Center for Device and Radiological Health, FDS, USA
Title: Regulatory aspetcs of co-development of biomarkers and companion diagnostics
Biography: Soma Ghosh
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.