About the project and description of the research programme

Up-to-date Status of the Scientific Issues in Bulgaria and Europe

The ultimate goal of translational medical research is to build a bridge spanning the gap between basic research and clinical practice.

Translational research in medicine is a branch of medical research that attempts to more directly connect basic research to patient care. Traditionally, basic research has been separated from the daily clinical practice of medicine. New diagnostic and prognostic tools and novel therapeutic approaches used to be developed independently of the clinic, and often disregarded shortly afterwards. Therefore, translational medicine typically refers to the "translation" of basic research into real benefits for real patients. The focus is on the functional link between the laboratory work and the practice at the patient's bedside. This is often called the "bench to bedside" definition. Some professionals consider translational medicine in a much broader context, referring to the patient environment driven research process, and the embrace of a more research driven clinical practice of medicine.

At a pan-European level the strong necessity for a faster and more efficient translation of research findings into the development of innovative strategies for the prevention, diagnosis and treatment of diseases which are of particular relevance for European member states and that have a high medical and economic burden has been recognized through international multidisciplinary initiatives:

• The European Advanced Translational Research Infrastructure (EATRIS) - www.eatris.eu,
• The European Clinical Research Infrastructures Network (ECRIN) - www.ecrin.org и
• The Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) - www.biobanks.eu.

The goal of those activities is to shorten the timelines from basic research discoveries to clinical benefits.

Functional relationship between different EU sponsored initiatives in Translational Biomedical science

In the field of Hematology the necessity for a translational approach is quite strong because of the marked biological and clinical heterogeneity of the entities in concern. The first successful example of the implementation of this approach at an international level was the establishment of unified classification of hematological malignancies which translated the acquired current knowledge about morphological, immunological, cytogenetic and molecular features into clinically relevant categories(Jaffe 2001). Even more importantly it became evident that clinical features are defined by certain subcellular abnormalities which can be readily identified and potentially targeted by novel therapeutic approaches.

Based on the recognition that translational research is becoming a new specialty area in the field of Hematology that requires a very broad set of skills, the European Haematology Association (EHA) during the latest congress in Copenhagen, June 2008 announced a new initiative that will be launched in 2010 in collaboration with the American Hematology Association (ASH) – the Translational Research Training Institute (TRTI). Translational research training is also an integral part of major EHA activities such as the development of an European Haematology Curriculum, called the CV-Passport (ECAH project - Establishment and accreditation of a system of speciality training and continuing education in Hematology across EU countries; funded by the EC: Leonardo Da Vinci - 2002-4545 / 001-001 LE2- 22ACTH) and the subsequent application for a Leonardo da Vinci Lifelong Learning Programme “European Network for Harmonisation of Training in Hematology”, which has passed initial approval in June 2008 and where Margarita Guenova (the present project coordinator)) is actively participating (Supplementary material – list of projects).

A particular proposal for a new COST Action BM0801 focused on hematological malignancies “Translating genomic and epigenetic studies of MDS and AML” was announced at the 171st CSO meeting – 18/19 June 2008. A process of joining the project by the current applicant is in progress and Assoc. Prof. M. Guenova (the project coordinator) has been proposed as the national coordinator for the action.

Besides, with the significant advances in technologies and the increasing number of test options over the past decade for the scientific assessment of hematological malignancies it is neither technically feasible nor cost-effective for these complicated and expensive analyses to be performed in all routine local laboratories. However it is crucially important to maintain laboratory research for translational medicine This can be achieved by performing traditional tests in-house (e.g. morphology and basic phenotyping) and out-sourcing the difficult, new expensive tests to a central facility. The aim of this approach is to make the excellence available to as many investigators groups as possible thereby ensuring equity of access and improvement in the quality of investigations.

Advantages of a centralised haemato-oncology laboratory services:

• Laboratory and diagnostic standardization
• Uniform disease definitions
• Uniform approaches to disease monitoring
• Flexibility to enable rapid response to scientific and technical developments with the rapid introduction of new laboratory tests
• Database of cases
• Retrospective case review
• Epidemiology
• Sample banking
• Participation in research networks
• Close ties with multiple clinical service units, including national trials
• Centre of expertise for teaching and training
• Supports clinical excellence

Some countries are now supporting and recommending that laboratory hemato-oncology services be centralized such as in the United Kingdom (UK) national guidelines (NICE Guidelines). This approach supports excellence in patient care, teaching and research and is efficient. A centralized laboratory service provides a critical mass of scientific and medical expertise which is available to a larger number of investigators than would otherwise be impossible. Collaboration is feasible and will support national and European networks. Centralized diagnostic facilities are better and able to respond to new demands, be they clinical, scientific (e.g. introduction of new investigations), political or economic and should be sustainable. Moreover, across Europe there are initiatives to integrate all major research and diagnostic groups into national (such as the German Acute and Chronic Leukemias competence network formed in response to a directive from the German Federal Ministry for Education and Research - www.lymphome.de, www.kompetenznetz-leukaemie.de) or European Platforms on Leukemia Diagnostics (www.leukemia-net.org) and European Networks of Excellence.

It is tempting to envisage that it is just the time to establish a Center of Excellence for Translational Research in Bulgaria thus leading to harmonization of biomedical research practice in Bulgaria with the European standards. This would provide the infrastructural and human resources of our country to join these initiatives and thus to contribute to the international multidisciplinary efforts to understand and integrate modern genomics technologies with the aim of translating these into a clinical environment.