Soma Ghosh

Center for Device and Radiological Health, FDS, USA

Title: Regulatory aspetcs of co-development of biomarkers and companion diagnostics


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.


An important requirement in the development of targeted therapies is identification of clinically relevant biomarkers, such as DNA mutations or protein overexpression. The detection of appropriate biomarkers is essential for the safe and effective use of targeted therapies and serves as the basis for development of companion diagnostic devices. There are several regulatory considerations for successful biomarker-targeted therapy-companion diagnostic co-development programs. My talk will highlight challenges and opportunities associated with these programs.