Psychedelics 3.0: Challenges and Opportunities in a Rapidly Evolving Field

Life Sciences, Drug Discovery & Development, Fundamental Research,
  • Friday, December 01, 2023

Discover a groundbreaking webinar delving into psychedelic drug development in revolutionizing clinical trials. There is a significant unmet need for medicines to treat neuropsychiatric and neurological conditions in underserved patient populations. Recently, there has been renewed interest in psychedelic, hallucinogenic and dissociative compounds to meet those needs. In clinical trials, a wide array of these compounds are showing efficacy across a variety of indications.

This webinar will cover how psychedelics have progressed from their origins as a spiritual aid to their acceptance as a treatment for neuropsychiatric conditions to the development of next-generation compounds (neuroplastogens) that seek to preserve neuroplasticity-promoting benefits without the hallucinogenic or psychomimetic effects. To understand this journey, attendees will learn about the unique clinical, operational and regulatory challenges that are relevant to efficiently and successfully developing mainstream “psychedelic therapies” for use in neuroscience indications.

Join leading experts from Syneos Health and Delix Therapeutics as they each provide their own unique perspectives during a round-table open discussion about the current and future state of psychedelic drug development and how to actively navigate the rapidly evolving field of clinical trials for these revolutionary treatments.


Andy Moniz, Syneos Health

Andy Moniz, Vice President, Therapeutic Strategy & Innovation — Neuroscience, Syneos Health

Andy Moniz, Vice President, Therapeutic Strategy & Innovation — Neuroscience, has over 28 years of experience in pharmaceutical research in both pharmaceutical/ biotechnology companies and leading CROs. He has been involved in all aspects of clinical development in neuroscience and has led the strategic development planning for multiple compounds resulting in successful filings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for multiple mood disorders, including major depressive disorder (MDD), anxiety disorders including GAD and SAD, autism spectrum disorder, ADHD and psychotic disorders. Andy leads the Innovative Therapeutic Consortium for Psychotherapeutics.

Message Presenter
Zelma Gandy-Don Sing, Syneos Health

Zelma Gandy-Don Sing, PhD, Lead Clinical Scientist, Syneos Health

Zelma Gandy-Don Sing, PhD, is a Lead Clinical Scientist with Syneos Health. She completed her doctoral program at The University of Texas at Austin in clinical psychology. With over 25 years of professional experience as a clinical psychologist, she has worked in a variety of public and private settings conducting clinical research, performing psychological assessments, delivering direct therapeutic interventions, leading mental health program evaluation and providing consultation and technical assistance to programs offering psychological services.

For over a decade at Syneos Health, she has been responsible for supplying primary scientific oversight and therapeutic expertise for clinical trials across a range of neuroscience indications including major depressive disorder, schizophrenia, anxiety disorders, sleep disorders, personality disorders, epilepsy, migraine and Tourette syndrome. Most recently, she has been privileged to work with other members of the Syneos Health Consortium on psychedelic research to expand our knowledge and support advancements in the treatment of psychiatric disorders.

Message Presenter
Aaron Koenig, Delix Therapeutics

Aaron Koenig, MD, Chief Medical Officer, Delix Therapeutics

Dr. Aaron Koenig is the Chief Medical Officer at Delix Therapeutics. He received his MD from the University of Pennsylvania School of Medicine and completed a residency in Adult Psychiatry at the Western Psychiatric Institute & Clinic of UPMC, where he also served as a Chief Resident for Research. He subsequently completed a clinical fellowship in Geriatric Psychiatry at the hospital of the University of Pennsylvania, followed by a post-doctoral research fellowship in psychiatric genetics and translational research at the Harvard T.H. Chan School of Public Health.

Dr. Koenig is a diplomate of the American Board of Psychiatry and Neurology (ABPN) and has been involved in clinical and translational research throughout his career, with a particular focus on the development of treatments for neuropsychiatric disorders with high unmet needs. Prior to Delix, Dr. Koenig was Vice President of Early Medical Science (Clinical Development) at Sage Therapeutics, and earlier in his career worked in Biogen’s Alzheimer’s Disease Research Unit.

Before joining the industry, Dr. Koenig served as a clinical investigator at the Massachusetts Alzheimer’s Disease Research Center and practiced as a clinician in the MGH Memory Disorders Unit in the Department of Neurology at Massachusetts General Hospital.

Message Presenter
Lindsay Crampton, Syneos Health

Lindsay Crampton, Executive Managing Director, Head of Risk and Program Management Advisory Group, Syneos Health

Lindsay Crampton is an Executive Managing Director at Syneos Health, and the head of the Risk and Program Management Advisory Group within Syneos Health’s consulting business unit. Mrs. Crampton’s commitment to patient safety and post-market surveillance started in 2004 when she began her career in patient and pregnancy registries at Syneos Health under the Real World Late Phase team. Mrs. Crampton has since gained extensive experience in safety surveillance, real world evidence, data analytics, Risk Minimization Action Plans (RiskMAPs), Risk Evaluation and Mitigation Strategies (REMS), and observational patient and pregnancy registries, having launched the first shared system REMS in 2010 and leading multiple REMS and post-marketing requirements since.

Message Presenter
Leslie Moldauer, Syneos Health

Leslie Moldauer, MD, MBA, Vice President of Medical Management, Syneos Health

Dr. Leslie Moldauer, MD, MBA is the Vice President of Medical Management at Syneos Health. She has 35 years of diverse clinical experience as a Psychiatrist seeing inpatients and outpatients. During her career, she has worked on numerous Phase I, II, III and IV clinical trials as a Medical Monitor at clinical research organizations (CRO). She has seven years of experience as a Principal Investigator or Sub-Investigator on over 100 clinical trials including depression, anxiety, PTSD, migraine headache, Alzheimer’s Disease, Mild Cognitive Dementia, weight loss, smoking cessation and vaccines. She has worked at Syneos Health since 2017.

Message Presenter

Who Should Attend?

This webinar will appeal to CEO, CSO, CMO, CDO, COO VP, SVP, EVP, Sr. Director, Director, Head, etc. of:

  • Venture Capitals (VCs) – private equity firms looking to financially back psychedelic research, biotech companies, venture partners, CMOs, clinical operations, involved in R&D and designing the product development
  • Pharmaceutical/biotechnology companies in the psychedelic space including any company in the neuroscience space (CNS [central nervous system], psychiatry, pain/analgesia, neurology) in the following fields/roles:
  • Clinical development
  • Clinical science
  • Clinical operation
  • Regulatory
  • Clinical project management
  • Business development
  • Clinical Scientist

What You Will Learn

Attendees will gain insights into:

  • The current landscape of psychedelic research in clinical trials
  • How this landscape is going to change; taking examples of previous work and recognizing how things will evolve and shift in the future
  • The REMS (risk evaluation and mitigation strategies) requirements — when to start thinking about the future commercialization component

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