A Plan for Academic Biobank Solvency—Leveraging Resources and Applying Business Processes to Improve Sustainability Diane Uzarski, D.N.P., M.P.H., R.N.1, James Burke, M.D., Ph.D.2, Barbara Turner, Ph.D., R.N., F.A.A.N.3, James Vroom, D.H.A., F.A.C.H.E®, C.P.A.3, and Nancy Short, Dr.P.H., M.B.A., R.N.3 Abstract Researcher-initiated biobanks based at academic institutions contribute valuable biomarker and translational research advances to medicine. With many legacy banks once supported by federal funding, reductions in fiscal support threaten the future of existing and new biobanks. When the Brain Bank at Duke University’s Bryan Alzheimer’s Disease Center (ADRC) faced a funding crisis, a collaborative, multidisciplinary team embarked on a 2-year biobank sustainability project utilizing a comprehensive business strategy, dedicated project management, and a systems approach involving many Duke University entities. By synthesizing and applying existing knowledge, Duke Translational Medicine Institute created and launched a business model that can be adjusted and applied to legacy and start-up academic biobanks. This model provides a path to identify new funding mechanisms, while also emphasizing improved communication, business development, and a focus on collaborating with industry to improve access to biospecimens. Benchmarks for short-term Brain Bank stabilization have been successfully attained, and the evaluation of long-term sustainability metrics is ongoing. Clin Trans Sci 2015; Volume 8: 553–557
Keywords: biobanking, biomarker research, sustainability Introduction
The value of biobanks—and the power of the high-quality biospecimens stored in their coffers—is well recognized by translational researchers. In 2012, Time featured the “Biobank” as transformative, and “One of the 10 Ideas Changing the World Right Now.”1 Mass media articles tout biobanks as rich sources of tailored therapies and biomarkers—enabling a future model of truly “personalized medicine.” This increased awareness has led to increased collections of high-quality, well-annotated samples of tumors, tissues, and body fluids for medical research.2 But there remains a challenge in connecting these valuable biospecimens with the researchers who seek them. Available biospecimens are underutilized, and many biobanks lack a longterm plan for sample use. The full value of a biobank is fully realized only when biospecimens are in the hands of capable researchers with a clear vision of how to conduct research using these biospecimens. Although biospecimen science is a relatively new field, academic researchers have collected and stored biospecimens for decades. The most famous biospecimens are cervical tissue samples taken from a patient named Henrietta Lacks at Johns Hopkins Hospital in 1951. Lacks’ cancerous samples became the first “immortal” cell lines—samples that did not die after a few cell divisions. The resulting HeLa cells (named using the first letters of “Henrietta” and “Lacks”) led to countless contributions to science, including Jonas Salk’s polio vaccine.3 Biobanking is a growing field, but remains a largely academic endeavor with 67% of biobanks affiliated with academic entities.4 Academic biospecimens often have a high degree of clinical annotation—priceless detailed patient demographic, laboratory, clinical and treatment data. Academic-based biobanks also offer a higher likelihood of patient follow-up, enabling the collection of additional data and samples, often from unique patient populations. Researcher-based academic biobanking engages clinicians in important discovery involving biospecimens.
Historically, researchers have relied heavily on government and industry funding to support the start-up and maintenance of biospecimen collections; however, external funding for biobanks has diminished in recent years, leaving biobanks under increasing cost pressure.5 And even when external funding is present, a shortfall often remains.6 Despite strong value recognition within their institutions, biobanks are unlikely to receive sufficient internal support to continue operations indefinitely. A number of academic-based biobanks have closed their doors due to funding shortfalls, leaving valuable biospecimens and the hopes of generous donors locked away in freezers. Biobanks are also at a disadvantage in that many researchers lack expertise in the complexities of biospecimen science. The first national US biobank survey, conducted in 2012 and funded by the National Human Genome Research Institute and the UNC Center for Genomics and Society, found that most biobanks (67%) are based in academic organizations. The study also showed that many biobanks are worried about underutilization of specimens and long-term funding. Biobank managers “want to make sure the specimens are used, and worry about how to make that happen.”4 Underuse of academic biospecimens is often a challenge due to restrictive policies and limited networking that may prevent researchers and private industry (including pharmaceutical companies) from accessing biospecimens.7 To ensure long-term stability, biobanks must improve their efficiency and effectiveness. Regardless of funding models, nearly all academic biobanks would benefit from the application of standard business principles.8 There is a need to shift to a market-focused approach that facilitates appropriate external collaborations and cost recovery. And while most academic biobanks may never be fully self-sustaining, a recent publication suggests a framework that broadens the term “sustainability” to include the operational and social aspects of long-term biobank success.9
1 Duke Translational Research Institute, Duke University, Durham, North Carolina, USA ; 2Duke Medicine, Duke University, Durham, North Carolina, USA ; 3Duke University School of Nursing , Duke University, Durham, North Carolina, USA .
