Abstract:

A common problem in drug development is that highly trained people become trapped in doing the work of their respective discipline without taking individual responsibility for the most important questions. ‘Getting the dosage regimen right’ is a fundamental problem in drug development that is often not well performed. The experience described here transformed a department from completing required clinical pharmacokinetic studies to focusing on the most important questions in dosage regimen design that did not have a unique solution. Elements of the story include vision, quality, best practice, automation, transformation and impact. Productivity was increased by 81% within 2 years by one measure and there was a substantial positive financial impact.

Keywords: Regulatory process

Document Type: Review article

Affiliations: 1: Pfizer Global Research and Development, Ann Arbor, Michigan, USA