Open Source Software in the Biopharma Industry: Challenges and Opportunities

• Activity Number: 100
• Type: Invited
• Date/Time: Monday, August 5, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Jose Carlos Pinheiro*+
• Companies: Janssen R&D
• Keywords: R packages ; drug development ; software validation

Abstract

Utilization of open source software, such as R and OpenBUGS, in clinical drug development conducted by the biopharmaceutical industry is, by and large, limited to simulations for trial/program design and exploratory analyses not included in regulatory submissions. A number of factors account for that, but chief among them is the (incorrect) perception that open source software cannot be validated and, therefore, is not accepted by regulatory agencies for analyses included in submission packages. Because research in statistical methodology increasingly makes its way into software via the open source route, this perception creates further hurdles for the utilization of novel statistical methods in an industry badly in need of innovative designs and analysis methods. This talk will discuss the challenges, perceived and real, to the broader utilization of open source software in clinical drug development and opportunities for addressing those challenges.