Vision & Mission
Proof-of-Concept: Basic research in clinical context
Together with the medical faculty, the University Hospital, and the University of Tübingen, the ZPM has launched different research projects, qualified to generate individual patient derived data, to integrate comprehensive data, and specially to analyse highly complex biological information. The overall goal of our efforts is the precise description of complex diseases in order to find new approaches for innovative therapies. The central questions of the Center for Personalised Medicine are geared to the well-established medical research areas of the University of Tübingen, namely oncology, immunology, cardiovascular diseases, neurobiology, and biology of infection.
Translation of Personalised Medicine into clinics: moleculare disease-boards
In tumor boards, for example, experts with varying skills (dermatological, gastrointestinal, gynecological tumors, etc.) from the same institution are brought together to discuss complex oncological cases. The discussion treats all of a patient’s clinical data – from her medical history, to X-ray and MRI imaging, to current treatment results, in order to determine the next steps in the patient’s treatment strategy.
Expert committees in molecular disease boards are not composed only of doctors from one specific specialty. The focus of discussion is not the type of tumor or disease, but rather its molecular make-up. Experts from the areas of genomic and proteomic analysis evaluate individual cases alongside bioinformatics specialists, drug experts, and attending physicians. The discussion is based on the molecular characteristics of the tumor, and the goal is finding the best possible treatment for the patient. Establishing these types of molecular tumor boards is another important step towards applied PM, and therefore an important focus of the ZPM. We have initiated our first molecular tumor boards. The knowledge gained from these boards will pave the way for subsequent boards in other clinical areas, and are already helping us integrate PM into daily clinical treatments here at the UKT.
Applying PM in Clinical Studies: N=1
Personalised medicine doesn’t just require a new way of thinking in everyday clinical treatment; it is also becoming increasingly important to change the way we conceptualize and complete clinical studies. The trend is moving away from huge patient cohorts and towards individualized approaches, called N=1 studies, which select the best possible treatment for each patient based on his molecular profile.
This radical new study design offers the advantages of exact stratification, but does inhibit research in other ways (difficult to make statistical evaluations, long periods before achieving significant results, less acceptance by insurers and pharmaceutical companies). Other new study concepts have also emerged. In a classical approach, patients are grouped based on their phenotype, or the type of tumor they have. All patients with breast cancer are treated in a study using medication approved for that cancer, disregarding underlying genetic realities.
In personalised studies – also called “basket trials” – treatment is selected based on the molecular profile of the tumor. It is possible that a patient with a gastrointestinal tumor (GI) will receive a medication targeting the specific mutation in his tumor, even if it is actually approved only for breast tumors (“off label use”). This creates problems not only with drug safety, but also in relation to the question of whether an insurer will cover the costs of the treatment. Close collaboration between the clinic and the insurer is important in overcoming this hurdle when developing such innovative study models.