20 years of clinical research at Fraunhofer ITEM

© Fraunhofer ITEM, Nico Herzog
Measurement of the nasal flow by rhinomanometry in the Fraunhofer ITEM Allergen Challenge Chamber was part of a clinical trial performed at the institute.

The year 2020 was a very special year for Fraunhofer ITEM – not only because of the corona pandemic, but also because it was the 20th anniversary of “Clinical Airway Research” at the institute. Exactly 20 years ago, Fraunhofer ITEM set up its own clinical research department in Hannover, with a special focus on inflammatory and allergic diseases of the lung. The aim was to advance translational research, i.e. to bring findings from applied and preclinical research into clinical trials – in a one-stop shop.

The start of our clinical research

Already in 1981, when the institute was founded, the lung and the airways were the focus of research at the institute, although then rather under aspects of environmental and occupational toxicology. Using in-vitro and in-vivo methods, the ITEM researchers studied the effects of airborne substances that enter the body via the respiratory tract. “Initially, we wanted to extend our spectrum to allow us to investigate the effects of airborne substances on human health directly. One example is an experimental study with dust from an industrial area in eastern Germany. We were able to show in this study that metal-containing fine dusts from the environment induced airway inflammation in healthy subjects,” says Prof. Jens Hohlfeld, Division Director of Airway Research. The pulmonologist played an active role in setting up this division 20 years ago. “Because allergies were on the rise, we were also interested in natural allergens such as pollen and their effects on human health – and in treatment options in particular. We, therefore, extended our research to include clinical trials with novel drugs for treating asthma and allergies.” In the beginning, it was mainly the pollen challenge chamber, also called the “meadow in the lab”, that caused an increase in clinical drug trials, especially of those targeting allergies. With their many years of expertise, our aerosol technologists played a key role in setting up our pollen challenge chamber – and their knowhow is also crucial to our current development work,” says Prof. Hohlfeld.

We keep growing

While the division started in 2000 with just a handful of staff headed by Prof. Norbert Krug and Prof. Jens Hohlfeld, today a team of more than 50 physicians, scientists, project managers, nurses, physician assistants, documentalists, medical and biological laboratory assistants, and students take care of patients and healthy study participants.

The buildings have also become larger over the years: After two expansions of the clinical facility in 2004 and 2006, a new building was eventually constructed to allow for further enhancement of the institute’s clinical research and to place the focus on early-phase clinical development with an expanded range of therapeutic areas. The Clinical Research Center Hannover – CRC Hannover for short – was thus planned as a new facility and institute extension of Fraunhofer ITEM, designed for collaborative work with the neighboring partners Hannover Medical School and Helmholtz Centre for Infection Research under one roof. The new building was inaugurated with an opening ceremony in the fall of 2014. With the availability of a phase-I ward, overnight beds and interdisciplinary diagnostic equipment including MRI imaging, the focus of clinical research at Fraunhofer ITEM has shifted towards experimental medicine and early-phase clinical development. “Our broad range of challenge methods with different allergens, endotoxin, rhinovirus, ozone, dusts or hypoxia in combination with invasive and non-invasive diagnostics within a qualityassured and custom-designed infrastructure make us an important and highly demanded partner for clients from the pharmaceutical industry,” says Prof. Hohlfeld. Meanwhile, the initial focus has broadened: from the lungs to nearby organ systems such as the skin and the immune system. And last but not least, the corona pandemic has shown the importance of research on infectious diseases. Following the appointment of the new institute director Prof. Thomas Thum, cardiac diseases will also play a major role in clinical and translational research at Fraunhofer ITEM in the future.

“We would have loved to celebrate our 20th anniversary with an international symposium, but unfortunately, like so many other events, this one also fell victim to the pandemic,” regrets Prof. Hohlfeld. Hopefully, celebrations will be possible again in 2021, because the whole institute will then have the opportunity to celebrate – the 40th anniversary of Fraunhofer ITEM!

Dr. med. Philipp Badorrek, specialist in clinical pharmacology, Head of Department of Clinical Airway Research, Fraunhofer ITEM

"At Fraunhofer ITEM, we have excellent possibilities to conduct clinical research in an academic environment. This means that we are not limited to the common standard, but can develop new techniques and models in our studies, contribute our own ideas, and use the excellent infrastructure of the CRC Hannover. Here, we have access to an MRI scanner for research only and an excellently equipped biomarker laboratory, which we have used very successfully in many of our studies."

Silvia Monden, assistant medical technician for lung function measurements, Fraunhofer ITEM

"I have been part of the team from the beginning and still enjoy working at Fraunhofer ITEM in the Division of Airway Research. Even though my specialty is lung function measurement, my job involves a lot of different activities, which is very motivating! For example, I was able to help establish new methods for specific and non-specific inhalations as well as the hypoxia chamber and the sleep laboratory, establish three new generations of lung function measurement software and hardware, write the corresponding SOPs, and train many colleagues in these procedures. It is exciting to work in such a dynamic environment.”

Dr. Diana Sims-Silbermann, Senior Trial Manager Early Development and Clinical Pharmacology, Janssen-Cilag GmbH

"As Senior Trial Manager for Early Development and Clinical Pharmacology trials for Janssen since 2007 I have had the opportunity to work with Fraunhofer ITEM on several phase l clinical trials in the recent past. The trials were performed with utmost professionalism and the quality of documentation was excellent. Site staff was responsive, attentive and performed the required protocol activities without deviation. The Principle Investigator exercised his oversight responsibility and was at all times available, cooperative and well-informed on the progress of the trial. I can highly recommend this site for any clinical trials within their therapeutic area of expertise."

Further information


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