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


Data standards For Stiles, perhaps the most exciting initiative has to do with standardizing safety data. "All drug companies tend to be compartmentalized by therapeutic areas, and how they do their studies is very team-dependent," he says. "Each team devises how they want to gather the data, create their statistical data packages, analyze the data, and do their own tables. Each one of those requires the statisticians and programmers to create their own statistical programming model."

But many data can be standardized: demographic data on patients, their conditions, what drugs they are taking, and so forth. On the safety side, in particular, it is possible to standardize data collection and analysis. "It doesn't matter whether you're collecting it on somebody with Alzheimer's disease or breast cancer," says Stiles. "The safety data are one and the same."

The new project aims at a deep level of standardization. "It starts with the simplest things and then goes down the line: tagging the data, how it will be analyzed, how it'll be pulled out, how it will be stored, and get to a package," Stiles says. "The agencies we've talked to about this are absolutely thrilled because when they get a data package from Wyeth for safety, they'll know what it will look like and where to look for what they want."

So Far, So Good

The transformation of Wyeth's R&D operation is a work in progress, and will remain one for a good time to come. Implementation began in January, under the guidance of Matt Bell, senior director of the Learn and Confirm implementation office. In general, he says, the projects are on track and on schedule. "We're exactly where we expected to be right now," he says. "So far, so good."

The Learn teams were put through a pilot program involving oncology, respiratory diseases, and a high-impact alliance team working on methylnaltrexone, which Wyeth is developing with Progenics for the treatment of opioid-induced bowel dysfunctions. Based on that experience, Learn teams were rolled out across clinical areas in June

The ECDC team is on track to get 10 Phase II centers up and running by the end of the year

A contract for logistics management is in negotiation, but Bell expects that full implementation of the complex program will take several years.

For the next six months, Bell says, the goal will be to see how the program works when applied to the entire pipeline. "We're at the start of the journey. And one of the things that is going to help us manage is Wyeth's focus on metrics—understanding the outcome at the team level in terms of time saved or quality improved or value added and then holding the teams to that. Not just saying you're doing something, but actually measuring it.

"Through the rest of this year and next year the organization should, in theory, start to see improvements," Bell says. "And if you don't see things changing, then you go back and ask the question, 'Why are we not seeing any changes?'"

In truth, Wyeth's R&D leaders seem to be expecting more than measurable change—they seem to be expecting transformative change. A year or so of asking unaskable questions and poking at the very foundations of R&D seems to have created a sense that R&D could be a very different thing than it is today.

And there is an impatience to get there. "Why can't we cut drug development time in half?" asks Schneider. "As you go from Phase I to II, II to III, you actually have some blank space—some transition zones you have to go through. If you can eliminate those, you save time right there. If you can collapse them in such a way that you don't have to repeat the whole phase or do it all separately, you can save even more time. So why can't you cut it in half?"


ADVERTISEMENT

blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here