Correspondence: Diane Uzarski ([email protected]) DOI: 10.1111/cts.12287
WWW.CTSJOURNAL.COM
VOLUME 8 • ISSUE 5
553
Uzarski et al. A Plan for Academic Biobank Solvency ■
Academic banks could improve their ability to become nearly sustainable by leveraging university-wide resources to the greatest extent possible, to: • understand biobanking customer needs through market research, • develop a compelling value proposition,8 • achieve economies of scale and understand the costs of doing business,8 • adopt a well-defined cost recovery program and fee-forservice model to cover operational costs,8 • implement biobanking best practices to reduce regulatory and legal risks, and • develop communication strategies to inform researchers and industry collaborators of biospecimens available for future research. Although evidence supports the need for biobanks to develop a sound cost recovery model (that may include fee-for-service), there are limited publications that provide researchers with information about the potential to achieve biobank sustainability amid the limited resources of academia, and the long-term effectiveness of cost recovery models. This article illustrates one example of how an established tissue bank is implementing innovative changes to preserve a valuable asset and position the biobank to achieve eventual sustainability. This model can be applied to other struggling biobanks and can inform the development of new biobanks in an academic setting. Background
Alzheimer’s disease (AD) is an age-associated neurodegenerative disease that causes impairment in memory, language, judgment, and behavior. Alzheimer’s affects more than 5 million Americans and is the leading cause of dementia in older adults and the sixth leading cause of death in the United States.10 In the US alone, the cost of care for people with dementia is estimated at more than $200 billion annually.11 Currently available AD treatments provide only symptomatic relief, temporarily improving brain function in patients with mild to moderate disease. Significant setbacks are delaying the development of drugs to prevent or treat AD, making continued research more critical in advancing our understanding of disease pathogenesis and to aid in therapeutic development. A recent decline in human brain tissue research has been identified as a contributor to the relatively slow rate of development of new neurodegenerative disease treatments. There are no totally reliable animal models available for AD research since Alzheimer’s is a uniquely human disease. Human brain tissue and related samples can aid researchers in understanding the AD process and developing new biomarkers and treatments. Located at Duke University, the Joseph and Kathleen Bryan Alzheimer’s Disease Research Center (Bryan ADRC) provides care to patients with AD and other memory disorders, conducts discovery and basic research, and supports the development of effective treatments and preventive strategies for AD and related conditions. The Kathleen Price Bryan Brain Bank and Biorepository (“Brain Bank”) at the ADRC is a premier biorepository, with a 25-year history of providing access to longitudinal clinical information and quality biospecimens. In 1991, researchers at the Bryan ADRC identified apolipoprotein E (ApoE4) as the leading genetic risk factor for AD using Brain Bank samples.12 The Brain Bank currently houses a collection of 1,200 human brains, as well as cerebral spinal fluid (CSF) biospecimens, 554
VOLUME 8 • ISSUE 5
and DNA samples from consented donors over 55 years of age. Perhaps the most unique feature of the Brain Bank is its collection of “normal” non-Alzheimer’s biospecimens derived from consented cognitively normal individuals who have been preregistered and consented for autopsy upon death, in addition to biospecimens from Alzheimer’s patients. All biospecimens are accompanied by extensive clinical, pathology, and neurocognitive data, collected annually on living consented individuals. Research subjects receive annual follow up and detailed cognitive testing to ensure that brain specimens are well-characterized. In 2012, the Bryan ADRC learned that a grant submission to the National Institute on Aging (NIA) had not been funded, leaving the Brain Bank without a funding source for annual operating expenses. The Duke University School of Medicine and the Department of Neurology did not want to lose years of investment and expertise in AD research. They demonstrated a commitment to the living consented cohort and restructured departmental finances to fund the basic operations needed to keep the Brain Bank’s doors open. Realizing that closure would be inevitable without a permanent funding source, ADRC leadership reached out to the Duke Translational Medicine Institute (DTMI) for assistance and initiated an effort to transform the Brain Bank into an adaptable and largely selfsustaining enterprise. Methods
A DTMI project leader organized a small multidisciplinary core team, and developed a nontraditional approach for an academic entity by applying operational and business development processes traditionally used in private industry. The team used project management and a systems approach to leverage internal and external resources to develop a comprehensive business strategy, implement key components, and evaluate preliminary results. By self-organizing, asking hard questions, basing decisions on financial impact as well as intrinsic value of the research, reaching out to diverse groups within an academic organization’s large web, and weaving in industry and research brokers providing matchmaking services, the Brain Bank has created and put into action a plan for achieving long-term viability. The aims of the ADRC Brain Bank sustainability project were to: • Develop and implement a comprehensive sustainability plan that allows for short-term strategies to address immediate financial concerns, and long-term financial and operational sustainability through focused business development and streamlined operations. The business strategy is detailed in Figure 1. • Achieve financial solvency, by stabilizing the current economic deficit and expanding capacity for greater industry collaborations involving biospecimens. The Fiscal and Operational Sustainability Plan
The development of a comprehensive business strategy for the Bryan ADRC Brain Bank was the cornerstone for the sustainability effort. Once developed, the two-phase plan was presented and vetted to key stakeholders within the Department of Neurology, Duke Translational Medicine Institute, and the School of Medicine, ultimately receiving critical executive support. Key elements of the Sustainability Plan are displayed in Figure 2. WWW.CTSJOURNAL.COM
Uzarski et al. A Plan for Academic Biobank Solvency ■
Figure 1. Principal tenets of brain bank business strategy.
Figure 3. A system approach to biobanking sustainability.
Figure 2. Fiscal and operational sustainability plan components.
