Ten post jest także dostępny w języku: polski
Dirk Kreder was appointed president of the Polish biotechnology company Mabion.
New president of Mabion
Dirk Kreder has extensive experience in managing small and large pharmaceutical companies in Europe and the United States. He has contributed to the development and registration of biosimilar and generic drugs on markets in several dozen countries. He has 10 years of experience in the development and commercialisation of over 20 drugs. He is the founder and president of Anteris Medical, Anteris Helvetia and Anteris Systems, operating in the small medical equipment segment.
Dirk Kreder has served on the Supervisory Board of Mabion since 2018. Following his appointment as President, he resigned from that position. At the same time, Krzysztof Kaczmarczyk was elected Chairman of the Supervisory Board. Maciej Wieczorek, who had previously held the position of the Chairman, became a deputy.
Strategy change for MabionCD20
Mabion’s activity is focused on conducting research and development works enabling the implementation of new biotechnological and biosimilar drugs. The company is currently conducting activities aimed at marketing authorisation by the European Medicines Agency (EMA) of the monoclonal antibody MabionCD20. It is an oncological drug, biosimilar to MabThera/Rituxan manufactured by Roche.
Mabion recently announced that it has modified its regulatory strategy for the drug. He wants to obtain a marketing authorisation directly on a large commercial scale. Previously, the company had a two-step strategy, i.e. obtaining a small scale authorisation and then (based on the variation application) a large scale marketing authorisation. The change of strategy results from the potential possibility of waiving additional, larger clinical trials. According to the company, the new registration pathway is also the most optimal in financial and time terms.