Mar 18, 05:30 PM - 07:30 PM (PT)
Greater San Diego Chapter: Where REMS Meets Reality - Psychedelics, Patients, and Clinical Trials
This is a in-person event
Location:
Aquillius
10918 Technology Pl
San Diego, CA 92127
Event Description:
This session explores the promise of psychedelic therapies through the lens of lived patient experience, regulatory insight, and hands-on clinical trial management. The panel will examine what it truly takes to design clinical trials and Risk Evaluation Mitigation Strategies within psychedelic clinical research. Attendees will gain a practical understanding of how patient voice, regulatory requirements, and real-world trial execution intersect to create safe, scalable access to emerging treatments such as ibogaine and other psychedelic compounds.
Speakers:
James “Bart” Bartelloni: Chief Revenue Officer, Harvest Connect, LLC
Jamie Freedman: Executive Director, Head of Clinical Operations, Definium Therapeutics
Rachel Bonfanti: Director, Risk Management and Scientific Consulting, UBC
Cynthia LaCivita, Pharm.D.: CLL Consulting, LLC (former Director, Division of Risk Management, CDER, FDA)
Learning Objectives:
Describe strategies for the design of psychedelic clinical trials to support patient safety and regulatory approval.
Explain how clinical trial management practices must adapt to operationalize REMS requirements in studies involving psychedelic therapies, including ibogaine.
Understand how integrating lived patient experience can inform both REMS development and practical trial execution to enable safe, scalable access to psychedelic treatments.
Event Agenda:
5:30 - 6:00 PM | Networking
6:00 - 7:00 PM | Educational Panel
7:00 - 7:30 PM | Networking
Registration Information:
This event is free to attend. Click here to register before 3/18/26. Each attendee is required to have their own registration – only one registration per transaction.
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.
San Diego, CA, United States