Using an Open-Source Software in Pharma: Opportunities and Challenges

Music City Center 

The pharmaceutical industry is increasingly adopting open-source software (OSS) to drive innovation, enhance efficiency, and reduce costs across research, development, and manufacturing. A well designed and documented OSS offers numerous opportunities, including increased collaboration, transparency, and accelerated drug discovery through advanced computational tools. It enables cost-effective solutions for clinical trial design and simulation, data analytics, and regulatory compliance while fostering a culture of scientific openness. However, the integration of OSS in pharma also presents challenges within an organization. These include concerns about data security, regulatory compliance, software validation, training for associates, and long-term support. Additionally, the lack of standardized frameworks and potential intellectual property risks may hinder widespread adoption. This talk will share some of the firsthand experiences regarding the benefits and limitations of using OSS in the pharma. It'll highlighting strategies to overcome challenges and maximize its potential. By leveraging OSS effectively, pharma companies can drive innovation while maintaining compliance and ensuring data integrity in a highly regulated industry. The talk will highlight a few examples including tools developed inhouse with a pharma and tools adopted from Comprehensive R Archive Network (CRAN) in collaborations with academia.

open-source software