Rise of Genomics in Clinical Trials - 6

Rise of Genomics in Clinical Trials * Leveraging Genomics to De-Risk Clinical Trials and to Enhance Outcomes

Pharmaceutical companies and their research
partners are looking for new ways to incorporate
human genome and microbiome-based insights
into their clinical trial designs, but are met with
challenges related to the cost and time to deploy
and operate in GxP-compliant systems.

participant selection, optimize intervention,
discover companion diagnostics, drug targets,
and pathways/genes to exploit. The result is
broader incorporation of genomic information
into research, clinical development, clinical
diagnostics, and manufacturing.

Optimize and De-Risk Clinical Trials

Promoting a drug from the laboratory and
preclinical testing arena into first-in-human
Sequencing human and microbiome genomes,
studies and clinical trials represents the largest,
in combination with other omics and imaging
most costly gamble in the drug discovery pipeinformation, is increasingly relevant in therapeutic
line. DNAnexus de-risks this process by enabling
areas such as oncology, cardiovascular, immune/
companies to transition validated NGS pipelines
inflammatory, and rare diseases. In order to
from translational research environments into
optimize and de-risk clinical trials, investigators,
regulated clinical development and, for approved
with their collaborators and sponsors, must mine
drugs, into clinical and companion diagnostics
vast volumes of data for biomarker-driven
development, all in compliance
with HIPAA, CAP/CLIA, and GxP
regulations. In addition, this
Promoting a drug from the laboratory and
framework has been designed
preclinical testing arena into first-in-human
to complement CTMS vendors
studies and clinical trials represents the
of choice.

largest, most costly gamble in the drug
discovery pipeline.
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| ClinicalOMICs.com

The DNAnexus Clinical Trial Solution (CTS) provides investigators,
collaborators, and sponsors with

a secure and compliant cloud-based Platformas-a-Service (PaaS), with complete control over
genomic data, analysis, and reporting pipelines
to ensure consistent results across Contract
Research Organizations (CROs) and other research
partners. DNAnexus also provides scientific applications and services for translational informatics,
secondary analysis and interpretation, application qualification, and LIMS and EDC integration.

How Pharma Leverage CTS
The DNAnexus CTS facilitates association of
participants' genomic profiles with their clinical
results. Insights are used to support adaptive trial
design and refine participant selection criteria for
subsequent phases, increasing the likelihood of a
successful efficacy and safety outcome. DNAnexus
hosts the CTS and provides scientific expertise in
human and microbiome genome analysis, translational informatics, and clinical integration.
A flagship pharmaceutical customer uses the
CTS to integrate patient and microbiome
sequencing data for a multi-site study using
validated bioinformatic pipelines:
http://www.ClinicalOMICs.com
Rise of Genomics in Clinical Trials

Table of Contents for the Digital Edition of Rise of Genomics in Clinical Trials
