Zurich, Zurich, Switzerland
Lead of a tissue and cell-biorepository compliant with quality guidelines, providing cryogenic infrastructure and regulatory advice (EU-GMP, MDR and ISO 13485) towards biomedical research clients comprising clinical trials with ATMPs or MDs.
Lead of a tissue and cell-biorepository compliant with quality guidelines, providing cryogenic infrastructure and regulatory support (EU-GMP, MDR and ISO 13485) towards biomedical research clients comprising interventional clinical trials (GCP/ICH) with ATMPs or MDs.
Establishment of a cell-and tissue biobank associated to a clean-room core-facility. Infrastructural and regulatory support stakeholders in their translational projects towards GMP compliancy, comprising FIM interventional clinical trials (GCP/ICH) using ATMPs or MDs. This role includes, e.g. risk management, qualification (IQ/OQ/PQ) of infrastructure and process validations.
Study co-lead, development, execution, and closing of mono-center clinical trial (NCT00526695) in collaboration with Institute of Anesthesiology. Organisation and distribution of donated obstetrical material to other laboratories. Co-founder of International Placenta Stem Cell Society (IPLASS). Lead of the FP6-project “Cryobanking of stem cells for human therapeutic application” (CRYSTAL), a European consortium of academic and industrial partners. Development of GLP/GMP relevant cell isolation/expansion/cryo protocols with focus on adult progenitor- and stem cells from obstetric sources with objective to translate into clinical interventions.
Development of a new anti-angiogenic cancer therapy approach: tumour growth inhibition by depletion of tumour-associated macrophages (TAMs) in combination with anti-vascular endothelial growth factor (VEGF) antibody treatment.
Bioengineering of biomatrices containing cell-demanded peptide/protein release systems.