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Life Sciences Report 2017 / 2018

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24 Life

24 Life Sciences Report – In vitro Diagnostics © Charité – Universitätsmedizin Berlin, AG Blanchard “Our working group focuses on systematic analysis of the glycome, and is part of the excellent basic research environment in the Berlin-Brandenburg area. Key industry players are also present in the region, meaning that paths for joint R & D projects are particularly short.” Prof. Dr. Véronique Blanchard Group Leader AG Glycodesign and Glykoanalytics, Institute of Laboratory Medicine, Clinical Chemistry and Pathobiochemistry, Charité – Universitätsmedizin Berlin Basic research IvD development starts with consolidating knowledge on biomarkers as indicators for biological and pathogenic processes. One hot spot for medical research in the capital region is the Berlin Institute of Health (BIH), which connects medical research by the Charité – Universitätsmedizin Berlin and basic research from the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) to strengthen translational research. By doing so, the systems medicine approach of the BIH combines biomarker research at a genomic and proteomic level with clinical patient data for specific indication areas. The Institute of Laboratory Medicine, Clinical Chemistry and Pathobiochemistry at the Charité – Universitätsmedizin Berlin is active in the field of pathobiochemical mechanisms for diagnostic, prognostic and therapeutic purposes. Glycodesign and glycoanalytics are two of the main research topics, research is focused on identifying and developing glycanbased biomarkers in tumor diagnostics and in chronic inflammatory diseases. The protein glycosylation plays a crucial role in essential biological processes such as immune responses, cell differentiation and development, cell-cell interaction, and signal transduction. Alterations in glycosylation are linked to vast numbers of diseases and disorders. Systematic knowledge of disease-related changes in glycosylation as well as its integration in genomic and proteomic data allows a new understanding of biomedical mechanisms, opening up new possibilities for diagnostics, therapeutic approaches and prevention. An additional institution, focused on medicine for an aging society, including point-of-care-testing assays, is the Brandenburg Medical School “Theodor Fontane”, founded 2014 as medical university in the state of Brandenburg. Technology development As the need for medical diagnostics increases, one innovation seems to follow the next. Berlin-Brandenburg enjoys a strong position in this field, developing solutions for next generation in vitro diagnostics like sensor-actor molecules and autonomous biosensors, as well as genome, proteome and glycan-based multiplex analytics. The majority of IvD © Metanomics Health GmbH “The Metanomics Health GmbH technology platform, our scientific and clinical expertise, and the innovative and stimulating environment in Berlin-Brandenburg have helped us establish an outstanding proprietary clinical biomarker program: we identify and validate simple and complex novel metabolic biomarkers up to the prototype stage, then sub-license these to diagnostic partners with direct access to the healthcare market.” Dr. Tim Bölke Managing Director, Metanomics Health GmbH

Life Sciences Report – In vitro Diagnostics 25 © Metanomics Health GmbH High Throughput-Laboratory for Metabolome Analyses. are performed in highly automated and advanced hospital laboratories, but in recent years, many more have been developed for point-of-care testing (POCT). Point-of-care tests are useful because they can answer questions very quickly. Currently, the greatest challenge in the field is miniaturizing analytic devices. The Fraunhofer Institute for Cell Therapy and Immunology IZI in Potsdam-Golm is developing an in vitro diagnostics (IvD) platform consisting of a cartridge the size of a credit card (lab on-a-chip) and a base station. Beside scientific institutions, regional companies like Scienion AG, Metanomics Health GmbH, Medipan GmbH, and Metabolomic Discoveries GmbH are also focused on innovative technology development. Metanomics Health is one of the world’s leading companies in the metabolite analysis field and uses mass spectrometric detection methods. The company developed a metabolic blood test for the early detection of pancreatic cancer – a cancer for which the five-year survival rate is less than 6% due to the lack of early diagnostic tests. Clinical trials Berlin-Brandenburg is an excellent location for implementing clinical validation studies. With the Charité – Universitätsmedizin Berlin, one of Europe‘s largest university hospitals with more than 35,000 beds and a wide spectrum of outstanding basic research, the region offers broad access to a patient collective of urban and rural populations of about 180 ethnicities for implementing clinical trials to validate biomarkers. The Charité Research Organisation allows researchers to access a large group of patients in the capital region for clinical trials. It provides the capabilities and collaborations that modern translational, experimental and exploratory clinical development groups are looking for. PAREXEL, an important provider to the biopharmaceutical and medical device industries for developing and commercializing new medical therapies, is also located in Berlin. Labor Berlin, one of the largest clinical laboratories in Europe, combines the expertise of the Charité and Vivantes laboratories and offers complete solutions for any type of laboratory diagnostics for the diagnostics industry.

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