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Wyeth’s R&D Strategy: Spoonfuls Of Enrollment With A Dash Of Outsourcing

Executive Summary

Wyeth research and development efforts are focusing on global patient enrollment as a key method to accelerate the drug development process

Wyeth research and development efforts are focusing on global patient enrollment as a key method to accelerate the drug development process.

"We're a global industry, we're a global company, and this is all about how to do global enrollment everywhere. And enrollment equals speed equals time to market," Wyeth VP-Clinical Programs Ira Spector said at the Drug Information Association's annual meeting in Philadelphia June 20.

Wyeth's focus on enrollment is one component of the company's "Springboard" project, introduced last year, which aims to prepare the corporation for the future by making it more time and cost efficient.

"The bottom line is, a billion dollars in ten years, which has sort of been the industry model for the last several years [for bringing a product to market], isn't washing very well with the public," Spector said.

Wyeth's global patient enrollment initiative was the initial focus of the Springboard project, which consists of many initiatives stretching across the entire corporation, from marketing to R&D.

"Enrollment is the key. It's sort of like real estate where it's like location, location, location," Spector said. "In clinical development, it's enrollment, enrollment, enrollment."

Spector cited enhanced regulatory requirements, such as the larger number of patients needed for studies and the increased number of studies often required for an NDA, as one cause of inefficient recruitment.

"In Wyeth's experience, we have situations now where...we're looking at 50% more patients in order to meet those trials, an increase in proportion of number of sites that don't obtain their enrollment goals despite their past performance...more indications that are getting more and more difficult to recruit...and the difficulty of recruiting patients in the Western world."

"In the U.S. and Western Europe, somewhere between 2% and 4% of potential patients enter into clinical trials, and that's an issue," Spector said.

As a result, Wyeth is looking to the rest of the world to conduct clinical trials. In 2004, about half of the company's sites were in the U.S. and half in the rest of the world. Last year that shifted dramatically, with 36% of sites in the U.S. and 64% elsewhere.

The company's goal for 2006 is to have just 30% of trials conducted in the U.S. and 70% in other areas of the world.

Spector maintained that this strategy does not negatively affect U.S. patients' access to clinical trials. "It's really a good thing in terms of finding new places to find patients and their effect on submissions," he said.

"I should point out that we do not go to regions where we don't intend to market products. So in addition, this is all about opening up new markets for the organization," he added.

A recent Tufts report found that companies with the fastest drug development times are characterized by standardized clinical trial practices and higher levels of outsourcing (1 (Also see "Clinical Trial Speed Improved By Standardized Practices, Outsourcing" - Pink Sheet, 22 May, 2006.), p. 12).

Although Wyeth will be increasing its level of outsourcing, Spector maintains that it is "not necessarily" always the answer.

"Off-shoring works well when the work can be easily segmented or digitized; the driver's usually cost. It's very good for sub-components of work. It's very good for transactional work."

However, he advised against outsourcing "when the effort requires very close coordination, very high quality, where you really need a project manager to be close, where it's very strategic, and you've got a rapid proximity to various components in terms of decision-making."

Wyeth is using "enhanced clinical development centers," another Springboard initiative, to help drive patient recruitment outside of the U.S.

The enhanced clinical development centers are Phase II "supercenters" that will be located in areas of high patient density such as Rio de Janeiro and Beijing. The company hopes to have 10 to 12 of these centers operational by the end of the year.

"We think this is really going to revolutionize Phase II. There is no reason for Phase II durations to be as long as they are," Spector said.

"Outfitting those sites with the latest technology in terms of remote data capture, working with the regulators early so that we can bring the drug in and start trials in a timely fashion, getting enrolled very, very quickly" is the concept of these centers, he said.

Wyeth has said that it was shifting R&D funds from Phase III projects to early stage programs in an effort to continue meeting its goals of submitting two NDAs for new molecular entities per year (2 (Also see "Wyeth Shifting R&D Funds To Early-Stage Compound Research And Licensing" - Pink Sheet, 3 Oct, 2005.), p. 19).

As part of a Springboard initiative dubbed "24/7," Wyeth currently has clinical enrollment call centers in the U.S., Paris and Australia that are open 24 hours a day, seven days a week, including holidays.

"They're there for two reasons. One, we don't like patients to wait more than an hour to get into a trial, so if there's an issue with randomization at the site, the site can pick up a phone and always get a blind expert to help with enrollment. [Two,] in case a site has difficulty and needs to break the blind, there's always [someone] there that they can talk to."

Additionally, Wyeth is looking to adaptive clinical trial designs for R&D efficiencies. "Adaptive trials have significant opportunity to alter the way we do drug development by allowing us to do dose selection in a more effective manner or allowing us to potentially go seamlessly from one phase into another, providing we have this worked out with the regulatory agencies in advance," Spector said.

FDA's Critical Path opportunities list highlights streamlining of clinical trials - including using adaptive, enrichment and non-inferiority designs - as a key to improving the drug development process (3 (Also see "Personalized Medicine Is Closer Than You Think, FDA’s Throckmorton Says" - Pink Sheet, 8 May, 2006.), p. 23).

Wyeth is looking to reshape its entire drug development model from Phase I, II and III to a system that involves just two major components: learn and confirm (see 4 (Also see "Wyeth Replacing Three-Phase Development With “Learn And Confirm” Model" - Pink Sheet, 3 Jul, 2006.)).

The success of adaptive clinical trials is largely dependent on having the right technology in place, specifically remote data capture, Spector said.

In 2004, less than 10% of Wyeth's clinical trials were conducted using remote data capture. Last year it was a little bit over 40% and this year the company has already surpassed its goal of 90%, Spector said.

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