Autoren

Gene holds a Masters and doctorate in physiology and protein biochemistry from Wayne State University School of Medicine. He is Vice President of Regulatory, Quality and Compliance Policy and Management Operations at Genentech.

Before joining Genentech in 2000, he served for 21 years in various roles at the FDA, Center for Biologics Evaluations and Research, managing overall research and review actives relevant to therapeutic Biotech products. For the last 15 years, he also has served both as an FDA and Industry representative in Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). He served as repporteur of ICH Q6B "specifications of Biotech Products".