Artificial intelligence (AI) is a field within computer science that focuses on the automation of intelligent behaviour and machine learning. AI promises to revolutionise drug development from the discovery of new active substances to the optimisation of clinical trials. By using AI-supported analytics, companies can monitor and evaluate large volumes of data in real time, enabling them to detect deviations early and identify potential quality issues. However, where there is light, there is also shadow. Behind the promising potential lie complex challenges in the areas of data protection, ethics, and regulation.