Company: Paul-Ehrlich-Institut, Federal Institute for Vaccines & Biomedicines
Job title: Scientific-Regulatory Expert, Biomedicines & CDx
Dr. Jörg Engelbergs is currently working for the Paul-Ehrlich-Institut (PEI) in Langen, Germany, as regulatory-scientific expert and assessor for biopharmaceuticals, especially Biotechs (Monoclonal Antibodies) with focus on Quality/CMC, Non-Clinic, Biomarker / Companion Diagnostics (Personalized Medicines). He is involved in the scientific assessments of GCP conformity of clinical phase I-III drug trials and the European process of market authorization of biopharmaceuticals, comprising scientific assessments and national / EMA advices. Dr. Engelbergs is member of the Pharmacogenomics Working Party (PGWP) at the European Medicines Agency (EMA) and member of the newly established Heads of Medicines Agencies (HMA) CTFG Sub Group on IVD/CDx.
He holds a Diploma in biology and a PhD in cell biology (cancer research) / biotechnology. Before he joined the PEI, he has gained large experience in experimental neuropharmacology and cancer research. In this time he was last head of “Neuropharmacology laboratory” and in parallel head of the clinical core “Genotyping service center” (SNP, mutation and expression profiling) both at Department of Neurology at University of Essen Medical School, Germany.