Biopreservation and Biobanking - Ziath - 11

COMPREHENSIVE SAMPLE MANAGEMENT
11
Future state-Management evaluation phase
Any future state model must take into consideration
the company's culture. Do we employ internal capital for
sample management? Do we outsource all sample management
functions completely? Or, do we employ a hybrid
model that combines established assets with onsite expertise
from outsourced providers? These are all questions that
must be considered upfront. Another major factor in the
model equation is the cost of building and maintaining a
world-class biorepository. When incorporating the cost of
compliant facilities, informatics systems, and a global logistics
infrastructure along with staff to manage sample
inventories, an onsite biorepository facility can easily require
an investment of $9 million or more over a 10-year
period.6 This internal cost does not include the external cost
of sample inventory loss or data management costs when
managing samples not stored in onsite facilities.
Outsourced sample management models allow companies
to eliminate capital and overhead expenses associated with
sample management. The ability to integrate biospecimen data
is essential to successful clinical operations.2 An outsourced
model provides sample management experts who focus on
ensuring the viability of sample assets and consolidation of
sample data within a single, centralized database that is
accessible to the research customer. It is important to find an
outsourcing partner with advanced technology solutions that
can unify sample data from multiple research laboratories,
CROs (Contract Resource Organizations), or biorepository
facilities located in various areas around the world. The improved
sample lifecycle management expertise and technology
brought to a research organization by an outsourced
sample management service provider enables a research organization
to focus on their research core competencies and to
speed future research advancements to the market.
Some companies have existing resources and infrastructure
to leverage to support internal sample management, but lack
the technology and sample lifecycle process expertise to
manage their sample assets more efficiently. Complete insourcing
(onsite) or hybrid models that combine insourcing
and outsourcing approaches to sample management exist in
which sample inventories are either fully or partially stored
onsite. The onsite samples are managed by an outsourced
provider who may supply expert staff, standard operating
procedures, and data management technology. An insourcing
or hybrid model allows a company to leverage existing capital
resources, refocus staff resources on the science, and places the
management of critical scientific sample assets with a service
provider who has expertise in samplemanagement.7 This trend
is especially advantageous for bioscience companies that require
the flexibility to accommodate changes in the storage
volume of their research sample inventories, but do not have
the scalable operations and infrastructure to support the expansion
or retraction of these inventories.
Conclusion
If a researcher knew today what was to be discovered in a
sample tomorrow, one would not need a sample management
strategy to preserve these materials and their associated
data. Unfortunately, however, the prospective scientific
value of a particular sample will only be realized postanalysis.
In the post-genomic era, new advances in medical
science are highly dependent on high-quality, properly
preserved patient samples. Therefore, preserving the integrity
of scientific sample assets has become increasingly
important in nearly every medical research discipline, as
these valuable materials can be exploited to support biomarker
discovery, personalized medicine, and development
of other genomic-based treatments. Additionally, the need
for properly preserved samples will continue to grow due
to the need for retrospective analysis of samples in a study.
However, to realize the full potential of collected samples,
a comprehensive strategy for sample management is required
that includes the assessment of internal and external
resources, development of consolidated information technology
solutions for leveraging sample assets, and the
utilization of improved sample lifecycle management
processes. Formalized sample preparation processes,
compliant sample collection, reliable transportation and
chain of custody, Good Storage Practices, and robust IT
and data management solutions are all important considerations
when establishing a comprehensive sample asset
management plan.
Disclosure Statement
No competing financial interests exist.
References
1. Ginsburg G, Burke T, Febbo P. Centralized biorepositories
for genetic and genomic research. JAMA 2008;299:1359-
1361.
2. Rogers J, Carolin T, Vaught J, Compton C. Biobankonomics:
A taxonomy for evaluating the economic benefits
of standardized centralized human biobanking for translational
research. J Natl Cancer Inst Monographs 2011 2011:
16-23.
3. National Cancer Institute. 2011 Best Practices for Biospecimen
Resources. [http://biospecimens.cancer.gov/practices/2011
bp.asp]. Retrieved on February 27, 2012.
4. Michael C. Biorepositories for long-term preservation and
future analysis. J Clin Res Best Pract 7;1:2011.
5. College of American Pathologist. Specialty Accreditation
Programs. [www.cap.org]. Retrieved on February 27, 2012.
6. Mills J. The need for good storage practice. Biopres Biobank
7;2:2009.
7. Sweeney S. Strategies for improving the onsite management
of scientific sample assets. Pharmaceut Outsourcing
September 2011.
http://biospecimens.cancer.gov/practices/2011bp.asp http://biospecimens.cancer.gov/practices/2011bp.asp http://www.cap.org
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