Biobanking 3.0: Evidence based and customer focused biobanking Daniel Simeon-Dubach a, ⁎, Peter Watson b,c a medservice–Biobanking consulting & services, Hoerndlirain 22, 6318 Walchwil, Switzerland b BC Cancer Agency, Victoria, BC, Canada c Office of Biobank Education and Research, Dept. of Pathology, University of British Columbia, Vancouver, BC, Canada abstract article info Article history: Received 8 October 2013 Received in revised form 8 December 2013 Accepted 13 December 2013 Available online 6 January 2014 Keywords: Biobank Infrastructure Sustainability Biobanking 3.0 Quality Customer-focus Stakeholders Biobanking is a new and very dynamic field. To achieve long term financial sustainability of biobank infrastructures we propose that a new focus is needed on activities, products and services provided by the biobank that relate to the external stakeholder: biobanking 3.0. Earlier stages of biobanking are biobanking 1.0 (primary focus on the number of biospecimens and data) and biobanking 2.0 (primary focus on the quality of biospecimens and data). Both stages 1.0 and 2.0 are predominantly product oriented areas and have required a mostly internal focus on operational development within the biobank itself. In this paper we will introduce our concept of biobanking 3.0 which capitalizes on the earlier stages but dictates a shift in focus to enhancing the value and impact for the three major sets of external stakeholders (people/patients, funders, and research customers) and creating a path to balanced and planned investment in biobank infrastructure and the sustainability of biobanking. Biobanking 3.0 will improve real understanding as well as perceptions of value across different stakeholders. Patients and donors will appreciate seeing how their biospecimens and data are effectively used for research. Funders will value the ability to plan efficient targeting of funding and to monitor the impact of their support. Researchers will capitalize on the ability to translate their ideas into effective knowledge. Ultimately adoption of biobanking 3.0 will impact on the sustainability in the three main dimensions relevant to biobanking: social sustain- ability (acceptability), operational sustainability (efficiency), and financial sustainability (accomplishment). Crown Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. Introduction In a special issue of Time magazine in 2009 biobanking was featured as one of “10 ideas changing the world right now” [1]. Human biobanking has certainly evolved into a dynamic and complex activity. However a new period of metamorphosis is needed to allow the idea to emerge into a fully fledged discipline that is capable of continuing to drive research and discovery. The need to evolve further is in part at- tributable to persistent fragmentation and lack of harmonization around standards. But it is also needed because of the pressure of rising costs involved in current approaches to biobanking that threatens to outstrip the costs of previous forms of research infrastructure such as animal care facilities and optical imaging units [2] as demand continues to rise. In view of this there is an urgent need to consider a transforma- tion of our approach to biobanking. Biobanking has thus far already seen at least two recognizable stages of evolution. But we propose that a new focus is now needed on activities, products and services provided by biobanks that relate to the needs of external stakeholders in order for the biobank infrastructure to become sustainable. In this paper we clarify our definition of a human research biobank and why it is worth investing in biobanking, then introduce the concepts advocating for a renewed focus: biobanking 3.0, and offer some solutions for implemen- tation of the essential features of biobanking 3.0 to meet the challenges ahead in modern biobanking (Fig. 1). It can be argued that modern biobanking has developed only in the last few decades. Consequently international biobanking organizations like ISBER [3], P3G [4], ESBB [5] and national and supranational struc- tures like BBRB (Biorepositories and Biospecimen Research Branch of NCI, previously known as OBBR) [6], the Canadian Tumor Repository Network CTRNet [7] and the European biobank network BBMRI [8] were established in the early 2000s. It has also been just over a decade since international biobanking best practice guidelines were developed and published for the first time by some of the above-mentioned insti- tutions and by the OECD, respectively [4,6,9–11]. Evidence of the dynamic nature and growth of biobanking has been the need for updates of best practice guidelines in a relatively short period. These activities have been paralleled by the introduction of new laws in many jurisdictions dealing specifically with biobanking. The founding of these societies and the publishing of guidelines, best practices and recommendations, clearly indicate that the area of biobanking has become established as an independent scientific and professional entity. Professionals with different skills are also now working in biobanks. This includes among others those who can handle the large amount of data often involved, those in charge of all aspects of clinical biobanking of biospecimens, ethical and legal experts and last Clinical Biochemistry 47 (2014) 300–308 ⁎ Corresponding author. E-mail address: biobanking@medservice.ch (D. Simeon-Dubach). 0009-9120/$ – see front matter. Crown Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.clinbiochem.2013.12.018 Contents lists available at ScienceDirect Clinical Biochemistry journal homepage: www.elsevier.com/locate/clinbiochem