2024 Conference Agenda

Day One - May 23, 2024

Registration & Continental Breakfast

Join us for breakfast and visit with our exhibitors

Chairperson's Opening Remarks

Peter Hendricks, Ph.D., Professor, Department of Psychiatry, University of Alabama Birmingham

Optimizing Psychedelic Trials: Therapy, Monitoring and Artificial Intelligence

Standardizing the psychotherapeutic component in psychedelic clinical trials is challenging yet essential for widespread adoption and at-scale delivery. In this panel discussion, we'll explore how to improve consistency at both ends of the spectrum, from psychological support to therapy. We'll discuss the challenges of ensuring consistent delivery amidst the variability introduced by therapists and monitors, and examine innovative approaches to recruiting, training, and overseeing them.

George McBride, Chief Commercial Officer, Clerkenwell Health

Todd Solomon, Ph.D., Director of Global Clinical Development, CNS & Digital Medicine, MindMed

Julia Forte, Executive Director, Project Management, Worldwide Clinical Trials

Danielle Schlosser, Ph.D., Chief Innovation Officer and Co-founder, mpathic

George McBride
George McBride
Danielle Schlosser, Ph.D.
Danielle Schlosser, Ph.D.
Todd Solomon, Ph.D.
Todd Solomon, Ph.D.
Julia Forte
Julia Forte

Clinical Progress of a Novel Short Acting Psilocybin Analog

The presentation will cover the Reunion phase 1 data and phase 2 start up activities for a novel short acting psilocybin analog. We will share details on the novelty of RE104 and our results of the phase 1 study which makes strong PD connections to being similar to psilocybin in every way except the duration of the trip (3.7 hrs vs. 6-8 hrs). The talk will also cover our launched phase 2 study in postpartum depression and phase 2 program in psychiatric distress in Cancer.

Mark Theeuwes, Chief Operating Officer, Reunion Neuroscience

HBL20030: A Novel Psychedelic-Based Treatment for Schizophrenia with Prominent Negative Symptoms

Schizophrenia affects millions of people worldwide. It is characterized by positive and negative symptoms. Negative symptoms are the most important cause of chronicity and social and occupational incapacitation in patients with schizophrenia. There is no specific treatment for negative symptoms and this is urgently needed. Based on an original, heuristic hypothesis (Heresco-Levy and Lerer, Molecular Psychiatry, 2023) that is supported by extensive preclinical research, we have developed a novel treatment for schizophrenia with prominent negative symptoms. HBL20030 is a proprietary formulation of D-Serine, a full agonist at the glycine site of the NMDA receptor, and the psychedelic drug, psilocybin. Ideally, a psychedelic-based treatment for negative symptom schizophrenia should have preclinical evidence supporting a low likelihood of worsening positive symptoms and evidence supporting potential efficacy for negative symptoms, such as enhanced neuroplasticity. We have demonstrated in rodent models that HBL20030 does not induce a head twitch response, (suggesting lack of psychedelic effects in humans), and does induce downstream markers of neuroplasticity. A phase 1B trial of HBL20030 in patients with chronic schizophrenia with prominent negative symptoms is scheduled to commence in mid-2024.

Bernard Lerer, MD, Professor of Psychiatry, Director, Hadassah BrainLabs - Center for Psychedelic Research, Hebrew University

Morning Break

Join us for morning coffee and tea, visit with our exhibitors and our Scientific Poster presenters

Panel Session: Navigating Legal Challenges in Research: Best Practices Under the Federal Analogue Act

This session will provide researchers with a comprehensive understanding and practical approach to complying with the Federal Analogue Act. Attendees will gain insights into best practices for handling controlled substances and analogues, ensuring both scientific integrity and adherence to federal regulations. The goal of this session is to equip researchers with practical knowledge to conduct compliance-focused research, emphasizing legality and ethical practices. The speakers will clarify the process and requirements for obtaining necessary registrations for substance handling in research and development and provide actionable guidance on the management, storage, and disposal of controlled substances within research environments. Lastly, they will share a framework for training and supervising research personnel in the context of controlled substance regulations.

