Sustainability in Biobanking: Model of Biobank Graz

Abstract

Research infrastructures remain the key for state-of-the-art and successful research. In the last few decades, biobanks have become increasingly important in this field through standardization of biospecimen processing, sample storage, and standardized data management. Research infrastructure in cohort studies and other sample collection activities are currently experiencing a lack of long-term funding. In this article, the Biobank Graz discusses these aspects of sustainability including the definition of sustainability and necessity of a business plan, as well as cost calculation model in the field of biobanking. The economic state, critical success factors, and important operational issues are reviewed and described by the authors, using the example of the Biobank Graz. Sustainability in the field of biobanking is a globally important matter of necessity, starting from policy making and ending with security and documentation on each operational level.

Introduction

During the last few decades, the academic research landscape has changed dramatically, especially in the field of biomedical research. Until the late 1990s, studies utilizing human biospecimens mostly used collections with small sample numbers. As an example, the number of biospecimens documented per publication in cancer research increased from about 50 in the 1990s to about 200 twenty years later.¹

At the same time, the academic research landscape had to face serious shortcomings in terms of sustainability. One major reason for this was a lack of long-term research strategies from the single scientist level to university level and from national to European, to finally the international level. This lack of a strategic approach was due to short-term research funding and diversity in funding mechanisms,² insufficient career models, and obvious fragmentation of the research community. In this scenario, particular problems arose for highly qualified scientists who could often not be provided with adequate infrastructure and could not be offered sustainable career development programs. These shortcomings were recognized and mentioned by policy makers at the national and international levels.

As a result, the European roadmap for research infrastructures, ESFRI (European Strategy Forum for Research Infrastructures) was developed to improve the situation.^3,4 ESFRI infrastructure consortia are designed to be maintained for more than 20 years, and provide sustainable access to resources, technologies, and insights that have emerged from European research. The peculiarity of this initiative is that there is only one kind of ESFRI for a particular research field. Thus, a unique platform for European cooperation is created, which should effectively reduce the fragmentation of the European research landscape.³

As a corollary, one of the ESFRI research infrastructures, the Biobanking and BioMolecular resources Research Infrastructure (BBMRI) relates to sustainable access to biological resources, such as human biological samples and associated data. Hence, BBMRI represents the basis and key resource for the development of biomedical sciences and medicine. This initiative started from an EU-funded FP7 preparatory phase⁵ and finally led to installation of BBMRI-ERIC (BBMRI-European Research Infrastructure Consortium) with its headquarters in Graz, Austria.⁶

BBMRI-ERIC is based on national activities⁷ playing a crucial role in policy making of biobanking and sustainability in biobanking within Europe. Although policy making of biobanking in Europe was only developed in the last decade (2005–2015), it is quite advanced. However, at the same time, it is still the local efforts to attain sustainability of each and every biobank that makes the difference.⁸

Collecting of biological samples is nothing new.⁹ Already in 1811, an Austrian decree was enacted that demanded the “establishment and maintenance of collections in anatomical and pathological cabinets” for the promotion of teaching and research in anatomy and pathological anatomy.¹⁰ However, the modern methodological and cooperative use of these resources opened a variety of new opportunities. Samples and data have been archived for years and decades as back-up for routine diagnostic procedures. Today, such collections allow scientists to create large and significant retrospective cohorts, even with rare diseases.

Looking at local biobanks, it is the clinical biobanks embedded into large hospital settings that still contain such collections. Biobank Graz in Austria is more than a structured collection of biological samples and their clinical data.¹¹ Biobank Graz is an active partner of local and international scientists in developing and realizing future-oriented research projects¹² In addition, Biobank Graz' management fosters progress and expands cooperation, and hence is particularly valuable for sustainability. Biobank Graz is a division and central research facility of Medical University of Graz, which provides not only an organizational affiliation, but also provides strategic and financial sustainability.

