Dr Elena Wolff-Holz is currently working as M.D. at the Paul-Ehrlich-Institut and is Chair of the Biosimilar Medicinal Products Working Party (BMWP) and expert in the Oncology Working Party (OWP) of the CHMP, where she contributes to the development of major guidelines, reflection papers and reviews product applications. Overall, Elena has 20 years of professional experience, including 14 years in the biotech industry where she held various positions in clinical development and medical marketing functions at Centocor Inc (now J&J) and Amgen in the US and in Germany before joining the German national regulatory agency. In the area of biotherapeutics, she is responsible for advising companies on drug development issues , reviewing applications for marketing authorization in the EU and assessing clinical trial applications. Her work has resulted in several (co-)authorships in scientific journals and several presentations at (inter-)national conferences. She is also a lecturer at Institutes covering training of experts and executives from academia, regulatory bodies and biopharmaceutical industry. Elena is a physician by training with an M.D. degree from Heidelberg University and a postdoctoral fellowship at Harvard Medical School.