619Institute of Medicine’s Role in Personalized Medicine
The Institute of Medicine (IOM) is an independent, nonprofi t organization that
works outside of US government to provide unbiased and authoritative advice to
decision makers and the public ( http://www.iom.edu ). In 2010, the IOM started a
new committee, Review of Omics-Based Tests for Predicting Patient Outcomes in
Clinical Trials, that will look at predictive ‘omics-based tests and eventually issue a
report and recommendations on how to determine when these tests are fi t for use as
a basis for designing clinical trials, for stratifying patients, and measuring patient
response in clinical trials – activities relevant to the development of personalized
medicine. It expects to release its fi rst report in Spring of 2012. Although the specifi c
details of the committee’s tasks remain uncertain, its charge is to review the pub-
lished literature to identify what criteria will be appropriate for evaluating tests
based on ‘omics tools, including genomics, epigenomics, proteomics, and metabo-
lomics tests. After conducting this review, the committee will recommend an evalu-
ation process for when these tests are fi t for use in designing and stratifying trials and
measuring patient response. The group also will identify which criteria are important
for the analytical validation, qualifi cation, and utilization components of the test
evaluation process. After developing those evaluation criteria, the committee then
will apply them to three cancer clinical trials conducted by researchers at Duke
University. For example, one of these Duke studies involved partnering with Eli
Lilly and used Affymetrix gene-expression data with corresponding drug- response
data to provide personalized chemotherapy regimens for two types of lung cancer.
Although how the committee will apply these criteria has not yet been deter-
mined, several approaches may be used. The committee may assess the analytical
methods used to generate and validate the predictive models, examine how the
source data were used to develop the test and how the predictive models were gen-
erated, or evaluate the use of predictive models in clinical trials.
Jackson Laboratory for Genomic Medicine
In 2011, The Jackson Laboratory (Jax, Bar Harbor, Maine) announced plans to build a
genomic medicine research center in Connecticut and is working with the state’s gov-
ernor and the University of Connecticut (UConn) to ask the legislature to help fund the
building and its operations. Jax Genomic Medicine would be located on the UConn
Health Center’s campus in Farmington, and would employ 300 people over the fi rst 10
years and a total of 600 within 20 years. Jax Genomic Medicine would combine Jax’s
genetics and genomics expertise with the clinical and biological capabilities of
Connecticut’s institutions, including UConn and Yale University. Specialty areas for
the new lab could include cancer, aging, genetic disorders, metabolic diseases, and
others. Space would be dedicated to the translation of new applications such as diag-
nostics and computational services into commercial products. Jax wants to help the
UConn center to expand its faculty and to advise the state’s economic development
agencies to identify the best industrial and biotech partners in personalized medicine.
Role of Academic Institutions in the US