By Michael Szpir

In the jungle of the marketplace, the pharmaceutical industry is now experiencing enormous pressures to evolve into a different kind of animal. In 2004, the U.S. Food and Drug Administration (FDA) reported that the annual number of new drugs and biologics submitted for approval dropped from 97 to 40 between 1993 and 2003, even though spending on research and development increased two and a half times during the same period. Similar developments have been seen at regulatory agencies around the globe. Such trends threaten the extinction of big pharma as we know it.

People in the industry feel the pressure coming from all quarters. The withdrawal from the marketplace of widely used drugs, such as Merck's Vioxx® (Whitehouse Station, NJ), because of health risks has heightened public concerns about drug safety. Add to that the growing expectations of shareholders for greater profits, and there's little doubt that something must change in the business of making new therapeutics.

“The challenges for the pharmaceutical industry are mounting, and we don't see an end to that anytime soon,” says Barry Springer, vice-president of enabling technologies at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD; Raritan, NJ).

Among those challenges is the need to bring drugs to the marketplace faster than ever before. It now takes about 10 to 15 years from the time a company files an investigational new drug application with the FDA to reach final regulatory approval. Just about everyone thinks that's unacceptable. “There are some diseases that aren't being met with good medicines, so there's a real patient need out there,” says Springer.

And, of course, the longer it takes to produce a drug, the costlier it is. The Center for the Study of Drug Development at Tufts University (Boston, MA) estimates the cost of bringing a new therapeutic to the market at about $948 million (in 2003 dollars). “Time is the most precious commodity we've got,” says Steve Projan, vice-president and head of biological technologies at Wyeth (Madison, NJ). “The patent clocks are ticking while we do clinical trials—with a $365 million-dollar-a-year drug, you lose a million dollars every day you don't get that drug on the market,” he says.

So what is big pharma doing about all of this? For one thing, the industry isn't sitting back hoping that some new technology will come around the corner to save them. “The bloom has gone off the rose of buying the next new thing—the technology that is going to wipe everybody else out,” says Bob Clark, director of the Informatics Research Center at Tripos (St. Louis, MO).

Instead, industry leaders are taking a hard look at some of the technologies already on hand. “Although we're always looking for new technologies, a lot of our focus is to take existing technologies and push them as far as we possibly can,” says Springer. The future of the industry hinges on where they do the pushing.

It Takes a Village to Create a Drug

Big pharma is starting to appreciate that how the technologies are integrated into the drug-discovery process is key to getting the most out of them. “It used to be data, data, data,” says Clark, referring to the mountains of data generated by high-throughput technologies. “Now, it's info, info, info.” People nowadays recognize that they need to share information, rather than just generate more data, Clark says. Indeed, Tripos has been working with Bayer (Pittsburgh, PA), Bristol-Meyers Squibb (New York, NY), and Wyeth Pharmaceuticals to develop software to do just that.

As a result, there's a shift toward bringing people together into interdisciplinary teams, rather than isolating scientists like factory workers who toil independently on different aspects of drug discovery. “Several new research centers have all the different groups in the same building, rather than, say, having one building for biology and one for chemistry,” says Clark. “Companies now recognize that discussions over cups of coffee are extremely valuable,” he adds.

Schering-Plough (Kenilworth, NJ), for example, has implemented a systematic method of bringing together key stakeholders from drug discovery, development, manufacturing, and marketing, according to Thomas P. Koestler, president of Schering-Plough Research Institute. “We integrate a diversity of input into our decision-making process,” he says. “We listen to the assessments of marketing experts as promising compounds are discovered; we involve manufacturing colleagues early in the clinical trial-development cycle, as well as our researchers, clinicians, and colleagues from distribution,” he adds. The goal, he maintains, is to focus their energies on the most effective ways to bring a valuable drug to market, and to learn early in the process whether a compound is viable for continued work.