- 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 (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
- Senior Consultant
- Granzer Regulatory Consulting & Services, Germany
Dr. Zoubek is passionate biochemist with large experience in the mitigation of protein aggregation and degradation, and the effective design of formulation studies - 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 Characterization & Preformulation and Head QC. Robert has seen many Peptides and Proteins exhibiting different propensities in aggregation. Over the years he gained a profound understanding about parameters causing aggregation, ways to mitigate aggregation, how to design studies effectively and the real challenges in aggregate analytics.
QC/QA Managers/Supervisors, Pharmacovigilance, Regulatory Managers and Specialists, Biotherapeutics Analytical Scientists, Process Science Research & Development, Product Stability Managers and Specialists, Drug Product Development Scientsts, R&D Heads/Managers, CMC Heads/Managers, Biotech Products Formulators