Shivai Gupta

Shivai Gupta, PhD, is an AI Regulatory Specialist at Weave.Bio, where she helps pharmaceutical and biotech companies navigate the intersection of artificial intelligence and regulatory science. She holds a PhD in Immunology and brings a rare combination of bench science, regulatory, and technology expertise to her work, having spent time at the FDA before moving into industry roles spanning CMC, digital biotech, and scientific informatics. Shivai has spent her career translating complex science into practical strategy, whether that means guiding biologics teams through regulatory submissions or helping AI platforms earn adoption across CMC, Regulatory Affairs, and Medical Writing teams. Her work sits at the center of one of the most consequential shifts in modern drug development: how sponsors build, validate, and defend AI-driven decisions to regulators. She writes and speaks regularly on AI governance in clinical research, with a focus on making emerging regulatory frameworks clear and actionable for scientific and business leaders alike.