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Conference Agenda

DAY ONE - MAY 4, 2021 (central daylight time)

9:30 am A Crystal-clear View of Psychedelic Drug Actions
In this talk Dr. Roth will:
- Present new findings which illuminate the 'hidden pharmacology' of psychedelic drugs and show why this information is therapeutically important
- Show how we can leverage an understanding of the molecular details of psychedelic drug actions to discover new psychedelic and non-psychedelic neuropsychiatric medications
Bryan Roth, MD, Ph.D., Michael Hooker Distinguished Professor of Pharmacology, University of North Carolina Chapel Hill School of Medicine

10:00 am Chemistry and Biology of Novel 5-HT2C/2A Agonists - Looking Beyond Lorcaserin
In this presentation, Dr. Kozikowski and Dr. Shreeniwas will discuss the following:
- Discovery of Novel 5-HT2 Agonists - Chemistry and Pharmacology
- ADME/PK Parameters
- Behavioral Biology
- Medical Indications
- Future Challenges
Alan Kozikowski, Ph.D., Chief Scientific Officer, Bright Minds
Revati Shreeniwas, MD, Chief Medical Officer, Bright Minds

10:40 am Ultra-large Library Docking for New Chemotypes with New Pharmacology
Beginning with the structure of targets like the 5HT2a receptor, libraries of 100 million to 2 billion molecules are screened for complementarity, and high ranking ones are tested for in vitro and ultimately in vivo modulation of the targets and the behavior they control. New developments that have opened up chemical space for the discovery of novel chemotypes will be considered, including the use of both ultra-large general libraries (about 2 billion molecules) as well as more focused bespoke libraries around particular scaffolds (about 75 million molecules each) will be considered.
Brian Shoichet, Ph.D., Professor, Department of Pharmaceutical Chemistry, University of California San Francisco

11:10 am Discovery and Development of New 5-HT2AR Agonists
The NBOMe-class of compounds have provided several useful tool-compounds used to interrogate the function of the 5-HT2A receptor in both preclinical and clinical research. Furthermore, data from the preclinical development of novel 5-HT2AR agonists within Lophora will also be presented.
Jesper Langgaard Kristensen, Ph.D., Professor, Medicinal Chemistry, Department of Drug Design & Pharmacology, University of Copenhagen, Chief Scientific Officer, Lophora

11:40 am The NYU Psilocybin Cancer Project
This talk will review the historical and recent research on psychedelic-assisted psychotherapy for advanced cancer-related psychiatric and existential distress.
Stephen Ross, MD, Associate Director, NYU Langone Health Center for Psychedelic Medicine

12:10 pm Lunch Break

12:40 pm Focused Pharma: Innovating Design of Fast-acting Therapeutics for Neuropsychiatric Health
DARPA traditionally supports high-risk/high-reward research efforts to establish feasibility and de-risk novel approaches for advanced development of technology relevant to national defense. Military servicemembers suffer a disproportionate impact of mental health conditions, and could benefit from rapid-acting therapeutics. Focused Pharma as a program is bringing together applications of structural biology, novel medicinal chemistry, new and established preclinical behavioral and physiological model systems. The program is designed to take new chemical compounds, unrelated to any in existence, from their interactions with the target all the way through preclinical evaluation and determine if the relationships between receptor target engagement and signaling pathway activation can be leveraged to produce fast-acting psychiatric medications that do not produce hallucinatory or dissociative effects. There is a clear need space for innovation in psychopharmacology. Phenomenological studies show evidence for effect, but mechanistic information is required to elaborate phenomena into predictable treatment effects. This development space would be well-served by a diverse array of tools to help establish mechanisms.
Tristan McClure-Begley, Ph.D., Program Manager, Focused Pharma, Defense Advanced Research Projects Agency (DARPA)

1:10 pm Challenges in Conducting Clinical Research with Schedule I Psychedelics: From the 1960s to the Present
This presentation will detail how LSD research changed in 1962 with the introduction of the regulatory laws we function under now, explaining what they are, and why the reason research ended during that period wasn’t because of a government crack down, but because no one had submitted an NDA after decades of federal support. Dr. Bonson will also discuss current issues for evaluating safety and efficacy and will finally discuss evaluation of abuse potential.
Katherine Bonson, Ph.D., Senior Pharmacologist, Controlled Substance Staff, United States Food & Drug Administration

