Mr Bernd Liedert | Senior director biosimilars
Boehringer Ingelheim Pharma Co Gmbh

Dr. Liedert, trained as a pharmacologist, is familiar with both sides of the table, the developers´ objectives and the regulators´ perspective on biosimilars development: Today he is Senior Director, Clinical Development Biosimilars at Boehringer Ingelheim, guiding biosimilar monoclonal antibodies and related molecules starting from Due Diligence, over bioequivalence and Phase III studies to BLA/MAA (immunology, oncology) Across programs he is Strategic Advisor for Extrapolation and Clinical Immunogenicity.
For more than 6 years he served as Head of Immunopharmacology at Merck Serono (FIM, POC studies, companion diagnostics) and was in charge of the clinical design of Merck Serono´s initial biosimilars´ programs in 2012.
Before, Dr. Liedert got insight experience of the Health Authorities´ perspective, when he served as regulator at the Paul-Ehrlich-Institute (PEI), the German Federal Agency for biologics. At the EMA, he represented the PEI and Germany in the Safety Working Party. He was co-author of several guidelines, which focus on risk mitigation for early clinical trials, immunogenicity and comparability/biosimilarity exercises.