Debarshi Dey, PhD, is a global Biometrics and Data Science executive with more than 15 years leading quantitative strategy in oncology, hematology, and immunology drug development across both biotech and large pharma, including Novartis, LivaNova, MorphoSys, and Galapagos. His career spans the full development lifecycle, from Phase I dose-finding through pivotal NDA and BLA submissions, with deep expertise in Bayesian and adaptive trial design and in regulatory interactions with the FDA, EMA, and PMDA. At both Galapagos and MorphoSys he built data science organisations from the ground up, scaling them to a combined headcount of more than fifty.

He has led statistical strategy for multiple global approvals, including tafasitamab (Monjuvi) in diffuse large B-cell lymphoma, which achieved FDA approval and EMA conditional marketing authorisation on its first review cycle, as well as CAR-T cell therapy programmes for myelofibrosis and lymphoma. He has partnered directly with chief medical officers, regulatory, and clinical leadership in FDA Type D meetings and EMA Scientific Advice, and is a frequent keynote speaker on adaptive design and AI in drug development, an invited journal reviewer, and a published author in Blood Advances, the American Journal of Hematology, and Clinical Cancer Research.

He holds a PhD in Applied Statistics from the University of California, Riverside, and master's and bachelor's degrees in Statistics from Calcutta University. His work focuses on translating complex statistical concepts into clear, practical insight that helps clinical teams make better development decisions, the same approach he brings to his teaching.