Advanced biobanking and good management

This paper has three main propositions. First, the success of translational research requires changes in practice and culture by universities, hospitals and industry. Second, biobanking networks are one of the most effective ways of enabling those changes ? if the networks have standards that can reach across universities, hospitals and industry. Third, a network quality management system based on ISO9001 requirements can be an effective tool to drive the changes required for a biobanking network to function. The goal of academic biomedical research has been to serve a scientific good: to understand the human organism in health and disease. The goal of clinical and industrial research has been to serve a public good: to develop and innovate for the alleviation of human disease and ill-health. Today, in the rapidly changing landscape of biomedical research, academic researchers are capable of and are being encouraged by society to address both goals. To address two goals in place of one goal requires changes in work practices by, and shifts in culture of, academia, clinicians and industry. One important change in practices is due to large research infrastructures whose use is also driving cultural shifts. One basic research infrastructure ? the biobanking network ? can provide large-scale sample management to support the analysis and meta-analysis of biomarkers required across translational research - from research to development to innovation. The EU and some Member States have made progress in constructing such a network. The problem of ensuring consistency and interoperability across network has not been fully resolved. In the UK, an academic national DNA banking network introduced a system to promote consistency and interoperability - an ISO9001 quality management system - driven by the need for stakeholder engagement. Recently, this system was overhauled to create for the first time a Quality Network Management System (QNMS). This may be one of the most effective ways of achieving the changes in practices and culture that we require for successful translation to improved health of populations.