Amelia Furbish, PharmD, Ph.D., Pharmacist, Medicinal Chemist, Medical University of South Carolina

Kimberly Chew, Esq., Senior Counsel, Co-founder, Psychedelic & Emerging Practice Group, Husch Blackwell

Megan Francis, Ph.D. Candidate, Medical University of South Carolina

Anthony Coulson, President, NTH Consulting

Amelia Furbish, PharmD, Ph.D.
Amelia Furbish, PharmD, Ph.D.
Kimberly Chew, Esq.
Kimberly Chew, Esq.
Megan Francis
Megan Francis
Anthony Coulson
Anthony Coulson

Manufacturing The Future of GMP Psychedelics: What Researchers, Clinicians, and Drug Developers Need to Know

Prepare to explore the "do's and don'ts" of GMP psychedelic manufacturing—a global regulatory expectation that demands the full grasp of researchers, clinicians, and drug developers. In this presentation, Optimi Health CEO Bill Ciprick shares his insights into manufacturing the next generation of psychedelic drugs. He explores the modern GMP roadmap, emphasizing patient safety while improving accessibility and effectiveness. Attendees will gain insights into sourcing GMP validated psychedelic drugs and learn about the evolving landscape of manufacturing, from traditional methods to future approaches.

Bill Ciprick, Chief Executive officer, Optimi Health

Designing a Psychedelic Clinical Trial for Borderline Personality Disorder

Patients with borderline personality disorder have an increased risk of substance abuse and suicide but lack treatment options specific to hallmark symptoms. There have been several industry-sponsored trials evaluating potential treatments for borderline personality disorder in the last decade, some with promising results. This talk will describe how a clinical trial of a psychedelic in patients with the disorder might be designed, including management of the unique symptoms that pose a challenge in a psychedelic setting.

Christine Moore, Ph.D., Vice President, Neuroscience, Scientific Solutions, Worldwide Clinical Trials

Understanding the Most Important Question in Fundraising for Psychedelic Drug Programs

In the ever-evolving landscape of drug development, securing later-stage funding remains a critical bottleneck, especially in the burgeoning field of psychedelic medicine. One of the key challenges currently facing drug development companies is navigating the complex path from research to commercialization. This session aims to introduce a groundbreaking approach to address this challenge. This session will be of particular interest to drug developers grappling with commercialization challenges. This approach is uniquely positioned to not only advance the clinical science but also to build a strategy for commercialization, thereby addressing the most pressing issue in the psychedelic industry today.

Jeeshan Chowdhury, MD, Ph.D., Chief Executive Officer & Co-Founder, Journey Colab

Luncheon

Panel Session: Can Psychedelics be an Effective Treatment for Pain

Panel Chair: Peter Hendricks, Ph.D., Professor, Department of Psychiatry, University of Alabama Birmingham

Psychedelics are Potent Anti-inflammatories in Human Disease Models

Charles NIchols, Ph.D., Professor, LSU Health Sciences Center

(tentative title) The NIH's Role in Furthering Psychedelic Research for Pain

Michael Oshinsky, Ph.D., Director, NINDS Office of Preclinical Pain Research, National Institutes of Health

Psychedelics for Pain and Therapeutic Alliance: Hyperscan Neuroimaging the Patient/Therapist Interaction

Vitaly Napadow, Ph.D., Lac, Professor/Director, Center for Integrative Pain Neuroimaging, Harvard Medical School/Mass General Hospital

Peter Hendricks, Ph.D.
Peter Hendricks, Ph.D.
Charles Nichols, Ph.D.
Charles Nichols, Ph.D.
Michael Oshinsky, Ph.D.
Michael Oshinsky, Ph.D.
Vitaly Napadow, Ph.D.
Vitaly Napadow, Ph.D.

