As Sr. Strategy Advisor, Product Development iBiopsy®, Mike Doherty participates in the iBiopsy® BU’s strategy definition and coordinates activities for product development. He is instrumental in the development and implementation of iBiopsy® regulatory plans, to optimize iBiopsy® product introduction in the US (FDA) and in Europe (EMA). His role is also central in providing recommendations for clinical data acquisition strategies and evaluating the most effective data sources. Mike actively participates in the creation of the iBiopsy® product classification and training protocols and ensures these protocols meet regulatory standards. Mike comes to Median with a unique experience in medical product development as well as in defining and driving regulatory strategies for the FDA approval of medical products. Before joining Median, Mike was Senior Vice President, Head of Product Development at Foundation Medicine from 2017 to 2019. Previously, he served as Head of Regulatory Affairs worldwide at Roche and Genentech from 2002 to 2016.