Since the year 2000, the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM has been successfully conducting early clinical trials with patients and healthy volunteers. A further expansion of this unit became necessary before long and is now being put into practice with the construction of the CRC Hannover, which will be built on the grounds of the Fraunhofer ITEM. The costs of approximately 40 million euros – building costs and technical equipment – will be borne by the Fraunhofer-Gesellschaft (funds provided by the German Federal Ministry of Education and Research) and the Land Lower Saxony. The latter will additionally provide startup funding for the first five years. The CRC Hannover is thus an important project within the Translational Alliance in Lower Saxony “TRAIN”.

TRAIN is a cross-disciplinary alliance of university and non-university research institutes in the Hannover/Braunschweig area, funded by the Lower Saxony Ministry of Science and Culture. Know-how and infrastructure are being pooled, so as to accelerate the transfer of new candidate drugs and vaccines from bench to bedside.

The three partners to the CRC Hannover – Fraunhofer ITEM, MHH, and HZI – will be using the center collaboratively to conduct early clinical trials for the development and registration of novel medications and to do patient-oriented research. The CRC Hannover will enable the collaboration of experts, staff sharing, and a joint use of facilities, services and, above all, of technical equipment. Special equipment worth 10 million euros will be brought in by the HZI based on special funding from the Land Lower Saxony, while the MHH will contribute cutting-edge diagnostic imaging technology. A steering committee staffed by all three cooperation partners will be responsible for the strategy regarding the type and degree of the center’s utilization.

The broad research potential of the three partners will be used to acquire and conduct also joint clinical research projects.

Fraunhofer ITEM

The Fraunhofer ITEM has generated a wealth of expertise in the field of respiratory diseases (allergic rhinitis, bronchial asthma, chronic bronchitis/COPD). For inflammatory and allergic diseases of the airways, the institute has been offering research and development services from the molecular level through to clinical trials for ten years already. For 30 years now, scientists at the Fraunhofer ITEM have been studying the toxicology of airborne substances. The institute’s Division of Pharmaceutical Biotechnology with its GMP unit enables the manufacture of clinical investigational products of biopharmaceuticals in compliance with the German Drug Act. 

MHH

The Hannover Medical School has been engaged in clinical research for many years and has been able to establish large cohorts of patients, who up to now, however, have participated mostly in clinical studies in the advanced stages of drug development. For early clinical research there has been no appropriate infrastructure available. Furthermore, the conditions for conducting research projects have not been optimal in the past. At the same time, though, basic research has spawned the development of innovative therapeutic and diagnostic concepts, which now are supposed to quickly find their way into clinical research. The CRC Hannover is to bridge the gap between basic research and clinical research. In addition to setting up research stations, the Hannover Medical School will contribute supreme competence in the field of imaging.

HZI

The Helmholtz Center for Infection Research in Braunschweig, Germany, investigates the mechanisms of infectious diseases and the body’s defense against these. The scientists are aiming to lay the foundations for the development of new medications and novel vaccination strategies and then systematically undertake the further development of their research results towards medical applications. To this end, the HZI, in collaboration with the MHH, has already set up a center for experimental and clinical infection research (TWINCORE), where basic research and clinical research are brought together.

Six thousand square meters of floor space will be available for research laboratories, outpatient examination rooms, special investigations, accommodation of study participants, the clinical unit, and the center administration.

Clinical trials

• 30 intensive-monitoring beds (for clinical trials of phases I and IIa)
• 30 beds for study participants who do not require intensive monitoring
• Outpatient section for preparatory examinations
• Cinema, gym, and cafeteria for study participants

Examination techniques

• Sonography
• Endoscopy
• Cardiovascular stress tests, provocation tests
• Sleep laboratory
• Metabolism laboratory
• Imaging techniques (MRT, PET, CT)
• Hearing and balance tests
• EEG
• Renal dialysis

Research laboratories

• Biomarker development
• Protein and gene expressions
• Immunology
• Biobanking for storage of biological samples