Reading between the lines of statements such as “once the molecular causes of a disease have been deciphered”, we understand that it “will be possible to adapt cancer, diabetes or cardiovascular disease treatments to the specific requirements of individual patients”. Medicine will no longer be an empirical medical skill of healing, it will become a rational molecular science (Regine Kollek). Adepts see this as nothing short of a paradigm change in the medical field.

Personalised medicine is a controversial term and there are many different opinions as to what really lies behind this term. Urban Wiesing, philosopher and medical doctor from Tübingen and chairman of the Central Ethics Commission of the German Medical Association, believes that the term is wrong as it renders complex issues too simple. "Personal characteristics do not manifest themselves on the personal level, but on the molecular level." (Spektrum der Wissenschaft, 1/2011). The term is somewhat misleading as it suggests that the biomarker-based grouping (stratification) of patients also sees groups as if they were only one individual. The "Zukunftsreport Individualisierte Medizin und Gesundheitssystem" (Future Report: Individualised Medicine and the Healthcare System, TAB report) published by the "Büro für Technikfolgenabschätzung beim Deutschen Bundestag" (Office of Technology Assessment at the German Bundestag, TAB) is of the opinion that the stratification of patients into subpopulations of single individuals has no practical or economic advantage and suggests to use the term "stratifying medicine" instead of "personalised medicine".

The enigmatic term is also misleading in that it does not relate to an actual holistic medical system that focuses closely on individual patients, but is actually just a suggested practise to be used, for example, in cases where a genetic test on a given individual comes up with extremely negative medical findings that show that the patient has a high risk of developing a certain disease. The differences in meaning between individual and person are rather subtle and it would appear that the labels "individualised" and "personalised" are used somewhat arbitrarily.

Personalised medicine is rather like a lucky dip containing the wishes and hopes of biomedical research. The TAB report (2009) developed a typology that shows what personalised medicine can be about:

• biomarker-based stratification (formation of groups)
• genome-based information about health-related traits
• individual risk profiling
• differential intervention strategies
• one-of-a-kind therapeutics (implants or prostheses tailored to a specific patient's requirements)

The healthcare industry also hopes to benefit from personalised medicine. The pharmaceutical industry is hoping that the time-consuming and costly research & development processes will lead to greater efficiency, new drugs, target structures as well as new strategies for mechanisms of action and therapies.

Roche, the huge Swiss pharmaceutical concern that sells diagnostics and therapeutics as a single package, has an unusual business model. In contrast to many of its competitors, Roche has an in-house diagnostics branch, which was strengthened in 2010 by the acquisition of the diagnostics specialist BioImagene. The Swiss drugmaker Novartis is also strengthening its personalised medicine portfolio with the acquisition of the American cancer diagnostics specialist Genoptix which offers laboratory services for the diagnosis of bone marrow, blood and lymph gland cancer (NZZ, 24^th January 2011). At present it is difficult to say whether or not these two companies are starting a major trend.

The leading German biotech company Qiagen, which offers 20 different tests for certain (cancer) preparations, is also increasingly targeting the field of personalised medicine. The company hopes to double its current revenues (50 million euros) in this field by 2013.

The medical technological and diagnostics industries also hope to expand their product spectrum to cover all the steps involved in medical treatment. And perhaps patients themselves (who are rarely the real focal point of industry) should take more responsibility for their health by undergoing genotyping and multiparameter testing, which would provide them with information about their risk profile and probability of developing a certain disease.

At the moment, research is focused on gaining knowledge; high-throughput technologies are being developed to come up with or refute hypotheses. Researchers are looking for (molecular) biomarkers to identify and characterise as well as developing test-, measurement- and analysis methods. Systems biology approaches are regarded as the perfect way of bringing together huge amounts of data to create integrative models. Cautious estimates assume that it will take between 10 and 15 years before this becomes possible.

Tens of thousands of biomarkers are known, but only a small number is used for clinical applications, said Bärbel Hüsing of the Fraunhofer Institute for Systems and Innovation Research in reference to a recent Nature paper (13^th January 2011, George Poste, Bring on the biomarkers). The author of the 2008 TAB report on individualised medicine and the healthcare system (June 2008) says that this confirms her assumption that personalised medicine has reached a transition phase, and now it is the turn of translation. We have now reached the stage where the huge number of biomarkers that have been identified need to be sorted to define those that might be worth validating and continuing on to clinical application. And this requires regulatory authorities to put in place an adaptive clinical trial designed to answer user-oriented questions.

