The idea of a “one-click” Biologics License Application (BLA) has become the ultimate benchmark for what AI could enable in drug development — a world where data moves seamlessly from discovery to submission, with every result, dataset, and citation verified, traceable, and regulator-ready. But how far are we actually from that reality?

This session explores the technologies, infrastructures, and cultural shifts needed to bring automation to one of the most complex and high-stakes processes in life sciences: regulatory submission. The discussion will cut through the hype to define what “submission-grade AI” really means, the challenges that still stand in the way of full automation, and what it will take to build the regulatory trust required to get there.
Join us as we examine the future of AI-driven submissions — and ask the provocative question: could the next BLA really be submitted with a single click?

Learn how scalable, cloud-based AI infrastructure accelerates model training, data integration, and collaborative research across global drug discovery teams.

Explore practical strategies for building high-quality, diverse datasets that reduce bias and improve model performance across drug discovery pipelines.