Abstract

Biomarkers can be used for a variety of purposes in clinical research and drug development, and while molecular and imaging biomarkers have utility in such research, digital biomarkers are increasingly being used to assess physiological concepts and to be used as endpoints in clinical trials. This talk will present an overview of digital biomarkers in general, how to think about their use in clinical research, and two examples of digital biomarker until in clinical research studies.

Bio

Dr. Matthew Wipperman joined Regeneron in 2019 on the Quantitative Translational Sciences team in Precision Medicine, part of Early Clinical Development & Experimental Sciences. Across biomarker studies, he leads strategy, design, and exploratory data analyses, specifically focusing on clinical, demographic, omics, imaging, and digital biomarkers for Regeneron’s clinical development programs (from early experimental phase 0 to late-stage phase 4 trials). This work drives the discovery and validation of innovative biomarkers and clinical trial endpoints, the elucidation of mechanisms of action and drug pharmacodynamics, identification of sub-populations where pharmaceutical interventions will be effective, and exploration of alternative indications for approved drugs. His academic interests and work at Regeneron include the use of data science, statistics, and AI/ML to elucidate fundamental mechanisms of human biology, immunology, and physiology. This approach is especially crucial when dealing with deeply phenotyped individuals in small clinical studies (large P small N), allowing for more precise and meaningful insights into patient-specific characteristics and outcomes.

Matthew actively initiates and leads collaborations with diverse teams across clinical, research, regulatory, and external functions, to ensure scientific and clinical success of projects. He holds a BA and PhD in Chemistry, and an MSc in Clinical and Translational Science, with 15 years of experience in laboratory, computational, and basic scientific domains. Prior to Regeneron, he worked in clinical biomarker research at Sloan Kettering, where he led clinical biomarker and immunology work in infectious disease clinical research. He also continues to sit on the faculty in the Department of Medicine at Weill Cornell Medicine as a courtesy appointment, reflecting his ongoing connection to academic medicine.