Prof. Dr. Uwe Platzbecker
Project Lead
Medical Clinic I, Hematology, Cell Therapy and Hemostaseology, University Hospital Leipzig, University of Leipzig
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SaxoCellClinics is responsible for the clinical support of all innovative research projects of SaxoCell as well as for the bundling and networking of the clinical expertise of the three locations Leipzig, Dresden and Chemnitz. Within the cluster, SaxoCellClinics acts as a contact, interface and communicator in the field of ATMPs between research institutes, authorities (PEI, ethics committee), industrial partners, patient advocacy groups, study groups, as well as the SaxoCellOmics and SaxoCellSystems platforms. SaxoCellClinics is structured to provide access to the above-mentioned stakeholders and various services at different levels. In the first level (ground floor), general advice for potential research projects and clinical studies is given and access to further processes/levels or partners in SaxoCell is provided. In the subsequent levels 1-4, the consulting and networking processes are specifically tailored to the respective projects and their stage of development. Furthermore, the translation of innovative therapy products into clinical practice is accompanied.
1. Clinical project advice: Evaluation of the implementation potential and further consultation of the projects with the involvement of the Advisory Board. The basis for this is the establishment of a central coordinating structure for clinical and regulatory aspects in the field of gene and cell therapy and the development of uniform standards and regulatory processes.
2. Project management and coordination of clinical studies: Optimization of the translation of clinical studies of phases 1-3 in the field of cell and gene therapy by supporting measures such as protocol development, preparation of further documents (SOPs and study plans) and submission of documents to authorities.
3. Consulting and network formation: Networking within the cluster with the central structures and the platforms SaxoCellSystems and SaxoCellOmics. Comprehensive networking with the regional directorate, BfArM, patient representatives and health insurance companies. Project-related direct advice from authorities (ethics committee, PEI) on a regular basis.
4. SaxoCell-Bio: Development and coordination of the ATMP register and the biobank (SaxoCell-Bio) for gene and cell therapies in Saxony.
Prof. Dr. Uwe Platzbecker
Project Lead
Medical Clinic I, Hematology, Cell Therapy and Hemostaseology, University Hospital Leipzig, University of Leipzig
More information on external website
Silke Gloaguen
Coordinator
Medical Clinic I, Hematology, Cell Therapy and Hemostaseology, University Hospital Leipzig, University of Leipzig
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CONTACT
SaxoCell CLINICs
E-mail: clinics@saxocell.de