1:40 pm Leveraging Data to Drive and Improve the Future of Psychedelic Medicine
The emergence of the psychedelic medicine industry is providing a unique opportunity to build a better system of psychiatric and mental healthcare, in part by leveraging data and advanced technology to guides drug development and intelligently inform patient experience. To that point, Entheon is developing a personalized system of psychedelic medicine that utilizes data analysis, while implementing the latest advancements in EEG technology and AI/machine learning platforms in order to develop a safe & effective means of administering psychedelic medicine. In addition, Timothy will speak to the challenges of bringing a scheduled drug, such as dimethyltryptamine (DMT), through a research pathway to a point of commercial readiness, while also highlighting why Entheon chose DMT as our target molecule for therapeutic application.
Timothy Ko, Chief Executive Officer, Entheon Biomedical

2:10 pm The Psychedelic Hype Cycle - Inflated Expectations, Disillusionment, and the Slope of Enlightenment
In this presentation, Eleusis founder Shlomi Raz will discuss the Gartner "Hype Cycle" as it relates to the psychiatric applications of ketamine and psilocybin, highlighting the challenges to unlocking the therapeutic potential of this emerging therapeutic class.
Shlomi Raz, Chief Executive Officer, Eleusis

2:40 pm The Integration of Psychedelic Therapy and Clinical Virtual Reality
The merger of VR as a complimentary tool for enhancing a clinical psychedelic experience is now a viable and compelling option. To support this vision, a model that informs the safe and thoughtful integration of VR-delivered content with therapeutic psychedelic experiences is needed. This presentation will briefly describe how VR is applied in a theoretically informed and empirically validated fashion for mental health treatment and describe the elements of a proposed model for providing patients with informed VR options for shaping the direction of their psychedelic experience to address therapeutic targets of relevance.
Albert Rizzo, Ph.D., Director, Medical Virtual Reality - Institute for Creative Technologies, Research Professor, Dept. of Psychiatry and School of Gerontology, University of Southern California

DAY TWO - MAY 5, 2021 (central daylight time)

9:30 am Prolonged Epigenetic Alterations Following Single Exposure to a Psychedelic in Mice
Clinical studies report that psychedelics exert rapid and sustained antidepressant responses. Our data suggest that a single administration of the psychedelic DOI induced fast-acting effects on mouse frontal cortex dendritic spine structure and fear extinction via 5-HT2A receptor. This was associated with long-lasting changes in chromatin organization at enhancer regions of genes involved in synapse assembly, suggesting epigenetic plasticity as a critical component that contributes to the antidepressant action of psychedelics.
Javier Gonzalez Maeso, Ph.D., Professor of Physiology and Biophysics, Virginia Commonwealth University School of Medicine

10:00 am MDMA and Ketamine: Translating Mechanism into Better Therapy
Among the emerging class of rapid-acting psychiatric therapies, MDMA and ketamine have the strongest clinical evidence for efficacy. Understanding how these drugs trigger lasting behavioral transformations is the first step toward designing safer, more precise therapies. In this presentation, Dr. Heifets will review our group's efforts to define these drugs' actions in animal models, in terms of coordinated ensembles of neural circuits across the brain.
Boris D. Heifets, MD, Ph.D., Assistant Professor, Dept. of Anesthesiology, Perioperative & Pain Medicine, Stanford University School of Medicine

10:30 am Hot Topics in Psychedelic Drug Development: From Successful Clinical Trials to Maximizing Benefits in the Post-approval World
This session will bring together speakers representing government, industry, and the non-profit sector to discuss some of the biggest issues facing developers of psychedelic drugs.
Moderator: Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates

How Non-clinical Research Can Inform the Clinical Development and Prescribing of Psychedelic Drugs
Evidence from non-clinical research with the ‘legacy’ psychedelics can help address important questions about tolerability, safety and abuse for the next generation of novel, psychedelic drugs that are being developed by the pharmaceutical industry.
David J. Heal, Ph.D., Executive Director, DevelRx Ltd., Visiting Professor in Pharmacy & Pharmacology, University of Bath

Design and Operational Challenges in Psychedelic Clinical Trials
This presentation will highlight some of the operational challenges that are unique to clinical trials with psychedelics (e.g., what is the appropriate control condition, can participants be effectively blinded, etc.).
Marion Coe, Ph.D., Scientist, Pinney Associates

