Assessment of module 3 (quality/CMC) of the eCTD dossier in the context of variation applications and marketing authorization applications for national, MRP/DCP and centralized procedures. Assessment of module 3 of clinical trial applications from first-in-human to phase III.Scientific advice to applicants both at the national level and for the EMA.Human and veterinary medicinal biologicals including antibodies, vaccines, ATMPs (gene and cell therapy products), blood products.

Regulatory quality control of medicinal products available on the Danish market.Regulatory quality control of centrally authorised medicinal products available in EU/EEA countries in collaboration with the EDQM and the EMA.Knowledge of regulatory guidelines i.e., Phar. Eur., ICH, EU directives, EMA guidelines, ISO.Elaboration of new international standards.Collaboration with other authorities in Europe as part of the Official Medicines Control Laboratories (OMCL)… Show more Regulatory quality control of medicinal products available on the Danish market.Regulatory quality control of centrally authorised medicinal products available in EU/EEA countries in collaboration with the EDQM and the EMA.Knowledge of regulatory guidelines i.e., Phar. Eur., ICH, EU directives, EMA guidelines, ISO.Elaboration of new international standards.Collaboration with other authorities in Europe as part of the Official Medicines Control Laboratories (OMCL) network.Expert in the following test methods: cell-based potency assay, monocyte activation test (MAT), bacterial endotoxin LAL, factor VIII assay, SDS-PAGE, HPLC, UV-VIS spectrophotometry, ELISA, real-time PCR. Show less

R&D, incretin biology, diabetes, obesityDevelopment and evaluation of cell-based assays particularly in primary cells such as pancreatic islets, neurons and hepatocytes to test GLP-1-, GIP- or GCG-based peptides. Development of affinity and potency assays for the GIP structure-activity relationship (SAR) analysis.Design of mode of action studies for semaglutide.Isolation and culture of primary cells such as pancreatic islets and hypothalamic neurons.Knowledge of GLP-1 and… Show more R&D, incretin biology, diabetes, obesityDevelopment and evaluation of cell-based assays particularly in primary cells such as pancreatic islets, neurons and hepatocytes to test GLP-1-, GIP- or GCG-based peptides. Development of affinity and potency assays for the GIP structure-activity relationship (SAR) analysis.Design of mode of action studies for semaglutide.Isolation and culture of primary cells such as pancreatic islets and hypothalamic neurons.Knowledge of GLP-1 and GIP intracellular signalling pathways. Knowledge of intracellular signalling pathways involved in pancreatic beta-cell function, proliferation and death.Management of the rodent pancreatic islet isolation facility during one year. Delivery of high-quality pancreatic islets to different projects in Novo Nordisk pipeline.Supervision of technicians. Show less

Research in diabetes- study of the effect of PAR2 in beta-cell function (in collaboration with Lund University, Sweden)- identification of novel incretin targets- support to gut-to-beta cell project with isolation of intestinal epithelial cells- mode of action studies of semaglutide.Supervision of one technician and a master student.

Research in ERK cell signalling- study of the physiological role of the MAP kinase Erk3 by using the Erk3 knockout mouse model- study of the role of Erk3 in tumorigenesis and cellular senescence.Extensive experience with embryo and adult mouse dissection.

Research in diabetes- study of CREMalpha and DUSP14 as negative regulators of GLP-1 signalling in pancreatic beta-cells.Supervision of one technician.

Research in diabetes- identification of anti-apoptotic peptides to prevent pancreatic beta-cell death (targeting the IL-1beta, IFN-gamma, TNF-alpha, FasL proinflammatory pathways)- role of the incretin GLP-1 in the regulation of pancreatic beta-cell mass and function.Extensive knowledge of GLP-1 intracelluar signalling pathways.Extensive knowledge of intracelluar signalling pathways involved in pancreatic beta-cell proliferation and death.Supervision of one technician and a… Show more Research in diabetes- identification of anti-apoptotic peptides to prevent pancreatic beta-cell death (targeting the IL-1beta, IFN-gamma, TNF-alpha, FasL proinflammatory pathways)- role of the incretin GLP-1 in the regulation of pancreatic beta-cell mass and function.Extensive knowledge of GLP-1 intracelluar signalling pathways.Extensive knowledge of intracelluar signalling pathways involved in pancreatic beta-cell proliferation and death.Supervision of one technician and a medical doctor. Show less

Research in inflammatory bowel disease and nitric oxide