Prior to joining Invitae, Dr. Hambuch designed and led the implementation of the first CLIA-certified, CAP-accredited laboratory to offer whole genome sequencing at Illumina. She has authored over 20 papers on the implementation and application of NGS techniques in a clinical laboratory. Over her career, Dr. Hambuch has worked as a scientist at Ambry genetics, an assistant professor at the University of Munich, and a post-doctoral fellow at the Centers for Disease Control (CDC). She earned her Ph.D. at UC Berkeley, her B.S. at UC Riverside, and did her medical genetics training at UCLA. Dr. Hambuch is board-certified in clinical molecular genetics. She is an active fellow of the American College of Medical Genetics and Genomics, and a member of the American Society of Human Genetics. Dr. Hambuch also serves on multiple national and international advisory groups, including the Scientific and Industry Advisory Board for Genome Canada and CLIAC.
New federal rules are driving significant shifts in development and marketing of “follow-on” CDx and “Co-CDx”/novel therapeutics and immuno-therapies. The panel will discuss the rapidly evolving regulatory and reimbursement landscape and the impact of new FDA and CMS policies on investor/company approaches to managing companion diagnostic development risk.