Kellie Yarnell, VP, Genomic Laboratories
The introduction of Next Generation Sequencing (NGS), or deep sequencing has massively transformed the genomics paradigm. With ultra-high throughput, scalability, and speed, this innovative DNA sequencing technology has made it easier for researchers to study biological systems and gather information at a level that was previously deemed impossible. Combined with clinical data, readily accessible genomic data acquired from NGS is now driving a revolution in clinical trial workflows, thus accelerating the development of personalized and more targeted treatments.
Despite such potential, effective use of NGS in many clinical environments is still underutilized. The key reason behind this is the massive volume of genetic data that NGS is capable of generating within a relatively short amount of time. Usually, a clinical exome- or genome-sequencing test detects 16,000 to 23,000 variants in protein coding genes and may yield terabytes of data per patient. This ever-increasing volume and variety of complex data has introduced a new challenge. Without an innovative approach and a capable bioinformatics team, accurate and prompt interpretation of such massive clinical genomic data is a daunting task for biotech firms and pharmaceutical companies. For these organizations that often work under tight timelines, having an experienced partner that can help transform science and data into actionable medical insights can make all the difference. This is where Q2
Solutions—a leading global clinical trials laboratory services company—cements its cornerstone. Kellie Yarnell, VP of Genomics Laboratories at Q2
Solutions, says, “Our goal is to bring globally-harmonized clinical trial testing to pharma sponsors and help them accelerate their drug development programs.”
A Blended Approach
Solutions is a joint venture of Legacy Quintiles (now IQVIA), the world’s largest provider of clinical product development and integrated healthcare services, and Quest Diagnostics, a global leader in diagnostic information services. Q2
Solutions was established in 2015, to combine their parents’ clinical trial testing footprint, and leverage the scientific expertise and operational excellence of both companies. The result is an industry-leading clinical trial testing organization.
Today, with a relentless focus on quality and innovation, Q2
Solutions combines the best of each parent organization’s laboratory services capabilities to fulfill its mission of ‘treating each sample as if a life depends on it.’ In fact, Q2
Solutions takes pride in having the necessary technologies and scientific expertise to provide effective clinical trial laboratory solutions and services to cater to the needs of its clients.
Carving a Niche in Laboratory Services with Innovation
Solutions’ forte lies in end-to-end laboratory services—ranging from biomarker discovery and assay development to application of precision medicine—and providing enterprise-wide biospecimen and consent management solutions.
Our goal is to bring globally-harmonized clinical trial testing to our pharma sponsors and help them accelerate their drug development programs
Through its genomics laboratory services, Q2
Solutions is able to offer comprehensive DNA and RNA sequencing services, from whole genome to targeted panel gene expression profiling and genotyping assays, along with bioinformatics analysis expertise, which supports pharmaceutical and biotechnology product development needs. The carefully orchestrated consultation between Q2
Solutions and sponsors helps a business choose platforms and assays that distinctly fit their clinical trial needs.
Alongside, as a part of its biomarker laboratory services, the firm helps drug developers generate a biomarker identification strategy to help drive the clinical and commercial success of a drug. This includes biomarker testing services including immunoassays, flow cytometry, genomic, liquid chromatography–mass spectrometry (LC/MS), as well as anatomic pathology and molecular pathology solutions. Q2
Solutions’ scientific experts—that reside in multiple CAP-accredited laboratories across the globe—help strategize translational design to develop assays and that can discover and/or evaluate robustness of biomarkers in order to accelerate the process of integrating and optimizing biomarker strategies in clients’ clinical trials.
Solutions’ depth of experience in the field has helped many of its clients involved in clinical programs utilize genomic biomarkers to identify potential stratification strategies, enabling successful primary endpoints in clinical trials. For instance, Kellie notes that some of their pharmaceutical clients enter the clinical development phase without a genomic biomarker strategy. Rather they bio-banking genomic specimens, hoping for future biomarker discovery. Q2
Solutions has helped such clients quickly analyze the specimens and carry out broad-based genomic testing to identify potential biomarkers. “Our world-renowned biomarker services help pharma companies integrate biological markers across their development plan, which enable them to reach clinical trial endpoints across all phases of development faster,” mentions Kellie.
The True Testament of Excellence
Most clinical development programs require enrollment of patients globally, and therefore testing in various geographies is advantageous for development programs. Q2
Solutions helps sponsors enable such laboratory testing by providing specimen collection kits, a courier network, and a biorepository, in addition to project management and data management. Q2
Solutions has various centers of excellence around the globe for anatomic pathology, flow cytometry, genomics, bioanalysis, and more. Specifically for genomics, the firm has a center of excellence at Research Triangle Park in North Carolina, where it develops complex genomic testing protocols, and then deploys those using globally harmonized standard operating procedures and quality systems to laboratories in the U.S., U.K., and China.
As part of the same process, Q2 Solutions also offers standard training across all the labs as well as concordance analysis of validation data prior to patient sample testing. In this manner, the organization assures that all of its clients receive the same level of service and high-quality data on multiple continents to support globally harmonized trials.
"With a relentless focus on quality and innovation, Q2 Solutions combines the best of each parent organization’s laboratory services capabilities to fulfill its mission of ‘treating every sample as if a life depends on it’"
Recently, to enhance its early phase discovery and translational capabilities across technologies, Q2 Solutions announced the launch of a Translational Sciences and Innovation Laboratory (TSAIL) in North Carolina. This lab will be co-located with the Q2 Solutions’ Genomics Center of Excellence in that region. “The market for biomarker testing in clinical trials has expanded rapidly in the last few years. To complement this growth, we created TSAIL,” affirms Kellie. TSAIL will provide an environment to evaluate early phase biomarkers across multiple technologies such as AP, flow cytometry, and genomics, in an effort to circumvent some of the challenges associated with moving biomarkers and technologies from discovery into clinical trials, thereby helping to accelerate drug development. The innovation lab will also allow customers to access a broad range of Q2 Solutions’ services, including biomarker assay development, bioinformatics, data analytics, and digital innovations, as well as evaluation of novel technologies within a flexible environment.
Charting the Path Forward
According to Kellie, “having a great idea isn’t enough to build a successful company. What it really takes is a team of skilled people to make it shine.” This is one of the core principles on which Q2 Solutions is built upon. The firm encourages a culture of open-mindedness, transparency, honesty, and innovative approaches to finding out what is right for its clients, and consequently, help them reach their goals. “Our team of smart and dedicated scientists and bioinformaticists listen to our clients’ problems and needs, be it assay sensitivity, decreasing the turnaround time, reducing the cost, or speeding up the analysis process. Then, having an expansive toolkit to choose from, our subject matter experts take our clients’ real-world needs and pick a methodology that satisfies the most critical of those needs,” remarks Kellie.
Over the last four years, this atypical approach of working in collaboration with clients and business partners has helped Q2 Solutions carve a unique niche for itself. Treading ahead, the company is looking to ensure that it stands at the forefront of innovative clinical trials. Q2 Solutions is set to develop a number of new genomic technologies around testing plasma and blood samples. At the same time, the company is also experimenting on single-cell genomic sequencing and digital pathology solutions to drive precision medicine solutions across the biomarker continuum.
The implementation of genomics in clinical trials is critically important for the future of precision medicine. With its innovative approach, unrivalled commitment, and complementary strengths and expertise to transform genomic data into actionable insights, Q2 Solutions is creating a positive change in the way clinical trials are being pursued.