Psychedelics in the Post-approval World: Scheduling, REMS, Treatment Models, Cost, and Access Issues
In this presentation the speaker will explore more broadly post-approval issues including potential REMS, different treatment paradigms and their impact on final patient cost.
Rick Doblin, Ph.D., Founder & Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Ensuring Equitable Access to Psychedelics for People of Color, Indigenous Populations, and the Disadvantaged: Pre and Post Approval
Our presenter will discuss strategies to increase minority participation in clinical trials as well as ways to ensure that historically disadvantaged peoples are able to access approved psychedelic drugs.
Ismail Ali, J.D., Policy & Advocacy Counsel, Multidisciplinary Association for Psychedelic Studies (MAPS)

12:30 pm Lunch Break

1:00 pm Hot Topics in Psychedelic Drug Development: Panel Discussion
Moderator: Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates
Marion Coe, Ph.D., Scientist, Pinney Associates
Jack Henningfield, Ph.D., Vice President, Research, Health Policy, and Abuse Liability , Pinney Associates
David J. Heal, Ph.D., Executive Director, DevelRx, Ltd., Visiting Professor in Pharmacy & Pharmacology, University of Bath
Ismail Ali, J.D., Policy & Advocacy Counsel, Multidisciplinary Association for Psychedelic Studies (MAPS)
Rick Doblin, Ph.D., Founder & Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

1:30 pm Operational Considerations for the Administration of Moderate Doses of LSD: Quantitative and Qualitative Perspectives of Safety
In this presentation, Neiloufar Family, will discuss Eleusis' Phase 1b LSD trial, which evaluated the safety, pharmacokinetics, and subjective effects of 50 µg, 75 µg and 100 µg lysergic acid diethylamide (LSD) in healthy adults within an interventional paradigm. She will present safety results, participant perspectives, and operational implications for the delivery of psychedelic therapies.
Neiloufar Family, Ph.D., Psychiatric Research Director, Eleusis

2:00 pm Potential Mechanisms Underlying Psilocybin Therapy for Major Depressive Disorder
Psilocybin therapy has shown potential efficacy in treating a variety of etiologies and presentations of mood disorders. We will review the evidence for efficacy of psilocybin therapy in patients with major depressive disorder. We will also review potential directions for understanding psychological and neural mechanisms that may underlie the therapeutic efficacy of psilocybin therapy.
Frederick Barrett, Ph.D., Associate Professor of Psychiatry and Behavioral Sciences, Center for Psychedelic and Consciousness Research, Behavioral Pharmacology Research Unit, Johns Hopkins School of Medicine

2:30 pm Psychedelics as Powerful Anti-inflammatory Therapeutics
In this presentation Dr. Nichols will discuss the discovery of psychedelics as anti-inflammatories in his laboratory, what they have learned about the underlying mechanisms, therapeutic efficacy in various rodent models of human inflammatory related diseases, and discovery efforts to develop new potent anti-inflammatory psychedelics with reduced behavioral effects.
Charles Nichols, Ph.D., Professor, Department of Pharmacology & Experimental Therapeutics, LSU Health Sciences Center

DAY THREE - MAY 6, 2021 (central daylight time)

9:30 am Filling the Unmet Need for Pure, Well-Characterized Psychedelic Compounds
There are many psychedelic drugs (and non-psychedelic tryptamines), but only a few of them have been scientifically investigated. Chemically characterizing these drugs is essential to developing them as safe, consistent and effective products (marketable drugs). The few psychedelics with the most research are the ones that have been able to advance down a path towards mainstream adoption. CaaMTech has synthesized and characterized more tryptamines than anyone else in history. Developing many options gives the industry the best shot at finding the best lead compound to bring to the marketplace.
Andrew Chadeayne, Ph.D., Founder and CEO, CaaMTech

10:00 am Psilocybin Therapy: Removing Barriers to Access through Legalization and Litigation
In recent years there has been increasing interest in use of psilocybin for a variety of mental health conditions, including relief of anxiety and depression at the end of life. This presentation will discuss recent innovative efforts to remove barriers to access to psilocybin for therapeutic use.
Kathryn Tucker, JD, Special Counsel, Emerge Law Group

