Executing Successful Psychedelic Studies from Protocol to Patient
About this webinar
Psychedelic clinical trials present unique challenges that can make successful execution fundamentally different from small molecules. The psychedelic experience, blinding, psychotherapy assistance and previous use, for example, introduce complexity that sponsors need to address early in the development process. Experienced cross-functional teams and sites with the right medical expertise, infrastructure and capabilities can help sponsors navigate these challenges.
In this webinar, the featured speakers will share complementary perspectives from CRO and site network organizations on what it takes to successfully design and execute psychedelic trials. The discussion will focus on three critical areas: translating the unique characteristics of psychedelics into thoughtful trial design, operationalizing complex studies at the site level and developing assessment strategies that support reliable and meaningful data. By bringing these perspectives together, the webinar will highlight strategies for anticipating challenges, strengthening study execution and building effective partnerships from the outset.
Ultimately, successful psychedelic development depends not only on a well-designed protocol, but on early collaboration with experienced partners who understand how to bring that protocol to life.
Register for this webinar to learn how psychedelic studies can be designed and executed to address trial complexity and support reliable study outcomes.
Who should attend
- Drug Development
- Clinical Operations
- Medical Affairs
- Regulatory Affairs
- Project Management
What you will learn
- Translating the unique challenges of psychedelics into effective trial design
- Strategies for successfully executing complex studies at the site level
- Approaches to assessment and data collection that support reliable results
- How early collaboration with experienced partners can strengthen trial execution
Featured Speakers
Andreas Schreiner, MD
Dr. Schreiner has considerable experience as a Clinician, Clinical Researcher and Investigator, and brings more than 25 years of drug development experience within the pharmaceutical industry and CRO environment. He has contributed to numerous global development programs, including Phase II and III programs for various psychiatric (e.g., MDD, TRD, GAD, SAD, PTSD, schizophrenia and BD) and neurologic disorders. In his current role, he provides strategic planning, coordination and scientific expertise across neuroscience and analgesia projects, as well as consultative services spanning the full product lifecycle.
Dr. Schreiner is a board-certified Psychiatrist and Neurologist. He studied medicine at the Universities of Heidelberg and Mannheim, Germany, and completed residencies in the University Department of Neurology and in Psychiatry at the Central Institute of Mental Health, both in Mannheim, Germany.
Rishi Kakar, MD
Dr. Rishi Kakar, MD is the Chief Scientific Officer and Medical Director at Segal Trials and a nationally recognized leader in psychedelic and CNS clinical research. He is a board-certified psychiatrist and Principal Investigator with experience on more than 200 Phase I-IV clinical trials studying innovative treatments for depression, PTSD, schizophrenia, substance use disorders, and other neuropsychiatric conditions. Dr. Kakar is among the earliest community-based investigators in the United States to receive a DEA Schedule I research license and has led pioneering studies of psilocybin, LSD, 5-MeO-DMT, methylone, and other emerging psychedelic therapies, including single-site complex PK focused dose finding studies within the psychedelic space. He is a frequent advisor, sought out speaker, and collaborator across the pharmaceutical and biotechnology industries. As Medical Director of Segal Trials’ Center for Psychedelic and Cannabis Research, Dr. Kakar oversees specialized research infrastructure designed to support the unique operational, regulatory, and clinical requirements of psychedelic studies.
Partner for this event
Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more visit premier-research.com.