Definition of Sustainability at Biobank Graz

There are different approaches and ideas about sustainability in the field of biobanking.¹³ The definition of sustainability in biobanking at Biobank Graz is based on its expertise in the field and comprises:

a. meaningful goal setting

b. timely planning

c. extensive and accurate project management

d. sustainable financial and economic concepts (e.g. business plan)

e. a cooperative approach to implementation

f. clear-cut infrastructure planning^14,15 (IT, sample handling, storage etc.)

g. setting up a specific access policy and transparent governance concepts

h. installation of a quality management system (certification)

i. developing and maintaining a human resources strategy including education and training

j. developing and maintaining an ethical, legal, and social implications (ELSI) and public relations strategy

k. providing a precise risk management

l. providing an exit strategy and termination concept

The implementation of the above-mentioned items has been successfully achieved at Biobank Graz. The development of a business plan in terms of strategic and financial sustainability has been a major goal from the beginning.

As a common trend of the last decade, the amount of public funding has decreased year by year in Europe generally, and in Austria particularly. Hence, respective short- and long-term plans needed to be developed to counteract this shortfall in funding. Access to long-term funding for biobanks is rare but important, and strategies to recover costs of data and biospecimen processing and distribution are emerging.^16,17

One example of a short-term strategy is shown here: First, Biobank Graz evaluated the whole process chain of collecting, storing, and distributing samples. Then, the associated costs were analyzed and related to each specific chain link. Finally, Biobank Graz developed a transparent cost calculation for samples distributed to scientific partners, and thus has set up a handling fee that at least partly compensates for the reduced public funding.

However, long-term financial sustainability requires more than just charging for sample handling costs. Currently, many efforts are being made to push the biobanking field towards R&D projects. The lack of data on costs and outcomes in the field of biobanking makes quantification of costs currently quite difficult.¹⁸ Nevertheless, a biobank market value has been demonstrated that shows an annual growth of 20%–30%.¹⁸

Different Definitions of Sustainability

The field of biobanking is interdisciplinary and multidirectional regarding arrangement and disposition within the landscape of biomedical research. Hence, based on the diversity within the field, the understanding of the term sustainability depends on the local strategy and biobank. This, of course, further increases fragmentation of the biobanking field. Therefore, there is the need for a general direction of sustainability in biobanking, at least the need for a general basic understanding of sustainability in the field.

In general, two major types of human biobanks can be defined: (1) Disease-focused and population-based biobanks collect samples/data only from a specific type of disease or cohort following long-term perspectives; (2) Clinical biobanks do not focus on a specific cohort or disease, but collect any type of sample from any donor arriving at the hospital.

Biobank Graz pursues both collection strategies. Accordingly, Biobank Graz has decided to support both types of collections using the following collection strategies: (1) A cross-sectional clinical biobank, which contains basically unselected pathological samples and clinical data from the entire population of southeastern Austria. This biobank represents all detected diseases at their natural frequency of occurrence, yielding a large amount of epidemiological data; (2) A disease-focused clinical biobank, providing different types of human biological samples of high quality and with detailed clinical follow-up data during the whole disease course, and long-term observation for specifically selected cohorts in targeted disease groups.

Biobank Graz unifies in itself the two major groups of human biobanks. Hence, the sustainability approach of Biobank Graz needs to be comprehensive and combine the ideas and required tools for both types of biobanking, and therefore may be of use for the entire biobanking society.

What Are the Top Items that Should Be Covered By a Biobank Business Plan?

The development of a business plan is a duty towards the funding institution independent of private or public funding. It can be used as a sophisticated tool of sustainability and sustainable development for the biobank, and is the best way to show financial transparency. Therefore, it is one of the central documents of a biobank. The business plan of Biobank Graz is updated annually and newly drafted every 4 years, containing the following headings:

