Oryzon Appoints Rolando Gutierrez-Esteinou, A Veteran Neuropsychiatry Executive, As Chief Medical Officer, To Lead CNS Clinical Development And Strengthens CNS Pipeline

Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company focused on epigenetics, has appointed Rolando Gutierrez-Esteinou, M.D., as Chief Medical Officer, CNS Programs. Dr. Gutierrez-Esteinou is a Harvard-trained psychiatrist with more than 20 years of experience leading global neuroscience and psychiatry drug development programs. He brings extensive expertise in late-stage clinical development, regulatory strategy, and market approval pathways.

“It is a privilege to join Oryzon as Chief Medical Officer and help advance vafidemstat, the only LSD1 inhibitor in clinical development for CNS indications, for the treatment of agitation and aggression in patients with borderline personality disorder”, said Dr. Gutierrez-Esteinou. “I came to Oryzon because they think differently about the pathophysiology of CNS disorders and the use of epigenetic approaches to seek safer, more effective treatments for people with BPD and other psychiatric disorders. People with BPD live with deep disability and distress that current medicines do not adequately relieve. Vafidemstat may become the first treatment of its kind in a field that has not seen progress in many years. My aim is to lead a clinical program that is scientifically rigorous, ethically sound, and truly centered on patients, so that it can bring real relief to those in need. We will work side by side with patients, investigators, and regulators, and we will move with the urgency that this serious unmet need demands.”

Most recently, he served as Chief Medical Officer at Atai Life Sciences, where he oversaw a portfolio of CNS clinical programs and built a multidisciplinary development organization supporting multiple psychiatric trials. Over the course of his career, he has held senior leadership roles at major pharmaceutical companies, including Johnson & Johnson, Bristol Myers Squibb, and Novartis, as well as in biotech and CRO settings. His clinical development experience spans Phase I through Phase IV programs across schizophrenia, mood disorders, addiction, and cognitive impairment.

“Rolando is an outstanding addition to Oryzon’s executive team,” said Carlos Buesa, Chief Executive Officer of Oryzon. “He brings a rare combination of deep clinical expertise in psychiatry, extensive late-stage CNS development experience, and proven regulatory leadership. His strong track record in advancing innovative therapies through pivotal development and supporting successful regulatory submissions will be invaluable as we prepare to move vafidemstat, our lead CNS program, into Phase III clinical development for the treatment of agitation and aggression (A/A) in borderline personality disorder (BPD), while also expanding its clinical development in A/A in autism spectrum disorder and in negative symptoms of schizophrenia, with a clear path toward future regulatory approval.”

He has played a key role in multiple late-stage development initiatives and regulatory submissions, including supplemental New Drug Applications (sNDAs) and label expansions for CNS therapies such as Risperdal (risperidone) and Abilify (aripiprazole). Dr. Gutierrez-Esteinou has led regulatory interactions with major 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 National Institutes of Health (NIH). Oryzon also expressed its gratitude to Dr. Michael Ropacki for his leadership of the vafidemstat program as CMO–CNS over the past six years.