Progressing Beyond Exploratory Endpoints: The Value of Digital Biomarkers in Neuroscience Clinical Studies

Todd Rudo, MD, EVP, Chief Medical Officer, 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, MD, Professor, Department of Neurology & Neurosurgery, McGill University, President and CEO, NeuroRx, Senior Advisor, 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. Mark Opler, VP eCOA Neuroscience, 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^©.

Kristen Sowalsky, PhD, DC, VP, Medical & Scientific Affairs, Precision Motion, 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 PhD 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.