Tysabri’s PML Count Climbs to 28, and Some Reflections From Biogen Idec’s Departing CEO

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of that. Gene therapy was going to be huge. Then it was RNAi. And all sorts of other stuff.

“It’s always been difficult to pick the technologies and platforms that will turn into products because it always sounds a lot easier than it is and more logical than the biology turns out to be. That’s one. The second is that regulatory success by no means [translates into commercial success]. You really have to think carefully about all your products. Just getting over the regulatory hurdle, and getting the whole organization to understand that getting over the regulatory hurdle is not sufficient.

“How intractable the whole R&D productivity issue has been for the industry. I’ve been around 30 years in the industry, and every three or four years along comes some new thing that’s going to somehow improve our hit rate or drop the costs. Well, none of that has happened. The regulatory hurdles go up, the trial sizes go up, the timelines get longer, things get more expensive, and the hit rates don’t go up, they go down.

“If I want to be futuristic, I would ask how we’re going to change the paradigm. We’re still living in a paradigm of placebo-controlled trials that were put in place in the 60s, 70s and 80s. It won’t work any longer over the next 30 or 40 years. Frankly, a lot of basic problems got solved. This idea that you’re going to do comparative effectiveness studies—they sound great as headlines, and they play well with the public, but when you run the statistics, they don’t work at all.

“So I think there’s got to be really new thinking in the industry. It’s going to take a while, and it will need to take hold with the regulators. The whole Critical Path Initiative at the FDA has always been disappointingly underfunded, and do not [have] enough intellectual horsepower, but the industry has to rally around it and help come up with some new paradigms, and move the regulators to a point where the paradigms are meaningful and put into place. This whole equation is heading to a place where innovation is really going to be crimped.”

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