The pharmaceutical industry has its share of problems —patent expirations, pressures on margins, regulatory creep (or perhaps more accurately "regulatory pounce"), battered reputation, and the like. But behind them all is One Big Problem. It takes too long and costs too much to develop new products. And so the search is on, both at drug manufacturers and FDA, for insights that will shave time and costs from drug development. Progress is already being made. Average development time, by at least one report, is down slightly in recent years. And a recent study from the Tufts Center for the Study of Drug Development noted that the tier of top performers had shortened development time by about 20 percent in the past five years, while holding regulatory time steady.
Perhaps the boldest and most interesting model to emerge in the past few years is being put in place today at Wyeth, where a year-long program of research, discussion, and planning is culminating in radical change to the way the company carries out development, including:
» A complete reorganization of the R&D function that puts control of drugs—and therapeutic-area portfolios—in the hands of project teams» Aggressive cost-cutting initiatives that aim to save both money and time
» A shift away from traditional Phase I through III development and toward seamless use of adaptive trials
» Most important, a new approach to drug development, called Learn and Confirm, that Wyeth thinks will provide better data, improve late-phase success rates, and deepen insight into how drugs actually work in diverse patient populations.
Wyeth's new approach to clinical research originally grew out of a broader, corporation-wide initiative called Springboard, which began a year and a half ago as a search for ways to be effective within a lower-cost structure. "Initially R&D wasn't even part of the thought process," explains Bruce Schneider, Wyeth Research's executive vice president and chief of operations. "But [Wyeth Research president] Bob Ruffolo volunteered that we should be challenging ourselves to see what we could do to do things more effectively in the future.
"Initially, cost was the emphasis, but as we got into it, we also talked about ways to radically change the way that we actually developed drugs to see if we could somehow collapse phases, eliminate phases, that sort of thing. We had a strategic perspective on the one hand and an operational perspective on the other. So we tried to hit both of those at the same time."
The R&D Springboard effort started with a half dozen participants who referred to themselves as the "wacky thinker" group. One of them was Charles Gombar, vice president for product management. "We really looked for people who were not going to give us the same old, 'This is how you do pharmaceutical development, dah-dah-dah,' but who could really think of different ways of doing things," he says. "We sat around and we asked a lot of fundamental questions. We were willing to question everything.