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.
Speakers
Andreas Schreiner, MD, Senior Vice President, Medical Affairs, Neuroscience & Analgesia, Premier Research
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.
Message Presenter
Rishi Kakar, MD, Chief Scientific Officer and Medical Director at Segal Trials, Premier Research
As a Chief Scientific Officer and Medical Director, Dr. Kakar plays a key role in the development and execution of scientific strategy for Segal Trials and provides oversight to the medical team. Dr. Kakar is a board-certified Psychiatrist who has been focused on investigating new treatments for patients suffering from mental illness through rigorous research for over 12 years. Dr. Kakar has been a Principal Investigator of over 200 Phase I to IV outpatient and inpatient clinical studies in indications including ADHD, depression, anxiety, bipolar, PTSD, schizophrenia, substance abuse and other neuropsychiatric conditions.
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Dr. Kakar maintains a specialized focus on early-phase research and has contributed to many First-in-Human, SAD and MAD studies. Driven by a long standing passion to explore innovative treatment options for mental illness, Dr. Kakar was one of the earliest private researchers to receive DEA Schedule 1 license to conduct research on Psychedelics. Dr. Kakar currently serves as a Medical Director for Segal Trials’ Center for Psychedelic and Cannabis research and is investigating the potential of Psilocybin, LSD, Cannabis and 5 MeO-DMT among others for treating various psychiatric conditions.
Dr. Kakar has extensive experience collaborating with pharmaceutical, biotech and clinical research organizations and has been highly sought after for his input on research methodology and clinical trial design. He received his Medical Degree from Albany Medical College, and thereafter, he pursued his Psychiatry training at Georgetown University School of Medicine.
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Who Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited to:
- Drug Development
- Clinical Operations
- Medical Affairs
- Regulatory Affairs
- Project Management
What You Will Learn
Attendees will gain insights into:
- 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
Xtalks Partner
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.
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