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About

Dr. Jörg Engelbergs rounded

Dr. Jörg Engelbergs

Regulatory-Scientific Expert

Paul-Ehrlich-Institut, PEI

Dr. Jörg Engelbergs is currently working for the Paul- Ehrlich-Institut in Langen as regulatory-scientific expert for polyclonal and monoclonal antibody based therapeutics, including biosimilars and fusion proteins (pharmaceutical quality / CMC and non-clinic) and further as expert for biomarkers / personalized medicines. He is involved in the European process of authorization of biopharmaceuticals, comprising scientific assessments and advices. Further activities are assessments of GCP conformity of clinical phase I-III trials, national and third-country (USA/Asia) GMP inspections, and basic research on biomarkers. For EDQM he is acting as expert in the Host-Cell Protein Working Party and in the P4Bio Working Party and for EMA he is acting as member in the Pharmacogenomics Working Party. He has been also co-author of the EMA guideline on production and quality control of monoclonal antibodies and related substances. Dr. Engelbergs holds a Diploma in biology and a PhD. in cell biology and biotechnology. Before he joined the PEI, he has gained large experience in experimental cancer and neuropharmacology research with focus on targeted monoclonal antibody and biomarker based personalized biomedicines. In this time he was head of "Neuropharmacology laboratory" and in parallel head of clinical core “Genotyping service center" at Department of Neurology at University of Essen Medical School. Before, he has been scientific project leader in various cancer research projects and in parallel head of the "Monoclonal antibody research and production unit" at the Institute of Cell Biology at the West German Cancer Center.

 

Robert Zoubek rounded

Dr. Robert E. Zoubek

Senior Consultant

Granzer Regulatory Consulting & Services, Germany

Robert has 20 years of experience in development of biologics and biosimilars. His expertise comprises the Characterisation of the Originator molecule, the cell line development incl. candidate selection phase, API and drug product development, production processes, and fill & finish. Robert is Senior Consultant at Granzer Regulatory Services and advises clients on CMC from early development up to marketing authorization for Europe and USA.

Until he joined Granzer Regulatory Services, Robert worked in several positions at the Formycon/Germany, a leading developer of Biosimilars for regulated markets. As Director Scientific Affairs he led Formycon´s drug product development and analytical services. Before that, Robert was Head of Protein Characterisation & Preformulation and Manager Quality Operations. In those positions he supervised Formycon´s GMP-Quality Control and analytical labs, the core of Quality-Biosimilar development.

Robert earned the PhD from the University of Erlangen-Nuremberg for his research on the wound-healing peptide Thymosin beta 4 and he was awarded Master of Business Administration from the University of Manchester. He also holds a MSc from the University of Munich.