make product-development decisions. In addition, IBM Life Sciences Solutions Thursday said it would include data-capture, clinical research record-keeping, patient-tracking, and reporting software from Phase Forward Inc. in its offerings, as well as host the software through IBM Global Services.

Clinical drug trials today are conducted much the way automobile crash tests were 15 years ago, says Mike Pavia, chief technology officer for Millennium Pharmaceuticals Inc., a $196 million Cambridge, Mass., drug research and development firm which conducts R&D for Bayer, Abbott Laboratories, and American Home Products. "Car engineers built a prototype and smashed it against a wall. Then they would look at where the damage was and create a new prototype."

Just as the auto industry has moved to online simulations, so must the pharmaceuticals industry, Pavia says. A recent study from the Tufts Center for the Study of Drug Development estimates that new prescription-drug development costs about $800 million. Pavia agrees with the estimate, but attributes 75% of the development cost to unsuccessful projects that don't bring products to market.

Oracle, PricewaterhouseCoopers, and Pharsight will put together a package of software and consulting and integration services, due in early 2003; it will include some combination of Oracle 9i, Warehouse Builder, Workflow, Discoverer, and Reports, with Pharsight's Clinical Workbench, Knowledge Server, and Trial Simulator. German drug maker Boehringer Ingelheim GmbH and a second undisclosed company will contribute to the development process and have signed on to use the new software and services. The package's primary value will be integration of data-management and simulation software, targeted at the biotechnology and pharmaceuticals industries.

Advances in clinical data repository solution's data-management and Web-based integration technology will make it possible for drug companies to determine earlier on in the development process whether they've got a winner or a loser on their hands. That's no small feat, considering that most of the money spent during this process represents wasted efforts. It's not uncommon for drug companies to enter the long, expensive clinical development phase of a product without really knowing a drug's chance for success, according to Arthur Reidel, Pharsight's president and CEO. "One way to alleviate this problem is to help drug companies conduct more effective simulated drug trials, using existing data about the drug's composition, as well as potential conditions it could be used to treat," he says.

Eighty percent of potential new drugs fail in the clinical trial phase, says Reidel. "The two key factors in drug development--speed vs. safety--don't have to be a zero-sum game, if researchers can get better information earlier in the development process," he says.

The average drug requires 68 trials to get to market, Pavia says, and can take anywhere from eight to 15 years. Shaving time off that process means saving money. Each day lost on the path of clinical development represents an estimated $1 million to $2 million loss of revenue for pharmaceutical companies and, more importantly, a delay in bringing life-saving drugs to market, says Shiv Tasker, Phase Forward's president and CEO.

The benefits of dropping a drug that's not going anywhere are staggering, says Keith Howells, senior director of pharmaceutical applications for Oracle. "Everyone is worried about the cost and availability of drugs--whether it's Cipro or treatments for HIV."

Millennium Pharmaceuticals has been using Pharsight's computer-assisted trial-design and decision-making software and consulting services to help make its processes more efficient. Simulation software combined with good data cuts down on the number of actual trials that need to be performed by analyzing trial data and creating data models that can answer researchers' questions.

Clinical trial bottlenecks typically result from managing large volumes of data from a variety of data sources, such as clinical trial management and laboratory database systems. This situation will be exacerbated by continued genome research. Drugs on the market today, for example, are designed with knowledge of about 500 of the 40,000 genes in the human genome, Pavia says. "We've only scratched the surface."

For the past eight years, Millennium has conducted research for other drug makers to help these companies determine where in the genome their new medications should focus to better fight diseases and treat ailments. As new information about the genome pours in, the need for improved data analysis will increase.

"Information derived from genome research will wash through IT systems over time," says Simon Hughes, a partner with PricewaterhouseCoopers' Global Pharmaceuticals Group. Being able to analyze this information and extract data out of it is a major piece of business in the biotechnology space.

Pharsight's model-based approach is more advanced than existing statistical-analysis methods because it creates mathematical models for managing data that can simulate drug performance on a digital patient. The scenario is as simple as simulating a drug's use in 200 users rather than 100 users. "Using digital simulations, you can run drug trials more frequently at a lower cost," Reidel says, adding that the FDA won't approve drugs based entirely on simulated data.

Analysts say cost savings will be only part of the new package's appeal. "The real value proposition here is reducing the number of human participants in the clinical trial process by using simulation software," says Forrester Research senior analyst Michael Barrett. There are fewer obstacles to adopting simulation technology, because researchers aren't treating people as specimens.

The ability to conduct a high number of trials is an important differentiator between drugs in the market, says Phase Forward's Tasker, whose company's Web-based InForm software uses the Internet to collect and manage clinical trial data. Phase Forward in August acquired Clinsoft Corp. to expand its presence outside North America, particularly into Japan and Australia. Clinsoft's Clintrace software also filled Phase Forward's need for a safety-reporting tool, used to inform regulatory agencies about adverse drug reactions detected during the trial process.

The acquisition also enabled Phase Forward to offer both its own InForm Web-based data-collection application with Clinsoft's Clintrial data-management application.