At the AI & Digital Health Summit in Basel 2025, hosted by Novartis, pharmaceutical leaders, including representatives from companies like Novo Nordisk, Roche, and Sanofi, discussed the integration of AI in clinical development, highlighting its transformative potential and the challenges in its implementation. Novo Nordisk demonstrated a significant advancement by reducing the time for generating Clinical Study Reports from up to 15 weeks to same-day delivery using AI, with regulators showing a preference for the AI-generated versions due to their completeness and objectivity. The conference emphasized that while AI promises efficiency in drug development, especially in documentation automation and agentic AI, the greatest hurdle remains organizational transformation, as the adoption of AI requires changes in employee roles and workflows, often met with resistance due to concerns over professional identity and career progression. Presenters, including Maxwell Lawson from Novartis and Thomas Brookland from Roche, stressed the need for a co-learning approach between regulators and the industry to foster innovation without compromising compliance, highlighting ongoing debates over regulatory frameworks like the EU AI Act. The summit reinforced the message that successful AI integration in the pharmaceutical sector hinges on balancing productivity gains with stringent compliance, and companies like Ona are developing platforms to help navigate these challenges by providing AI-driven solutions that ensure both efficiency and regulatory adherence.