From biomarkers to tailor-made therapies

<ic:message key='Bild vergrößern' />

In the search for biomarkers, the scientists in Greifswald are greatly dependent on modern mass spectrometers. Source: Hans-Werner Hausmann, University of Greifswald

14.12.2010  - 

The central idea of individualised medicine is to assume that each person is unique across a variety of characteristics, and that there is thus also a need for individual medical treatment. Together with partners from industry, research, and medicine, scientists at the University of Greifswald have begun an initiative to more deeply explore this concept: The GANI_MED project – supported with more than 15 million euros from Federal and State Governments – will be taking a broad approach to bringing tailor-made therapies to the clinic.

Many of today's pharmaceuticals do not work for all patients. This is because the genome differs from person to person, which can lead, for example, to differences in the absorption of pharmaceutical substances in the body. In some patients, a small dose is enough to have an effect, while much larger doses are required in others. To help resolve this issue, scientists and physicians around the world are conducting research into individualised medicine. A cluster of excellence for this area was recently founded in Munich (more…). Researchers in Greifswald are also taking up the subject with the “Greifswald Approach to Individualized Medicine – GANI_MED”. “The goal of personalised medicine is to increase the effectiveness of treatments, avoid undesirable effects, and to reduce costs using the most modern diagnostics and the subsequent application of new therapy approaches that are oriented towards the needs of the individual patient,” says project coordinator Heyo Kroemer. A central aspect of GANI_MED is the ‘Study of Health in Pomerania’ (SHIP), which has been underway at the University Hospital since 1997. Using DNA, blood and urine samples from more than 7,000 individuals, the study has already provided many new insights, for example into the genetic background of high blood pressure (more ...).

Assisted by this study, it is hoped to develop personalised therapies for diseases that are set to become increasingly significant as a result of demographic change, making them cost drivers in the health system. “Research will be carried out specifically in the individual project areas of heart disease, diabetes, kidney failure, stroke, and fatty liver disease,” says University Hospital Greifswald Medical Director, Marek Zygmunt.  Work will focus in particular on the identification of genetic biomarkers that play an important role in the emergence of disease. In the coming years, data from 6,200 sick individuals will be gathered via clinical trials. The researchers hope to find new biomarkers for disease through the comparison of diseased patients with healthy participants in the SHIP study. This will enable the further expansion of the health study database. Already today, comprehensive information about the genome, metabolism, the body, and social environment is available for every single subject. These data will now be supplemented by images of the entire body, captured using magnetic resonance imaging (MRI). “This wealth of data is needed in international scientific circles, and provides a basis for the gradual transfer of personalised medicine into clinical practice,” says Zygmunt. For example, the genetic material in an individual can influence what actually happens when drugs enter the body. This can affect how quickly and how long they function, and the side effects that they cause. This knowledge is crucial when selecting the most appropriate therapy for each patient, which thus represents a tailor-made therapy.

Since 1997, a large number of residents of Western Pomerania have been undergoing health screening in the context of the SHIP health study.Source: UK Greifswald

Answering ethical and economic questions

The development of new methods of analysis are required to help researchers identify individual specific features in the emergence and progression of disease as reliably as differences in treatment outcome and course of treatments Bioinformatics will also play a crucial role, specifically to deal with the large volumes of data that are generated by these kinds of studies. For project participants, it will be important to maintain close connections with clinical research. The promise is that individualised concepts will test better for suitability for the treatment of patients.

Alongside the University and the Greifswald University Clinic, also in the network are the Helmholtz Centre Munich, the Leibniz Center for Diabetes Research, the German Cancer Research Center in Heidelberg, and the Universities of Mainz and Tübingen, as well as a range of other scientific bodies. Industry is also supporting the project: Siemens is participating, as well as specialist companies such as Bruker BioSpin GmbH and Decodon GmbH. The project is financed by the Federal Ministry of Education and Research and the state of Mecklenburg-Vorpommern. A total of 15.4 million euros has been made available over a period of five years; 14 million of this originates from the BMBF program ‘Cutting Edge Research and Innovation in the New Federal States.’ The current project, which will run until September 2014, is about more than just pioneering medical work: “It is unique to see physicians, theologians, computer scientists, business economists, biologists and many other scientists working on a new vision from the outset,” said university rector Rainer Westermann. The business economists will be dealing primarily with health economic issues, specifically whether individualised medicine can provide a means of cutting back the explosion in costs in health care.

The project also hopes to answer some of the fundamental ethical questions that are raised by the possibilities of individualised medicine: Do we really want to know everything that research can tell us? Fixed regulations are required so that these new methods do not create entirely ‘transparent’ patients, think the researchers. “Individuals must be reassured that their rights to privacy are guaranteed. We want to give people opportunities to preserve a high level of intimacy,” says theologian Martin Langanke from Greifswald. The ethicists in Jena know just how difficult it will be to answer these questions – for many years they’ve been dealing with the complex issues surrounding genetic engineering.

“We stand at the beginning of an evolution”

Hopes are high in the field of medicine. Project coordinator Kroemer and his researchers are also aware of this. “Ultimately, individualised medicine must be measured by whether it can sustainably influence the development of diseases, and whether personalised therapies actually increase health effectiveness. We stand at the beginning of a new evolution, but we hope to do this alongside society, and seek to intensify the dialogue on the prospects and limitations of personalised medicine.”