Soma Ghosh
Center for Device and Radiological Health, FDS, USA
Biography
After completing her doctoral degree from the School of Life Sciences at Jawaharlal Nehru University, New Delhi, India, Dr. Ghosh continued her training in molecular biology at the National Institutes of Health (NIH/NICHD), Bethesda, MD, where her work dealt with the mechanisms that regulate cellular DNA replication during animal development. Her focus then shifted to development of sequencing-based assays to support clinical decision making in cancer therapy and management, an area she pursed as a molecular geneticist at the Sidney Kimmel Comprehensive Cancer Center in Johns Hopkins Medical Institute. Currently, Dr. Ghosh is a regulatory scientist at the FDA where she is actively involved in the review and approval of companion diagnostic devices.
Abstract
Abstract : Regulatory aspetcs of co-development of biomarkers and companion diagnostics