1. Biobank Graz

1.1. Profile

1.2. History of Biobank Graz

1.3. Operational Structure

1.3.1. Human Resources

1.3.2. Infrastructure

1.3.3. Financing/Funding

2. Business Environment

2.1. International Environment

2.2. European Environment

2.3. Biobank Graz—Research Projects

2.4. Competition: Advantages, USPs, Capacity

2.5. Location Analysis

3. Services of Biobank Graz: Service Portfolio

4. Market

4.1. Market Segmentation/Market Analysis

4.2. Customer Stock, Segmentation

4.3. Customer Groups

5. Scientific and Economic Structures around Biobank Graz

6. Development Plan of Biobank Graz

6.1. Vision

6.2. Critical Success Factors and Strategic Goals

6.2.1. Promotion of the Targeted Epidemiologically Relevant Study Cohorts

6.2.2. Integration of Selected Collections and Cohorts

6.2.3. Cooperation in (inter-) National Projects

6.2.4. Central Positioning in Europe/Austria

6.2.5. Active Communication and Targeted Cooperation

6.2.6. Active Cooperation in the IT Sector

6.3. Organization and Management

6.4. Infrastructure Development

6.5. Personnel Development

6.6. Development of Operational Costs

6.7. ELSI-Dissemination Development

6.8. Public Relations

7. Risks and Hazards

8. Exit Strategy and Termination Possibility

9. Strengths, Weaknesses, Opportunities, and Threats (SWOT) Analysis

All chapters of the business plan are strongly correlated to each other and strengthen at least one or two other chapters. Respective links are made in the text, ensuring an understandable description of the holistic picture of economic sustainability. Some chapters are more central, such as development of operational costs. Here, invariably all operational costs can be found in parallel with the prioritized development of such costs (from “is a must” to “nice to have”).

In the case of a publicly funded biobank, at least infrastructure, human resources, and education,¹⁹ as well as the R&D projects, should be essentially covered by the business plan. High-quality biospecimens and associated structured data are pivotal for the progress of basic and clinical research in the field of medicine, biotechnology, and pharmacy. The combination of high quality samples and structured data is accompanied by high costs. However, most biobanks dealing with this combination are academic institutions with public funding. Especially in this scenario, long-term financing plays a crucial role in the establishment and maintenance of biobanks. Hence, even academic and publicly funded biobanks need to evaluate their own economic position, as do biobanks in commercial enterprises.

One of the many publicly available and easy-to-use economic analysis tools for a respective financial exploration is the Boston Consulting Group (BCG) analysis method.^20,21 Biobank Graz used the well-described method in its breakdown analysis for the business plan. The example of a BCG analysis shows that Biobank Graz has a strong economic position, as there are quite a number of innovations and services that can act as “cash cows” for the field of medical research (Fig. 1).

FIG. 1.

Economic BCG analysis of the position of Biobank Graz in the research landscape.

Within a biobank, “cash cows” provide the revenue required to turn customer requests into a leading and beneficial service, to cover the administrative costs of the company, and to fund research and development. To secure sustainability of this position, further innovative developments in sample quality and management, as well as cooperation, are essential. Furthermore, upgrading of IT infrastructure appears to be pivotal for further innovative development of automation and data management.

Which Components of the Business Plan Should Be Revisited: Just Those Related to Budget?

The annual revision of a business plan should contain all components that influence the funding stability and financial future. Especially if it is done before the annual budgeting process, independent of whether the biobank is located in the public or private sector, the revision opens the chance of correcting budgeting and keeping the development direction given by the vision. The experience of Biobank Graz has shown that this procedure strengthens the position of a biobank during budgeting negotiations by providing the particular arguments and facts required for approval and reallocation of the proposed budget. On the other hand, an annual revision of the business plan builds the basis for annual reports of a biobank, as well as for extramural funding agencies.

Based on this, the annual revision of the business plan should at least contain: organizational profile (may change, e.g., from administrative to scientific); structure and infrastructure of organization; human resources (are there only lab technicians or also research experts?); budget, including cost calculation for project requests and third-party funding; updating of the service panel; positioning on the market and research landscape; expansion into target groups, as well as vision for the future. It should be considered that a risk analysis needs to be carried out continuously, and a retrospective summary should be provided by the end of the year.

The Most Important Factors for Operation of a Biobank

Provided that the operation of a given biobank is financially covered, there is still a significant number of central management areas that need attention. Those areas are based on the vision of the given biobank and should be planned and budgeted in the business plan to maintain sustainability. These areas could include:

• Public relations: Without the trust of donors in biomedical research, no one would provide specimens to a biobank.

• Cooperation with internal and external partners: Cooperation with researchers/research organizations is pivotal for collection and investigation of biospecimens.

• Infrastructure for quality assurance and management: Otherwise, the “trash in—trash out” principle will apply.

• Data management: Securing privacy is a must. At the same time, data management may become the bottleneck for project management of a biobank, since data acquisition for retrospective studies can be very time-consuming in population-based collections.

