P213: Effective Communication of Drug Benefit-Risk Profiles through Automation for High-Quality Regulatory Documentation
Poster Presenter
Vasanti Anand
Regulatory Writer
BMS United States
Objectives
To effectively communicate a drug's benefit-risk profile in alignment with industry standards and guidelines using automation tools, thereby improving the consistency, efficiency, and compliance of regulatory documents and ultimately patient safety.
Method
An intelligent automation cloud-based solution using generative AI was developed to generate executive summaries for Safety Aggregate Reports (SARs) encompassing clinical to post marketing stages of development. This use case will leverage AI to fetch text from the body of various SAR documents.
Results
The BOT allows the Scientific Writer to upload the source documents and have the respective Executive Summary/Synopsis generated in approximately 5 minutes. The solution uses programming AML and Generative AI to extract the content. At the end of the process, SWs can download the output from the website. This automation would bring in consistency between documents with ZERO redundancies.
Similar machine learning automation methodologies are also being adopted across SARs (end-to-end) with the use of BOTs and for summarization of health authority query responses using different source documentation that help to ensure adherence to GVP Module VII guidance and compliance (inter- and intra-document alignment). These results along with the ability to drive process efficiencies, reduction in authoring time, compliance, etc. will be presented at the Global DIA conference in June 2025.
Conclusion
Generation of accurate submission-compliant safety aggregate report Executive Summaries are paramount when these are independent distinct documents submitted globally to Ethics Committees and regulatory authorities. Historically, several inconsistencies and errors were identified across Executive Summaries and body of the reports leading to several health authority queries and/or quality issues.
The implementation of automation BOTs will enable scientific writers to dedicate more time to crafting strategic and consistent benefit-risk profile messages across submission documents. This approach aims to save time, enhance consistency, minimize redundancies, and ensure overall compliance across all therapeutic areas. Ultimately, this will promote the creation of high-quality regulatory documentation, thereby optimizing patient benefits.
