Commercialization of Biobank Data: The Case Auria Biobank (original) (raw)

Commercialization of Biobanks

Biopreservation and Biobanking, 2012

Biobank policy and regulations profoundly vary between different societies. One area with profound differences in culture and tradition concerns commercialization, and the possibility of using the human body as a capital resource. In the United States there is acceptance of this possibility, whereas European law is based on principles that categorically prohibit selling parts of the human body. We suggest that questions of commercialization in the area of biobanking must be considered in relation to different ethical values, notably the principle of best possible use of collected biobank materials for the benefit of vital patient interests.

A review of the key issues associated with the commercialization of biobanks

This 'issues paper' was generated through a 'virtual workshop process' over the course of several months. The authors first outlined relevant issues and key literature. A draft was then distributed, comments were received, and a revised draft was circulated among authors for approval. The use of a 'virtual workshop process' shaped both the tone and coverage of this article, though we hope in a way that still provides a detailed and useful summary of central issues on this topic. We believe that this paper-the collaborative work of globally situated ELSI researchers-exemplifies 'ELSI 2.0' (Jane Kaye et al., Research Priorities. ELSI 2.0 for Genomics and Society, 336 Science 673 (2012)).

Biobanking-an ongoing challenge for personalised medicine BRoTHER – a new biobank network in the centre of Europe to promote digitalisation in biobanking

2018

Biobanking is a fast-growing field in basic, clinical and translational research. With that, biobanking is crucially involved in the further optimisation of personalised medicine, which is one of the leading concepts in modern medicine. Since personalised medicine works with highly specific and well-characterised cohorts, the interaction of biobanks will become more and more important to enable the setting up of relevant collectives for basic and translational research. In special characterised entities and in rare diseases, a multicentre approach is crucial to ensure the inclusion of significant numbers of biobank specimens in an appropriate time. Digitalisation and the possibility to share information and knowledge by digitalisation represent an important issue within the networking of different biobanks which are active in the clinical context. The interaction and cooperation of biobanks of different countries must overcome specific challenges even if these countries are located within the European Union. The project, BRoTHER (Biobank Research on Telemedical Approaches for Human Biobanks in a European Region), is aimed at analysing the obstacles which have to be overcome if clinical related biobanks from two national healthcare systems wants to work together and set up common biobank projects by help of digitalisation. Furthermore, BRoTHER is created to disseminate the idea of biobanking to young academics and to a broader public. The project is supported by a grant of the Bavarian-Czech University Agency (BTHA) with funding coming from the Bavarian State Ministry of Finance.

Sustainable value creation in the commercialisation of innovation: the case of Auria Biobank

International Journal of Entrepreneurship and Innovation Management

The purpose of this study is to examine how different logics of commercialisation are part of sustainable value creation in an emerging area of healthcare. This paper presents an inductive interpretative case study to examine the emerging field of personalised medicine from the perspective of a biobank seeking to create value on its depository of tissue samples, patient records, and digitised data. This study increases our understanding of the challenges and opportunities faced by a company when developing innovations in healthcare. It contributes to the literature on the commercialisation of innovation by exploring how sustainable value creation in an emerging industry builds on both planned and emergent commercialisation activities and how different logics of commercialisation are a part of sustainable value creation in personalised medicine.

Advancing Professionalization of Biobank Business Operations: A Worldwide Survey

Biopreservation and Biobanking, 2018

Quality specimens from biobanks are key resources to support reproducible research. Sustaining biobanks requires robust management. We recently published a pilot survey that indicated that over half the participating biobanks had business plans in place and another third were working on business planning. While the results provided a clue to the status of business planning in biobanking, it was concluded that a longer and more indepth survey and analysis were required. In April 2017, an extended survey was distributed worldwide in English, French, Chinese, German, and Spanish, through multiple channels. The survey was built using the Survey Monkey tool. Our hypothesis was that those biobanks that already have a business plan also have a more professional management structure. The questions were designed to understand more details about each biobank's business operations and communications. A total of 276 biobanks participated (China 65, France 40, United States 34, Spain 27, Germany 24, Australia 23, and rest of the world 63). About two thirds of the biobanks were established in the last 10 years. The responses provided data on the size of biobanks answering the survey, their status of business planning, and how and through what mediums they are communicating with customers. Biobanks with a business plan or preparing to have one showed a clear trend of having a customer strategy for marketing the samples and communicating with customers. No trend could be seen regarding websites and activities in social media. We confirmed our hypothesis that biobanks that have or are in the process of preparing a business plan are showing a trend toward more professional structures. In the biobanking community, the business mind-set and use of the business plan as a management tool have not quite arrived.

Biobankonomics: Developing a Sustainable Business Model Approach for the Formation of a Human Tissue Biobank

JNCI Monographs, 2011

The preservation of high-quality biospecimens and associated data for research purposes is being performed in variety of academic, government, and industrial settings. Often these are multimillion dollar operations, yet despite these sizable investments, the economics of biobanking initiatives is not well understood. Fundamental business principles must be applied to the development and operation of such resources to ensure their long-term sustainability and maximize their impact. The true costs of developing and maintaining operations, which may have a variety of funding sources, must be better understood. Among the issues that must be considered when building a biobank economic model are: understanding the market need for the particular type of biobank under consideration and understanding and efficiently managing the biobank's "value chain," which includes costs for case collection, tissue processing, storage management, sample distribution, and infrastructure and administration. By using these value chain factors, a Total Life Cycle Cost of Ownership (TLCO) model may be developed to estimate all costs arising from owning, operating, and maintaining a large centralized biobank. The TLCO approach allows for a better delineation of a biobank's variable and fixed costs, data that will be needed to implement any cost recovery program. This article represents an overview of the efforts made recently by the National Cancer Institute's Office of Biorepositories and Biospecimen Research as part of its effort to develop an appropriate cost model and cost recovery program for the cancer HUman Biobank (caHUB) initiative. All of these economic factors are discussed in terms of maximizing caHUB's potential for long-term sustainability but have broad applicability to the wide range of biobanking initiatives that currently exist.

Biobanking 3.0: Evidence based and customer focused biobanking

Clinical Biochemistry, 2014

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 sustainability (acceptability), operational sustainability (efficiency), and financial sustainability (accomplishment).