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European Biopharmaceutical Review

Regional Focus: Denmark

Personalised medicine means giving the right medicine in the right dosage to the right patient at the right time, and research involves developing methods to diagnose and stratify patient populations to allow for targeted treatment modified to the genetic and disease profile. Where traditional medicine is based on the identification of symptoms and their treatment with a given medication, personalised medicine, conversely, is based on the fact that each patient’s symptoms can differ according to the individual’s hereditary endowment, cell division, metabolism profile and so on. Thus personalised medicine comprises individual diagnosis, allowing a stratification of patients, and resulting in an independently modified treatment.

It’s not only the patients who benefit from the personalised medicine concept; the public healthcare system also profits as money can be saved, patients can recover quickly, and consequently treatment can be cheaper than before. But since personalised medicine is still a relatively new field, there are currently only a few drugs on the market.

Danes are frequently in the front line when it comes to the development of new products and methods, and Danish researchers regularly announce new technologies and medicines (1). This is not a coincidence; Danish research competences have developed over 200 years from beer to microbiology, and from dairy products to enzymes, and today Denmark is home to worldleading companies in these fields. The Danish biotechnology cluster is a story of development through collaboration, which has turned the country into a major hub in diabetes care, cancer, CNS research and industrial enzymes (2).

Interdisciplinary Collaboration

Interdisciplinary collaboration is an important factor for the development of personalised medicine, as this area of research is based on the integration of a variety of disciplines, including traditional disease research, genomics, proteomics, bioinformatics and pharmacogenomics.

Collaboration between specialists from varying disciplines is crucial to the success of personalised medicine, as it requires specialist knowledge from various scientific areas to combine the genetic findings, clinical knowledge of specific diseases and expert skills in integrating large quantities of information. Furthermore, personalised medicine is based on integrating the knowledge of basic researchers and clinicians, and requires close collaboration between diagnostic and pharmaceutical companies.

In Denmark there is a long tradition of close collaboration between research institutions, academic and commercial researchers, and a number of highly skilled diagnostic companies (3). The collaborations between academia and industry in Denmark are based on informal as well as formal relationships occurring not only between researchers in the same field, but is distinguished by being highly interdisciplinary (4). A recent example is a Danish interdisciplinary research team consisting of physicians, veterinarians, biologists and biochemists that found an important key to make a predictive marker for the effects of chemotherapy. Chemotherapy used to treat cancer patients also holds adverse effects, which is of course undesirable. The key in this example is a protein analysis that could predict whether a given chemotherapy treatment will work efficiently. Researchers discovered the protein tissue inhibitor metalloproteinases-1 (TIMP1), which blocks the effects of certain types of chemotherapy. If patient breast cancer cells contain TIMP1, there will be a risk that conventional chemotherapy will lose its level of impact, and the patient must be offered alternative treatments for their breast cancer.

Public Healthcare and Databanks in Denmark

The high performing Danish national health insurance system and hospital services offer important advantages for personalised medicine researchers. The system operates with shared, integrated records that follow the patient throughout their life. This gives physicians and researchers the opportunity to study disease development based on data input from a large patient population over a very long time period.

The public health service system in Denmark also uses numerous comprehensive registers and statistical databases of extremely high quality – not least of which is Denmark’s national personal identification number system, where all residents are registered with the public health service system and other health organisations where they are receiving treatment. This system, along with numerous statistical databases, disease and registers and journal records, offers unique opportunities for epidemiological research. Given that the aforementioned registers have a long history in Denmark, researchers also have a long tradition of performing register research, public health studies and epidemiological research, all of which are important prerequisites for the identification and segmenting of relevant target segments and patient populations within personalised medicine.

A good example is the Danish Cancer Register, a population-based registry containing data on the incidence of cancer throughout Denmark since 1942. Reporting cancer was made mandatory by an administrative order in 1987. Today, the register is considered to be one of the most reliable in the world and is used extensively in research into the causes and spread of cancer.

Diagnostics: A Prerequisite for Successful Personalised Medicine

Diagnostics is the key to personalised medicine; this new medical paradigm not only requires insight into the patients’ symptoms, but also a deep understanding of the mechanisms underlying the symptoms. Thus, reliable diagnosis is a prerequisite for any successful personalised therapy or drug. Traditionally, diagnostics have been based on the identification of symptoms. In personalised medicine, however, biomarkers are used for diagnosis and stratification of patients, and drugs will be developed to treat specific genetic alterations or damage.

 Danish companies are particularly strong in diagnostics based on disease causes. For example, the Danish diagnostics company Dako pioneered the diagnostic test market with its HercepTest – one of the best known examples of commercialised personal medicine – where the test for HER2 protein (c-erbB-2 oncoprotein) is used to determine which group of women with breast cancer would receive the greatest benefit from treatment with Genentech’s cancer agent Herceptin. This medicine is used to treat a special type of breast cancer, affecting approximately 25 per cent of women who develop the disease.

Clinical Trials: Test of New Medicine

Denmark has been cited as the third best country in the world, and the best in Europe, in which to conduct clinical research (5). Furthermore, the Danish publication-citation record for clinical research studies is ranked as the best in the world (6).

Denmark’s long history of accurate and comprehensive medical database keeping, combined with the fact that all residents in Denmark have access to healthcare, provides researchers with a rich source of medical and genetic information. The majority of the databases are available to researchers at little or no cost once their research project has been approved. Once registered, subjects participating in clinical trials can be tracked via their personal identification numbers. This ensures a stable number of subjects are able to contribute to the successful completion of a large number of trials every year (7). One of the reasons that Denmark has achieved this status is that the public recognises that research is needed in order to advance medicine. Thus, it is relatively easy to recruit and obtain consent from eligible study participants in Denmark.

Conclusion

Being able to test and validate new medical and pharmaceutical products is essential for successfully developing new therapies, especially in the field of personalised medicine. In this new area, a lot of clinical research is needed before a pipeline of products is ready to be sent to market. Combining interdisciplinary collaboration and access to robust databases is a critical part of this discovery process.


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Rasmus Beedholm-Ebsen is Regional Project Manager at Invest in Denmark, part of the Ministry of Foreign Affairs. Rasmus received his PhD in Medicine at Aarhus University. He worked as a post-doc at the Department of Medical Biochemistry at Aarhus University before joining Invest in Denmark. Rasmus also holds an MSc in Molecular Biology and a Graduate Certificate in Business Administration.
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Rasmus Beedholm-Ebsen of Invest in Denmark
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