Biobanking in the COVID-19 Era and Beyond: Part 1. How Early Experiences Can Translate into Actionable Wisdom.

The era of COVID-19 has brought about a number of novel challenges for the global biobanking community. To better position the biobanking community to cope with current and future challenges, the International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force was convened to identify needs and gaps in biobanking tools (existing resources that support good practice), for example, standards, best practices, business, etc. and to make recommendations to benefit the community. Toward these goals, the Task Force assembled a set of questions to explore individual biobanks' experiences, with emphasis on identification of key challenges and approaches, including tools employed. A survey was designed with the use of these questions and administered by ISBER. This article presents a summary of the aggregated data obtained from the survey responses, illustrating some of the major issues encountered and identifying which tools the survey respondents found most useful. In particular, this article focuses on the challenges identified during the early months of the COVID-19 era. Recommendations are provided to support biobank emergency preparedness for the future, address lessons learned, and propose solutions to bridge identified gaps. The analysis and the complete survey dataset will also inform the larger Task Force goal to develop specific tool recommendations.

Opportunities and Risks for Research Biobanks in the COVID-19 Era and Beyond.

The SARS-CoV-2 pandemic, which caused a global outbreak of COVID-19 disease, has been a crisis of extraordinary proportions, causing serious impacts for research and public health. Biobanks have played a key important role in understanding the disease and response. In our article we will highlight the opportunities and risks of biobanks during and after the pandemic. The different aspects of safety and sustainability have and will be the main challenges for biobanks. Furthermore, the role of biobanks in biomedical research and public health has been emphasized as well as opportunities that have arisen for their participation in research.

Advancing Professionalization of Biobank Business Operations: Performance and Utilization.

Biobanks are now in the spotlight as key enablers supporting preclinical, clinical, and environmental research. Awareness of their value has increased along with the need for these infrastructures to be sustained through business-focused practices. Following our 2017 pilot survey on biobank business planning, we initiated a more comprehensive 38-question multiple-language worldwide survey on biobank sustainability. Two hundred seventy-six biobanks of various sizes and stages of business planning (in place, in progress or none) responded. About two-thirds were established in the last 10 years. Survey results confirm our hypothesis that biobanks with business plans or preparing such plans are trending toward more professional structures. Specific survey data focusing on performance metrics and utilization, as related to sustainability, are presented. Biobanks most frequently measured basic performance metrics (sample utilization, samples collected, samples distributed, internal projects supported). Metrics less often reported included sample and data quality, cost recovery, citations, and publications, typically correlating with higher levels of biobank complexity and professionalism. Biobanks reported supporting projects for both internal and external use, with support of projects within their own organizations as the main driver of biobanks, independent of business plan status. Having a business plan seemed to be a key factor for biobanks that had developed sustained support for external commercial projects. While under half of the biobanks reported both target and actual utilization rates, the responses provided valuable data on utilization. Target utilization rates were much higher (2.5 to 5 times higher) than the rate of actual use. Many of the biobanks report less than 10% utilization. Biobanks with low utilization rates make sustainability a very distant and likely unreachable goal. Our survey has provided some basic data about biobank business planning globally. Continued research should be done, with the data and information shared within the community for the good of all biobank stakeholders.

Biospecimen Data Reporting in the Research Literature.

A substantial fraction of biomedical research depends on the reliability of human biospecimens but variations in sample manipulation during collection, processing, and storage can differentially alter molecular integrity and influence interpretation of the resulting derived data. Details of biobanking processes are rarely adequately described in research publications, preventing reviewers, readers, and scientists seeking to replicate the findings, from appreciating and adequately considering preanalytical variations contributing to results. To address these shortcomings, a set of reporting guidelines, the Biospecimen Reporting for Improved Study Quality (BRISQ) criteria, were developed in 2011. In this study we evaluated the uptake and reporting of BRISQ criteria in 324 articles across four leading biomedical journals using human biospecimens and published before (161; in 2010) and after (163; in 2014) the delineation of the BRISQ guidelines. We found that even within journals recommending use of BRISQ, manuscript-level uptake. and reporting of the relevant biospecimen information is not widespread or uniform. In the future, an enhanced biospecimen reporting strategy to better serve the needs of researchers, reviewers, and journals may be considered to strengthen research reproducibility for the benefit of the research community at large.

Advancing Professionalization of Biobank Business Operations: A Worldwide Survey.

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 in-depth 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.

Crisis Management for Biobanks.

All organizations are subject to risk and uncertainty. Adverse events may disrupt normal organizational activity and may even cause complete failure of business operations. Biorepositories are also at risk and there have been instances where multiple samples or entire collections have been destroyed. Biobank guidelines accordingly recommend the establishment of contingency plans to reduce risk to an acceptable level. In this review article, we will use general theory on risk management and illustrate how such principles can be used to establish a practical crisis management plan for any biobank organization.

Biospecimen User Fees: Global Feedback on a Calculator Tool.

The notion of attributing user fees to researchers for biospecimens provided by biobanks has been discussed frequently in the literature. However, the considerations around how to attribute the cost for these biospecimens and data have, until recently, not been well described. Common across most biobank disciplines are similar factors that influence user fees such as capital and operating costs, internal and external demand, and market competition. A biospecimen user fee calculator tool developed by CTRNet, a tumor biobank network, was published in 2014 and is accessible online at www.biobanking.org . The next year a survey was launched that tested the applicability of this user fee tool among a global health research biobank user base, including both cancer and noncancer biobanking. Participants were first asked to estimate user fee pricing for three hypothetical user scenarios based on their biobanking experience (estimated pricing) and then to calculate fees for the same scenarios using the calculator tool (calculated pricing). Results demonstrated variation in estimated pricing that was reduced by calculated pricing. These results are similar to those found in a similar previous study restricted to a group of Canadian tumor biobanks. We conclude that the use of a biospecimen user fee calculator contributes to reduced variation of user fees and for biobank groups (e.g., biobank networks), could become an important part of a harmonization strategy.

Quality Assurance in Biobanking for Pre-Clinical Research.

It is estimated that not less than USD 28 billion are spent each year in the USA alone on irreproducible pre-clinical research, which is not only a fundamental loss of investment and resources but also a strong inhibitor of efficiency for upstream processes regarding the translation towards clinical applications and therapies. The issues and cost of irreproducibility has mainly been published on pre-clinical research. In contrast to pre-clinical research, test material is often being transferred into humans in clinical research. To protect treated human subjects and guarantee a defined quality standard in the field of clinical research, the manufacturing and processing infrastructures have to strictly follow and adhere to certain (inter-)national quality standards. It is assumed and suggested by the authors that by an implementation of certain quality standards within the area of pre-clinical research, billions of USD might be saved and the translation phase of promising pre-clinical results towards clinical applications may substantially be improved. In this review, we discuss how an implementation of a quality assurance (QA) management system might positively improve sample quality and sustainability within pre-clinically focused biobank infrastructures. Biobanks are frequently positioned at the very beginning of the biomedical research value chain, and, since almost every research material has been stored in a biobank during the investigated life cycle, biobanking seems to be of substantial importance from this perspective. The role model of a QA-regulated biobank structure can be found in biobanks within the context of clinical research organizations such as in regenerative medicine clusters.