• Biobanking associated research: Biobanking is an interdisciplinary and developing biomedical area. To be at the cutting edge of this research area, it is mandatory to know and meet the needs of new analytical methods.

• Continuous evaluation of research benefits using biobanking “success factors”. The respective evaluation parameters include:

• Diversity of biospecimens

• Diversity of sample requests (by researchers)

• Quality and quantity of provided samples and data

• Development of an interdisciplinary biobanking team

• Number of successful biobanking associated research projects

Frequent Errors in Planning of Sustainability

Currently, none or only very few biobanks are planning any termination or exit strategy. When calculating these costs, the following items need to be taken into account: professional recycling of samples in the time frames of given law; dismantling of infrastructure; maintaining paper archives (informed consents should be archived at least 30 years, research documentation and accounting at least 10 years). Table 1 only shows the costs of termination of the technical part for Biobank Graz. The total amount of money needed for termination is much higher and needs to be available at the time of termination.

Table 1.

Cost Calculation Disposal of All BB Samples

	Amount of samples at BB	Weight per unit [slide/block/tube] (g)	Total weight (g)	Max. weight (g)	Amount containers	Price/container [€]	Tonnage price [€](159€ per ton)	Price in total [€]
Paraffin slides (yellow/orange container)	19,000,000 slides	6	114,000,000	20,000 per 25 L container	5,700	3.95	18 126	40,641
Paraffin blocks (black container)	6,000,000 blocks	5	30,000,000	8000 per 30 L container	3,750	18.50	—	69,375
Cryo samples (black container)	30,000 cryotubes	5	150,000	8000 per 30 L container	19	18.50	—	3,451.50
Blood samples (green container)	1,500,000 liquid sample tubes	3.0	4,500,000	20,000 per 25 L container	225	6.50	—	1,462.50

Personnel costs	Hourly rate [€]	Duration of disposal [n]	Amount of personnel	Personnel costs [€]
Average BMA (biomedical analyst)	28.00	1,780	4	199,360
Average MTF (medical technical specialist)	25.00		4	178,000
Average archive	21.00		4	149,520
				526,880
					Total Costs [€]	641,810

When Is the Best Time to Start Thinking About Sustainability?

Before starting routine processes of a biobank, the first thoughts should include mid- to long-term planning, including sustainability aspects. Also, a number of specific analyses need to be performed, including the analysis of the status quo at the respective site (e.g., university), analysis of space and logistics at the site (e.g., hospital), market analysis, SWOT analysis, etc. At Biobank Graz, the SWOT analysis has delivered a developmental strategy with specific deliverables and milestones, which has clearly strengthened Biobank Graz.

The experience gained at Biobank Graz has led to a number of workshops where this knowledge was distributed. For example, Table 2 shows the SWOT analysis for emerging biobanks in Central and Eastern European countries, while Table 3 displays the strategy development for emerging biobanks as a result of the analysis shown in Table 2. Afterwards, these strategies were prioritized based on two essential criteria: (a) crucial factors, which can decide “go” or “no go,” and (b) practicability which resulted in a concrete wok plan for 2015 to 2017 (Table 4).

Table 2.

SWOT Analysis: Biobank Tirana & Pristina

Strengths: - Focused patient collective - Samples - Access to public - Access to students - Opinion leaders - Unique epidemiology profile - Key player enrollment	Weaknesses: - Limitation of health care system (motivation, low salaries of all personnel) - HIS & LIS status - Low budget - Low budget & financing (Albania) - Lack of experience - Idea of academic career - No dedicated personnel - Uncoordinated ethic landscape (Kosovo) - QM system - Infrastructure service - Lack of space - Sample circulation
Opportunities: - Collection opportunity potential - International collaboration - Interdisciplinary collaboration potential - Academic research potential (young generation) - European(international) and private funding - Collection of private institutions	Threats: - No legal & ethical framework (Albania) - Economic risks - Brain drain - Sustainability - Legal & ethical implementation - Weak coordination of responsible authorities - No motivation of research and development (culture)

Table 3.

