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Since its founding in 1982, Quintiles has become a leading clinical research organization, from
first-in-human studies to post-launch monitoring. In 2013, Quintiles acquired Expression Analysis
(EA) to expand its genomic testing analysis services throughout the entire process of drug
discovery and development. Dr. Patrick Hurban, a trained molecular biologist and geneticist and
EA’s Global Head of Genomic R&D, tells Nature how the marriage between EA and Quintiles
benefits researchers.
Q: How does Expression Analysis help
advance drug development?
EA was spun out of the Duke University Medical
Center’s Microarray Core Facility in 2001, primarily
performing high-quality, high-throughput RNA
expression services on microarray chips. Since
then, we have expanded so that almost anything
you can think of that would help scientists
understand the impact of genomics on patients
and disease is something that we might support.
Without giving a laundry list of technologies,
our primary focus is on nucleic acid extraction
technologies, array-based technology for both
genotyping and expression, and sequencing assays
we can use for somatic mutation detection—
essentially genotyping by sequencing. And of
course our heritage in gene expression analysis
positions us to thoroughly understand and exploit
RNA expression analysis by sequencing.
For each of those different technologies, we
have the ability to do very broad-based assays,
such as whole exome sequencing to identify
particular biomarkers of potential interest,
down to very targeted assays, such as profiling
for a single gene or a set of genes and mutations.
Importantly, our bioinformatics team is just stellar,
and their reach spans all of our technologies.
Q: What interested Quintiles in EA’s
early-stage genomics services?
Many of the researchers and companies we
worked with were the same folks that Quintiles
was working with, but we were talking to
different parts of the businesses: discovery on
our part, and clinical development on their
part. By combining forces, we can now provide
comprehensive genomic technologies across the
entire continuum of drug development. We can
begin with biomarker discovery programs early
in clinical development and then progressively
develop those candidate biomarkers as market-
ready companion diagnostics; this ability is very
powerful for advancing clinical research quickly
and efficiently.
For example, let’s say we perform retrospective
whole exome sequencing on some clinical
samples and determine an association between
clinical outcomes and specific genes, specific
mutations within those genes, or domains
within the encoded proteins. We can then make
a customized, targeted assay. Depending on
the level of resolution that we would need for
further development, we can work with one of
our diagnostic development company partners
on a companion diagnostic strategy so that
we can couple the therapeutic candidate to a
specific diagnostic platform.
Q: How do you help clients choose which
technologies and services are best for
their program?
First and foremost, we help clients determine
how much of a discovery element should be
included in their program. We might recommend
targeted assays that specifically focus on genes
that are involved in a particular disease. The
advantage of this type of strategy is that looking
at fewer analytes provides greater precision
and accuracy. If they suspect that those genes
are not telling the whole story then we can do
something else, such as whole exome sequencing
or our Quintiles comprehensive cancer panel.
This approach gives us the ability to look at those
specific genes and gene rearrangements that we
highly suspect are involved, as well as the ability
to discover more.
Q: Can you tell us more about the Quintiles
comprehensive cancer panel?
This is a targeted sequencing assay of around
200 genes that have shown high frequency of
genomic variation in cancer and play important
roles in cell signaling pathways that impact
drug response and resistance for both existing
and emerging drug classes. In fact, the panel
covers about 98% of the most common gene
mutations currently reported in cancer, and can
detect point mutations, insertions, deletions,
structural rearrangements and changes in copy
number. This panel had its genesis in Quintiles’
Translational R&D – Oncology group, which is
led by Sarah Bacus, PhD, and combines their
deep oncology expertise with our genomics
expertise. Dr. Bacus’ team has even used the
panel to identify novel, druggable genomic
variations in a rare form of breast cancer, the
results of which will be presented in a plenary
session at the upcoming EORTC-AACR-NCI
Molecular Targets and Cancer Therapeutics
symposium in November.
Q: Other than cancer, what disease areas do
you think will be impacted by genomics in
clinical development?
The two that come to mind are infectious
diseases and autoimmune diseases. With
infectious diseases, we need to consider the
genomes of both the host and the pathogen.
We already know that many pathogens become
more virulent or more drug-resistant via genomic
changes, so following these changes during
disease progression and in response to therapy
will become more common. There’s also an
increasing awareness that an individual is actually
a collection of genomes—the human genome
plus the genomes of the particular milieu of
microorganisms that live in the gut and elsewhere.
These microbiomes are dynamic, and we are only
beginning to understand the impact that changes
in the gut microbiome have on disease.
Likewise, genomic developments in
autoimmunity are very early-stage and exciting.
The link between autoimmune disease and the
HLA locus is well established, but the HLA locus
is incredibly complex. As genomic technologies
become better at penetrating this complexity, it’s
very likely that our understanding of autoimmune
diseases will increase.
Patrick Hurban, PhD, Global Head of Genomic Research and Development, EA, Quintiles
INSIDEVIEW:QUINTILES
By combining forces,
we can now provide
comprehensive genomic
technologies across the
entire continuum of drug
development.
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