Learn & Confirm - Pharmaceutical Executive

ADVERTISEMENT

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


Pharmaceutical Executive


As a result, the team came up with the idea of Early Clinical Development Centers—major hospitals, internationally sited, with which the company would create formal relationships for performing early-phase trials. The target was to find about 15 high-volume hospitals in the United States, Western and Eastern Europe, India, China, Hong Kong, and Latin America. Each site is required to have experience in electronic data capture (Wyeth uses EDC in 95 percent of new studies), and sites are audited in advance to identify weaknesses and training needs.

The expectation is that in a typical Phase II trial of 200 to 300 patients, five or six sites will provide 40 to 60 patients per study. Given the size of the hospitals Wyeth is currently negotiating with (which had not been made public at press time), that seems reasonable: One, for example, sees 9,000 outpatients a day. Another has 30,000 new cancer patients a year.

Outsourcing clinical logistics Stiles estimates that Wyeth is involved in clinical trials with 45,000 patients at 5,000 sites around the world. And that represents a logistical nightmare. "We have to get the drugs out to the sites. We have to get out all of the paperwork. We have to have blood drawing equipment and EKG machines if that's necessary. And then we have to get them back. After a study closes, you have to account for every one of your test article drugs. Yet, that is not a core competency, certainly not a physician's and not our team's."

The expertise is readily available, however, at large global logistics companies like Federal Express. And Wyeth is currently negotiating with an unnamed company to take over its entire clinical supply logistics function. "We're almost finished," says Stiles. "Their computer systems will tie into ours because we have to make the drug and keep it in our warehouse, but then they'll be responsible around the world. It'll be just like when you order a book on http://Amazon.com/ You enter it in and it says, 'OK, it has left Seattle. It will be in Philadelphia tomorrow morning.' We can do that."

24x7 operations "We don't believe in working 12-hour days," says Stiles. "Yet, we're not interested in outsourcing everything that we do." And so Wyeth's R&D operation is dispersing its centers worldwide to allow for an around-the-clock pass-off of work.

"We will have a site in Mumbai with 400 Wyeth people working on data management, statistics, writing," Stiles explains. We're not sending them work that we don't want or cleanup work. They are part of our teams, and likely we'll have another one of these sites, perhaps in Eastern Europe."

Cost-optimization tool A major cost of clinical trials comes in the form of lab tests, x-rays, and purchases of various sorts—all of which vary considerably by geographical location. One key Springboard initiative is to develop a tool that tracks and compares these costs. "Let's say we need a MRI of the brain for Alzheimer's disease every three months for two years, and we want to do this study in Buenos Aires and Paris," Stiles says. "We'll have a system that tells us what's the cost range at different sites for different vendors so the people writing the protocol can say, 'OK, I can get this for this price. The tradeoff of doing it over here for that price is the following and build it in.'

"We're beginning to use that right now as we speak. We think we can drive an awful lot of cost out. It also helps us to be better negotiators when we're going after pricing. We can look at it and say, 'Sorry, but we can do better than that.'"


ADVERTISEMENT

blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here