Press releases

(Hannover) Together with representatives from industry, government and academia, Dr. Gabriele Heinen-Kljajić, Minister for Science and Culture of Lower Saxony, and Prof. Reimund Neugebauer, President of the Fraunhofer-Gesellschaft inaugurated the High-Performance Center Translational Biomedical Engineering in Hannover on April 25.

(Hannover, Germany) After 21 years of successful leadership, Professor Uwe Heinrich ceded his position as Fraunhofer ITEM executive director to Professor Norbert Krug as of January 1, 2017.

(Hannover/Regensburg, Germany) Scientists of the Regensburg-based Project Group for Personalized Tumor Therapy (Fraunhofer ITEM/University of Regensburg) and colleagues from Icahn School of Medicine at Mount Sinai discovered new mechanisms of early metastatic spread in breast cancer. Results have been published in the latest issue of the renowned journal Nature (doi:10.1038/nature20785, doi:10.1038/nature20609).

(Hannover, Germany) The Fraunhofer Project Group for Personalized Tumor Therapy will become a division of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM in Hannover as of January 2017 and will thus be included in the financing model of the Fraunhofer-Gesellschaft.

The new EU-wide Medical Device Regulation (MDR) is scheduled to become effective in mid-2017, entailing consequences for manufacturers of medical devices. Among other obligations, they will be required to provide more documentation to comply with the new legislation. The expertise pooled at Fraunhofer ITEM, in particular in the Division of Translational Biomedical Engineering, enables comprehensive support in the implementation of the new regulation.

(Hannover, Germany) The Fraunhofer-Gesellschaft, on behalf of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, has signed an asset transfer agreement with Takeda GmbH to exclusively transfer its Surfactant and Continuous Powder Aerosolization (CPA) program assets to Fraunhofer ITEM. The transfer includes the CPA technology platform – the technology for continuous aerosolization of powdery substances – and the know-how to manufacture recombinant surfactant protein C, together with the associated intellectual property. The Fraunhofer ITEM is thus in a position to continue the development of therapies involving continuous inhalation of surfactant and other medications, begun 10 years ago as contract research on behalf of industry.

The aim of the comprehensive EU project “EU-ToxRisk” is to lay new foundations for a paradigm shift in toxicology – towards more efficient and animal-free hazard and risk assessment of chemicals. An international consortium of 39 partner organizations from academia, industry and regulatory authorities will participate in this project receiving funding of 30 million euros. The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM is bringing in its expertise with a focus on inhalation toxicology. EU-ToxRisk will be kicked off in Egmont aan Zee in The Netherlands) in mid-January 2016 and will run for a period of six years.

In spring 2015, regulatory approval for the Braunschweig-based Fraunhofer ITEM Division of Pharmaceutical Biotechnology was extended to include aseptic, automated fill and finish of small-volume liquid dosage forms in vials and ampoules – at batch sizes of several 100 to a few 1000 units.

What scientists have been discussing for no less than 100 years has now been proven by scientific evidence: the grass pollen count in the air has an impact on atopic dermatitis – leading to considerable deterioration of symptoms in those suffering from this skin disorder.

A novel therapeutic principle is aimed at controlling the airway inflammation in allergic asthma, to mitigate the course of the disease. With its comprehensive expertise, Fraunhofer ITEM successfully performed toxicology testing of the novel DNAzyme-based drug developed by sterna biologicals GmbH & Co. KG and also part of the clinical trials. The results of the proof-of-concept study in man have now been published in the renowned “New England Journal of Medicine”.