The Cost Recovery Model
The team conducted a careful analysis of operational costs associated with the Brain Bank, including both personnel and nonpersonnel expenses. The personnel expense consisted of fixed and variable costs related to all aspects of biobanking, including patient consent, IRB management, biospecimen collection, preparation and storage, and management of data (including neurocognitive assessments and administrative time). Nonpersonnel expenses included fixed and variable costs such as equipment, maintenance, and supplies. After costs were identified, the team developed revenue projections for 5 years, considering all potential sources including academic and industry research agreements, grants, donor gifts, and departmental funding. These conservative estimates were calculated based on historical biospecimen allocation information for a 5-year period, broken down by biospecimen sample type, number of orders, and size of orders for each consecutive year. An initial biospecimen rate structure was developed as a fee-for-service model based on total fixed and variable personnel and nonpersonnel costs, and tiered by customer base. A careful market analysis revealed that these rates fell above market competitors. A revised tiered pricing structure based on researcher and pharmaceutical company dynamics was proposed to the Department of Neurology. This final rate structure covers fixed costs and a reasonable amount of variable costs, and will move the Brain Bank to the breakeven point when sample transaction volume increases. The final rates were marginally less (approximately 25% lower) than the rate based on actual costs. We believed it was important to keep competitive rates to allow for more sample transactions. WWW.CTSJOURNAL.COM
Leveraging Existing Resources
The core project team recognized early on that like many academic medical center departments, our limited resources and financial constraints would threaten the success of the project. A systems approach—developing and building connections with diverse groups at Duke, each contributing with expertise and local knowledge—was needed for the project to succeed. Our initial questions included: Given resource constraints, how can the funding problem be addressed? Is it realistic to leverage university-wide resources, including Department of Neurology, faculty, finance and business strategy staff, and students to be successful? Should the Brain Bank become an established core resource within the School of Medicine? An extended project team aided in implementing the Sustainability Plan, which was then used to communicate the value of the Brain Bank to internal stakeholders and leverage resources. Existing personnel at various Duke organizations, and an MBA student from a local university were recruited to join the effort. Figure 3 illustrates this systems approach. Project Management
We used a project management approach to provide the necessary framework to develop, implement, and evaluate this sustainability effort. The approach was especially helpful given the myriad of stakeholder organizations and departments within Duke. Most team members were not directly affiliated with the Brain Bank, making it essential that the project leader work across departments to communicate goals and progress, identify obstacles, and recommend changes as the project evolved. It was especially valuable that the Project Manager possessed a wealth of knowledge in the biobanking realm. This seasoned experience, combined with institutional knowledge, lent a greater ability of the project leader to gather these resources and garner support. VOLUME 8 • ISSUE 5
555
Uzarski et al. A Plan for Academic Biobank Solvency ■
private industry, government, and external researchers. When setting cost-recovery parameters, Duke had to work not only within distinct business income and nonprofit tax status limitations, but also restrictions on the use of bond or grantfinanced facilities. Results
Figure 4. Tactics for short- and long-term sustainability.
Tactics for Short- and Long-Term Sustainability
The Sustainability Plan outlined and organized specific strategies into two phases: First financially stabilizing the bank (Phase I), then focused development of fiscal, business and operations functions of the Brain Bank (Phase II). Timelines were developed and strategies assigned to resources on the team. Figure 4 lists specific tactics for consideration to stabilize and improve longterm financial solvency of an academic biobank. Legal and Contractual Concerns
The development of a biobanking cost-recovery model represents a paradigm shift at Duke. One major issue was how faculty members should structure Sponsored Research Agreements with pharmaceutical companies, and Material Transfer Agreements (MTAs) with other nonprofit entities, and avoid the notion of selling biospecimens. The Brain Bank was developing a cost recovery model rather than a potential profit source. Close collaboration with the School of Medicine, Duke Office of Counsel, and the Duke Office of Research Collaborations early in the project was imperative to developing the proper infrastructure and guidelines. The approach ensured the bank would operate within the appropriate legal, nonprofit and tax limitations for Duke as an educational, research and healthcare institution. This was especially relevant given the plan to collaborate with 556
VOLUME 8 • ISSUE 5
After the sustainability strateg y was developed and vetted through knowledgeable internal resources, it was used to garner internal support. Stop-gap funding for a 1-year period, along with in-kind operations funding was secured through the Department of Neurology and School of Medicine to support scaled-down operations. The Bryan ADRC made the hard decision to cease enrolling new individuals to the Autopsy Program, while continuing to support the retrieval of brains from previously consented deceased patients, as well as the processing, storing, and allocation of biospecimens. Several operational enhancements were made, including the installation of a secondary temperature monitoring system to strengthen sample security through the support of the Duke Biobank. Biobanking informatics will be enhanced in 2015 when the enterprise-wide Core Research at Duke program goes live. The Brain Bank applied to the School of Medicine for and received designation as a core research facility, providing a critical path of ready access to Duke researchers. It also enabled a funded voucher program for researchers using Brain Bank biospecimens. School of Medicine administration approved the cost recovery model and biospecimen rate structure. The tiered rates were implemented for internal and external research collaborations, and the Brain Bank recently issued its first invoice for a research project involving brain tissue for $11,000. Other projects are in the queue with promise