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Wyeth Replacing Three-Phase Development With “Learn And Confirm” Model

Executive Summary

Wyeth is moving to a "learn and confirm" paradigm for clinical development that will focus on better understanding the medical value of a molecule up-front

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Wyeth lives and learns in trial development

Wyeth is reaping the benefits of its "learn and confirm" approach to clinical development, U.S. President Geno Germano tells analysts during a June 12 presentation at the Goldman Sachs Global Healthcare Conference. The firm announced last year it was replacing its three-phase development process with "learn and confirm" to better understand the medical value of a molecule up-front (1"The Pink Sheet" July 3, 2006, p. 19). Wyeth and other pharma companies have touted adaptive trial designs as a way to streamline the clinical development process and decrease the time and length of trials. That approach may eliminate agents that could fail on a larger scale later in development, Germano points out. For instance, "in one of our programs where we initiated an adaptive trial design, we were able to explore multiple dose ranges for a given product and determined that frankly it didn't have the activity that we thought it would have," he noted. "And while that's unfortunate, the good news is it's unfortunate at several million dollars less cost than it would be if we were to find out using a traditional approach to dose ranges and dose-finding studies"...

Wyeth lives and learns in trial development

Wyeth is reaping the benefits of its "learn and confirm" approach to clinical development, U.S. President Geno Germano tells analysts during a June 12 presentation at the Goldman Sachs Global Healthcare Conference. The firm announced last year it was replacing its three-phase development process with "learn and confirm" to better understand the medical value of a molecule up-front (1"The Pink Sheet" July 3, 2006, p. 19). Wyeth and other pharma companies have touted adaptive trial designs as a way to streamline the clinical development process and decrease the time and length of trials. That approach may eliminate agents that could fail on a larger scale later in development, Germano points out. For instance, "in one of our programs where we initiated an adaptive trial design, we were able to explore multiple dose ranges for a given product and determined that frankly it didn't have the activity that we thought it would have," he noted. "And while that's unfortunate, the good news is it's unfortunate at several million dollars less cost than it would be if we were to find out using a traditional approach to dose ranges and dose-finding studies"...

Wyeth’s Successful R&D Renovation: Neuroscience Shows Early Returns

Six months after unveiling its "Project Springboard" efficiency initiative, Wyeth is holding up its neurosciences portfolio as an example of the success of the work-in-progress transformation of the company's R&D business

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