Sumithra Mandrekar, PhD, is currently Professor of Biostatistics and Oncology at the Mayo Clinic, Rochester MN, and Section Head for the Cancer Center Statistics within Mayo Clinic. She is the Group Statistician for the Alliance for Clinical Trials in Oncology, which is one of the 4 NCI funded national clinical trials networks for the conduct of phase II and III clinical trials. Her primary collaborative areas are lung cancer and leukemia. She is the faculty statistician for the national adjuvant lung cancer trial, ALCHEMIST, an 8000 patient trial, which is part of the NCI precision medicine initiative. Her primary research interests include adaptive dose-finding trial designs for Phase I trials, designs for predictive biomarker validation, and general clinical trial methodology related to identification of alternative Phase II cancer clinical trial endpoints. Dr. Mandrekar has co-authored over 140 original papers; several book chapters and editorials; and has given numerous lectures, invited presentations and workshops on these topics.