for additional revenue. A relationship with a biomarker research broker has resulted in several inquiries for potential research collaborations involving brain tissue. New processes were implemented to support the Core Resource designation, including an online tissue request form, invoicing, and a revised MTA. The School of Medicine Communications Department is launching a plan to inform internal and external researchers, patients, and the local community about the Brain Bank’s unique features, interest in collaborative research opportunities, and achievements in Alzheimer’s research. This homegrown advertising is recommended to market the availability of biospecimens to researchers and industry.13 The team is also targeting institutional events and external conferences to increase the demand for samples. Duke Medicine’s Enterprise-Wide Speed Review (EWSR) group, is providing support and coordination to the Brain Bank as it ramps up industry collaborations. Composed of faculty, researchers and research administrators, this group was formed as a vehicle for faculty wishing to engage in industry partnerships in order to optimize potential collaborations. WWW.CTSJOURNAL.COM
Uzarski et al. A Plan for Academic Biobank Solvency ■
Discussion
Academic researchers and staff invest significant effort and resources to develop patient trust and build biorepository collections. Intact biospecimens and data are university assets with great potential for advancing groundbreaking research. Over the past several years, the biobanking community has begun to develop increased awareness of the need for both financial and operational sustainability. Many biobanks—such as the Sun Health Research Institute in Arizona and the Washington University School of Medicine—have successfully implemented fee-for-service, cost-recovery models to ensure biobank viability. However, additional publications evaluating a variety of business development and financial models are needed. Securing institutional buy-in as early as possible cannot be overemphasized. Without this support, a lone researcher or biobank faces daunting challenges. Keeping the resource team engaged and informed during a long process will prove invaluable, but indeed challenging. Sustainability efforts may take several years, and it is difficult to continue infusing energy and make progress over an extended period of time without dedicated project management. A market-driven and customer-focused approach is a culture shift in an academic organization. Thus, it is important that staff embrace a need for biobanking excellence, responsiveness, and quality in all aspects of the business, including operations best practices and informatics. This may prove challenging for researchers and staff focused on day-to-day biobank operations. Legal and contractual nuances and university policies are often complex, especially when implementing fee-for-service. Therefore, it is necessary to engage these groups early to understand the goal of cost recovery, and to work through policy nuances and perceptions that the biobank will “sell” biospecimens as a profit source. Conclusion
The Brain Bank’s Sustainability Plan was first used to garner institutional support, and then as a blueprint for short-term and long-term operational and fiscal changes. The cogent plan established credibility by defining the research need and delineating the Brain Bank’s value as a university research asset. Using the milestone-driven, project management approach ensured that progress would be monitored closely and communicated to key stakeholders. The seasoned clinician project leader with extensive biobanking knowledge used her industry and institutional credibility to achieve deliverables quickly. Future standardization and collaboration among biobanks will allow researchers to access samples from a network of biorepository collections.12 The Bryan ADRC Brain Bank supports
WWW.CTSJOURNAL.COM
the development of such research networks. In the meantime, the implementation of a cost recovery model coupled with stop-gap funding resulted in a short-term “win” for the Bryan ADRC. Its long-term success will be measured by the metrics implemented and the critical role of brain bank specimens in AD research. Acknowledgments
The authors wish to express thanks to Suresh Balu, Strategy & Innovation, Duke Translational Medicine Institute for his mentorship and guidance. His emphasis on a “market-focused approach” to biospecimen assets was a critical aspect of this project. Thanks also to Victoria Christian for embracing a project management and systems approach in translational research, and for providing generous support of this lengthy project. Finally, many thanks to Meggan Monroe for her encouragement, mentorship and unique insight, along with meticulous editing of this publication. Source of Financial Support
This work was enabled through funding from Duke’s Clinical and Translational Science Award UL1TR001117. References 1. Park A. 10 ideas changing the world right now: Biobanks. Time Magazine. 2009. 2. Beach T. Alzheimer’s disease and the valley of death: Not enough guidance from human brain tissue? J Alzheimers Dis. 2013; 33(S1): S219–233. 3. Skloot R. The immortal life of henrietta lacks. New York: Crown Publishers, 2010, pp, 93–97. 4. Henderson G, Cadigan RJ, Edwards T, Conlon I, Nelson A, Evans, J, Davis A, Zimmer C, Weiner B. Characterizing biobank organizations in the U.S.: results from a national survey. Genome Med. 2013; 5(1): 3. 5. McDonald S, Sommerkamp K, Egan-Palmer M, Kharasch K, Holtschlag V. Fee-for-service as a business model of growing importance: the academic biobank experience. Biopreserv Biobank. 2012; 10(5): 421–424. 6. The Research Universities Futures Consortium. The Current Health and Future Well-Being of the American Research University. 2012: 13–15. Available at http://www.researchuniversitiesfutures. org/RIM_Report_Research%20Future’s%20Consortium%20.pdf. Accessed Oct 17, 2014. 7. Hewitt R, Hainaut P. Biobanking in a fast moving world: an international perspective. J Natl Canc Inst Monogr. 2011; 42: 50–51. 8. Vaught J, Rogers J, Carolin T, Compton C. Biobankonomics: developing a sustainable business model approach for the formation of a human tissue bank. J Natl Cancer Inst Monogr. 2011; 2011(42): 24–31. 9. Watson PH, Nussbeck SY, Carter C, O’Donoghue S, Cheah S, Matzke LA, Barnes RO, Bartlett J, Carpenter J, Grizzle WE, et al. A framework for biobank sustainability. Biopreserv Biobank. 2014; 12(1): 60–68. 10. Alzheimer’s Association. 2012 Alzheimer’s disease facts and figures. Alzh Dement. 2012; 8(2): 14–15. 11. Cowen and Company (2012), Alzheimer’s Disease Report. 12. Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer’s disease in late onset families. Science. 1993; 261(5123): 921–923. 13. Schudellari M. Biobank managers bemoan underuse of collected samples. Nat Med. 2013; 19(3): 253.
