VP, Worldwide Regulatory Affairs, Cephalon
BIGGEST HIT: 3 NDAs in one year
ROLE MODEL: Aventis' R&D head Frank Douglas "who moved to Germany, and learned the language and lifestyle to lead a global
Eric Floyd pulls no punches about Big Pharma's famous fear of change. "If you think outside the box, you can be viewed as
a threat. If you are perceived as a threat, they challenge and frustrate you," he says. That's how Floyd found his way to
Cephalon, one of the industry's fastest-growing biotechs
Like so much else in pharma, what's required from regulatory has changed so much and so fast that "the old mindsets and models
are no longer sustainable," says Floyd. "We're seeing 45-year-old CEOs because they understand the challenges—and because
the boards understand it, too."
At Cephalon, he finds the flexibility, fast-response, and forward-thinking that's missing at the large caps—and mandatory
at the predictably unpredictable FDA. "We need to anticipate the agency's concerns, and build them into our clinical programs
and marketing strategies," he says. "There's no guidance yet with the new REMS, so we need to influence change internally."
Given FDA's knockdown of Cephalon's Fentora application for noncancer indications, Floyd will get the chance to have influence
as Cephalon ramps up its controls over the prone-to-abuse product in its argument to the agency.