Psychedelic agents have long been explored for use as medicinal treatments – from shamans using these for centuries, to academic or government-sponsored projects, to industry-sponsored drug development.
However, the potential benefit of psychedelics in the treatment of persistent psychiatric illnesses like depression and behavioral disorders has been overshadowed by the notoriety of this class of agents being scheduled. The relatively recent resurgence in this field creates a new challenge: conducting scientifically rigorous, high-quality clinical trials with previously researched molecules within today’s regulatory environment.
For sponsors, investigators and regulators, psychedelics pose new clinical trial considerations. Dosing patients with these investigational products requires careful selection of both the clinical site, supportive therapists, efficacy raters, and the patient themselves. Trust and support are paramount in this unique research partnership.
In this webinar, panelists from Worldwide Clinical Trial’s psychedelic operational teams will discuss the unique requirements of psychedelic clinical development, demystifying the complex operations.
(Moderator) Richard Bennett, Senior Director, Therapeutic Strategy Lead, Neuroscience, Worldwide Clinical Trials
Richard Bennett is Senior Director and Therapeutic Strategy Lead in the Neuroscience franchise at Worldwide Clinical Trials. With two decades in the industry, he has advanced through the traditional clinical operations roles such as clinical research associate and clinical trial manager and has spent many years as a leader of clinical development programs in both the larger pharma and biotech setting. He has worked on neuromuscular disorders, rare diseases, critical care, pain and palliative care, dermatology, and epidemiology programs. His direct experience working with large pharma and small and emerging biotech firms has given him a deep understanding of the needs of our sponsors.
Julia Forte, Senior Director, Project Management, Worldwide Clinical Trials
Julia Forte holds over 25 years of clinical research industry experience across a variety of indications, the majority of which is in CNS. She has successfully assisted in leading all Phases of clinical trials in large global environments across multiple CNS therapeutic areas with a major focus in major depressive disorder and treatment resistant depression. Over the past few years, Julia has been involved in the oversight and management of trials with psychedelic compounds in treatment resistant depression, MDD, PTSD, and anorexia. Her current responsibilities include overseeing and providing operational advice and supporting the project managers and study teams to ensure high-quality and timely delivery of these programs.
Christine K. Moore, PhD, Vice President, Neuroscience, Scientific Solutions, Worldwide Clinical Trials
Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions provides strategic scientific guidance across multiple programs, driving neuroscience clinical research of the highest quality for the company. With over 25 years of drug development and commercialization experience, Dr. Moore’s experience extends from scientific to operational expertise across neuroscience indications, with specialization in analgesia and addiction. As one of the original team members at Worldwide Clinical Trials, she has held diverse roles within CROs as well as with large and small pharma. Her unique and broad industry experience allows for planning clinical trials that are both methodologically rigorous and feasible, and that will ultimately enable commercial product adoption by payers and health care providers after approval.
Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies, Worldwide Clinical Trials
Rolana Avrumson has over 23 years’ clinical experience, 14 years’ experience in clinical trial research, and has worked for Worldwide Clinical Trials since May 2014. As the Senior Director of Clinical Projects, her primary responsibilities include oversight of the operational and clinical conduct of assigned studies, including rater, CRA, and patient training, source eligibility reviews, data surveillance, sponsor reporting, and scale management. Additional responsibilities include management of clinical staff, protocol review, oversight of eCOA & other technology vendor responsibilities, as well as collaboration with key study functional groups.
Ms. Avrumson has held significant roles in global and domestic phase I/II/III/IV trials in a number of indications with pediatric, adult, and geriatric populations including psychiatry (e.g. mood disorders, psychotic disorders, anxiety disorders, addiction, ADHD), neurocognitive disorders (e.g. Alzheimer’s Disease, MCI, TBI), movement disorders (e.g. Parkinson’s), and various rare disease and pain indications (e.g. ALS, Myasthenia Gravis, Neimann-Pick Type C, neuropathic pain, and arthritis trials). As a Clinician in applied practice, she has specialized in areas of Mood, Anxiety, Psychotic, Movement, and Neurocognitive disorders, as well as Addictions, Posttraumatic Stress Disorder, and Eating Disorders.
Ms. Avrumson has a Master’s Degree in Rehabilitation Counseling Psychology with a specialty in Substance Dependence from the University at Albany, Albany, NY and a Bachelor’s Degree in Clinical Psychology from Tufts University, Medford, MA.
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
- Patient Recruitment
What You Will Learn
Attendees will learn about:
- Site Selection: Psychedelic experience, infrastructure and key team members
- Patient Access: Identifying appropriate participants for clinical research with psychedelics
- Set & Setting: Expectation setting through preparation and standardization of the ceremony environment
- Permissions: Navigating the existing regulatory frameworks and obtaining the necessary licenses
- Avoidance of Bias: Management of blinding, controlling the placebo-response within efficacy assessments and training programs for raters and therapists
Worldwide Clinical Trials
Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries.
Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, and Asia, Worldwide is powered by its more than 3,000 employee experts.