Psychedelic drugs may offer promise for the treatment of certain mental health conditions, such as post-traumatic stress disorder (PTSD), but the development process is less straightforward than traditional medicines due to negative preconceptions and clinical study complexity.
As psychedelics move from recreational use into clinical development, there is a need for greater clarity on the regulatory framework for these therapeutics. Psychedelic studies also present unique challenges related to protocol design, site selection and study execution.
In this webinar, the expert speakers will explore the current landscape of psychedelic clinical development and discuss critical considerations for ensuring scientific rigor, patient safety, data quality and ethical conduct. They will also provide a comprehensive review of the recent advisory committee (ADCOM) meeting and the FDA action letter concerning Lykos’ new drug application (NDA) for the use of 3,4-methylenedioxymethamphetamine (MDMA) as a treatment for PTSD.
The attendees will gain a better understanding of the regulatory landscape for clinical trials involving psychedelic drugs, including current perspectives and guidance that can influence study design and execution. The speakers will explore the key considerations necessary for designing and operationalizing studies within this unique and emerging field.
Register for this webinar to explore the emerging field of psychedelic clinical development and gain insights into the regulatory frameworks and unique challenges associated with these therapies.
Speakers
Carlos Langezaal, PhD, Senior Director of Regulatory Affairs, Premier Research
Carlos Langezaal, PhD, Senior Director of Regulatory Affairs, is a regulatory professional with 30 years of experience in regulatory affairs. Most of his previous positions were as Global Regulatory Lead in which he was responsible for developing strategies to achieve regulatory and business objectives globally.
Carlos has experience across all stages of global drug development from pre-IND/CTA through Phase III/registrational phase, as well as life cycle management of marketed products, including indication extensions and other filings. Therapeutic areas include allergy, respiratory, dermatology, general medicine, CNS and hematology/oncology.
Carlos has prepared and led critical communications/interactions to/with global health authorities, such as meetings with the US Food and Drug Administration (FDA) at all stages of development, with the European Medicines Agency (EMA) and (Co-)Rapporteurs regarding requests for information (Oral Explanations) and with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). He has also led many types of regulatory filings, including NDA/MAA, IND/CTAs, sNDA/sBLA, and line extensions for new indications or safety label updates.
Message Presenter
Andreas Schreiner, MD, Senior Vice President, Medical Affairs, Neuroscience and Analgesia, Premier Research
Dr. Schreiner has considerable experience as a clinician, clinical researcher, and investigator, and brings more than 23 years of global experience within the pharmaceutical industry and clinical research environment. In his role, he is responsible for providing strategic planning, coordination, knowledge, and expertise in neuroscience and analgesia projects and/or standalone consultative services for development programs covering entire product lifecycles.
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 PresenterWho 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
- Project management
- Regulatory affairs
What You Will Learn
Attendees will learn about:
- Review of the recent ADCOM meeting and FDA action letter for Lykos’ NDA for using MDMA as a treatment for PTSD
- Regulatory perspectives and guidance on clinical trials with psychedelic drugs
- Key considerations for designing and operationalizing psychedelic drug studies
- Approaches for selecting the right contract research organization (CRO) partner
Xtalks Partner
Premier Research
Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.
Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.
As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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