PPT-Biomarker Verification and

Clinical Grade Assays Sanford A Stass MD University of Maryland Baltimore Biomarker Reference Laboratory 32 nd EDRN Steering Committee Meeting September 1214 2017 Clinical Laboratory Improvement Amendments CLIA. Biomarker Potential and . Limitations of . Circulating miRNA. Performed by the . Data Management . a. nd Resource Repository (DMRR). ERCC . D. ata Analysis. 1. Williams Z., et al. . (. 2013. ) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations. Biomarker Potential and . Limitations of . Circulating miRNA. Performed by the . Data Management . a. nd Resource Repository (DMRR). ERCC . D. ata Analysis. 1. Williams Z., et al. . (. 2013. ) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations. Christopher . Jennison. , University of Bath. Robert A. Beckman, Daiichi Sankyo Pharmaceutical Development and University of California at San Francisco. Agenda. TOPIC 1: Where do subgroups come from? Empirical data or basic science? How does this vary as a function of developmental stage? . CRF Completion guidelines. Overview. General CRF . completion. Patient details header. Registration CRF. After registration. Almac. Test Request Form. Blood CRF. Color Sample Requisition Form. Screening and . Methods in Clinical Cancer Research. February 12, 2015. Effective incorporation of . biomarkers into phase II trials. There are many roles for biomarkers in Phase II trial designs.. Examples of biomarkers with pivotal role in development of new therapies. 2018 . AACR Annual Meeting. April 15, 2018 . Edward Chu, MD. UPMC Hillman Cancer Center. University of Pittsburgh School of Medicine. Drug . “. A. ”. Time (years) . Percent . One Size Fits All Approach. New . findings and methods for feed engineering to face present and future challenges in salmon . aquaculture. Presenter:. Albert . Caballero Solares, . Ph.D. Collaborators:. X. Xue. 1. , J.R. Hall. 2. John Michael Sauer, PhD. Critical Path Institute’s Predictive Safety Testing Consortium. Tucson, Arizona. jsauer@c-path.org. So you have a biomarker(s) that you want to use for regulatory decision making…now what do you do?. Authors: . Kieu Vu, John . Arend. , Nichole . Cadez. , Deb Darnell, Valerie . Somma. , . Randi Rycroft, . Loria. Pollack, . Paran. . Pordell. . Women’s Wellness Connection. BCCP (Triple negative breast cancer). physIQ. TEAM. Gary . Conkright. , CEO. Dr. Steve . Steinhubl. , CMO. Stephan . Wegerich. , CSO. Chris . Economos. , CCO. John . Varaklis. , . physIQ. Advisor. physIQ. : Extracting Insight from Biosensor Data. Teresa K. Chen, MD, MHS. Assistant Professor of Medicine. University of California, San Francisco. San Francisco VA Healthcare System. Overview. Type of work: Disease progression . Pathway: X01 grant mechanism. Rui. Tang (Vertex Pharmaceuticals), . Michael . Hale (Shire Plc. ), and . Jing Huang (. Veracyte. Inc. .). March 22, 2017. A Visualization Tool Measuring the Performance of Biomarkers for Guiding Treatment . Limitations of . Circulating miRNA. Performed by the . Data Management . a. nd Resource Repository (DMRR). ERCC . D. ata Analysis. 1. Williams Z., et al. . (. 2013. ) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations. Harriet Feilotter, PhD, FCCMG, FACMG. Professor, Dept of Pathology and Molecular Medicine, Queen’s U. Director, Molecular Genetics, KHSC. 2. Disclosures. I have the following financial relationships to disclose: .