Despite its low degree of commercialisation, personalised medicine has “reached” the stakeholders of the healthcare sector. The healthcare research policy of Minister Schavan’s department, in which personalised medicine is to play a prominent role, illustrates this rather well. In 2007, the German Federal Health Minister Schavan laid out a roadmap for personalised medicine, highlighting the field of personalised medicine as an important issue. In the new German 5.5-billion-euro health research programme, personalised medicine is already among the six fields of action which the German government hopes will lead to tailored therapies, better diagnostics and cost reductions.

In March 2011, the Evidence-Based Medicine network will hold a congress entirely dedicated to personalised medicine. The scepticism expressed by the supporters of medical evidence seems to be a matter of principle: they fear that growing personalisation will make it increasingly difficult to identify the clinical effect of treatments. Innovation researcher Hüsing compares this debate to a tightrope walk where it is necessary to decide at some point whether one wants to adhere to the established principles of proof of efficiency, safety and harmlessness or whether these principles need be abandoned in favour of more flexible forms in order to not prevent innovations from being implemented. The stakeholders of evidence-based medicine are now finding themselves having to deal with these kind of questions, which did not even exist around two years ago.

The first strategic alliances and research projects have been initiated in Germany. They are all pursuing ambitious goals, whether they will achieve what they have set out to do, only the future can tell.

In Greifswald, a consortium from academia and industry is concentrating on the task of “transferring individualised medicine into a university hospital” (Innovationsreport 26th November 2010). The project is supported by the German and the Mecklenburg-West Pomerania governments with funding of around 15 million euros, and will run until 2014, initially focussing on the most common diseases. Gani_Med (Greifswald Approach to Individualised Medicine) bases its work on a population study involving around 7,000 people. The project also involves non-university institutions and companies, including ones from Baden-Württemberg (Dr. Margarete Fischer-Bosch Institute for Clinical Pharmacology in Stuttgart, DKFZ, the University Hospital of Heidelberg, the Interfaculty Centre for Ethics in the Sciences at the University of Tübingen as well as Bruker BioSpin GmbH (Rheinstetten)).

The "m4 – personalised medicine and targeted therapies cluster" that was established in the Greater Munich Area in 2010 aims to become “an internationally recognised centre and model region for personalised medicine”. The cluster brings together 100 biotech and pharmaceutical companies, hospitals and scientific institutes, whose activities are coordinated by the cluster management organisation BioM with the goal of improving the discovery of drugs and their individual efficiency and safety.

The network has around 100 million euros available for its activities and hopes to bring on board small- and medium-sized companies that develop diagnostics and therapeutics. Around 100 partners have already joined forces to work on a number of projects. The cluster managers will manage the complex process of cooperation by putting into place suitable infrastructures, including an academy providing education and training in the life sciences, a decentralised clinical trial centre, a biobank alliance and a funding agency for future drug developers.

Walter Pytlik, BioRegionUlm
(c) BIOPRO Baden-Württemberg GmbH

Literature:

"TAB report" - Zukunftsreport des Büros für Technikfolgenabschätzung "Individidualisierte Medizin und Gesundheitssystem“ (Future Report: Indivudualised Medicine and the Healthcare System; by the Office of Technology Assessment at the German Bundestag, TAB), Report of the Committee for Education, Research and Technology Assessment  (https://www.gesundheitsindustrie-bw.dedip21.bundestag.de/dip21/btd/16/120/1612000.pdf)

Bärbel Hüsing, Juliane Harti, Bernhard Bührle, Thomas Reiß, Sibylle Gaisser. Individualisierte Medizin und Gesundheitssystem. TAB work report no. 126. Berlin, 2008, 348 pages (https://www.gesundheitsindustrie-bw.dewww.tab-beim-bundestag.de/de/publikationen/berichte/ab126.html)

Health Research Programme of the German Government
https://www.gesundheitsindustrie-bw.dewww.forschung-fuer-unsere-gesundheit.de

Khoury, MJ: Dealing with the Evidence Dilemma in Genomics and Personalized Medicine, in: Clinical Pharmacology & Therapeutics, Vl. 87 No 6, June 2010, 635ff.

German Ethics Council - "Bioethics Forum" on personalised medicine, Berlin, 25th June 2009, audio recording, www.ethikrat.org

Salari K, 2009 The Dawning Era of Personalized Medicine Exposes a Gap in Medical Education. PLoS Med 6(8): e1000138. doi:10.1371/journal.pmed.1000138