VOLUME 8 • ISSUE 5
557
Keywords: biobanking, biomarker research, sustainability Introduction
The value of biobanks—and the power of the high-quality biospecimens stored in their coffers—is well recognized by translational researchers. In 2012, Time featured the “Biobank” as transformative, and “One of the 10 Ideas Changing the World Right Now.”1 Mass media articles tout biobanks as rich sources of tailored therapies and biomarkers—enabling a future model of truly “personalized medicine.” This increased awareness has led to increased collections of high-quality, well-annotated samples of tumors, tissues, and body fluids for medical research.2 But there remains a challenge in connecting these valuable biospecimens with the researchers who seek them. Available biospecimens are underutilized, and many biobanks lack a longterm plan for sample use. The full value of a biobank is fully realized only when biospecimens are in the hands of capable researchers with a clear vision of how to conduct research using these biospecimens. Although biospecimen science is a relatively new field, academic researchers have collected and stored biospecimens for decades. The most famous biospecimens are cervical tissue samples taken from a patient named Henrietta Lacks at Johns Hopkins Hospital in 1951. Lacks’ cancerous samples became the first “immortal” cell lines—samples that did not die after a few cell divisions. The resulting HeLa cells (named using the first letters of “Henrietta” and “Lacks”) led to countless contributions to science, including Jonas Salk’s polio vaccine.3 Biobanking is a growing field, but remains a largely academic endeavor with 67% of biobanks affiliated with academic entities.4 Academic biospecimens often have a high degree of clinical annotation—priceless detailed patient demographic, laboratory, clinical and treatment data. Academic-based biobanks also offer a higher likelihood of patient follow-up, enabling the collection of additional data and samples, often from unique patient populations. Researcher-based academic biobanking engages clinicians in important discovery involving biospecimens.
Historically, researchers have relied heavily on government and industry funding to support the start-up and maintenance of biospecimen collections; however, external funding for biobanks has diminished in recent years, leaving biobanks under increasing cost pressure.5 And even when external funding is present, a shortfall often remains.6 Despite strong value recognition within their institutions, biobanks are unlikely to receive sufficient internal support to continue operations indefinitely. A number of academic-based biobanks have closed their doors due to funding shortfalls, leaving valuable biospecimens and the hopes of generous donors locked away in freezers. Biobanks are also at a disadvantage in that many researchers lack expertise in the complexities of biospecimen science. The first national US biobank survey, conducted in 2012 and funded by the National Human Genome Research Institute and the UNC Center for Genomics and Society, found that most biobanks (67%) are based in academic organizations. The study also showed that many biobanks are worried about underutilization of specimens and long-term funding. Biobank managers “want to make sure the specimens are used, and worry about how to make that happen.”4 Underuse of academic biospecimens is often a challenge due to restrictive policies and limited networking that may prevent researchers and private industry (including pharmaceutical companies) from accessing biospecimens.7 To ensure long-term stability, biobanks must improve their efficiency and effectiveness. Regardless of funding models, nearly all academic biobanks would benefit from the application of standard business principles.8 There is a need to shift to a market-focused approach that facilitates appropriate external collaborations and cost recovery. And while most academic biobanks may never be fully self-sustaining, a recent publication suggests a framework that broadens the term “sustainability” to include the operational and social aspects of long-term biobank success.9
1 Duke Translational Research Institute, Duke University, Durham, North Carolina, USA ; 2Duke Medicine, Duke University, Durham, North Carolina, USA ; 3Duke University School of Nursing , Duke University, Durham, North Carolina, USA .
