Germany
Educational background: Pharmacist, PhD, MBA and various Expert Qualifications (e.g. Qualified Person) Professional Experience: Worked for global pharma companies for about 30 years Started career at Roche (Basel, Switzerland), and joining Sanofi in 1997. Since then has held various roles in the field of injectable drug delivery systems for biotherapeutics with expanding responsibility: QA/QC, Manufacturing, Supply Chain, Key Account Management of device partner companies, Global Medical Device Surveillance, and until September 30, 2024, Global Device Leader and Drug Device Integrator. Present position: Independent Consultant & Advisor Achievement examples: - Drug Device Development & Industrialization for Lantus(R) SoloStar, the first disposable pen for a once-daily insulin - Setting up a cross-functional technology team on 'Large Volume Drug Delivery' which has become the On-Body Delivery platform for Drug Device Combination developments like the subcutaneous administration of isatuximab (Sarclisa(R)) - Expert consultancy in development of high-end antidote emergency injectors. Special interests: Pioneering new fields in biotherapeutics such as Drug Device Integration during Research & Development phase, gaining new insights and learnings in biotherapeutics and Drug Delivery Device technologies, building and forming new concepts, processes and establishing cross-functional diverse teams. Publication examples: - Approaches in subcutaneous delivery of monoclonal antibodies (2016) (https://www.europeanpharmaceuticalreview.com/article/43818/approaches-subcutaneous-delivery-monoclonal-antibodies/) - Standardization of the Reconstitution Procedure of Protein Lyophilizates as a Key Parameter to Control Product Stability (2020)(https://www.sciencedirect.com/science/article/pii/S0022354919306690)
Independent Consultant, Drug Delivery Systems Biomolecules, Medical Devices; Qualified Person Has successfully led development activities for an Emergency Use Autoinjector platform.
Leadership of a Biomolecule Cluster (Peptides & Monoclonal Antibodies)