AI/ML in drug product development & manufacturing - report on the 8th APV Winter conference.

Artificial Intelligence and Machine Learning (AI/ML) have already revolutionized Drug Discovery. However, Chemistry, Manufacturing, and Controls (CMC) remains in "digital infancy". This report from the 8th APV Winter Conference with 55 participants details a critical industry shift toward Digital Design and Quantitative Formulation. Five cooperative shifts are necessary for this transformation: redefining scientists as orchestrators, democratizing computational fluency, prioritizing structured data, optimizing strategic experimentation, and aligning with evolving regulatory frameworks. Critical challenges like data reliability, model explainability, and "human-in-the-loop" accountability are addressed. Through case studies ranging from physicochemical profiling, formulation and process development, equipment design, manufacturing and analytical control, and biopharmaceutics, the conference demonstrated how AI/ML creates high-fidelity and interoperable architectures advancing drug product development and manufacturing.