Cutting edge research as well as further innovations in the life science industry will strongly depend on transnational access to high quality information for academia and industry in an efficient and secure manner. Additionally it is becoming more and more important to take into account the whole spectrum of medical, scientific and technological issues related to personalized medicine. Novel solutions for data and knowledge exchange will improve industry’s access to research infrastructures thereby improving infrastructure’s impact on innovation. This could be achieved by so called ‘Expert Centres’.
Expert Centres provide a framework to integrate pre-competitive public and private research and development by facilitating integrated access to medical and scientific data and knowledge. Furthermore access is facilitated to a broad spectrum of complementary expertise from each of the participating BMS RIs (Biological and Medical Sciences Research Infrastructures) and industry partners. The aim is to reduce fragmentation through harmonisation of procedures, improve quality by implementing common standards and foster high-level collaboration. This novel framework for data and knowledge exchange will create a win-win situation between academia and industry by enhancing collaborative research, sharing data, technologies, expertise and increasing competitiveness.
With the help of reliable (quality-defined) and open data we generate a huge common resource of knowledge, which is key to boosting the knowledge-based economy. Although as much data and knowledge as possible should be open and freely available to everybody there are some restrictions to be considered, such as ethical and legal issues on the data side, and IP issues on the knowledge side (Fig.1).
To make data open and freely available the ethical and legal basis has to be clarified, particularly when data relate or can be related to individuals, such as health data. Furthermore a lack of reproducibility of scientific data is a major threat for society and industry, resulting in losses of billions of EURO spent on R&D every year. Therefore, reliability of data sources needs to be ensured and data quality standards implemented. A dedicated governance and technical infrastructure has to be implemented to facilitate access. Another important element is the establishment of a proper incentive system, both for academia and industry, to sharing data and knowledge and to make it available and accessible.
This principle should be applicable to all BMS RIs since the generation of data and knowledge is a common product relevant for every research infrastructure.
Here are some Considerations for a distributed, federated Expert Centre.
Example: BBMRI-ERIC Expert Centres
BBMRI-ERIC faces the challenge that human biological samples are finite resources and providing access is subject to a series of ethical and legal restrictions, thus requiring innovative solutions for efficient utilisation. Therefore, BBMRI-ERIC developed the concept of Expert Centres as public-private partnerships in the precompetitive, non-profit field to provide a new structure to perform research projects under a novel model of academic-industry collaboration.
BBMRI-ERIC Expert Centres function as a common entity of the public and the private sectors (Fig. 2).
The private industry sector needs access to human biospecimen and medical data to develop innovative products, such as biomarkers and drugs to keep or gain market leadership. Human biological samples and medical data are provided as donations and are considered as common goods, and commercialization of human bodily materials is forbidden according to the European Oviedo Convention (ETS 164) and by national legislation in most Member States. In addition, providing access to these resources on a cost recovery basis is difficult because of the complex stakeholder situation (e.g. patients, medical doctors, hospitals, universities, funders). Therefore engaging academia and industry in research collaboration, for which Expert Centres provide a proper framework, is a solution to overcome the hurdles.
The concept of the Expert Centres associated with BBMRI-ERIC foresees the primary analysis of quality defined human biological samples using the latest analytical technology and standardized procedures. This should result in best possible usage of finite resources by the transformation of biological samples into data and knowledge that can be shared and jointly used by academia and industry. Such a quality-defined knowledge base will enhance academic research and lay the foundation for new product development by industry.
BBMRI-ERIC associated Expert Centres are characterised by:
- Access to quality-defined human biological samples and medical data,
- State-of-the-art banking and analytical technologies,
- High level of standardization,
- Professional quality management,
- International interoperability,
- Cost efficiency,
- Flexible solutions for generation of intellectual property,
- Ethical and legal compliance.
BBMRI-ERIC associated Expert Centres can be established in different countries. Since Expert Centres have to implement common quality standards and participate in common proficiency testing, data generated in different Expert Centres should be well suited for integrated data analysis, which would also allow the analysis of samples in the country of origin, avoiding the need for transnational sample shipment in international collaboration. This is of particular relevance for global research collaboration since many countries have posed severe restrictions on sample shipment.
van Ommen GJ, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton JE, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet. 2015 Jul;23(7):893-90
Examples of Expert Centres which currently exist
EXCEMET (an Expert Centre for metabolomics): The goal of EXCEMET is to further develop technologies and standardize procedures for broad application of metabolomics in biological and medical research, as well as medical diagnostics. The work includes the further development and refinement of harmonization of SOPs and the establishment of a common quality assurance system. It´s a not-for-profit public-private partnership based on a consortium agreement between participants from academia and industry. EXCEMET is a distributed Expert Centre of leading institutions in different countries.
SciLifeLab (Science for Life Laboratory): Is an Expert Centre which provides access to a broad range of large-scale molecular analyses, state-of-the-art as well as unique technologies and resources developed by the partners, and with bioinformatics support to assist in the interpretation of results. The services are available for academic and industry users and the centre has a strong ambition to also develop new technologies and reagent resources.