Correspondence: Diane Uzarski ([email protected]) DOI: 10.1111/cts.12287
WWW.CTSJOURNAL.COM
VOLUME 8 • ISSUE 5
553
Uzarski et al. A Plan for Academic Biobank Solvency ■
Academic banks could improve their ability to become nearly sustainable by leveraging university-wide resources to the greatest extent possible, to: • understand biobanking customer needs through market research, • develop a compelling value proposition,8 • achieve economies of scale and understand the costs of doing business,8 • adopt a well-defined cost recovery program and fee-forservice model to cover operational costs,8 • implement biobanking best practices to reduce regulatory and legal risks, and • develop communication strategies to inform researchers and industry collaborators of biospecimens available for future research. Although evidence supports the need for biobanks to develop a sound cost recovery model (that may include fee-for-service), there are limited publications that provide researchers with information about the potential to achieve biobank sustainability amid the limited resources of academia, and the long-term effectiveness of cost recovery models. This article illustrates one example of how an established tissue bank is implementing innovative changes to preserve a valuable asset and position the biobank to achieve eventual sustainability. This model can be applied to other struggling biobanks and can inform the development of new biobanks in an academic setting. Background
Alzheimer’s disease (AD) is an age-associated neurodegenerative disease that causes impairment in memory, language, judgment, and behavior. Alzheimer’s affects more than 5 million Americans and is the leading cause of dementia in older adults and the sixth leading cause of death in the United States.10 In the US alone, the cost of care for people with dementia is estimated at more than $200 billion annually.11 Currently available AD treatments provide only symptomatic relief, temporarily improving brain function in patients with mild to moderate disease. Significant setbacks are delaying the development of drugs to prevent or treat AD, making continued research more critical in advancing our understanding of disease pathogenesis and to aid in therapeutic development. A recent decline in human brain tissue research has been identified as a contributor to the relatively slow rate of development of new neurodegenerative disease treatments. There are no totally reliable animal models available for AD research since Alzheimer’s is a uniquely human disease. Human brain tissue and related samples can aid researchers in understanding the AD process and developing new biomarkers and treatments. Located at Duke University, the Joseph and Kathleen Bryan Alzheimer’s Disease Research Center (Bryan ADRC) provides care to patients with AD and other memory disorders, conducts discovery and basic research, and supports the development of effective treatments and preventive strategies for AD and related conditions. The Kathleen Price Bryan Brain Bank and Biorepository (“Brain Bank”) at the ADRC is a premier biorepository, with a 25-year history of providing access to longitudinal clinical information and quality biospecimens. In 1991, researchers at the Bryan ADRC identified apolipoprotein E (ApoE4) as the leading genetic risk factor for AD using Brain Bank samples.12 The Brain Bank currently houses a collection of 1,200 human brains, as well as cerebral spinal fluid (CSF) biospecimens, 554
VOLUME 8 • ISSUE 5
and DNA samples from consented donors over 55 years of age. Perhaps the most unique feature of the Brain Bank is its collection of “normal” non-Alzheimer’s biospecimens derived from consented cognitively normal individuals who have been preregistered and consented for autopsy upon death, in addition to biospecimens from Alzheimer’s patients. All biospecimens are accompanied by extensive clinical, pathology, and neurocognitive data, collected annually on living consented individuals. Research subjects receive annual follow up and detailed cognitive testing to ensure that brain specimens are well-characterized. In 2012, the Bryan ADRC learned that a grant submission to the National Institute on Aging (NIA) had not been funded, leaving the Brain Bank without a funding source for annual operating expenses. The Duke University School of Medicine and the Department of Neurology did not want to lose years of investment and expertise in AD research. They demonstrated a commitment to the living consented cohort and restructured departmental finances to fund the basic operations needed to keep the Brain Bank’s doors open. Realizing that closure would be inevitable without a permanent funding source, ADRC leadership reached out to the Duke Translational Medicine Institute (DTMI) for assistance and initiated an effort to transform the Brain Bank into an adaptable and largely selfsustaining enterprise. Methods
A DTMI project leader organized a small multidisciplinary core team, and developed a nontraditional approach for an academic entity by applying operational and business development processes traditionally used in private industry. The team used project management and a systems approach to leverage internal and external resources to develop a comprehensive business strategy, implement key components, and evaluate preliminary results. By self-organizing, asking hard questions, basing decisions on financial impact as well as intrinsic value of the research, reaching out to diverse groups within an academic organization’s large web, and weaving in industry and research brokers providing matchmaking services, the Brain Bank has created and put into action a plan for achieving long-term viability. The aims of the ADRC Brain Bank sustainability project were to: • Develop and implement a comprehensive sustainability plan that allows for short-term strategies to address immediate financial concerns, and long-term financial and operational sustainability through focused business development and streamlined operations. The business strategy is detailed in Figure 1. • Achieve financial solvency, by stabilizing the current economic deficit and expanding capacity for greater industry collaborations involving biospecimens. The Fiscal and Operational Sustainability Plan
The development of a comprehensive business strategy for the Bryan ADRC Brain Bank was the cornerstone for the sustainability effort. Once developed, the two-phase plan was presented and vetted to key stakeholders within the Department of Neurology, Duke Translational Medicine Institute, and the School of Medicine, ultimately receiving critical executive support. Key elements of the Sustainability Plan are displayed in Figure 2. WWW.CTSJOURNAL.COM
Uzarski et al. A Plan for Academic Biobank Solvency ■
Figure 1. Principal tenets of brain bank business strategy.
Figure 3. A system approach to biobanking sustainability.
Figure 2. Fiscal and operational sustainability plan components.
