Fraunhofer ITEM aims to protect man from health hazards in our industrialized world and to contribute to the development of novel therapeutic approaches. Focusing on lung and inhalation, Fraunhofer ITEM has pooled its expertise in three business units: In the business unit Drug Development, we develop and test novel medications against respiratory diseases. Scientific expertise covers manufacturing of biologics, preclinical and clinical development. The business unit Chemical Safety is dedicated to determining the risks from potentially harmful substances. Scientific expertise includes toxicology testing, exposure assessment, analytical methods, regulatory research and risk assessment. The business unit Translational Biomedical Engineering offers many years of experience in the development of medical devices – specifically neuro-implants and medical aerosolizers – including testing and testing scenarios, safety and risk assessment. All business units offer regulatory support. Numerous test systems are available, including in-vitro, ex-vivo and in-vivo. Studies can be performed in compliance with GXP regulations. A Regensburg-based division is dedicated to personalized tumor therapy including development of diagnostic tests to enable early detection of disseminated cancer cells and prediction of the response to therapy of metastatic progenitor cells. Fraunhofer ITEM is one of about 70 institutions of the Fraunhofer-Gesellschaft, Europe's leading organization for applied research.