TITLE
Opportunities, Challenges and the Role of Real-World Evidence in Designing Clinical Trials of Ibogaine as an Addiction Therapy.

ABSTRACT
Ibogaine, granted MHRA approval for human testing, joins the current landscape of psychedelic medicines in clinical development. Online forums endorse the benefits of ibogaine as an “addiction interrupter” and open label pilot studies of ibogaine-assisted drug detoxification have shown positive benefit. Dr. Mash will discuss the opportunities and challenges in executing clinical trials. She will discuss the importance of real-world evidence (RWE) to complement data from clinical trials as the greatest opportunity area.

BIOGRAPHY
As a neuroscientist, lecturer, and inventor who has dedicated more than 30 years of research to unlocking the secrets of the human brain, Professor Mash is nationally recognised as a leading researcher in the fields of genomic research, neurobiology of addiction and brain disorders, playing a pivotal role in over 300 published studies.

Professor Mash received her Ph.D. in Neuropharmacology from the University of Miami Leonard M. Miller School of Medicine. She completed a fellowship in Neurology and Neuroanatomy at Beth Israel Hospital, Harvard Medical School. She is Professor Emeritus of Neurology and Molecular and Cellular Pharmacology, University of Miami Miller School of Medicine. Dr. Mash is the founder and former director of the University’s Brain Endowment Bank, one of six federated NIH NeuroBioBanks. She is currently on the faculty of Dr. Kiran C. Patel College of Medicine at Nova Southeastern University.

She is the CEO and Founder of DemeRx Inc., a clinical stage drug development company advancing ibogaine and its active metabolite noribogaine for the treatment of opioid use disorder. DemeRx has partnered with ATAI Life Sciences -- a global biotech platform with a special focus on psychedelic medicine -- to develop ibogaine for those suffering from opioid use disorder. Dr. Mash works with a team of academic and industry researchers to advance small molecules from basic discoveries in the laboratory to the patient’s bedside.