The Cost Recovery Model
The team conducted a careful analysis of operational costs associated with the Brain Bank, including both personnel and nonpersonnel expenses. The personnel expense consisted of fixed and variable costs related to all aspects of biobanking, including patient consent, IRB management, biospecimen collection, preparation and storage, and management of data (including neurocognitive assessments and administrative time). Nonpersonnel expenses included fixed and variable costs such as equipment, maintenance, and supplies. After costs were identified, the team developed revenue projections for 5 years, considering all potential sources including academic and industry research agreements, grants, donor gifts, and departmental funding. These conservative estimates were calculated based on historical biospecimen allocation information for a 5-year period, broken down by biospecimen sample type, number of orders, and size of orders for each consecutive year. An initial biospecimen rate structure was developed as a fee-for-service model based on total fixed and variable personnel and nonpersonnel costs, and tiered by customer base. A careful market analysis revealed that these rates fell above market competitors. A revised tiered pricing structure based on researcher and pharmaceutical company dynamics was proposed to the Department of Neurology. This final rate structure covers fixed costs and a reasonable amount of variable costs, and will move the Brain Bank to the breakeven point when sample transaction volume increases. The final rates were marginally less (approximately 25% lower) than the rate based on actual costs. We believed it was important to keep competitive rates to allow for more sample transactions. WWW.CTSJOURNAL.COM
Leveraging Existing Resources
The core project team recognized early on that like many academic medical center departments, our limited resources and financial constraints would threaten the success of the project. A systems approach—developing and building connections with diverse groups at Duke, each contributing with expertise and local knowledge—was needed for the project to succeed. Our initial questions included: Given resource constraints, how can the funding problem be addressed? Is it realistic to leverage university-wide resources, including Department of Neurology, faculty, finance and business strategy staff, and students to be successful? Should the Brain Bank become an established core resource within the School of Medicine? An extended project team aided in implementing the Sustainability Plan, which was then used to communicate the value of the Brain Bank to internal stakeholders and leverage resources. Existing personnel at various Duke organizations, and an MBA student from a local university were recruited to join the effort. Figure 3 illustrates this systems approach. Project Management
We used a project management approach to provide the necessary framework to develop, implement, and evaluate this sustainability effort. The approach was especially helpful given the myriad of stakeholder organizations and departments within Duke. Most team members were not directly affiliated with the Brain Bank, making it essential that the project leader work across departments to communicate goals and progress, identify obstacles, and recommend changes as the project evolved. It was especially valuable that the Project Manager possessed a wealth of knowledge in the biobanking realm. This seasoned experience, combined with institutional knowledge, lent a greater ability of the project leader to gather these resources and garner support. VOLUME 8 • ISSUE 5
555
Uzarski et al. A Plan for Academic Biobank Solvency ■
private industry, government, and external researchers. When setting cost-recovery parameters, Duke had to work not only within distinct business income and nonprofit tax status limitations, but also restrictions on the use of bond or grantfinanced facilities. Results
Figure 4. Tactics for short- and long-term sustainability.
Tactics for Short- and Long-Term Sustainability
The Sustainability Plan outlined and organized specific strategies into two phases: First financially stabilizing the bank (Phase I), then focused development of fiscal, business and operations functions of the Brain Bank (Phase II). Timelines were developed and strategies assigned to resources on the team. Figure 4 lists specific tactics for consideration to stabilize and improve longterm financial solvency of an academic biobank. Legal and Contractual Concerns
The development of a biobanking cost-recovery model represents a paradigm shift at Duke. One major issue was how faculty members should structure Sponsored Research Agreements with pharmaceutical companies, and Material Transfer Agreements (MTAs) with other nonprofit entities, and avoid the notion of selling biospecimens. The Brain Bank was developing a cost recovery model rather than a potential profit source. Close collaboration with the School of Medicine, Duke Office of Counsel, and the Duke Office of Research Collaborations early in the project was imperative to developing the proper infrastructure and guidelines. The approach ensured the bank would operate within the appropriate legal, nonprofit and tax limitations for Duke as an educational, research and healthcare institution. This was especially relevant given the plan to collaborate with 556
VOLUME 8 • ISSUE 5
After the sustainability strateg y was developed and vetted through knowledgeable internal resources, it was used to garner internal support. Stop-gap funding for a 1-year period, along with in-kind operations funding was secured through the Department of Neurology and School of Medicine to support scaled-down operations. The Bryan ADRC made the hard decision to cease enrolling new individuals to the Autopsy Program, while continuing to support the retrieval of brains from previously consented deceased patients, as well as the processing, storing, and allocation of biospecimens. Several operational enhancements were made, including the installation of a secondary temperature monitoring system to strengthen sample security through the support of the Duke Biobank. Biobanking informatics will be enhanced in 2015 when the enterprise-wide Core Research at Duke program goes live. The Brain Bank applied to the School of Medicine for and received designation as a core research facility, providing a critical path of ready access to Duke researchers. It also enabled a funded voucher program for researchers using Brain Bank biospecimens. School of Medicine administration approved the cost recovery model and biospecimen rate structure. The tiered rates were implemented for internal and external research collaborations, and the Brain Bank recently issued its first invoice for a research project involving brain tissue for $11,000. Other projects are in the queue with promise for additional