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Volume 2, Issue 3(Suppl) Oncol Cancer Case Rep
ISSN: 2471-8556 an open access journal
Page 67
Notes:
Cancer Therapy & Biomarkers 2016
December 05-07, 2016
conferenceseries.com
CANCER THERAPY,
BIOMARKERS & CLINICAL RESEARCH
15th World Congress on
December 05-07, 2016 Philadelphia, USA
Regulatory aspects of co-development of biomarkers and companion diagnostics
Soma Ghosh
Center for Devices and Radiological Health, US FDA, USA
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 con-
siderations for successful biomarker-targeted therapy-companion diagnostic co-development programs. My talk will highlight
challenges and opportunities associated with these programs.
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.
Soma Ghosh, Oncol Cancer Case Rep 2016,2:3(Suppl)