Speakers

Dr. Elena Wolff-Holz is VP, Global Head Clinical Development at Biocon Biologics Ltd.  Prior to that, she was a senior regulator at Germany’s National Competent Authority Paul-Ehrlich-Institute for 14 years and has extensive knowledge in the development of biologic therapeutics, with a focus on cancer and immunology. Since 2016, she has been the Head of the Biosimilar Medicinal Products Working Party (BMWP) within the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Elena has also been a member of the Scientific Advice Working Party (SAWP) of the CHMP since 2017. With over 28 years of experience, she has held several leadership positions in clinical development and medical marketing functions at major biotech companies, including Centocor Inc (now Janssen, J&J) and Amgen, in both US and Germany.

As a result of her work, Elena has earned multiple authorships and co-authorships in esteemed scientific journals and delivered numerous presentations at national and international conferences. Elena obtained her M.D. degree from Heidelberg University and completed a postdoctoral fellowship at Harvard Medical School