From data silos to insights: the PRINCE multi-agent knowledge engine for preclinical drug development.

The pharmaceutical industry faces pressure to improve the drug development process while reducing costs in an evolving regulatory landscape. This paper presents the Preclinical Information Center (PRINCE), a cloud-hosted data integration platform developed by Bayer AG in collaboration with Thoughtworks. PRINCE integrates decades of structured and unstructured safety study reports, leveraging a multi-agent architecture based on Large Language Models (LLMs) and advanced data retrieval methodologies, such as Retrieval-Augmented Generation and Text-to-SQL. In this paper, we describe the three-step evolution of PRINCE from a data search tool based on keyword matching to a resourceful research assistant capable of answering complex questions and drafting regulatory-critical documents. We highlight the iterative development process, guided by user feedback, that ensures alignment with evolving research needs and maximizes utility. Finally, we discuss the importance of building trust-based solutions and how transparency and explainability have been integrated into PRINCE. In particular, the integration of a human-in-the-loop approach enhances the accuracy and retains human accountability. We believe that the development and deployment of the PRINCE chatbot demonstrate the transformative potential of AI in the pharmaceutical industry, significantly improving data accessibility and research efficiency, while prioritizing data governance and compliance.