Isolating the Leadership Gene

Mullen's approach is to be open-minded but unsentimental and objective, eager for wide-ranging debate but decisive. In an increasingly information-flooded economy, where the experts are not necessarily the corporate leaders, Mullen is trying to create a culture of realism in an industry of hope and hype. It may be a formula for leadership beyond the walls of Biogen. "What makes the difference in what companies, and what drugs, succeed?" he asks. "There is an element of serendipity. But it's less than people would like to attribute. You have to be coldly objective. You can wish all you want: If I squint at this data long enough, I'll see a hint of a trend, then I'll do another experiment. You can spend a lot of money making bad bets.

"In the end, you have to be able to say, Here is where I am; here's the good news, here's the bad news. This is all I got."

Medical Marvels (I) Biogen's factory in Research Triangle Park, near Raleigh, North Carolina, delivers on the atmospherics of gee-whiz biotech. Many parts of the facility are accessible only by passing through air locks. In the air locks, employees don bunny suits and wash their hands with alcohol foam before entering manufacturing areas that are much cleaner than a hospital operating room. All to enter "factories" where the important stuff -- cells making medicine inside gleaming stainless-steel tanks -- is sealed off from human contact to start with.

Traditional modern medicine is based on chemistry. Drugs ranging from Tylenol to Lipitor are simply a mix of ingredients cooked up in large quantities in clean conditions. But biotech drugs can't be made by mixing a recipe of ingredients A, B, and C. The individual molecules of biotech drugs are such elaborate Tinkertoy structures, so sensitive to even the smallest errors in construction, that they can only be assembled by cells. In most instances, the drugs are made by an unsung hero of the biotech revolution: cells from the ovaries of Chinese hamsters.

Let the Facts Tell the Story

Jim Mullen is trained as an engineer, and he is well-known inside Biogen for being unafraid to plunge into the huge swells of data that drug research produces, in search of his own understanding and clarity for the scientists and executives around him.

Mullen has what can be an intimidating intellect and an intimidating stature. He is 6 feet, 4 inches tall, with wide shoulders, giant hands, and a kind of loose-limbed agility that gives him the air of a retired NBA player. But he is intimidating only to the degree that insisting on rigor is intimidating. He's personable in a quiet way and has a clear-eyed, often wry view of himself. He uses his intellect to dig for information -- sometimes with the bluntness of a backhoe, sometimes with the care of an archaeologist's trowel.

Despite leaps in technology and understanding, the world of biotech drugs remains an unsettling mix of medicine and business, science and gambling. "We're often making decisions in uncertainty," says Mullen. "If the organization is running correctly, the only decisions that get to my desk are the ones with high uncertainty. You have to be comfortable managing in uncertainty, because you never have all the information."

Such was the case a few years back, when Mullen was impatient to move on with development of Amevive, the psoriasis drug. "No industry spends more as a percentage of revenue on R&D than pharmaceutical companies," says Mullen, "and no industry is less sensitive to timelines than ours."

In 1999, Amevive was well into testing in humans. The first phase of such testing comes only after a drug has proven safe and effective in animals. Phase I human trials is a safety check. Phase II involves giving the drug to a limited group of patients. Phase III trials are placebo-controlled, double-blind experiments, where the drug and placebos go to a wide spectrum of patients.

"We were nearing the end of Phase II trials with Amevive," says Mullen, who was then president of Biogen, a year before he would become CEO. "That's the point where you have to determine the product profile -- how well it works, how quickly it works."

For Amevive, about 200 patients were enrolled in Phase II trials, and the testing was expensive: $30,000 per patient. Phase II -- the point where most drugs are really first tested on sick people -- is also the point at which most drugs fail and are canceled. In meetings over several months, Mullen asked basic questions: "What is the profile of Amevive? What's the speed of onset of action? What percent at two weeks? At four weeks? At six weeks? Like that. This group of physicians that we had working on the product didn't want to answer my questions."

Even two years later, his exasperation is easily refreshed. "I was asking questions more from a commercial, or a customer's, point of view. They apparently didn't think I had a right to stick my nose into it. I kept meeting resistance. Really, it was an attitude problem."