In this webinar, gain insights from the recent advisory committee (ADCOM) meeting and the US Food and Drug Administration (FDA) action letter for Lykos' new drug application (NDA) for using 3,4-methylenedioxymethamphetamine (MDMA) as a treatment for post-traumatic stress disorder (PTSD). Attendees will learn regulatory perspectives and guidance on clinical trials with psychedelic drugs. The featured speakers will share key considerations for designing and operationalizing psychedelic drug studies. The speakers will also discuss approaches for selecting the right contract research organization (CRO) partner.
TORONTO, Oct. 23, 2024 /PRNewswire-PRWeb/ -- 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.
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 psychedelics as medical treatments clinical development and gain insights into the regulatory frameworks and unique challenges associated with the clinical development of these therapies.
Join experts from Premier Research, Carlos Langezaal, PhD, Senior Director of Regulatory Affairs; and Andreas Schreiner, MD, Senior Vice President, Medical Affairs, Neuroscience and Analgesia, for the live webinar on Thursday, November 14, 2024, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Shifting Perceptions in Psychedelics: Challenges and Progress in Drug Development.
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Vera Kovacevic
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