Patient-Reported Tolerability Assessment Across Oncology Development 

Devin Peipert is the 125th Anniversary Chair and Professor of Health Outcomes Measurement at the University of Birmingham, where he works within the Centre for Patient Reported Outcomes Research (CPROR) and the Birmingham Health Partners Centre for Regulatory Science and Innovation (BHP CRSI). He is an investigator and psychometrician focusing on the application of patient reported outcomes (PROs) in patient focused drug development and in clinical monitoring to optimize patient management. In this capacity, he works extensively on establishing evidence to support PROs as clinical outcome assessments (COAs) to implement in drug trials, with a specific focus in kidney disease and oncology. He also conducts research examining new tools and methods to quantify and manage drug intolerability across multiple therapeutic areas, including oncology and solid organ transplantation. 

Josh Biber, a proven healthcare leader with a diverse background and experience utilizing strategic leadership and education. Currently an Associate Director at Takeda, which includes leading PRO strategy and providing scientific insight to meet the evolving needs of the company.  Specifically, he evaluates and generates empirical evidence to strengthen global development and commercialization activities, provides expertise in the design and implementation of real-world evidence in oncology, and provides outcomes research leadership and consultation expertise for products from early development through launch and commercialization. Before he was in healthcare, Josh served in the US Air Force, deploying several times as a member of Air Force Special Operations Command. 

Bill Byrom is a recognized leader in eClinical product strategy and electronic clinical outcome assessments with over 30 years of pharmaceutical industry experience. He combines deep clinical development expertise with technological innovation to advance digital health solutions. Bill specializes in clinical outcome assessments, sensor-based wearables, and technology-derived endpoints. His research explores COA application in oncology tolerability assessment, new COA measures, and frameworks for COA development from sensor-derived data. Bill consults with pharmaceutical companies and regulatory agencies on digital health initiatives. He has authored numerous publications, including two industry textbooks on ePRO, and serves on key industry committees: ISPOR task forces on ePROs and PerfOs, the C-Path Chronic Heart Failure working group, the EU-funded LABDA research program Executive Advisory Board, and the Duke University PARCR Project Advisory Board. 

Todd Everhart, MD, FACP, is the internal medicine leader at Signant. Dr. Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 25 years of experience in the practice of medicine and 15 years of experience in clinical development. Prior to joining Signant, Dr. Everhart held positions of Vice President, Medical Affairs and Vice President, Medical Informatics at Chiltern and Covance, and consulted independently in the areas of medical monitoring, medical data review, data analytics, and physician adoption of technology. He has worked in all phases of clinical development in numerous therapeutic areas including allergy & immunology, cardiovascular, hematology & oncology, infectious disease & HIV, neurology, ophthalmology, psychiatry, respiratory, and rheumatology.