2. INSIDEVIEW:QUINTILES
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Quintiles is widely known as a leading clinical research organization, having been performing
clinical trials for pharma and academic sponsors since it was founded in 1982. Recognizing the
importance of precision medicine to the future of drug development, Quintiles staked out an early
lead in the space through its acquisition of Expression Analysis (EA) in 2013. Nature talked with
Kellie Yarnell, EA’s VP of Genomic Operations, about the importance of integrating genomics with
clinical development. With an academic background in biochemistry and a career focused on
genomics and business development, she recently took over as global head of EA.
Q: How is genomics transforming
clinical development?
The ultimate goal of precision medicine is to
identify the appropriate target, the optimal dose
and exposure, and the right patient to get the
best outcome. Genomics has already helped
us head in that direction via the development
of genetic diagnostics, as well as providing
researchers the tools to better understand the
underlying genetic contributors to disease.
These developments have had a tremendous
impact on patient health and well-being, and
we believe that fully utilizing genomics during
clinical development can bring us even closer to
realizing the promise of precision medicine.
Including genomics in early trials can help
identify patients who may have a higher
probability of responding to a particular
therapeutic. These results can help stratify
populations in later phase trials, which has the
potential to reduce drug development costs
and timelines. Additionally, genomics can
reduce safety risks to the patient by minimizing
the enrollment of patients who are likely to
have serious adverse events, or are unlikely to
respond. Finally, genomics can improve efficacy
in later clinical trials by improving dosing
regimens. Overall, we are looking to integrate
precision medicine in all clinical trials to bring
lifesaving or life-enhancing drugs to patients
faster, while also improving patient safety and
therapeutic efficacy.
Q: How does the marriage of EA and
Quintiles help clinical trial sponsors
achieve their precision medicine goals?
Quintiles recognized the role that genomics
will play in personalized medicine and clinical
trials, and that is why they came to us to bridge
their clinical trial expertise with our genomics
expertise. In addition to our genomics expertise
and vast array of assays, we also have a strong
bioinformatics team to help with upfront
project design and downstream data analysis.
This team will ensure that the genomic results
from a trial will be statistically significant with a
higher likelihood of leading to biological insights.
So Quintiles can enroll the patients, and EA can
follow with genomic testing and bioinformatics
analysis to identify any potential genomic
biomarkers of efficacy, safety, responders
versus non-responders, and so on. We can help
translate those biomarkers into targeted assays,
and then clinically validate the assays to CLIA
standards and ultimately into FDA-approved
companion diagnostics. We have supported
clients with this strategy for years, and currently
have a number of sponsors working through just
that process.
Q: Wow, how does the FDA feel about
that trial?
The FDA is completely on-board with this
approach. The agency is actively looking at
how next-generation sequencing is going to be
regulated in terms of clinical trials and patient
treatment in a way that will benefit patients
without stifling innovation. They actually just
had a public workshop about this very topic in
February to get input from interested parties.
We are thrilled to be at the forefront of this
discussion and lead the way in putting these
solutions into practice to advance precision
medicine.
Q: How do you respond to skeptics who do
not believe that a CRO truly understands
precision medicine?
One of the things that has allowed us to
differentiate ourselves from other CROs is our
record in genomics work. In fact, most sponsors
are not skeptical because they are aware of
our record, particularly in shaping genomics
policy. Senior members of the EA team have
been involved in a number of standardization
initiatives, such as the MicroArray Quality
Control (MAQC) project, which was a joint
effort of the FDA and industry to confirm that
microarray-based data are replicable and robust
enough to be used in clinical settings. We have
leading or secondary authors on the research
papers that have resulted from the MAQC
project. EA team members also are heavily
involved in the second phase of this project,
the Sequencing Quality Control Consortium
(SEQC).
Q: Do you have any success stories
to share about your efforts in
personalized medicine?
One of our proudest efforts is a pre-profiling
study called “Feasibility Study of Biomarker
Analysis for Patients with Metastatic Colorectal
Cancer.” The goal is to identify mCRC patients
who have genetic mutations that could be
susceptible to certain FDA-approved therapies,
as well as those targeted by therapies in
development. The question is, “How do you
identify that small subset of patients in whom a
drug will be effective and eliminate the majority
of patients in whom it won’t work?”
The traditional method is to have giant trial
that includes all of those patients. In this trial,
we use a panel of 46 oncogenes known to have
impact in different tumors to assess patients
that walk into an oncology clinic. If they show a
genetic mutation that indicates a higher success
rate with a specific drug, we initiate a clinical site
right then and there to give the patient access to
the most suitable therapy.
Q: How else are you promoting the idea
of precision medicine?
We also work with other leading genomics
technology companies to provide grants to
further cancer research. Last year, we teamed
up with Illumina on an Oncology Research
Grant, in which we help researchers investigate
genomic data locked within Formalin-Fixed,
Paraffin Embedded (FFPE) tumor samples.
We just announced the two winners of our
sixth program in January: One that will profile
metastatic colon cancers that metastasize to the
lung for CpG methylation and transcriptomic
alterations, and one that will investigate
genome-scale DNA methylation and RNA
expression changes in epithelial ovarian cancer.
Kellie Yarnell, VP of Genomic Operations, Expression Analysis, a Quintiles Company
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