At a recent talk in Arlington, Virginia, the drugmaker’s chief scientist chatted about benchmarks and clinical trials, according to ClinPage. For instance, Wyeth is walking away from sites that find a patient or two, no matter how eminent the doc who found those patients. Instead, Wyeth is supporting regional centers.

And after studying where the patients can be enrolled in quantity, Wyeth is moving trials to Latin America and Asia. (click on the map) “In certain parts of Asia, I’ve got 10 times more patients than employees,” noted Ruffalo. “You can see where I am going to move resources. I have more employees in England than patients.”

But Bob is losing sleep over safety issues. “You’ll hear me complain a great deal about regulators. They are in a terrible situation right now. They are in a no-win situation. Guess who pays the price. We do. And patients do,” he says, adding that the FDA is rejecting drugs by looking too zealously at safety, and not balancing benefits with risks. “They are more conservative now than in the past. Regulators deny they’re more conservative than in the past. But it’s getting worse after Avandia. I’m losing sleep on this.”

As an example, he described a recent experience with an unidentified drug. One statistical endpoint (out of four) was missed by a fraction of a hair. In their totality, all of the numbers trended in the right direction, with sufficient statistical power, ClinPage writes. But the FDA rejected the drug and Wyeth was forced to repeat a trial. In the pre-Vioxx/Ketek/Avandia era, Ruffalo suggested, that drug would have been approved.

“We repeated the study. We hit the four endpoints. I wasted somewhere between $10-100 million to repeat that study because a regulatory agency wouldn’t use common judgment. This is a very large amount of money that, in my opinion, was wasted by a regulator in this environment. That money could have been used on new drugs or additional drugs. That’s what happens in a conservative regulatory environment.”