It's good to be the CEO of Biogen Idec ($BIIB). The stock has surged, there's a top late-stage candidate in the pipeline for MS, and everyone seems to like George Scangos (photo). In a wide-ranging interview with Investors Business Daily, Scangos discusses his excitement for new research in neurodegeneration and cancer, as well as his views of the FDA now that the new PDUFA discussions are under way.
"What I think the industry wants is predictability," says Scangos, "certainly with respect to time. If a drug is supposed to be decided upon in 10 months or 12 months, we'd like to have some confidence that it actually will be. That's a very important area in which there's general agreement on how it should work going forward."
In Scangos's view, it would be better if the REMS programs evolved, the agency became more consistent and reliable in terms of timing, and regulators allowed provisional approvals now available to cancer drugs for other diseases. He also highlights the attraction of emerging markets to drug developers of every stripe.
"It's harder for small companies to have that kind of global reach," says the CEO. "There are only a handful of biotech companies that can do that on their own. But for those that can, the developing world represents an incredible economic opportunity."
- here's the Q&A from Investors Business Daily