Appendix SPrivate/Public Funding Example:
International Genomics Consortium Expression Project for Oncology (expO)
The International Genomics Consortium (IGC) is a private, nonprofit 501(c)3 medical research
organization, operating to ensure full public benefit of the Human Genome Project. IGC’s
expression projects on human diseases will utilize a consortium model of enhanced and
accelerated tissue collection under standardized conditions to produce detailed data on the
molecular characterization of disease. The data will be available as a public, standardized,
regulatory-compliant, readily accessible, and searchable series of genomic databases for use by
the worldwide scientific community. The information emanating from this unique resource,
which joins together the public and private sectors, will stimulate research on the underlying
molecular mechanisms of diseases; the likely outcomes are the accelerated development of
diagnostic tests, improved treatments, novel therapies, and disease prevention.
Infrastructure and executive management positions in IGC are funded through multiyear,
committed support from entities in Arizona. Funding of the expression projects is derived
through donations from members, which include pharmaceutical and biotech companies,
technology and informatics companies, foundations, governments, academic and research
institutions (providing in-kind support), and private donors.
Governance
IGC is governed by a board of directors, which oversees an executive management team
comprised of a Chief Executive Officer, Chief Medical Officer, Chief Financial Officer, and
Chief Information Officer. A scientific advisory committee speaks to the vision, operations, and
opportunity represented by IGC. Each of the different expression projects for human diseases is
advised by an executive steering committee (ESC), which is comprised of members representing
the funding sources for the project. The ESC develops milestones for performance of IGC’s
projects, formulates metrics of deliverables, and offers advice regarding the execution of the
projects. Subcommittees of the ESC present recommendations on technology platforms,
information technology, clinical data, patient advisory affiliations, legal considerations, and
public relations.
Common Ground for Success of IGC
The research direction of the IGC was developed through a series of open meetings held in
multiple venues, which provided input from physicians, scientists, patient advocates, and leaders
in the fields of pharmaceuticals, biotechnology, business and government to define the benefit
from a national effort. The key leadership of IGC includes recognized leaders in cancer
treatment, genomics, and medical research.
expO
The goal of IGC’s Expression Project for Oncology (expO) is to standardize patient consenting,
tissue collection, genomic analysis, and data reporting in a “precompetitive” and regulatorycompliant
fashion. This international effort will obtain a significant number of both normal and
cancerous tissue samples. Gene expression analysis will be performed on these samples at a
central facility. Specific patient information associated with these tissues will be deidentified,
and the data will be released into the public domain.
IGC has the opportunity to work with 19 medical centers throughout the United States; sites
from the United Kingdom will also be included in the study, making expO an effort with
international support. These medical centers have agreed to provide samples for analysis and to
collect patient outcomes under the direction of a designated Principal Investigator. IGC intends
to utilize multiple host medical centers as hubs in the collection of annotated tissue samples. ICG
also intends to follow these patients and provide outcome information. expO uses a consortium
model to bring together public and private sector involvement in the acquisition and analysis of
human clinical tissue samples.
expO as a Public Utility
IGC will release all expO gene expression information into the public domain. The “consortium”
strategy has been critical to the rapid pace and success of the Human Genome Project.
Availability of expO data to cancer researchers worldwide will foster discussion and comparison
of existing computational and experimental approaches. The expO data will encourage
development of new bioinformatics approaches, leading to commensurately large datasets and
significant breakthroughs in the area of cancer genetics, epidemiology, and therapeutics.
expO Objectives
Database: The goal of expO is to collaboratively obtain and directly perform gene expression
analyses on a highly annotated set of normal tissue and tumor samples, with the release of all
data into the public domain. Information from the gene expression analysis, along with the
clinical information obtained at the point of acquisition of the tumor, will populate the expO
database, with regularly scheduled releases of the data. The data will be presented in a
standardized, computationally traceable fashion, allowing integration with data from other allied
scientific or clinical databases. The implementation of these informatics standards not only will
maximize the utility of the data in the database but also will allow researchers to compare data
independently generated, using the same methodologies and represented in the same
standardized format.
Repository of residual tumor tissue, tissue adjacent to tumor, normal tissue, and blood samples
from expO patients for follow-on studies: IGC plans to obtain patient consent to collect clinical
annotations, gather annual follow-up data, attain tissue and blood to support gene expression
profiling, and enable follow-on studies that will be managed through a tissue redistribution
process. Such follow-on studies could include haplotyping, single nucleotide polymorphism
(SNP) analysis, comparative genetic hybridization, DNA methylation, proteomics, kinomics, etc.
Intellectual Property (IP): IGC believes that the high-quality, standardized gene expression
profile data, combined with standardized, clinical annotation resulting from the expO, will best
help accelerate oncology research and clinical efforts if the data are deposited in public databases
and made available for the widest possible use by industry and academic researchers and
clinicians. The goal of the IGC will be to make all expO data publicly available and to impose no
IP restrictions.
Of particular value to industry is the fact that all participating academic members have agreed to
comply with the adopted IP strategy required by the IGC. Although the final decisions regarding
the need to patent any information emanating from this project will be made by the expO ESC,
the model used for the data generated by the SNP Consortium will be considered as a solution.
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