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The Statistical Software Revolution in Pharmaceutical Development: Challenges and Opportunities in Open Source

MCML Authors

Anne-Laure Boulesteix

Prof. Dr.

Principal Investigator

Biometry in Molecular Medicine

Abstract

Open-source statistical software development is increasingly the preferred solution for leveraging new statistical methods in the pharmaceutical industry. However, with a long history of relying on licensed analysis software, there are philosophical and organizational barriers to overcome. In particular, the sustainability, reliability, usability, and feasibility of maintaining open-source statistical software long-term must be ensured. Here, we describe the open-source revolution that is emerging in the pharmaceutical industry and how it facilitates greater scaling of innovative analytical methods in statistics. We discuss challenges to open-source software adoption and propose mitigation strategies. Furthermore, we illustrate the potential for open-source software development with examples of successful projects, which highlight the roles of cross-company collaboration, career paths, education, and community building.

article BSB+26

Drug Discovery Today

Feb. 2026.

Authors

D. S. Bové • H. Seibold • A.-L. Boulesteix • J. Manitz • A. Gasparini • B. K. Günhan • O. Boix • A. Schüler • S. Fillinger • S. Nahnsen • A. E. Jacob • T. Jaki