Across the industry we see numerous large-cap pharmas changing the way they do R&D—some a little, others a lot. Would you
characterize these efforts as successful? What do you think is the future focus of R&D innovation?
I see a lot of different people doing a lot of different things in Phase I, like blurring the phases and looking at I/II rather
than totally distinct trials, adaptive clinical trials, all sorts of pilot projects. They're all driven by many of the same
things I've been talking about: becoming a more effective organization, geting the maximum information from the minimum patient
exposure, and decreasing the risk of the entire process. At AstraZeneca, we're looking at personalized medicine in terms of
selecting patients for our new therapies. We are doing adaptive trial designs. We are doing Phase I studies that have a major
pharmacodynamic or Phase II-type component in them.
The other area is, we're all beginning to do much more in the way of comparative studies. We no longer bring to the marketplace
a product that we know works, that we know it's relatively safe, but that we don't know whether it's better than the leader
in the class. So we are prepared to go head-to-head with the best available agents out there to show that we have some advantages.
If we don't do that, then when it comes to cost-effectiveness and payers paying, we won't be successful in the marketplace.
Do you have any final thoughts about specific areas that you think will see new ways of doing R&D?
I think most organizations will find ways of connecting their early-phase clinical to their late-phase discovery. People will
look to focus in on geographic regions. People will always chase the new science, wherever that comes. And I think we will
see more and more companies cutting back and becoming more flexible. By "more flexible," I mean working with the outside world
in accessing new science and new discoveries, being able to move quickly into different therapeutic areas and different mechanisms
when they start to break, and having a smaller, fixed internal cost base than previously.
And, certainly, for the next year, you'll have your hands full with your big increase in late-stage products.
What an exciting and great thing to happen. You know, we've spent two and a half years flogging ourselves to speed up the
pipeline and also to externalize to bring projects in. And if that means we have a lot of projects in later-phase development,
we'll live with that. As a corporation, we'll have to make some very difficult decisions about which of our children we like
the best. But that's a problem we don't at all mind having.