In 1747 Royal Navy physician James Lind—determined to find a treatment for the scurvy besetting British sailors—tested substances ranging from vinegar to cider to citrus fruits on selected groups of those afflicted. He found that the group given oranges, lemons, and limes largely recovered from the disease after six days. From that experiment came the term “limey.”

If only finding cures for disease was still that simple.

Today clinical trials are one of the most expensive and time-consuming parts of drug development and a major factor in their cost. Even after potential compounds are developed in the laboratory, about 1,000 of them are tested before just one reaches the clinical trial stage. The entire process of discovery, proof of concept, clinical development, and regulatory approval can take up to a dozen years.

The clinical trial stage alone involves dozens of steps including designing the trial, choosing investigators and test sites, recruiting participants, setting up protocols, collecting and analyzing enormous amounts of data, and, ultimately, if the drug proves safe and effective, obtaining regulatory agency approval. It’s a process that typically involves multiple departments in a pharmaceutical company, often relying on fragmented information and technology management systems.

Although pharma firms have invested heavily in clinical information technologies, they are often characterized by a loose confederation of legacy systems—each designed to address specific parts of clinical development. That model no longer works. If the pharma industry is to survive, clinical trials must be supported by standards, integration, and interoperability.

Hitting industry challenges head on

Wyeth Pharmaceuticals—which in 2007 spent $3.3 billion on research and development and typically has 100 to 150 drugs undergoing clinical trials—is addressing the problem head on, using a four-layer, business-driven blueprint developed by EMC Consulting.

Using the blueprint, an organization first defines its business objectives and, from them, determines which information, solution, and technology architectures will best achieve those business objectives. “It’s a holistic approach to getting new drugs to the public faster,” says Andrew Worley, Wyeth vice president of information for clinical trials. “We’re already seeing the benefits.”

What’s driving the shift?

In 2004 the U.S. Food and Drug Administration issued a paper about the slowdown in development of new medicinal products, challenging the pharmaceutical industry, academia, and the government to turn the situation around.

Unfortunately, in the years since, a number of industry trends have made it even more difficult for companies to rise to the challenge—a situation described by industry consultant Doug May as “a perfect storm of problems.”

One trend is that the industry’s traditional business model of relying on a few blockbuster drugs for their profits is falling apart as broad, long-term use of some of those drugs has revealed problems not initially evident. As a result, regulatory agencies around the world are getting tougher in approving new drugs.

Another challenge is that diseases are becoming harder to address and cure as longer life spans result in more people with chronic conditions such as those associated with obesity and with neurological diseases such as Alzheimer’s and Parkinson’s.

Drugs based on genomics— tailoring compounds to individuals rather than making them one-size-fits-all—may be part of the answer, but that is largely in the future.

Business architecture precedes IT infrastructure

These factors, along with growing cost and pricing constraints, have given pharmaceutical companies a stronger incentive than ever to increase clinical trial productivity. “Most of the pharmas have tried to address productivity by investing in their technology infrastructure,” says May. “But that’s not where the big business benefit lies. They should be starting from the top, with the business architecture.”

Last winter Wyeth undertook just that approach, developing a vision and direction to identify how its clinical operations unit wants to operate over the next three years, and then how to align its IT investment with that vision. The company chose a three-year timeframe, says Worley, because “any less than that doesn’t give you enough time to implement your vision, and any longer means too many things can change.”

Worley began by holding a series of workshops with about 30 stakeholders from five critical areas: drug supply, clinical operations, medical, laboratory, and executive management. From these workshops emerged an actionable process plan—or roadmap—that will change the way Wyeth develops new drugs. Workshop participants addressed what information people need to do their jobs and how it should be organized to ensure easy access, how information should flow between organizations and among all the people involved in clinical trials around the world, and how to interconnect the unit’s functional and IT stovepipes.

One vision, six imperatives

The resulting plan calls for “optimal utilization and effectiveness of trial operations resources enabled through aligned process, technology, and information investments.” The group also defined six imperatives for the vision:

• Support the development and maintenance of strong relationships with investigators and other site study personnel.
• Facilitate outstanding trial planning and design, optimized study placement, proactive site and study management, and consistent execution of harmonized processes.
• Capture and manage complete and trustworthy operational data to support timely and informed decisions.
• Optimize collaboration and information exchange with internal and external stakeholders.
• Provide flexibility to accommodate required variations at global locations.
• Continuously guide technology investments that are tightly aligned with the Global Clinical Team’s business objectives.

Although the plan has been in place only a few months, Doug May calls it “a real live business drama playing out.” Responding with a laugh, Worley says, “Maybe ‘drama’ is an exaggeration. But it’s certainly important, and delivering on it is both daunting and very exciting. I think it’s significant that much of our technology investment for 2009 will be directly affected by this blueprint.”

Healthy times ahead?

The big question of course is will the blueprint save time and money? Worley believes it will, both in return on investment (ROI) and cycle times. “Though it’s hard to predict exactly how much or how soon,” he says, “I firmly believe that taking all these steps to align our processes and improve the flow of information will help us get more new drugs to market sooner.”

In the future the mapping of the human genome may make it possible for pharmaceutical companies to develop personalized drugs based on individual genetic markers. It seems likely that the companies that have honed their time-to-market processes and skills will reach that goal first.