revenue. A relationship with a biomarker research broker has resulted in several inquiries for potential research collaborations involving brain tissue. New processes were implemented to support the Core Resource designation, including an online tissue request form, invoicing, and a revised MTA. The School of Medicine Communications Department is launching a plan to inform internal and external researchers, patients, and the local community about the Brain Bank’s unique features, interest in collaborative research opportunities, and achievements in Alzheimer’s research. This homegrown advertising is recommended to market the availability of biospecimens to researchers and industry.13 The team is also targeting institutional events and external conferences to increase the demand for samples. Duke Medicine’s Enterprise-Wide Speed Review (EWSR) group, is providing support and coordination to the Brain Bank as it ramps up industry collaborations. Composed of faculty, researchers and research administrators, this group was formed as a vehicle for faculty wishing to engage in industry partnerships in order to optimize potential collaborations. WWW.CTSJOURNAL.COM
Uzarski et al. A Plan for Academic Biobank Solvency ■
Discussion
Academic researchers and staff invest significant effort and resources to develop patient trust and build biorepository collections. Intact biospecimens and data are university assets with great potential for advancing groundbreaking research. Over the past several years, the biobanking community has begun to develop increased awareness of the need for both financial and operational sustainability. Many biobanks—such as the Sun Health Research Institute in Arizona and the Washington University School of Medicine—have successfully implemented fee-for-service, cost-recovery models to ensure biobank viability. However, additional publications evaluating a variety of business development and financial models are needed. Securing institutional buy-in as early as possible cannot be overemphasized. Without this support, a lone researcher or biobank faces daunting challenges. Keeping the resource team engaged and informed during a long process will prove invaluable, but indeed challenging. Sustainability efforts may take several years, and it is difficult to continue infusing energy and make progress over an extended period of time without dedicated project management. A market-driven and customer-focused approach is a culture shift in an academic organization. Thus, it is important that staff embrace a need for biobanking excellence, responsiveness, and quality in all aspects of the business, including operations best practices and informatics. This may prove challenging for researchers and staff focused on day-to-day biobank operations. Legal and contractual nuances and university policies are often complex, especially when implementing fee-for-service. Therefore, it is necessary to engage these groups early to understand the goal of cost recovery, and to work through policy nuances and perceptions that the biobank will “sell” biospecimens as a profit source. Conclusion
The Brain Bank’s Sustainability Plan was first used to garner institutional support, and then as a blueprint for short-term and long-term operational and fiscal changes. The cogent plan established credibility by defining the research need and delineating the Brain Bank’s value as a university research asset. Using the milestone-driven, project management approach ensured that progress would be monitored closely and communicated to key stakeholders. The seasoned clinician project leader with extensive biobanking knowledge used her industry and institutional credibility to achieve deliverables quickly. Future standardization and collaboration among biobanks will allow researchers to access samples from a network of biorepository collections.12 The Bryan ADRC Brain Bank supports
WWW.CTSJOURNAL.COM
the development of such research networks. In the meantime, the implementation of a cost recovery model coupled with stop-gap funding resulted in a short-term “win” for the Bryan ADRC. Its long-term success will be measured by the metrics implemented and the critical role of brain bank specimens in AD research. Acknowledgments
The authors wish to express thanks to Suresh Balu, Strategy & Innovation, Duke Translational Medicine Institute for his mentorship and guidance. His emphasis on a “market-focused approach” to biospecimen assets was a critical aspect of this project. Thanks also to Victoria Christian for embracing a project management and systems approach in translational research, and for providing generous support of this lengthy project. Finally, many thanks to Meggan Monroe for her encouragement, mentorship and unique insight, along with meticulous editing of this publication. Source of Financial Support
This work was enabled through funding from Duke’s Clinical and Translational Science Award UL1TR001117. References 1. Park A. 10 ideas changing the world right now: Biobanks. Time Magazine. 2009. 2. Beach T. Alzheimer’s disease and the valley of death: Not enough guidance from human brain tissue? J Alzheimers Dis. 2013; 33(S1): S219–233. 3. Skloot R. The immortal life of henrietta lacks. New York: Crown Publishers, 2010, pp, 93–97. 4. Henderson G, Cadigan RJ, Edwards T, Conlon I, Nelson A, Evans, J, Davis A, Zimmer C, Weiner B. Characterizing biobank organizations in the U.S.: results from a national survey. Genome Med. 2013; 5(1): 3. 5. McDonald S, Sommerkamp K, Egan-Palmer M, Kharasch K, Holtschlag V. Fee-for-service as a business model of growing importance: the academic biobank experience. Biopreserv Biobank. 2012; 10(5): 421–424. 6. The Research Universities Futures Consortium. The Current Health and Future Well-Being of the American Research University. 2012: 13–15. Available at http://www.researchuniversitiesfutures. org/RIM_Report_Research%20Future’s%20Consortium%20.pdf. Accessed Oct 17, 2014. 7. Hewitt R, Hainaut P. Biobanking in a fast moving world: an international perspective. J Natl Canc Inst Monogr. 2011; 42: 50–51. 8. Vaught J, Rogers J, Carolin T, Compton C. Biobankonomics: developing a sustainable business model approach for the formation of a human tissue bank. J Natl Cancer Inst Monogr. 2011; 2011(42): 24–31. 9. Watson PH, Nussbeck SY, Carter C, O’Donoghue S, Cheah S, Matzke LA, Barnes RO, Bartlett J, Carpenter J, Grizzle WE, et al. A framework for biobank sustainability. Biopreserv Biobank. 2014; 12(1): 60–68. 10. Alzheimer’s Association. 2012 Alzheimer’s disease facts and figures. Alzh Dement. 2012; 8(2): 14–15. 11. Cowen and Company (2012), Alzheimer’s Disease Report. 12. Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer’s disease in late onset families. Science. 1993; 261(5123): 921–923. 13. Schudellari M. Biobank managers bemoan underuse of collected samples. Nat Med. 2013; 19(3): 253.
VOLUME 8 • ISSUE 5
557
