Abstract
As guest editors of this sustainability issue of Biopreservation and Biobanking focused on business planning, utilization, and marketing, we invited a number of experts from different sectors of the biobanking arena to provide their views on business planning issues. Each expert was asked to provide a brief background statement on their biobanks, to build a context to understand their answers to the sustainability questions. We hope that these insights and experiences can provide valuable considerations and ideas for other biobanks who wish to develop or refine their own business plans, measure their utilization rates, and work toward financial sustainability. In addition, after the expert input was gathered, the guest editors invited an additional expert to provide summary comments and observations on cost and operational optimization strategies. The broad experiences from all of the experts included and scope of the biobanks they represent should provide a level of relevant representation for all interested parties.
Asterand Bioscience, Detroit, Michigan
Please provide a short description of your biobank, type, and who your biobank serves. Please include how your biobank is funded in this description.
Asterand Bioscience (Asterand Bio) is a company dedicated to providing high-quality human tissue-based products and services to researchers in a wide range of not-for-profit and for-profit organizations, including universities, government agencies, and pharmaceutical, biotechnology, contract research, and diagnostics companies. Established in 2000, Asterand Bio's biobank now contains more than 300,000 human solid tissue and biofluid specimens sourced from a worldwide network of more than 100 strategic partners, such as hospitals and clinics. The biobank is self-supporting with costs associated with operations, business development, administration, etc., offset by fees paid by our clients.
Samples are collected over multiple therapeutic areas (oncology, inflammatory, autoimmune, etc.) and “normal” donors and in several formats (frozen and fixed solid tissues, serum, plasma, whole blood, cerebrospinal fluid, synovial fluid, etc.). Most samples are collected prospectively as excess to surgical or diagnostic needs, but some are from postmortem donors or surgical archives. All prospectively collected samples are acquired with full IRB- or Ethics Committee-approved consent for research and supply to third parties. Surgical archives are obtained either with research consent or under an IRB-approved waiver of consent. Sample use is restricted to research for new therapeutic agents, diagnostics, etc., and use in humans is not permitted.
As well as providing “off-the-shelf” biospecimens, Asterand Bio also procures samples to meet customer-specific needs. These include fresh tissue and blood shipped directly from source to researcher, and samples collected under special conditions.
When did you develop a business plan for your biobank? Do you think the timing was appropriate and how often do you update it? Please note the key points you have included in your business plan. Do you have a specific person/group at your organization that is charged with the development/maintenance of your business plan? Please elaborate.
Although a business plan for our biobank was developed when the business was originally founded, we no longer use a formal written document during routine operations. The rapid and unpredictable changes in demand for human biospecimens in the fast-moving healthcare environment (e.g., because of changes in research direction, technologies, and therapeutic approaches) make it difficult to forecast even a few months ahead where demand may change. A written plan, therefore, becomes out-of-date quickly and needs frequent updating to remain current. This process is too onerous for a small organization like ours. Instead, over the past few years, our forward planning has been focused around the financial stability and development of the organization. It centers on preparation and maintenance of a budget looking 12–24 months ahead and based on inputs from our various teams, including tissue supply site management and development, laboratory, QC and QA operations, business development, and finance. The budget is largely based on historical data and trends, but we also try to plan for changes in demand for research samples and associated services and for introduction of new products, based on evidence from general market trends. This approach offers maximum flexibility and has been found to work well in our organization.
How do you define the utilization rate for your biobank? What is the target rate for your utilization of biospecimens and are you meeting your target(s)?
Our company's mission is to accelerate translational research from target to therapeutic use, and so we aim to maximize timely provision of human biospecimens to researchers. We try continually to increase the number of researchers we support and to maintain sufficient stocks of samples to do so. At the same time, we try to match our supply to demand over the medium to long term to ensure we hold the right samples to meet researchers’ needs quickly while avoiding accumulation of unwanted samples. To achieve this, we review monthly the quantity of samples on hand, and the details of samples supplied to researchers and received from our suppliers. This enables us to make timely adjustments to the requests we place with our supply sites and sometimes prompts changes in development of new supply sites to meet changes in demand. We typically aim to maintain levels of banked items (and some combinations of items such as tissue with matching biofluids) at equivalent to 1 to 2 years of estimated demand, depending on sample type, frequency, and size of requests from researchers, and speed at which we can change the supply rate.
How do you market your biobank and what are the most important marketing activities? If appropriate, include any successes you may have experienced reaching a new customer base through your marketing.
Asterand Bio has designated business development and marketing teams. Our business development team members are in regular contact with existing and prospective clients in their territories within the United States, Europe, and Asia-Pacific to identify and support their needs for human biospecimens and/or services. Our major clients are in the pharmaceutical, biotech, and diagnostics sectors.
Our marketing team has two main responsibilities. The first is to increase awareness and understanding of Asterand Bio's products through placement of advertising and attendance at conferences. The second is performing market research to understand trends in demands for human biospecimens and related services. This research aims to give our tissue supply and operations team early indication of changes in demand for Asterand Bio's products and services, and is particularly important because of the relative difficulty in rapidly increasing supply of some human tissue types. Input from business development and marketing teams may also identify new product opportunities whose development and marketing are then led by the marketing team.
Successes resulting from our marketing activities have included timely introduction of genetic mutation screening of our samples and maintenance of cohorts of prescreened tissue samples, identification of the potential to use surgical archive samples to support R&D for diagnostics, and a forecasted increase in demand for tissue samples with matching blood for use in development of “liquid biopsy” diagnostics for oncology.
How sustainable is your biobank today?
Asterand Bio's human tissue biobank started in 2000 and since 2009 the number of samples supplied to researchers has remained reasonably steady between 18,000 and 22,000 per year, with the current trend being upward. Sample acquisition has generally kept pace with demand and the number of specimen supply sites has increased significantly. So, although the mixes of samples acquired from our supply sites and provided to researchers have changed over the years (in terms of both disease and tissue type and format mix), the overall trend of our operations indicates a biobank showing consistent sustainability over many years with no indication of imminent decline.
What key success factors and/or challenges in your operational, financial, and social sustainability have you experienced?
Our greatest challenge continues to be matching biospecimen supply to demand, particularly in response to sudden increases in demand for specific specimen types. Solid tissue samples from donors with late-stage cancers or rarer diagnoses (e.g., pancreatic tumors and bone marrow from hematological malignancies) have consistently proved difficult to acquire, as have samples from organs affected by diseases/conditions not routinely treated by surgery (e.g., asthma, chronic obstructive pulmonary disease, and diabetes). Meeting the need for samples in these therapeutic areas is increasingly important as researchers work to apply human tissue studies in their searches for new drugs and diagnostics. In general, it is difficult to change supply rapidly, particularly if it requires new sources. This is true regardless of whether the aim is simply to broaden the supply base or to make up for an unpredicted shortfall like we encountered several years ago when a country providing part of our supply suddenly imposed restrictions on export of human research samples.
However, although we have inevitably encountered challenges in our business, perhaps the most important influences on our business have been our successes, particularly the early adoption of the highest ethical and technical standards in our collection processes and the maintenance of these standards throughout the organization's life. This has led recently to ISO and CAP accreditation for our biobank. These high standards, together with the commitment of our staff and strategic partners worldwide, mean that researchers can trust the quality of our biospecimens, which has ensured continued demand for these biospecimens over many years and the continuing success of our biobank.