Oryzon Genomics, S.A. announced the appointment of Rolando Gutierrez-Esteinou, M.D., as Chief Medical Officer, CNS Programs. Dr. Gutierrez-Esteinou is a Harvard-trained psychiatrist and an accomplished global clinical development executive with more than 20 years of leadership experience advancing neuroscience and psychiatry-focused drug development programs. He brings deep expertise in late-stage clinical execution, regulatory strategy, and pathways to market approval. Most recently, Dr. Gutierrez-Esteinou served as Chief Medical Officer at Atai Life Sciences, where he oversaw a portfolio of clinical-stage CNS programs and built a multidisciplinary development organization supporting multiple trials across psychiatric indications. Throughout his career, he has held senior leadership roles across global pharmaceutical companies?including Johnson & Johnson, Bristol Myers Squibb, and Novartis?as well as in biotech and CRO environments.
His experience spans clinical development from Phase I through Phase IV across major neuropsychiatric disorders, including schizophrenia, mood disorders, addiction, and cognitive impairment. Dr. Gutierrez-Esteinou has contributed to multiple late-stage development programs and regulatory submissions, including supplemental New Drug Applications (sNDAs) and label expansions for established CNS therapies such as Risperdal (risperidone) and Abilify (aripiprazole). He has led regulatory interactions with major global health authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan?s Pharmaceuticals and Medical Devices Agency (PMDA).
He completed his psychiatry residency at Harvard Medical School and held research fellowships at Harvard/McLean Hospital and the U.S. National Institutes of Health (NIH). Oryzon Genomics, S.A. also recognized Dr. Michael Ropacki, who has led the vafidemstat program as CMO?CNS over the past six years with significant success.
