"The Biobank is an essential instrument for biotechnology business development"

Carmen Garaizar, Director of the Basque Institute for Healthcare Research O+iker

The world of healthcare is a fundamental pillar for the development of a bioregion, because of the contribution it makes to knowledge and to biological samples, because of clinical validation it carries out on new drugs or as the end user of innovative products. The Basque Institute for Healthcare Research, O+Iker, is working to improve the integrated use of research generated by the healthcare system in the Basque Bioregion. Its director, Carmen Garaizar, explains the institute’s activities for BioBasque News, and assures us that one of the latest instruments that they have set up, the Biobank, is "essential for biotechnology business development".

O+Iker was founded in 2003 with the mission to push forward research work within the Basque healthcare system. After these first few years, how has the Institute done up to now, and what are the main activities that it has been behind?

During the first four years (2003–2006), O+Iker dedicated itself mainly to finding out "who does what, where and with what", as well as growing, in terms of the number of research workers, projects, equipment and financing.

The main activities during this initial period consisted of making inventories of all the researchers, projects, lines and resources, taking charge of management of all publicly-funded research projects, increasing public sources of funding for healthcare research and making new alliances with patients’ associations, universities and companies. In addition, our main functions were also to carry out the prioritisation of thematic areas and lines of research, to offer support to the researcher, both methodological and in the search for partners, etc., and to start up the Programme for the Intensification of Research Work, consisting of freeing up time to be able to dedicate it to research.

Now, in its second four year cycle (2007–2010), O+Iker is mainly dedicating itself to integrating healthcare system research in the BioBasque biocluster and creating a stable and sustainable research structure within the healthcare world. Its main activities during this second period are the creation of the Basque Biobank for Research, O+Ehun, the creation of the Health Research Institutes in Osakidetza (the Basque Health Service), the creation of the Office for the Management of Clinical Drug Trials, the creation of the Office for Patents and the Transfer of Knowledge and Technology, the implantation of bibliometric tracking, the promotion of a policy of motivation and recognition of research work, and participation in the Programme for Personalised Medicine and other programmes from the BioBasque Strategy.

We know that biomedical research is very advanced in the Basque Country, but what exactly is our health system doing research into, and who are they working with?

We have 25 thematic areas of research, but 8 of them are high priority. Research into healthcare services and technology makes up 24% of all projects and 33% of all external funding. Its main lines of research are the Evaluation of Clinical Practice, mainly in the Hospital of Galdakao, the Evaluation of Technology and the development of guides to clinical practice, especially in Knowledge Management and Evaluation in the Department of Health of the Basque Government, and the development and application of new medical and surgical technologies and procedures, which is carried out in nearly all the large Basque hospitals.

Secondly, research into genetics and biotechnology constitutes 15% of all research projects. Research here focuses in particular on neurological and endocrine illnesses and on cancer. Most of this research is carried out in the Hospitals of Cruces and Donostia, in collaboration with R&D agents from outside the healthcare world.

Research into Neurosciences also makes up 15% of all projects and its focuses on Neurodegenerative illnesses, Neurovascular illnesses, as well as Multiple Sclerosis and Muscular Dystrophy. This work is carried out in the 6 large Basque hospitals, especially in Cruces, Donostia and Basurto.

Paediatrics accounts for 13% of the total. Here the focus is on the study of rare diseases and on the consequences of premature births and disorders during pregnancy. This work takes place mainly in Cruces hospital.

Oncology is the next area of research, as it makes up 12% of all projects. Research here is centred especially on colon cancer and lung cancer, and the work is carried out mainly in the hospitals of Cruces and Donostia.

Research into Respiratory illnesses takes up 10% of the total. This work focuses on sleep apnoea, (Hospital of Txagorritxu), on COPD (Hospital of Galdakao) and on Respiratory illnesses (Donostia Hospital).

10% of research is also dedicated to the area of Psychiatry, which centres its studies on First Psychotic Episodes, schizophrenia and bipolar disorder. The leader in this area is the Santiago Hospital in Vitoria, and that with least volume is the Hospital of Basurto.

Finally, research in epidemiology, prevention and health promotion makes up 9% of the total. This is centred on the study of environmental contaminants and lifestyle habits. This work is carried out in particular in the Subdirectorate of Public Health of Gipuzkoa and in Primary Health Care in Bizkaia.

It may be difficult to choose, but could you tell us which achievements have been especially important in the biomedical research of our healthcare system?

