Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation at Takeda

Speaker

Andrew S. Robertson, Ph.D., JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as reliance pathways, regulatory predictability, and modernization through digital and AI—including GenAI in regulatory authoring, cloud-based regulatory submissions, and data-driven regulatory systems modeling.

With over 20 years of experience across the biopharmaceutical industry, academia, and government, Andrew has worked at the intersection of science, law, and policy to drive innovation and improve patient access to medicines. His career includes service as a science policy advisor at the U.S. Department of Health & Human Services and as a faculty researcher at the Wellcome Trust Sanger Institute. His scholarship spans regulatory science and innovation, with recent publications in Nature Reviews Drug Discovery (cloud-based federated platforms, 2025; alternatives to animal testing, 2024) and JAMA (regulatory predictability, 2023). He holds a JD from UC Berkeley School of Law and a PhD in Structural Biochemistry from the University of Cambridge, where he was a Gates Cambridge Scholar.