The psychedelic field is entering a new era. From early regulatory engagement to pending regulatory acceptance, what once felt fringe is now center stage with unprecedented attention from regulators and policymakers fueling a surge in medical and commercial possibility. At the heart of this momentum lies serious unmet need in treatments for numerous complex psychiatric, neurological and immune conditions and the promising results of psychedelics studied in difficult to treat disorders such substance use disorders, depression, and anxiety and trauma-related disorders. Regulation of psychedelics as a treatment option with reimbursement represents a significant opportunity for patients, sponsors, and overall public health. However, as with all medicines, opportunities come with risk and an array of regulatory and clinical complexities for developers trying to deliver therapies with a positive Benefit-Risk Assessment.
In this session, MMS Holdings’ Chief Executive Officer Dr. Uma Sharma and Dr. Amanda Beaster, Senior Director, Regulatory Strategy will reflect on the critical milestones that have shaped the current psychedelic drug development landscape. Together with moderator Ben Dudley, Chief Commercial Officer, they’ll examine the realities developers now face and share practical insights to help sponsors stay ahead.
Drawing on real-world sponsor and regulatory interactions, this session will explore the critical questions and emerging best practices that are actively shaping the regulatory conversation- as the industry stands at a clear inflection point.
- Understand how recent regulatory decisions and designations are reshaping the psychedelic development landscape
- Learn how to navigate common pitfalls in clinical and regulatory strategy for psychedelic therapies
- Discover why pharmacological differentiation and indication-specific strategies are critical to success
- Gain real-world insights from sponsor and regulatory interactions that are actively shaping the field
- Hear expert recommendations on balancing urgency with scientific and regulatory rigor
- Explore what’s changed—and why now is a pivotal moment for psychedelic drug development
- How recent decisions, milestones, designations, and precedent have shaped the current landscape
- The importance of pharmacological differentiation within the class and indication-specific strategies
- Common pitfalls and challenges in both regulatory and development strategy for psychedelics
- Why we’re at a potential turning point—and what’s changed
- Their experience-backed recommendations for sponsors looking to balance urgency with scientific and regulatory rigor in a fast-moving landscape.
This session is designed for professionals involved in the development, regulation, and commercialization of psychedelic therapies, including:
- Regulatory Affairs Professionals
- Regulatory Strategists
- Regulatory Affairs Managers/Directors
- Global Regulatory Leads
- Clinical Development Leaders
- Clinical Program Directors
- Clinical Operations Managers
- Medical Directors
- Medical & Scientific Experts
- Chief Medical Officers
- Clinical Scientists
- Translational Medicine Leads
- Pharmaceutical Executives
- CEOs, COOs, and CCOs of biotech/pharma companies
- Business Development Executives
- Portfolio Strategy Leads
- Psychedelic Program Stakeholders
- Psychedelic R&D Leads
- Neuroscience and Psychiatry Researchers
- Innovation and Pipeline Strategy Teams
- Market Access & Policy Professionals
- Health Economics & Outcomes Research (HEOR) Specialists
- Market Access Strategists
- Policy and Advocacy Leads
Who is this webinar for?
This webinar and panel discussion is designed for regulatory affairs professionals, clinical development leaders, medical and scientific strategists, and anyone involved in or exploring the evolving landscape of psychedelic drug development.
Will there be a recording available?
Yes, a recording will be shared with all registered attendees after the live session.
Where can I get more information on the content presented?
To connect with the presenters or learn more about the topics discussed, please email info@mmsholdings.com and our team will direct your inquiry to the appropriate expert.
As a science-first organization, MMS has been at the forefront of shaping several high-profile psychedelic development programs. With a wealth of first-hand insights our speakers bring both a pragmatic and big-picture lens —helping sponsors avoid missteps and make informed decisions within this evolving field.
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