Isolating the Leadership Gene

Thomas Bucknum, Biogen's executive VP and general counsel, remembers the reaction to the 90-day challenge being more pointed: "They were trying to be polite to him, but really, it was like, No fucking way can we do this. What's the boss smoking?

"Jim said, 'I refuse to accept that,' " Bucknum continues. "He said, 'Come up with a plan with that as your target. As you work through the details, we'll discover whether that's realistic.' "

Winkler and his group eventually developed a detailed plan for compiling the submission. The Amevive application went to the FDA 98 days after human trials ended -- and was filed for approval in Europe within an hour of being submitted in Washington. Mullen's point: In the biotechnology business, even with decadelong development cycles, time is money. The impact of shaving three months off of Amevive's 120-month development course can be huge -- if you beat a competitor, or if Amevive turns out to be a $500 million a year drug, which means that three months would add up to $125 million in sales.

Even more important, for Mullen, cutting the application time in half helped add urgency across Biogen. "This was nothing fancy," he says. "It was simple stuff. Make it a priority; set a goal. People don't relate to 10-year product cycles. Half the people here haven't even worked for 10 years, let alone 10 years at one company. You have to break the time frames down so a person can have an impact and see the impact."

Medical Marvels (III) The complexity of cellular biology has been a humbling experience for the human brain. CHO cells represent nature's advanced nanotechnology -- effortlessly doing things that people cannot.

A typical man-made "small molecule" medicine has a molecular weight of 500. The molecular weight of a water molecule is 18. But the molecular weight of one Avonex molecule is 25,000. If molecular weight is a crude measure of complexity, then comparing traditional medicines with biotech medicines is like comparing a calculator to a Pentium 4 PC.

If biotechnology looks to be the 21st century's alchemy, it can also seem as if the CHO cells are spinning gold rather than assembling interferon. The values of small quantities of clear fluid are incredible. Says John Palmer, a senior Biogen executive: "We could put a three-year supply of Avonex for all of Europe in the back of a taxi." These days, a three-year supply of Avonex for Europe is worth $750 million.

From Limits Comes Creativity

Jim Mullen has a relentless ability to focus. Unlike many people in demanding jobs, he doesn't do more than one thing at once. When he talks on the phone, he doesn't doodle, and he certainly doesn't read email. It's the same when he's in meetings. He pays attention, but if a meeting turns unproductive, Mullen is known to push back and say, "You aren't prepared. Call me when you're ready."

In the three years that Mullen has been president, and then CEO, at Biogen, much of his time has been spent on the unglamorous work of being in charge: personnel, structure, reviews. Mullen had 15 people reporting to him when he took over; now he has 9 -- and 2 of those are new hires who bring big-company experience to an organization that wants talent to grow into.

Discussions of structure and organization hardly inspire scientists, but Mullen is trying to help Biogen grow up without losing its youthful creativity. "The campfire culture doesn't work here anymore, with people sitting around telling each other what's going on," says Mullen. "We need to be organized looking to the future. The complexity of this company was, and is, rapidly increasing. We need to motivate people to take risks, we need to look for innovation and creativity, and we need to demand results. Why are we doing this experiment? Asking the questions in advance puts some objectivity in place."

Mullen has tried to force decision making in Biogen down, rather than up. "Decisions should be made at the level where there is maximum information," he says. And he's clear about the kind of decisions he should be making. Consider the case of Adentri, a drug for congestive heart failure that Biogen had in development for years, and that worked well. The drug was good at treating patients with acute problems -- lying on a gurney in an emergency room -- and was expected to be effective for treating chronic congestive heart failure. But the Adentri molecule (a creation of Biogen scientists) was so sensitive, it could not be taken as a pill or a shot (Avonex patients inject themselves). Adentri could only be administered by IV. Mullen, and Biogen's scientists and marketing people, knew that patients wouldn't use a drug they had to visit their doctor to take. The company spent millions of dollars trying to solve the delivery problem, without success. In practice, then, Adentri worked well in a hospital but was impractical for ongoing treatment at home.