Dr. Nierengarten: I’m not necessarily convinced that the FDA is more lenient. What I do see is a greater willingness within the agency to accept newer clinical trial designs. It’s being more receptive to the idea that for targeted agents, we don’t need to run a traditional, 1,000-patient study. We can look at surrogate endpoints, run smaller clinical trials and things like that. They still are rigorous in evaluating those newer designs, but they are different and they’re newer, and it’s nice to see the FDA being accepting of that.

TWST: What does the pipeline look like within your universe, now and as you look ahead?

Dr. Nierengarten: It’s pretty exciting, I think. There are a lot of therapies that are going through clinical trials that make a lot of sense. Of course they are not all going to work, but I think we’re seeing a very interesting phase in drug development these days, especially, again, with the more targeted agents. I’m pretty encouraged about the pipeline as it looks today, which means I’m encouraged how it’s going to look a few years from now.

I continue to keep my eye on genetic and cell therapies. Gene therapy seems to have been resurrected…

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