Learn & Confirm - Pharmaceutical Executive


Learn & Confirm
At Wyeth, a sweeping set of initiatives is transforming the R&D operation—and spotlighting a possible futurefor drug development.

Pharmaceutical Executive

PROVE IT "One of the things that is going to help us is Wyeth's focus on metrics. Not just saying you're doing something, but actually measuring it," says Matt Bell, senior director of the Learn and Confirm implementation office.
"It was an amazing year," Gombar says. "It damn near killed me, but it was incredible because it's not very often you're given that kind of an opportunity, where somebody says, 'Go and figure out how to do it a completely different way.'"

As part of the process, Wyeth executives talked with companies in other industries that faced similar challenges. From electronics companies, they heard about rigorous focus on cost and cost-optimization tools. Product development companies explained the art of encouraging experimentation and "early kill" decision-making. Global supply and logistics companies provided a view of the culture of process engineering. But perhaps the most productive discussions, with a leading company in the aerospace industry, at first seemed the least relevant.

"I was astounded at the analogies between what they do and what we do," Gombar says. "They're highly technically oriented, highly regulated, with long development times. Their full portfolio of projects was something like 2,000 projects. But if you did a cut of their $500-million-and-up projects, it was about 30 projects—so the size of their portfolio wasn't very different than the way we do things."

What Wyeth's team carried away from the interview was the idea of project-driven teams. "That industry went through a lot of turmoil and consolidation 15 years ago," says Gombar. "At the time, they structured their development teams the way most pharmaceutical companies do—highly matrixed, everybody belongs to the aligned function. They decided to change that. They made it project-driven instead of function-driven. For major projects, the project leader is king. The project leader has the budget, the people on the project report to the project leader, and so on." That concept went on to become a centerpiece of Wyeth's new approach to R&D.

The team talked with hundreds of people inside and outside Wyeth, collected several hundred new ideas, then gradually winnowed them down to 45. Some ambitious ideas were left by the roadside, such as a plan to move to totally paperless clinical trials. ("That's going to happen someday," says Gombar. "But not today.") The final list of 14 included:

creation of Early Clinical Development Centers (ECDC) to speed recruitment for Phase II trials

development of a cost-optimization tool for global trials

outsourcing of logistics for clinical trial materials

reorganization of R&D into project teams that control not just a single candidate, but an entire therapeutic portfolio. (More about these initiatives later.)

But from the process of creating and aligning these initiatives, some big questions emerged. The team members found themselves rethinking not just their own company's structures and procedures, but the basics of how clinical research is conducted across the industry.

Phase Out

"We wanted to see if we could push the system and the regulators, in particular, to see if we could generate some thinking around doing things more efficiently," says Bruce Schneider. "One idea that came out of this was collapsing the phases of development—to see whether you could collapse Phase I and II somehow and just start all your trials on patients, not volunteers. Or could you collapse Phase II and III together, which would be the big win for everybody?"


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