Speaker


From the Agenda

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2017-07-18 22:01

Dr.Bernd

Senior Director Clinical Development Biosimilars

Dr. Liedert, trained as a Clinical Pharmacologist, is familiar with both sides of the table, the developers objectives and the regulators perspective on biosimilars development: Today he is Senior Clinical Director, TA 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 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.