Strategy Development for Emerging Biobanks of Kosovo and Albania

			Environmental factors
			Opportunities				Threats
			European (international) and private funding	International collaboration	Tirana: Interdisciplinary collaboration potential	Pristina: Collection of private institutions	Sustainability	Economic risks	Tirana: No legal and ethical frame	Pristina: Legal & ethical changes
		Unique epidemiology profile	Grant proposals, attract Pharma, USP research market, new research collaborators	complementary cooperation with Biobank Graz, networking, advertising of the unique profile, learn how to make a higher quality	advertisement –> high interest in many fields of medicine for research and also for pharmaceutical industry	avoid loss of samples via: collaboration with private institutions, storage of all samples centralised at biobank (service for private institutions)	contacts to research community, networking in field of biobanking (BBMRI), funding, quality, personnel training	low socio-economic status gives rise to certain diseases –> catch money for documentation and collection of samples, sell infrastructure to keep collection	no advantage when the legal and ethical frames are not clearly defined—> therefore it is important to clearly demonstrate that it is necessary to implement rights and ethical frames, actively force a legal frame implementation	unique samples (importance for medical research) as argument for advantageous law changes or against disadvantageous law changes, take initiatives to facilitate the ethical process
Organisational factors	Strenghts	Focused patient collective	starting with a register and retrospective studies, finding out own research strenghts, define own research fields or interests, standardisation of sample processing, enhance code identification of samples and documentation system, formulate an ethical frame	training at Biobank Graz to ensure quality of focused collective, combination of sample collections with national and international partners, implementation of Good Scientific Practice regulations	advertisement –> high interest in many fields of medicine for research and also for pharmaceutical industry	collaboration with private institutions to enlarge sample collection	finding partners that are interested in focused patient collective (follow up), development of collection strategies, combination of different type of samples of same person, having reimbursement strategy, continuous education	open collection to pharmacology, rethink profile and find another field of interest with the same infrastructure	implementation of an informed consent, constantly follow law amendments, if necessary consultation of lawyer–> timely reaction to law changes, actively foster a legal frame implementation	constantly follow law amendments, if necessary consultation of lawyer–> timely reaction to law changes, implementation of an informed consent, take initiatives to facilitate the ethical process
		Already existing sample collections (sera, blood bank,…) in different laboratories (diseas and population based)	Grant proposals can be written soon –> no long sample acqusition, grant proposals in cooperation with different institutes can be submitted	Tirana: already existing samples can be used for international cooperations, other biobank cooperation partners can request for these samples, higher amount of samples of different institutes may be more attractive for international collaborators than small amounts Pristina: conduct project services/ provide samples for research very soon in an international collaboration	existing sample collections can be the basis for different research questions and so can be provided–> chance for puplications –> becoming more and more known as biobank	collaboration with private institutions, storage of all samples centralised at biobank (service for private institutions), common biobank databank to follow sample storage place	conformation of sample procedure (collection, storage, quality) on an international level, enlarge the national or local cooperation to be more competitive, contacts to research community, networking in field of biobanking (BBMRI), funding, quality, personnel training; merge sample collections into a common biobank –> make a brand & use it for networking, publishing of papers –> make biobank indispensable (being a figurehead)	not enough money to keep the systems running (fridge,…); not enough money to implement new strorage systems–> not enough space–> no new samples can be stored–> keep storage and sell empty storage systems	implementation of an informed consent, implementation of ethical board and legal frames for already existing sample collections, constantly follow law amendments, if necessary consultation of lawyer, timely reaction to law changes, actively force a legal frame implementation	implementation of an informed consent, constantly follow law amendments, if necessary consultation of lawyer, timely reaction to law changes, take initiatives to facilitate the ethical process
