ORYZON Appoints Dr. Iman Barilero As Senior Advisor For Regulatory Affairs To Strengthen Its Global Regulatory Strategy

Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company and global leader in epigenetics, has announced a strategic collaboration with Dr. Iman Barilero, PharmD, PhD, who will serve as Senior Advisor for Regulatory Affairs. In this role, Dr. Barilero will support the company’s advancement of its Phase III clinical program with vafidemstat for the treatment of Borderline Personality Disorder (BPD). Dr. Barilero brings over three decades of global regulatory leadership in central nervous system (CNS) disorders, neuropsychiatry, immuno-oncology, and rare diseases. 

She has extensive experience guiding late-stage development programs, securing worldwide approvals, and building innovative regulatory strategies. Her career includes direct interaction with major health authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, China’s CFDA, Health Canada, ANVISA in Brazil, and several others. Her background spans academia, large pharmaceutical companies, and emerging biotechs. 

Notably, during her tenure as Vice President and Head of Global Regulatory Science for CNS at Lundbeck, she led global regulatory initiatives for treatments targeting depression, bipolar disorder, schizophrenia, stroke, Alzheimer’s disease, Parkinson’s disease, and alcohol dependence. Among her key achievements was playing a central role in obtaining first-in-class label claims for cognition in major depressive disorder for Brintellix (also known as Trintellix). Under her guidance, the therapy achieved regulatory approvals across major markets including the United States, European Union, Japan, and China.

Commenting on the collaboration, Dr. Carlos Buesa, CEO of Oryzon Genomics, said, “This new collaboration forms part of Oryzon’s broader strategy to strengthen its Medical, Regulatory, and Strategic functions. Dr. Barilero’s deep expertise in CNS drug development and her leadership in global regulatory affairs will be critical as we prepare to move vafidemstat into Phase III trials and address all regulatory considerations identified by the FDA. Her insights will also help guide the advancement of our late-stage programs in Borderline Personality Disorder and Schizophrenia, as well as our early-stage initiatives in Autism Spectrum Disorder (ASD).”

Dr. Barilero expressed her enthusiasm for joining Oryzon, stating, “I’m thrilled to collaborate with Oryzon at this important stage as Senior Advisor for Regulatory Affairs. Vafidemstat represents a promising new approach for patients with CNS disorders, and I look forward to contributing my experience in global regulatory strategy to support its clinical development and ensure strong alignment with the FDA and other regulatory agencies.”

Oryzon’s growing CNS portfolio includes several programs targeting neuropsychiatric and neurodevelopmental disorders. Vafidemstat is currently being evaluated in EVOLUTION, a randomized, double-blind, placebo-controlled Phase IIb clinical trial designed to assess its ability to improve negative symptoms in patients with schizophrenia. In addition, the company is preparing to launch a new clinical trial evaluating vafidemstat in Autism Spectrum Disorder (ASD), expanding its reach within CNS therapeutic areas. Through this collaboration with Dr. Barilero, Oryzon aims to further strengthen its regulatory capabilities and accelerate the development of vafidemstat as a potential first-in-class therapy for Borderline Personality Disorder and other CNS-related conditions.