Researchers in the Basque healthcare system are participating in nearly twenty European projects, and sometimes collaborate with technology centres such as Ikerlan and Gaiker. In the Neonatal Unit in Cruces Hospital we are the leaders of one of these European projects, coordinating 22 other countries.

Basque clinical research groups are participating in 7 of the 9 Spanish CIBERs (Centres for Biomedical Network Research), as well as in 13 of the 21 RETICS (Thematic Networks for Cooperative Healthcare Research), and make up 4 of the 40 CAIBER Units (Support Centres for Biomedical Network Research) around Spain.

Furthermore, there have been almost 60 Healthcare/University/Private Company projects, which mostly consist of local collaborations, since 2004. The new patents and technology transfer service has processed nearly a dozen cases so far.

At international level, the biobanks are becoming essential tools for biomedical research. What can you tell us about the recently-presented Basque Biobank, O+Ehun?

The Biobank is a healthcare tool that regulates and guarantees quality, legality and ethics in research with biological samples. It is based on three basic processes; the collection of the biological samples from healthy, ill or deceased people, the processing and storage of these samples and their transfer to the scientific and technological community.

The structure of the Biobank is that of the centre of a network, with the management unified in the BIO Foundation via the figure of a central Coordinator and an on-line platform specially designed for the Biobank. The collection, processing and storage of the biological samples is carried out in each node of the Biobank, physically situated in 7 health centres belonging to the Basque Health Service (Osakidetza) and two private health centres. The management of the samples is carried out in the central coordinating node situated in BIOEF. The Biobank has sections for DNA, tumours, brains and miscellaneous tissue. It processes plasma, serum, cells, paraffin blocks, frozen tissue and tissue microarrays. It supplies DNA, RNA, proteins, metabolites and various types of tissue. It also has a large collection of samples from the healthy section of the population, for research.

Biobanks are highly regulated legal support tools for research which are essential for R&D and biotechnological and pharmaceutical business development. As a result of the biological samples that they provide, research centres can discover and validate biomarkers and therapeutic targets in particular, as well as carrying out basic molecular research.

The Basque Biobank for Research, O+Ehun, was accredited by the Department of Health of the Basque Government and has already transferred more than 10,000 biological samples to healthcare, academic and business research centres from this area. Right now, it is helping various centres from different Autonomous Communities around Spain with the creation of similar entities.

Translational research, transferring the results of research to clinical practice, appears to be both a challenge and an opportunity. How then are the research centres coordinated with the hospitals and other agents, including the administration?

It’s a change in paradigm and it is nothing new. It was begun before the Second World War, was on the point of disappearing during the 80s and 90s, and reappeared in the year 2000 with the millennium, when the completion of the human genome made it evident that there was great entrepreneurial potential in biotechnology, a sector which is now listed on stock exchanges. It coincided with the end of a decade, the 90s, in which the lack of application of science was questioned, economic returns on R&D investment were demanded and people were demanding transparency and reporting back over public funding.

In the world of healthcare, this movement had one very important repercussion; the rebirth of translational research. The term describes the need to accelerate the transfer of scientific results to clinical practice and the patient’s bedside. To do so, various measures were created; the elimination of physical and conceptual barriers between basic research, applied research and technological development, the orientation of clinical research towards the resolution of problems, the propulsion of public-private consortiums in R&D, the push to develop technological platforms for use in areas such as genomics, proteomics and other -omics, the fusion of classical, environmental epidemiology with genetic epidemiology for a better understanding of health determinants, which can be done thanks to new instruments such as biobanks, and so on and so forth.

All these notions had to be transferred to a suitable research structure, both inside and outside of the healthcare centres. Within them, we started up the creation of “Healthcare Research Institutes”. Outside, the creation of clusters extended in all directions, and bioregions such as BioBasque and other similar concepts became common in Spain, elsewhere in Europe and in the States, among others.

Biosciences need the healthcare world to provide them with the necessary knowledge for business development; about the clinical progress of illnesses, about patients’ needs and those of the healthcare system. They also need the input of biological samples and clinical validation of new drugs and healthcare products.

Furthermore, public healthcare has an important role as the client of an innovative end product. Public investment in this aspect of an innovation policy is important, not only in economic terms but also in conceptual terms, as an inspiration for private investment in new ideas.

One final but definitive aspect of the contribution of the healthcare system is related with other aspects which are less economically-important but which are tremendously powerful as generators of medium-term change, including innovation in management and new organisational models, and the concept of "health capital".