		Limitation of health care system (motivation)	project implementation (infrastructure and personnel), research results to clinic, Standard IT infrastructure to be used for public health	know how transfer in clinical and research disciplines, personnel exchange programme, statistical comparison with other countries, development of national regulatories	good research output and good cooperations fosters the motivation of people, higher local career potential	motivation of personnel via collaboration with private institutions: personnel exchange, team teachings, know-how exchange	dedicated biobank staff, gainig infrastructure, gaining opinion leaders (different specialities), public presentation, implementation of regulator body	search for private third-party money and shut down collection, keep the storage	facilitate the ethical process for research projects, initiatives to implement laws –> motivation of staff	take the initiative to implement laws, facilitate the ethical process for research projects –> motivation of staff
	Weaknesses	Lack of experience in biobanking	apply for mobility programmes (Erasmus, TAEX, COST, ministry of education, TEMPUS, HORIZON 2020), invitation of experts (focused workshops with experienced speakers)	information transfer, participation of network programmes with technical staff, dissemination of new biobanking ideas in CEE-network, participating/becoming part of BBMRI	interdisciplinary knowledge improves the experinence –> staff exchange, team teachings, workshops	via collaboration with private institutions: acquire knowledge (technical, sample handling, .)	working against brain drain, formulation of special contracts for staff	search for private third-party money and shut down collection, keep the storage	work is done but in a way that is not legally and ethically correct, people have to be trained in legal and ethical rights to prevent them of doing something that is forbidden; constantly follow law amendments, consultation of lawyer, international collaborations as exapmles for potential legal and ethical frames in the own country –> take initiatives for implementation of legal and ethical frame	constantly follow law amendments, consultation of lawyer, international collaborations as exapmles for potential legal and ethical frames in the own country –> take initiatives for implementation of legal and ethical frames; work is done but in a way that is not legally and ethically correct, people have to be trained in legal and ethical rights to prevent them of doing something that is forbidden
		No QM system and SOPs for sample collection and handling	apply for a grant to finance a person responsible to implement a QM system and IT system (Biobank databank)	learning from collaborators, adoption of SOPs, QM and IT systems of other collaborators	QM systems and SOPs already existing in other fields can be adoped and used	collaborate with private institutions: if applicable, adopt their QM system and SOPs (incl. Biobank databank) or implement it together	implementation of a standardized sample processing according to global standardized rules (GCP, GLP, etc.)	start with the implementation of a QM system and SOPs to get a basic quality level, in case of economic crisis adopt the SOPs but basic level should be retained	implement QM system & SOPs (incl. Biobank databank) according to present law, constantly follow law amendments and timely adapt QM system, SOPs & Biobank databank–> to be attractive for national and international cooperation partners	implement QM system & SOPs (incl. Biobank databank) according to present law, constantly follow law amendments and timely adapt QM system, SOPs & Biobank databank–> to be attractive for national and international cooperation partners
		Pristina: Separate sample collections at departments UCCK, NIPHK, Forensic medicine	merge sample collections via convincing of personnel of respective departments –> apply for fundings with collaboration of respective departments (regular collaboration, getting to know each other)	involve personnel of all respective departments in international collaborations –> see how departments in other countries collaborate and merge sample collections		collaboration with private institutions as model for collaboration	merge sample collections into a common biobank –> make a brand & use it for networking, publishing of papers –> make biobank indispensable (being a figurehead), conformation of sample procedure (collection, storage, quality) on an international level, enlarge the national or local cooperation to be more competitive, contacts to research community, networking in field of biobanking (BBMRI), funding, quality, personnel training	leave separate sample collections but with equal procedure (QM, SOPs) –> in case of shortage of money, one department might have more budget than the other		leave separate sample collections –> in case of legal & ethical changes, one department (Forensic medicine) might have other rights or possibilities than the other

