Lisa Meier McShane – AAADV Workshop

Lisa Meier McShane, Ph.D., is Associate Director, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute, National Institutes of Health, where she heads the Biometric Research Program, comprising Biostatistics and Computational and Systems Biology Branches. She earned a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. She is an internationally recognized expert on precision medicine clinical trial design; development of tumor markers and omics predictors for prognosis, therapy selection, and disease monitoring; and reporting guidelines for health research studies. Her statistical research interests include biomarker-driven clinical trial design, analysis of high-dimensional omics data, multiple comparisons methods, surrogate endpoints, and biomarker assay analytical performance assessment.

Dr. McShane serves on the Scientific Advisory Board for Science Translational Medicine and on the Editorial Boards for Journal of Clinical Oncology. She has served on American Society of Clinical Oncology committees that developed guidelines for HER2 and hormone receptor testing in breast cancer, EGFR mutation testing in lung cancer, and biomarkers in early stage breast cancer. She interacts frequently with FDA on biomarker-based initiatives and has served on FDA/CDRH Molecular and Clinical Genetics and Clinical Chemistry and Clinical Toxicology Panels. She has served as a member of Institute of Medicine Committee for Management of the Air Force Health Study Data and Specimens, the Consensus Committee on Management of the Air Force Health Study Data and Specimens-Report to Congress, and the Committee on the State of the Science in Ovarian Cancer Research.