Overcome Barriers to Psychedelic Therapies for CNS Diseases
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About this webinar
Psychedelic therapies are rapidly emerging as one of the most promising areas of innovation in central nervous system (CNS) research, offering potential new treatment approaches for individuals living with conditions such as depression, post-traumatic stress disorder (PTSD), anxiety, substance use disorders and other mental health challenges. As scientific understanding of these compounds continues to evolve, researchers are investigating their therapeutic potential to treat mental health disorders. This webinar explores the scientific advances, clinical development considerations and regulatory challenges shaping the future of psychedelic therapies for CNS diseases.
Ongoing research is examining the neurobiological mechanisms underlying psychedelic therapies and their potential to produce sustained therapeutic effects. However, translating these findings into clinical applications requires careful consideration of study design, treatment outcomes, safety and regulatory expectations.
The featured speakers will examine the current clinical development landscape, emerging biomarkers and endpoints, regulatory considerations and the role psychedelics may play in the future of personalized mental health care. Attendees will gain insights into ongoing clinical research, challenges in evaluating therapeutic efficacy and opportunities to develop more individualized treatment approaches.
Register for this webinar to learn about emerging psychedelic therapies for CNS diseases, the challenges of clinical development and the regulatory considerations shaping future treatment strategies.
Who should attend
- Clinical Research Scientists
- CNS Drug Development professionals
- Clinical Development Directors and Managers
- Neuroscientists and Psychiatrists
- Biomarker and Translational Research Scientists
- Regulatory Affairs professionals
What you will learn
- The potential of psychedelic therapies as emerging treatment approaches for depression, PTSD, anxiety, substance use disorders and other mental health conditions
- Neurobiological mechanisms that may drive therapeutic benefits and sustained symptom improvement
- The current pipeline of psychedelic therapies, ongoing clinical trials and challenges in translating research into clinical applications
- Emerging biomarkers and clinical endpoints for evaluating efficacy, optimizing treatment approaches and supporting precision medicine strategies
- Regulatory considerations and evidence requirements for approval, adoption and safe clinical implementation
- Opportunities for personalized mental health care based on patient characteristics and disease biology
- The potential of psychedelic therapies to expand treatment options for individuals who have not responded to conventional treatments
- The importance of collaboration among researchers, clinicians, regulators, sponsors and patient communities in advancing psychedelic therapies
Featured Speakers
Bob Dagher, MD
Dr. Bob Dagher has more than 20 years of leadership across clinical development, medical affairs and regulatory strategy in neuropsychiatry, neuroimmunology and rare disease. He has served as Chief Medical Officer at four biotech companies, leading programs from first-in-human through Phase III and BLA submission across mood disorders, psychotic disorders, neurodegeneration, ALS, MS and rare CNS diseases. Trained in psychiatry at Boston University Medical Center, he holds his MD from Bordeaux University and St. Joseph University School of Medicine.
As Chief Medical Officer at Clinilabs, Dr. Dagher brings a distinguished record of leading scientifically complex CNS drug development programs from first-in-human studies through Phase III and regulatory submission, precisely the full-development continuum that defines Clinilabs’ mission as the industry’s leading neurotherapeutic CRO, helping sponsor partners accelerate their CNS programs with the precision, integrity and CNS depth that only Clinilabs delivers.
Michael Gold, MD
Dr. Michael Gold is Chief Research and Development Officer at Compass Pathways, where he leads patient-centered clinical development focused on generating rigorous, transparent evidence and improving patient access to innovative therapies. With more than 30 years of experience in biopharmaceutical development, he has held leadership roles at AbbVie, Neumora, Johnson & Johnson and GlaxoSmithKline. A recognized leader in neuroscience drug development, Dr. Gold has authored more than 70 publications, served on multiple advisory boards and represented industry on FDA neuroscience advisory committees. He holds degrees in Chemistry, Mathematics, Computer Science and Medicine from the University of Miami and completed neurology training at Albert Einstein College of Medicine and a fellowship in Behavioral Neurology at the University of Florida.
Joseph Tucker, PhD
Dr. Tucker is a seasoned executive who has built several publicly traded biotechnology companies. Dr. Tucker was a Founder and Chief Executive Officer of Stem Cell Therapeutics, which he took public on the TSX (TSX: SSS). Stem Cell Therapeutics was acquired by Trillium Therapeutics (NASDAQ: TRIL, TSX: TRIL) in 2013. Dr. Tucker also held the position of Co-Founder and Chief Executive Officer of Epimeron Inc., a University of Calgary startup acquired as part of the creation of Willow Biosciences Inc. (TSX: WLLW). At Willow, Dr. Tucker served as Executive Chairman and Chief Operating Officer. Before founding these companies, he worked as a Healthcare Analyst at two investment banks and in technology commercialization at a university technology transfer office. Dr. Tucker received his PhD in Biochemistry and Molecular Biology from the University of Calgary.
Alan Metz, MD
Alan Metz, MD, is a Psychiatrist and Founder of Alan Metz Consulting LLC. He recently retired from IQVIA, where he was Senior Vice President, Strategic Partnerships and Chief Medical Officer for the Americas Region. At IQVIA/Quintiles for 16 years, Alan was the first Managing Director in the Customer Solutions Business, establishing strategic partnerships with pharma, then moving to a role as Head of the Global Therapeutic and Specialty Centers of Excellence, offering consultative and advisory services in drug development.
Previously with GlaxoSmithKline for 18 years, Dr. Metz served in various roles, including Global Head of CNS Drug Development, Head of CNS International and US Medical Affairs, Chief Medical Officer for North America and Head of the Office of External Affairs. He was involved in developing and commercializing a variety of CNS compounds, including sumatriptan, naratriptan, bupropion, lamotrigine, paroxetine, remifentanil, ropinirole and a wide variety of other therapeutic area compounds.
Dr. Metz obtained his MD from the University of Witwatersrand, Johannesburg, South Africa. He completed his psychiatry residency and fellowship at Oxford University in England, served as a faculty member at Tufts/New England Medical Center for seven years and is a member of the Royal College of Psychiatrists and a fellow of the American Board of Psychiatry and Neurology. He has part-time academic appointments at UNC Chapel Hill and Duke University.
Partner for this event
Clinilabs
Clinilabs is a global, full-service clinical research organization (CRO) focused exclusively on central nervous system (CNS) drug, device, and technology development. Drawing on deep, indication-level expertise, a proven process, and the latest technology, we expertly manage Phase 1-3 trials to accelerate treatments for a range of psychiatric, neurological, and substance use disorders, as well as rare and ultra-rare CNS disorders. With 25+ years of global experience, over 800 CNS clinical trial awards completed, and over 30+ marketed products across more than 25 indications, we are the industry’s leading neurotherapeutic clinical trial experts.