Iman Barilero

Dr Iman Barilero is a biopharmaceutical executive with over 30 years of global leadership in regulatory affairs and drug development across academia, large pharmaceutical companies, and biotech. She has a proven track record in guiding Phase II–III programs, securing global approvals, and developing innovative regulatory pathways, particularly in CNS and immuno-oncology. Her expertise includes direct engagement with major health authorities such as the FDA (CBER & CDER), EMA, PMDA, CFDA, Health Canada, ANVISA, and other.

Dr Barilero has held senior positions at Roche, Johnson & Johnson, Lundbeck, Agenus Bio, Poxel Pharma, Solid Biosciences, and Cytovation. At Lundbeck, she served as Vice President, Head of Global Regulatory Science for CNS, where she led global regulatory strategies for breakthrough therapies targeting depression, bipolar disorder, schizophrenia, stroke, Alzheimer’s disease, Parkinson’s disease, and alcohol dependence. She played a pivotal role in securing first-in-class label claims for cognition in major depressive disorder (Brintellix/Trintellix), and regulatory approvals across the US, EU, Japan, China, and other major markets.

She holds a Pharm.D. in Pharmacy and Pharmaceutical Chemistry and a Ph.D. in Molecular and Cellular Pharmacology.