Debarshi Dey
Vice President & Head of Biometrics & Data Science Galapagos NV
Dr. Debarshi Dey is Vice President and Head of Data Science at Galapagos NV, where he leads an integrated organization spanning Biostatistics, Statistical Programming, Data Management, Epidemiology, and Preclinical Statistics. With over two decades of experience in clinical development and data strategy, he has been at the forefront of advancing evidence-based decision-making across oncology and immunology programs, including pioneering CAR-T and small-molecule therapies.
A strong advocate for data-driven leadership, Dr. Dey has led initiatives that bridge regulatory science, real-world evidence, and AI-enabled analytics to accelerate drug development and regulatory interactions. His work focuses on transforming Data Science into a strategic partner in drug development—integrating innovation, quality, and patient-centric evidence generation.
Seminars
- Explore how EMA and FDA are evolving their frameworks and reflection papers to define when and how Real-World Evidence can support INDs, BLAs, and marketing authorisations
- Review recent case examples where RWE successfully contributed to regulatory decisions and what made these datasets “regulatory-grade”
- Discuss how improved data access, standardisation, and global collaboration can help biopharma generate credible, fit-for-purpose evidence accepted by multiple regulators
