Dr. Helge Neidhardt
Helge Neidhardt has over 30 years of pharmaceutical development experience with biologics covering projects on high purity natural proteins, recombinant proteins, monoclonal and conjugated antibodies. He worked at Aventis Behring and at sanofi in different responsibilities, leading internal as well as collaborative CMC projects through all stages of development with EMA and FDA. He participated to European industry groups developing joint position papers in the area of regulatory CMC. He has since worked as a consultant to support CMC biologics product development for large and small pharmaceutical companies.