Open-Source Software in Pharmaceutical Discovery

• Activity Number: 51
• Type: Topic Contributed
• Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
• Sponsor: Section on Statistical Computing
• Author(s): Gregory Warnes*+ and A. Max Kuhn and James Rogers
• Companies: Pfizer Inc. and Pfizer Global Research & Development and Pfizer Global Research & Development
• Keywords: software ; pharmaceutical ; R ; microarray ; genetics ; open-source

Abstract

Open-source statistical software is being used with increasing frequency for the analysis of pharmaceutical data, particularly in support of "omics" technologies within discovery. While it is relatively straightforward to employ open-source tools for basic research, software used in any regulatory context must meet more rigorous requirements for documentation, training, software lifecycle management, and technical support. We will focus on R---a full-featured, open-source statistical software package. We'll briefly outline R's benefits and then discuss the requirements for its use in discovery. Next, we will discuss key issues for organizations to be comfortable using it within regulatory arenas in clinical, safety, or manufacturing. We'll then discuss how well R meets these requirements and ask whether third-party commercial support can resolve some issues.