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Research Division Clinical Research

The research division Clinical Research headed by Dr. Frank Behrens deals with the conception, implementation and evaluation of clinical research projects in the indication areas of inflammatory, immune-mediated, neuroinflammatory diseases and pain disorders (AMG and non-AMG). In order to meet the challenges of immune-mediated diseases and related disorders such as inflammatory diseases and pain in translational research, the research division Clinical Research carries out innovative clinical research projects for the early detection, diagnosis and treatment of these diseases. In addition to the development of own drug candidates, Proof-of-Concept studies and investigator-initiated studies are performed. The development of innovative study designs aims to sustainably improve patient care in order to address the medical need in patient treatment. 

The in-house phase 1 units in Frankfurt am Main and Göttingen allow for early drug development of drug candidates and application to healthy subjects. The proximity to the institutes and clinics of the University Hospitals Frankfurt and Göttingen enables direct patient access as well as access to the expertise of the specific indications.

The scientific focus of the research division is represented by the working groups Human Pain Models , Characterization of Immunopathology, and Biomedical Analyticis.

Departments

The research division Clinical Research is divided into the departments Clinical Research at the Frankfurt am Main site and Clinical Research and Phase I Unit at the Göttingen site. 

 

Clinical Research - Frankfurt am Main

The division consists of an interdisciplinary team, which includes Clinical Project Management and Medical & Scientfic Operations for the implementation of innovative biostatistical methods in case number planning and study design.. An in-house biomaterial bank for the supplementary collection of various biomaterials from serum to skin samples, allows the incorporation of these samples into basic scientific analysis and characterization of diseases. Through strategic networking with the Fraunhofer Institute for Intelligent Analysis and Information Systems IAIS, a partnership on Healthcare Analytics in Translational Medicine has been established that integrates state-of-the-art data science methods into translational research.

Clinical Projectmanagement AMG/Non-AMG

(Direction: Dr. Tanja Rossmanith)

For joint research projects and contract research in the Clinical Research department all necessary infrastructural prerequisites and the necessary expertise for conducting clinical studies in accordance with all national and international specifications, including studies according to AMG and MPG are available. A quality management system enables the conduct of investigator-initiated clinical trials under sponsorship of the Fraunhofer-Gesellschaft. The indication-specific expertise of specialists for all immune-mediated and inflammatory diseases is ensured by the close proximity and cooperation with the clinical centers of the University Hospital Frankfurt.

Medical & Scientific Operations & Characterisation of Immunopathology

(Direction: Dr. Michaela Köhm)

The working group Medical & Scientific Operations provides a team of scientists and physicians to develop and implement care-relevant study ideas  in cooperation with the clinics of the University Hospital Frankfurt. Through innovative study designs, project-specific statistical algorithms and the development of novel, specific outcome parameters such as the use of predictive, novel and innovative imaging, integrated solutions can be offered from the initial study idea to the final report, adapted to the respective problem. The innovative study ideas and their solution concepts can be implemented by the data management and biostatistics team and directly displayed in the data collection and evaluation. Additionally, clinical research projects with focus on Characterization of Immunopathology and biomarker development, e.g. for early diagnosis of immune diseases, are initiated and performed.

Early Drug Development & Human Pain Models

(Direction: Dr. Carmen Walter)

The working group Early Drug Development has a modern phase I unit, in which studies of early clinical drug development (e.g. pharmacokinetics, pharmacodynamics, bioequivalence studies) can be performed under optimal conditions. An experienced and highly qualified team of (specialist) doctors and study nurses takes care of the study participants during all phases of their treatment.

The working group with its research focus in Human Pain Models can offer a wide range of high-quality clinical pharmacology services. Here, the scientific focus is pain, analgesia, smell and taste. Standardized methods of pain measurement are used, which, among other things, serve the development of analgesic drug candidates in healthy subjects.

Biomedical Analytics

(Direction: Dr. Robert Gurke)

The working group enables measurements of small exogenous and endogenous molecules by coupling of liquid chromatography and mass spectrometry while adhering to the highest analytical standards. One focus is on measuring lipid mediators and determining their relevance in the pathogenesis of immune diseases. The mass spectrometry platform is also available for measurements of further analytes (e.g. drugs and their metabolites) as part of (clinical) research projects.

 

Clinical Research and Phase 1 Unit - Göttingen

(Direction: Prof. Weber, Göttingen)

The working group provides the infrastructure and human resources to carry out clinical studies in the early phases of drug development in the indication area neuroinflammation. A modern phase I unit and an excellent interdisciplinary team offer all the structural requirements for the use of new drug candidates in healthy volunteers and patients with controlled disease activity.