Use of open source software in clinical drug development has been hampered by the incorrect perception that it cannot be validated and, therefore, is not acceptable for regulatory submissions. This session will discuss the challenges, perceived and real, to the broader utilization of open source statistical software in drug development (in industry, as well as in NIH-sponsored trials), and opportunities for addressing those challenges. It will feature speakers with practical experience with the use of open source software in drug development.

Learning Objectives:
Identify existing barriers to broader utilization of open source software in drug development
Describe strategies and processes that have been utilized to validate open source software in the biopharmaceutical industry
Discuss the benefits of open source software versus traditional commercial software.