Psychedelic Clinical Trial Design, Clinician Training and Preparations for Post-approval

Ethical delivery of psychedelic treatment calls for the presence of a dedicated clinician who can provide patients with psychoeducation, psychosocial support, and intervention in case of challenging experiences. Drug developers have tested a variety of models ranging from minimal supportive interaction to full courses of psychotherapy accompanying psychedelic dosing sessions. The design of these clinician’s protocols and procedures, as well as the training of clinicians in their delivery is key to creating scalable, repeatable, evidence-based interventions that will deliver reliable results in community-based care settings. This presentation covers key considerations for this aspect of psychedelic clinical trial design, clinician training, and preparations for post-approval.

Elizabeth Nielson, Ph.D., Chief Visionary Officer, Co-Founder and Lead Trainer, Fluence

Afternoon Break

Join us for afternoon coffee and tea, visit with our exhibitors and our Scientific Poster presenters

Unlocking Reimbursement: Strategies and Insights for Psychedelic Assisted Therapy

Explore the practical challenges and potential solutions at the intersection of psychedelic-assisted therapy (PAT) and our healthcare system in this talk led by David Esselman of BrainFutures, a nonprofit specializing in advancing equitable access to evidence-based mental health treatments. As we anticipate potential FDA approval of MDMA-assisted therapy for PTSD in 2024, David will dive into the complexities of medical coding for PAT, what makes the PAT model of care unique, and pinpoint the obstacles that practitioners and payers are likely to face in a post-FDA approval landscape.

David Esselman, Senior Advisor, Brain Futures

Breaking Barriers: Reimbursement and Access to Psychedelic Therapy

Dan Rome, MD, Chief Medical Officer & Co-Founder, Enthea

A Psychedelic Shift: Assessing the Potential for Nonmedical Use in a Changing Regulatory Landscape

FDA requires that potential for nonmedical use must be assessed for any investigational new drug that has CNS activity. Current regulatory recommendations may lack the nuance required to appropriately evaluate drugs with novel or previously unrecognized drivers of nonmedical use. Capturing and assessing the experiences, subjective effects, and/or changes in consciousness that may drive additional use for psychedelic drugs poses a challenge for the industry as a whole. This session will outline the requirements for an abuse potential summary in a marketing application, and address the unique challenges associated with assessing the nonmedical use (i.e., abuse or misuse) potential of psychedelic drugs.

Ritchie Patton, MBA, Manager, Regulatory Strategy, MMS Holdings, Inc.

Panel Session: Psychedelics to Cognitive Assessments: Bringing Precision Medicine to Mental Health Care

"Every 40 seconds, another individual dies from suicide (AFSP, 2024). Tens of millions more live with mental health conditions for which there is no good standard of care. Despite the considerable resources every year, these efforts have not been enough. Individuals suffering from mental illness are not getting the care that they need – in fact despite tremendous progress in reducing deaths from other illnesses such as cancer, the rates of suicide in the developed countries have not changed since World War II (Ducharme, 2019). Much of the recent breakthroughs in modern medicine are based on the concept of novel and accurate biomarkers and the field as a whole is moving towards the concept of precision medicine (Ahuja, 2019). This panel will focus on both these aspects. It will touch upon new treatments being developed, for example psychedelics (psilocybin, MDMA, others), along with ways AI and technology could be used to augment the treatment process. Specifically, we will also explore how advances in machine learning and digital biomarkers can lead to objective & unbiased measurements, both at scale and on a per-person basis to better understand the patient response and how to improve care. "

Gregory Ryslik, Ph.D., Chief Technology Officer, COMPASS Pathways

Gabriel Aranovich, MD, Advisory Board/Clinical Expert, Health Tech Program, Quantum Health/Cornell Tech

Amie Leighton, CEO & Co-founder, Allia Health

Gregory Ryslik, Ph.D.
Gregory Ryslik, Ph.D.
Gabriel Aranovich, MD
Gabriel Aranovich, MD
Amie Leighton
Amie Leighton

Evening Reception

Join us for Hors d'oeuvres & Drinks

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Arrowhead Conferences offer an experience that encompasses learning, networking and professional growth. We focus on bringing life sciences industry professionals together to help move research forward.

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