Table 4.

Strategic Workplan of Biobanks Tirana and Pristina 2015–2017

vision	Building-up biobank capacities aiming at the implementation of common biologic sample repositories and registries in Kosovo and Albania
CSF (critical successfactor)	Governmental and stakeholder relations	Ethical and legal regulation	Finance	Personnel	Infrastructure	Management	Research usage
global definition of CSF	Stakeholder relations / commitment (Ministry of Health with corresponding bodies, Ministry of Education and Science, Albanian National Agency for Research and Innovation, Associations of Patients)	Establishment and coordination of responsible authorities	Financial sustainability	Appoint responsible people for the implementation and keep a biobank running	Development and implementation of a functioning infrastructure chain for biobanking	Coordination of all biobanking activities	Vision and mission statement
strategic direction of impact (3 years)	Recognition, promotion, information, sustainable contact, dissimination of ideas in public and government, fund raising, preparation for publishing	Existing and functioning guidelines and regulations for biobanking in general and/or in specific diseases in both countries	Fund raising for establishment of small biobank (local and international)	Staff development plan (best case, worst case)	Start up project with databanking and existing samples (including reprospective IC)	Installation of a functional management team including strategies, operative and QM leaders	Definition of priority fields (unique selling points) in medical sciences for each country
operational objective planning of activities 2015 – 2017	1. Preparation of promotion materials (brochure flyers, powerpoint presentation) in own language and English2. Information of public3. Advertisment in newspaper and facebook–> people should not be afraid of this topic4. Promotion of ethical requirements to the government and responsible people –> especially in Tirana5. Adaptation of strategy in each country on local priorities (Albania: Oncology, cardiology, neurological diseases; Kosovo: HIV, CCHF, TBC, brucellosis)	1. Coordination (Kosovo) / establishment (Albania) of a general ethical committee2. Implementation of broad informed consent for biobanking, also retrospective3. Promotion of ethical requirements to the government and responsible people –> especially in Tirana4. Harmonization of guidelines with other European countries for sample exchange	1. Grant application including all resources (mobility of staff, infrastructure, e.g.TAIEX)2. Find out arguments for different stakeholders for infrastructure money3. Clear demonstration of required budget4. Generation of a list of possibilities to cover the requirements5. Demonstration of possibility of already existing capability	1. Presentation of the staff development plan to key stakeholder2. Staff training3. Staff presence in BBMRI or other international meetings / networks4. Involvment of medical and PhD students (master thesis)5. Generation of a list of possible exchange programms	1. Organizing and digitalisation of existing data2. Start with a pilot project/pilot department (Pristina: Institute of Public Health, Tirana: Immunology Lab)3. Establishment of minimal IT-requirements (with Graz)	1. Apply a person for operative management2. Follow ongoing project for sustainable personnel	1. First steps of using of biobanking samples

First, a presentation of the status-quo of the respective institutions was given to get an overview of the current situation. To determine the strengths, weaknesses, opportunities, and threats of each partner, a SWOT analysis was performed on site. The participation and involvement of important stakeholders of the relevant institutions in the discussion and the SWOT analysis has been shown to be very beneficial and seems to be a prerequisite for further establishment of a biobank. International collaboration, as well as European/international and private funding, were identified as crucial opportunities for these emerging biobanks, while economic risks and sustainability were identified to be the most relevant threats.

On the basis of these findings, SWOT strategies were developed. For example: Training at, and cooperation with, experienced biobanks as well as contact with the research community and the respective grant agencies are important strategic routes to overcome threats and identify respective alternative opportunities. A 4-year strategy and a respective 4-year business plan are essential prerequisites for setting up a biobank. Furthermore, these two documents are substantial for the inclusion of stakeholders and decision makers. This strategy is now operational for the newly established emerging biobanks in different Central and Eastern European countries.

Conclusion

Sustainability of biobanks has to be realized on more than the financial level, since without the trust and participation of the public, every biobank would be empty. Therefore, the ethical, legal, and social implications (ELSI) in relation to transparency and information flow between public and biobanks are at least equally important as are funding and operation.

Biobanks should intend to be a part of biomedical research progress by actively participating in national and international science, as well as development of novel methods for sample processing, storage, and usage in the field of biobanking. Biobanking is an interdisciplinary unique process without a firm ending date, and therefore recovery cost calculations for customer and long-term funding strategies are pivotal for maintenance and advanced development of biobanks.

Sustainability in the field of biobanking is an important matter of necessity, not only on the local but also on the global level, starting from policy making and ending with security and documentation on each operational level.

Footnotes

Acknowledgment

The authors would like to acknowledge the Austrian Federal Government, Ministry of Science, Research and Economy (BMWFW; Konjunkturpaket II) as well as the Local Government of Styria (Zukunftsfond Steiermark) for their support of further development in infrastructure and resources of Biobank Graz. We also acknowledge the cooperation with Lul Raka from the National Institute of Public Health of Kosovo and Genc Sulcebe from the University Hospital in Tirana, in the frame of the Higher-KOS project ‘CONEKT’. Biobank Graz is supported by funds of the BMWFW for BBMRI.at (GZ 10.470/0016-II/3/2013).

Author Disclosure Statement

No conflicting financial interests exist.

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