"I think it's probably one of the most hotly anticipated moments in recent biotech history," says Robert Scott in that endearing,
slightly embarrassed tone common to scientists hyping their own products. Scott is executive vice president of R&D and chief
medical officer at AtheroGenics, an Atlanta-based biotech, and his product, AGI-1067, is a novel anti-inflammatory that may
or may not be on the verge of a medical breakthrough in the treatment of heart disease.
A South African expat, Scott is also a refugee from Big Pharma who left his high-profile perch as Pfizer's worldwide medical
head of cardiovascular R&D to join AtheroGenics in 2002. To say that Scott leapt at the chance to steer AGI-1067 through an
ambitious, multifaceted 6,000-patient Phase III trial dubbed ARISE—and, hopefully, on to blockbuster status—is putting it
mildly. "It was an unprecedented research opportunity," he says. "Biotechs typically don't enter the cardio field because
of the size and expense of the outcomes trials required. And here was a drug with the potential to be a true innovation against
the disease that kills more people than any other."
Inevitably, Scott's move from the industry leader with close to 100,000 employees to a 100-person biotech is also a statement
of sorts, though Scott is careful when choosing his words. "I would never have got a Phase III of this complexity done in
this short a time frame at Pfizer," he says, and: "Here at AtheroGenics, the people at the meetings are the same people who
are doing the work. Decisions get made quickly because everyone understands the mission." And: "As head of cardio at Pfizer,
my job was no longer to be a great drug developer but to manage all the people who were doing the development and keep them
Scott's frustration with Big Pharma is no different from what many industry leaders voice. The pharmaceutical empires that
dominate the production of medicine, it is increasingly acknowledged, suffer from an advanced case of "too much"-ness: too
big, too bureaucratic, too centralized, too much management, too much inefficiency, too much regulation, too many stakeholders
involved in too many decisions resulting in too much caution.
Scott's data—unveiled at the American Academy of Cardiology's annual summit in New Orleans last month—were long the subject
of enormous anticipation, and for tiny AtheroGenics, the meeting was a do-or-die moment. For Scott himself, though, it had
an added poignancy. His former Pfizer colleagues were also on the bill, presenting final autopsy results on torcetrapib, another
cardio novelty hyped as a medical breakthrough right up to the day it crashed and burned in Phase III last fall.
If AGI-1067 eventually emerges as a winner, it will mark the first time a biotech has revolutionized a market as massive as
cardio. If it fails, well, it was a bold experiment, and science doesn't get much better than that. (As Pharm Exec went to press, the biotech announced that the ARISE data were decidedly mixed, falling short of the primary target—reducing
"soft" events like stent procedures, bypass surgery, and chest pain—but hitting key "hard" marks by reducing heart attack,
stroke, deaths, and diabetes-related symptoms.) Win or lose, though, no one will be writing the obituary of the biotech business
model. By contrast, when Pfizer's cardio blockbuster-to-be hit the wall, it was almost universally viewed as the last nail
in the coffin of the bigger-is-better business model, if not Big Pharma itself.