Digital Technologies for Assessing Patient Functioning in Multiple Sclerosis Clinical Trials

Substantial progress has been made in the development of disease modifying therapeutics for Multiple Sclerosis (MS) in recent years. The array of next-generation compounds for this complicated disease have made great strides in increasing the time between relapse and delaying disease progression. There are more therapies on the horizon adding to the busy landscape, so future treatment options must go beyond new routes of administration and dosing frequency to listen closely to the MS patient voice and address the additional—and often less visible—symptoms that impact health outcomes and quality of life.

Cognitive function and motor abilities have been noted by patients as being some of the most disabling aspects of the disease. Cognitive impairment alone affects 50-70% of patients; worsening cognitive processing speed particularly impacts patients’ quality of life, making even simple tasks more difficult. Furthermore, earlier, more precise identification of change or decline in motor abilities may shed light on aspects of therapeutic response or disease progression with relevance for patients and family members.

As pharmaceutical researchers develop new therapeutics targeting those symptoms that matter most to patients, they are faced with the challenge of how to measure these outcomes in clinical trials.

This webinar will present advances in validated tools and technologies to collect digital endpoints relevant to MS and other neuromuscular diseases that can improve signal detection and gather relevant data needed to measure treatment response. The speakers will review examples of how these technologies have provided high quality outcome measures via sensitive, reliable and objective assessments which fully characterize motor and cognitive impairment.

Speakers

Fay Horak, PhD, Chief Scientist, Wearables & Digital Biomarkers, ERT

Dr. Fay Horak is Chief Scientific Officer at APDM Wearable Technology, an ERT company. She is also Professor of Neurology, Behavioral Neuroscience, and Bioengineering and Director of the Balance Disorders laboratory at Oregon Health and Science University. Dr. Horak is a physical therapist and neuroscientist who is internationally known for her research on the physiology of balance disorders and their rehabilitation. Dr. Horak received a BS degree in Physical Therapy from the University of Wisconsin, a MS in Neurophysiology from the University of Minnesota and a PhD in Neuroscience from the University of Washington in Seattle.  She has received many national awards from the American Physical Therapy Association and is the first physical therapist to receive a prestigious MERIT award from the National Institutes of Health for over 30 years of continuous funding.  Dr. Horak has over 300 peer-reviewed papers and has had over 50 million dollars in federal grants. Dr. Horak has several patents for new technologies to measure and rehabilitate balance disorders.

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Chris Edgar, PhD, Chief Science Officer, Cogstate

Dr. Chris Edgar is an experienced leader in cognitive assessment and clinical endpoint strategy who provides expert guidance to Cogstate’s pharmaceutical customers throughout all stages of trial conduct, from study design and test selection through final analysis. Prior to joining Cogstate, Dr. Edgar oversaw clinical endpoint strategy for multiple neuroscience indications in the Patient-Centered Outcomes Research group at Roche. He holds a PhD in psychopharmacology from Northumbria University and has 20 years of pharmaceutical industry experience. Dr. Edgar has held other key industry positions including Principle Scientist at Roche, Senior Clinical Lead at Bracket/UBC, and Scientific Director at Cognitive Drug Research Ltd.

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