Development and Deployment of Liquid Biopsies in Bench Research and Clinical Trials in the UW Circulating Biomarker Core - Minimally invasive liquid biopsies have revolutionized our understanding of cancer biology and emerged as biomarkers for disease monitoring and drug development, but have been limited to a few commercial entities or academic laboratories with the requisite technological capacity. The Circulating Biomarker Core (CBC) at the University of Wisconsin Carbone Cancer Center (UWCCC) was established in 2017 to leverage innovative technologies and clinical research infrastructure, to expand access to these biospecimens and assays for UW faculty and NCI Cancer Centers across the country. Custom UW-developed liquid biopsy technology arises from a decade-long collaboration between bioengineering and biomarker researchers at UW and offers unparalleled sensitivity for rare target analytes. Dr. Jennifer Schehr, who played an integral role in developing and refining custom liquid biopsy technologies since joining the lab of the founding director, Dr. Joshua Lang, in 2015, was successfully recruited as facility manager for the CBC during its inception and continues to spearhead its trajectory. The CBC supports NCI-funded research programs both directly through services provided to specific NCI grants or trials, as well as indirectly as a shared resource facility pursuing the aims of the NCI cancer center support grant (CCSG) to advance scientific partnerships, precision medicine research and education. Dr. Schehr delivers high levels of scientific innovation and achievement in biology and biomarker discovery by providing expert scientific oversight, investment in developing increasingly more powerful computational tools for rapid data handling, and particular attention to thorough and continuous education and engagement of undergraduate and entry-level staff. The CBC has now supported 64 different projects involving 34 different protein and nucleic acid biomarkers, 9 NCI grants and 29 clinical trials from NCI cooperative groups, pharmaceutical companies and Universities. Dr. Schehr leads the development of new methods for new cancer types, new liquid biopsy biomarkers, and new clinical applications, as well as the setup, data management and biomarker utility evaluation for ongoing clinical trials. Dr. Schehr is also actively engaged in developing process controls and demonstrating analytical validity of custom technologies in pursuit of obtaining regulatory approval for implementation into routine clinical use. With the recent successful execution of a UH2 analytical validation for an mRNA panel in prostate cancer circulating tumor cells, the CBC has now gained approval for a UH3 regulatory-approved clinical trial, which will result in the first clinically actionable liquid biopsy developed by the CBC under Dr. Schehr. Future directions include the development of automated workflows for circulating tumor DNA (ctDNA) extraction and library preparation from >5,000 plasma samples over the next 5 years for a custom ctDNA assay that evaluates 821 targeted mutations and high-sensitivity fragmentomic patterning to differentiate tumor origin. Leveraging innovative problem-solving, computational tools for high efficiency, and an extensive collaborative network, Dr. Schehr will develop and implement novel liquid biopsy biomarkers into clinical use.
