Takeda Pharmaceutical Company Limited - 2025 Customer Recognition Awards: Innovative Problem Solver
Takeda Pharmaceutical Company Limited
Contact: Ryo Nakaya
Country: Japan
Award Category: Innovative Problem Solver
Tell us about the business problem you were trying to solve.
Takeda Pharmaceuticals aims to continuously create innovative medicines and deliver these new drugs to patients promptly. In pharmaceutical clinical development, it is crucial to quickly analyze data collected from clinical trial ensuring its quality to evaluate the efficacy and safety of drugs. However, preparing the analysis data and results for each trial can take several months and cost several hundred thousand dollars. Additionally, significant human resources are required to ensure the quality of analysis data and analytical results, which are created respectively for each trial. Efforts to improve and innovate daily tasks, such as ensuring the quality and speed of data analysis while controlling costs, are essential for delivering innovative medicines quickly and consistently to patients.
What SAS products did you use and how did you use them?
In clinical development area, SAS is the de facto standard for statistical analysis, and Takeda has implemented several initiatives with SAS 9 as the system foundation. Traditionally, most statistical tasks were performed by manual programming in the SAS language. Initially, a statistical analysis system combining Java and SAS was developed for creating analysis results and conducting additional analysis for inquiries from regulatory agency, facilitating standardized analysis report creation using a GUI with no coding. Furthermore, SAS macro programs that automatically generate ADaM creation programs in a semi-automated manner by reading the derivation logic documented in the analysis data specification (Spec) were established for creating analysis datasets in CDISC ADaM format.
What were the results or outcomes?
The statistical analysis system developed by combining Java and SAS at Takeda has been operational for Japan domestic clinical trials and regulatory submission activities, reducing costs per trial from several hundred thousand dollars to tens of thousands of dollars when compared to outsourcing. For regulatory inquiries, where outsourcing previously required a few weeks and tens of thousands of dollars to analyze 300 reports, the company successfully created them internally in just 2-3 days. The use of SAS macro programs for semi-automated ADaM creation allows automatic program generation for at least 50% of the variables in the target analysis datasets from the analysis data specification, which was pilot-tested across multiple trials. Particularly, the statistical analysis system involves Computerized System Validation (CSV), enabling standardized and efficient business operations through consistently standardized outputs generated by the system's standard SAS programs, thereby significantly contributing to Takeda's Japan domestic pharmaceutical development both in terms of cost and time while ensuring the quality of analysis results.
Why is this approach innovative?
The innovation in the statistical analysis system lies in the development of a browser-based application with Java language for the front-end, considering the system's lifecycle, while using the highly reliable and stable SAS 9 as the backend foundation. This combination achieves a system with long-term maintainability and reliable, stable results. Furthermore, the ability to output various analysis methods in the company's standard report format and the GUI-based approach allowing non-SAS programmers to easily create high-quality analysis reports is a significant point. The SAS macro programs for semi-automated ADaM creation from analysis data specifications automate the process that was previously manually performed, using Spec information as metadata. Similar to the statistical analysis system, such parameter-driven tool development could serve as a foundation for further automation using AI and RPA in the future. Recently, Takeda is rapidly globalizing and aims to leverage its experience in operational efficiency with SAS in Japan for company-wide automation moving forward.