10:30 am The Integration of Psychedelic Medicine into Mainstream Healthcare
In this presentation, Cosmo Feilding-Mellen will take stock of the current psychedelic innovation landscape, the vast potential for implementing psychedelic treatments in mainstream healthcare and the challenges faced by companies in bringing them to market. He will take a deep dive into the conditions that Beckley and other research organizations hope to address with psychedelic therapeutics. Furthermore, Cosmo will discuss the company’s research programs, from its exploration of synthetic compound 5-MeO-DMT to a landmark clinical trial of the effects of psilocybin on short-lasting unilateral neuralgiform headache attacks (SUNHA). Cosmo will also discuss:
• The barriers that Beckley and other companies must overcome to developed fully licensed psychedelic medicines
• The changes that will be required in healthcare systems for treatment delivery and associated therapy to be approved
• The unmet needs where psychedelic medicines may have a real impact
• The focus of current psychedelic research efforts and where the most promising progress is being made
• The outlook for psychedelic medicines and assisted psychotherapy as part of the healthcare system of the future .
Cosmo Feilding Mellen, Director, Chief Executive Officer, Beckley Psytech

11:00 am Psychedelic Applications to Treat Obesity and Weight Management
The presenter will break down the potential applications for psychedelics in the treatment of obesity and eating disorders. He will explain why new solutions are needed to treat obesity, and why there may be potential for psychedelics in this area. He will also examine what it takes to bring a drug of this kind to market, and the commercialization issues post approval.
Robert Tessarolo, Chief Executive Officer, NeonMind Biosciences

11:30 am Next Generation Psychedelics for Mental Health Indications
Dr. Tucker will share how patented derivative molecules can potentially address multiple psychological indications related to mental and behavioral health indications. The standard pharmaceutical candidate screening process is a consistent bottleneck in bringing standard pharmaceutical candidates to market and acts as a primary determinant of eventual clinical success or failure. This is especially true in the psychedelics industry due to a limited understanding of the mechanisms underlying observed clinical data. MagicMed is combining three major disciplines to create PsyAITM: AI-driven drug-discovery, synthetic biology and the 'psychedelic renaissance' to treat mental health conditions. Combining PsyAITM and the PsybraryTM, MagicMed's large-scale novel molecule creation platform, creates an opportunity to accelerate the development of optimized pharmaceutical candidates.
Joseph Tucker, Ph.D, Chief Executive Officer, MagicMed Industries

12:00 pm Lunch Break

12:30 pm The Future of Psychedelic Medicine
In this presentation, Henri will discuss the evolution of psychedelic companies. He will also highlight new compounds being developed and the conditions for which they are likely to be indicated. Finally, he will discuss the retail psychedelic market, nootropics as well as the opportunities and risks facing the field.
Henri Sant-Cassia, Founding Partner, The Conscious Fund

1:00 pm Ketamine-Assisted Psychotherapy: Review and Outcomes
In this presentation Dr. Verbora will discuss the following:
  • The mental health crisis
  • Review of ketamine as an antidepressant
  • Review of drug assisted psychotherapy Clinical outcomes of Field Trip Health
Michael Verbora, MBA, MD, Medical Director, FieldTrip Health, Assistant Professor, McMaster University

1:30 pm Next Generation Psychedelics for Mental Health Disorders
Psilera Bioscience is focused on harnessing the power of both natural and synthetic tryptamines for patient-driven medicines targeting neurodegenerative, mood and addiction disorders. This presentation will describe our efforts to expand chemical and biological knowledge around these psychedelics as well as their future in mindful medicine.
Jackie von Salm, Ph.D., Co-Founder & Chief Scientific Officer, Psilera Bioscience

2:00 pm Future Applications of Biomarkers, Accelerating Psychedelic Applications in Clinical Practice
As we apply the evolving science of psychedelics to treat mental illness, it is crucial that we work to demonstrate the efficacy and safety of psychedelic-assisted psychotherapy for patients. Do changes in neural networks predict the efficacy of therapy post psychedelic experience? Do these serotonergic agents reduce inflammation or stimulate nerve growth and neuroplasticity? Dr. Jetly will examine why these markers are crucial in psychedelic research and the advancement of these treatments to the mainstream. He will also discuss Mydecine’s novel research efforts including its drug development pipeline, international clinical trials around psilocybin for mainstream research and the company’s purpose-built technology platform for gathering better clinical trial data.
Rakesh Jetly, MD, Chief Medical Officer, Mydecine Innovations Group

2:30 pm Digital Therapeutics: Data Driven Science and Shifting Culture
This talk will uncover the latest developments in digital therapeutics from tech advances to wearables and explore how/why the big data (previously unavailable and undocumented) is a huge opportunity not only for companies but for the advancement of psychedelics. Through the utilization of an AI backed digital therapeutic tool therapists will be able to share practices and treatments of individuals on a global level, creating a Netflix of psychedelic therapy–optimizing quantified medicine at scale.
Kelsey Ramsden, President & CEO, Mind Cure

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