Telepsychiatry has always offered a tantalizing solution to the significant undertreatment of mental illness. With COVID-19, widespread stay-at-home measures and reduced offerings for face-to-face mental health services has skyrocketed the demand for in-home care and accelerated the promise of telepsychiatry.
Innovative decentralized or virtual trials are taking telepsychiatry in mental health research to the next level—that is, bringing it to the patient’s home.
During this interactive discussion, panelists will highlight the patient journey for a fully decentralized major depressive disorder (MDD) trial, including methodology for centralized raters, real-time patient dosage monitoring, and patient behavior insights from measured digital biomarkers to evaluate depression. We will also share insights for effective recruitment of a diverse patient population using a digital approach to attract and then engage participants.
The decentralized or virtual research model has become the standard in the current climate and this shift is helping to unlock the promise of telepsychiatry.
Thuy Le Nguyen, MPH, Senior Associate Director, Boehringer Ingelheim
Thuy Le Nguyen is a Senior Associate Director within the Study Management and Conduct of Clinical Operations at Boehringer Ingelheim Pharmaceuticals, Inc. Thuy has over 20 years of clinical research at BI, involved in many studies across different therapeutic areas including CNS, specifically in Alzheimer’s Disease, Schizophrenia, Borderline Personality Disorder and currently leading a Decentralized Clinical Trial in Major Depressive Disorder. Thuy holds a BS in Neuroscience from Trinity College, Hartford CT and a Master of Public Health from UMASS, Amherst.
Christopher Reist, MD, MBA, Medical Director, Psychiatry and Behavioral Science, Science 37
Christopher Reist serves as the Medical Director for Psychiatry and Behavioral Science. Prior to joining Science 37, Dr. Reist served for 17 years as Assistant Dean in the School of Medicine at UC Irvine and the Director of Medical Research for the Long Beach Veterans Affairs Healthcare System. Prior to this role he was the Chief of Mental Health, overseeing full service mental health care delivery to over 45,000 enrollees at the Long Beach VA Healthcare System. Dr. Reist received his undergraduate degree in chemistry and biology from Eastern Mennonite University in Harrisonburg, Virginia. Following medical training at the Virginia Commonwealth University in Richmond, Virginia, he completed a psychiatry residency at the University of California, Irvine. He has an MBA from the Anderson School of Management at UCLA. Dr. Reist’s clinical interests include schizophrenia, impulsivity, PTSD, pharmacogenomics, and psychopharmacology. He is a Distinguished Fellow of the Psychiatric Association and has been recognized as an Exemplary Psychiatrist by the National Alliance for the Mentally Ill. He is the author of two books, Psychiatry and Psychiatric Drugs and has contributed over 68 articles to the scientific literature.
Isaac Galatzer-Levy, PhD, Chief Scientific Officer, AiCure
Dr. Isaac Galatzer-Levy leads AiCure’s research and development (R&D) team on the development of AI based models to characterize illness, predict treatment courses, and select treatments based on digital phenotyping, or measurement of clinical functioning based on digital behavior. Dr. Galatzer-Levy’s background is in machine learning/AI, neuroscience, and clinical psychology. Dr. Galatzer-Levy has led large teams of researchers, received NIH, DOD, and foundation funding, published over 75+ peer-reviewed publications, and has contributed significantly to the emerging field of digital mental health. In both academia and industry, he has led efforts in biomarker and digital marker development for prediction and phenotyping across diverse neuropsychiatric diseases.
Gary Sachs, MD, Clinical Vice President, Signant Health
Dr. Gary Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders at Signant. He previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials. Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines. Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.
Who Should Attend?
This interactive and insight session is a must-see for any biopharmaceutical sponsor looking to implement or transition to a decentralized clinical trial. Titles can include:
- C-suite in Clinical Trials Management
- Therapeutic Lead / Head
- Clinical Development Director
- Clinical Development Manager
- Clinical Operations
- Clinical Risk Manager
- Information System Management
- Information Technology
- Innovation Lead / Head
- Medical Director
- Operational Director
- Project Management
What You Will Learn
In this webinar, participants will learn:
- From a sponsor perspective, the considerations and challenges of developing a decentralized clinical trial (DCT)
- How to operationalize a DCT trial: the considerations for technology platform, integration and implementation
- Considerations for investigators
- How real-time patient dosing is monitored and how digital biomarkers are measured
- How to maintain quality and consistency in your raters
Science 37 is making the promise of virtual trials the new reality. By engaging with patients from the comfort of their own home, we provide access to patients who can never be reached by traditional site-based models. We have proven to enroll faster, retain patients at a higher rate, and reach a more representative population. Science 37 has conducted more decentralized, interventional trials than any other company, using an expansive, in-house network of telemedicine investigators and home-health nurses, who are supported by the industry’s most comprehensive, fully integrated, decentralized clinical trial platform. Learn more at Science 37, and follow Science 37 on Twitter, LinkedIn, and Facebook.