Abstract
The advancement of digital technology has enabled high-resolution scanning of pathological tissue specimens, producing digital whole slide images (WSI) which can be evaluated in lieu of histological glass slides. The combination of artificial intelligence (AI) technology has accelerated the development of `AI-assisted digital pathology´, which is expected to have a wide range of applications from drug discovery to clinical diagnosis. However, there are several challenges such as regulatory acceptance for development and implementation under GLP. In our presentation, we will introduce the European BIGPICTURE project to create a large-scale database of WSI and our in-house efforts to implement digital pathology in GLP compliant toxicity studies.
[The BIGPICTURE Project] The BIGPICTURE project was established in 2021 to foster rapid development of AI in pathology. This project is a European public-private partnership co-funded by the Innovative Medicines Initiative (IMI) consortium, a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Its goal is to build a large-scale platform for sharing clinical and non-clinical WSI and AI algorithms. Other important objectives of the BIGPICTURE project are to develop regulatory, legal, and ethical frameworks for the optimal use of WSI and AI algorithms for non-clinical safety studies and clinical use. This project is the first European initiative to connect veterinary (toxicologic) and clinical pathologists, researchers, AI developers, patients, industry, and regulatory authorities in an ethical, quality-controlled platform, fully compliant with the EU General Data Protection Regulation (GDPR). It is being developed in a sustainable and comprehensive manner, and its achievements and challenges will be presented.
[GLP Digital Pathology] Boehringer Ingelheim is a German pharmaceutical company dedicated to the global development of innovative medicines and treatments. Through the digitalization of toxicological pathology, timely scientific discussions between pathologists across countries and regions have become possible. Therefore, we are working towards the implementation of digital pathology in GLP-compliant toxicity tests to accelerate the research and development of new drugs.
