Foreword
This report represents the collaborative efforts of scientists, clinicians, industry representatives,
and patient advocates who participated in the design of a National Biospecimen Network (NBN)
Blueprint with the ultimate purpose of accelerating scientific discovery in the battle against
cancer. The development of the NBN Blueprint was spearheaded by members of the National
Dialogue on Cancer (NDC), which, in addition to researchers, includes representation from the
National Cancer Institute (NCI), patient advocacy groups, and the pharmaceutical and medical
diagnostics industries. NDC is a nonprofit organization that brings together the principal leaders
of key organizations, institutions, and other constituencies from the public, private, and not-forprofit
sectors as coequal partners united to eliminate cancer as a major public health problem.
The NDC provides a unique platform for defining a common vision to combat cancer.
This document was written by Constella Health Sciences staff under contract to the NDC and
NCI, with substantial input provided by the NBN Design Team members, a group of experts
representing the NDC Tissue Access Working Group (TAWG). The Design Team was supported
by numerous ad hoc consultants, including representatives from the United Kingdom National
Cancer Tissue Resource, who have recently inaugurated a similar effort and whose strategic plan
provided insights that helped to accelerate the development process for the NBN Blueprint. The
deliberations were enhanced by site visits to biospecimen resource operations considered to
represent state-of-the-art facilities with optimal data access processes. The sponsoring agencies
and Constella Health Sciences staff gratefully acknowledge the contributions of these outside
experts who have volunteered countless hours reviewing earlier drafts and participating in
numerous consultative meetings that have been essential for the development of this Blueprint.
To further inform the Blueprint development process, a concurrent analysis of existing human
tissue resources was conducted by the RAND Corporation to identify a set of "best practices" for
the collection, processing, storage, annotation, and distribution of biospecimens in the
postgenomic era. Through site visits and interviews, the RAND team examined selected
repositories from government institutions, academic medical centers, and the private sector to
identify innovative strategies in terms of repository design, bioinformatics infrastructure, and
policies on informed consent and intellectual property and to determine aspects compatible with
the proposed NDC TAWG model. The results of these findings will be available in a separate
report that features options and recommendations relevant to the establishment of the NBN.
The NBN Blueprint also has been informed by the results of a voluntary NDC- and NCIsponsored
questionnaire administered at the July 2003 American Association for Cancer
Research international conference. Results from this questionnaire provide one snapshot of the
composite "portrait" of potential NBN customers. Meeting participants responded to a series of
questions about their affiliations, their specific specimen and data requirements, and the value of
well-characterized biospecimens such as those proposed by the NBN.
Based on these multiple information-gathering efforts, it appears that the time has come for a
centralized and accessible national repository of biospecimens focused specifically on supporting
genetic and proteomic research. If it is to be, such a resource will be realized only through the
concerted effort of individuals across the spectrum of cancer research, drug and diagnostic
development, and patient advocacy. This Blueprint is intended as the first step in an exciting and
bold endeavor to develop a large-scale national system of biospecimen and associated data
collection and dissemination. The system will support the application of genomic and proteomic
technologies for cancer research, to ultimately affect the way cancer and other diseases are
treated, thereby improving the quality of life for countless numbers of people.
This Blueprint presents a strategy intended to serve multiple constituents in the cancer research
enterprise, and it is being disseminated for broader public comment. It features six modules that
focus on various aspects of the NBN. The first two modules, "Why the National Biospecimen
Network?" and "Management of Ethical and Legal Issues," articulate the rationale, requirements,
and ethical framework for developing a national biospecimen network. The following three
modules, "Biospecimen and Data Collection and Distribution," "Bioinformatics and Data
Management," and "Communications," describe key operational aspects needed for system
implementation. Finally, the "Governance and Business Models" module outlines a
recommended management structure for the NBN to promote the participation of a broad range
of institutions and existing biospecimen resources. The Blueprint also includes a section entitled,
"National Biospecimen Network and Public Health," which describes the potential value of
linking a national biospecimen resource to epidemiological investigations. It concludes with a
proposal for moving forward, in the form of a "Demonstration Project."
This report and additional related information are available at the NDC Web site
(www.ndoc.org). The reader also is referred to the NCI Web site (www.nci.nih.gov).
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