Progressing Beyond Exploratory Endpoints: The Value of Digital Biomarkers in Neuroscience Clinical Studies
Learn how advances in eCOA, digital movement analysis and medical imaging methodologies are shaping the future of neuroscience drug development.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m.ET (NA-East)
- 16:00 – 17:00GMT (UK)
- 17:00 – 18:00CET (EU-Central)
Abstract:
Digital biomarkers are transforming neuroscience trials — moving from exploratory tools to validated, impactful endpoints. In this webinar, the featured speakers will share real-world examples and case studies showing how the strategic use of digital biomarkers can improve study precision, reduce timelines and lower sample size requirements.
Register for this webinar to explore how integrated digital strategies can enhance data quality and decision-making across psychiatric, neurologic and neurodegenerative clinical trials. Key areas of focus will include:
- Evaluating the role of digital biomarkers in improving study efficiency and timeline management through comprehensive endpoint strategies
- Assessing the application of wearable sensors and composite scores to advance movement disorder assessments
- Examining vocal biomarkers such as speech latency for objective and scalable measures in psychiatric research
- Reviewing advancements in brain imaging methodologies that contribute to the development of regulatory-ready endpoints in multiple sclerosis and related conditions
Speakers
Todd Rudo, M.D.
EVP & Chief Medical Officer at Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety.
Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Douglas Arnold, M.D.
Professor, Department of Neurology & Neurosurgery at McGill University
President and CEO at NeuroRx
Senior Advisor at Clario
Dr. Douglas Arnold is a leading figure in multiple sclerosis research and neuroimaging, with a career spanning over three decades at the intersection of academic medicine and clinical innovation. He founded NeuroRx in 2002 to apply cutting-edge imaging science to global clinical trials. NeuroRx is now part of Clario, where Dr. Arnold serves as Senior Advisor.
A Professor at McGill University and a Distinguished James McGill Professor, Dr. Arnold has directed the MRI lab at the McConnell Brain Imaging Center since 1985. His academic credentials include neurology training at the Montreal Neurological Institute and advanced MRI studies at the University of Oxford.
Dr. Arnold has authored more than 450 peer-reviewed publications and is among the top 1% of most-cited researchers worldwide. His work has significantly influenced MS treatment and imaging standards, with seminal studies featured in The New England Journal of Medicine and The Lancet. He continues to lead initiatives in AI-powered imaging and clinical trial optimization through his roles at NeuroRx and now Clario.
Dr. Mark Opler
VP eCOA Neuroscience at Clario
Dr. Mark Opler is Chief Research Officer, eCOA Neuroscience at Clario. In this role, he directs scientific research and leads ongoing studies in psychiatry, measure development, psychometric validation and other areas of neuroscience.
Dr. Opler is the Executive Director of the PANSS Institute and has served as a faculty member in the Departments of Psychiatry at New York University School of Medicine and in the Department of Neuroscience at Columbia University, College of Physicians and Surgeons. His academic research focuses on the etiology, phenomenology and treatment of serious and persistent mental disorders. He is a co-author and developer of several clinical assessment tools, including the SNAPSI, CGI-DS and NY-AACENT. He is also a contributor to the latest edition of the PANSS Manual©️.
Dr. Opler has received research support from the US NIMH, the Brain & Behavior Foundation (formerly NARSAD), the Stanley Medical Research Institute and the Qatar National Research Fund. He has co-authored more than 50 peer-reviewed publications and has contributed to multiple book chapters and review articles on clinical assessment, research methodology and mental health. He received his Ph.D. and MPH from Columbia University and his BSc from SUNY at Stony Brook. He is a graduate of the Psychiatric Epidemiology Training Program at Columbia University and completed his postdoctoral fellowship at the New York State Psychiatric Institute.
Kristen Sowalsky, Ph.D., DC
VP, Medical & Scientific Affairs, Precision Motion at Clario
Dr. Kristen Sowalsky is the Vice President of Medical & Scientific Affairs for Precision Motion at Clario. She oversees the scientific advisory, data science and biostatistical services for digital measures of human movement in clinical trials and academic research. Dr. Sowalsky has 18 years of combined experience in industry, academic/clinical research and clinical practice. Her academic achievements include a BS in Kinesiology and Exercise Science from Appalachian State University, a Doctor of Chiropractic from Logan University and a Ph.D. in Applied Neuromechanics from the University of Florida. Dr. Sowalsky is also a member of the University of Florida Industry Board. Passionate about improving the lives of patients and their families, Dr. Sowalsky aims to advance meaningful digital mobility outcome utilization to inform therapeutic innovation and development.