- Dr. Jörg Engelbergs
- Regulatory-scientific Expert
- Paul-Ehrlich-Institut, Germany
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 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 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.
- Dr. Robert E. Zoubek
- Senior Consultant
- Granzer Regulatory Consulting & Services, Germany
Dr. Robert E. Zoubek is passionate biochemist with large experience protein degradation and protein analytics - an experience which he combines with his profound knowledge about the regulatory requirements in the US and EU for the different development stages. At Granzer Regulatory Consulting & Services Robert supports clients in all questions concerning drug development, manufacturing and quality control for biologics, biosimilars and ATMPs. Before Granzer, he owned several positions at Formycon, Germany, and GlycoForm. UK. As Director Scientific Affairs he led Formycon's drug product development, formulation and analytical services and provided solutions for difficult-to-formulate proteins. Prior to that, he was Head of Protein Characterisation & Preformulation and Head Quality Control. Robert has seen many Peptides and Proteins exhibiting different propensities in degradation. Over the years he gained a profound understanding about parameters causing degradation, ways to mitigate degradation, how to design studies effectively and the real challenges in physico-chemical and biological analytics.