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When it comes to supporting clinical trials, having a global footprint is simply not enough for contract research organizations to maintain a competitive edge. Access to the latest technology to help meet the stringent development demands from their pharmaceutical clients has become equally important in the age of genomic-driven medicine.

Q² Solutions is keenly aware of this, which is why it recently announced a $73-million expansion of its center of excellence genomic testing center in Durham, North Carolina. The new facility will house a translational science and innovation laboratory where state-of-the-art technology for biomarker discovery will be tested with the intent to deploy it across its laboratories in China, Scotland and Singapore. The Ion Torrent Genexus System* is the latest platform Q² Solutions has taken up and is currently evaluating for its potential to better serve its clinical trial partners around the globe in the future. Launched in November 2019, the Genexus System is the first fully integrated NGS platform featuring an automated workflow that delivers results cost-effectively in a single day.    

Thermo Fisher Scientific recently spoke with Q² Solutions’ Kellie Yarnell, vice president, Global Genomics Operations, and Pat Hurban, senior director and global head, Translational Genomics, to discuss their future plans to expand their genomic services at each of their global locations, and how they believe the Genexus System can help them stay on the leading edge of a very competitive field.

“The ability to access results faster is probably one of the biggest motivations of our pharma partners right now”

How do the innovations provided by the Genexus System change the discussions you have with your pharmaceutical clients’ development needs?

Kellie Yarnell (KY): It changes the way we can talk to them about utilizing future NGS panels. The fact that we could theoretically get samples in the lab and results back in a matter of days is incredibly impactful. The ability to access results faster is probably one of the biggest motivations of our pharma partners right now.

How does the Genexus System align with Q² Solutions’ intention to build its Translation Science and Innovation Laboratory (TSAIL) co-located with its Genomics Center of Excellence in North Carolina?

KY: The intention of TSAIL is to bring a variety of technologies that cross the biomarker discovery continuum under one roof and offer our sponsors access to scientific expertise and innovation, not just across genomics but anatomic pathology, flow cytometry, immuno-assays … you name it. Pretty much anything that can help drive biomarker research within clinical trials.

We made the decision to co-locate the translational laboratory with the genomics lab as part of this expansion plan. While I believe that as an organization we would have adopted the Genexus System with or without TSAIL, platforms like the Genexus System demonstrate our commitment to being first and best-in-class by investing in these types of technologies early.

How does the Genexus System help Q² Solutions stay competitive?

KY: It definitely helps us be more competitive as a service provider compared to others in the market. It’s one of the reasons why we are interested in being an early adopter of this technology. We’d like to be able to offer this as quickly as possible. But another big piece for us is being able to give our clients access to multiple options across a variety of platforms.

Why is there a need for NGS on a global scale?

Pat Hurban (PH): There are a lot of reasons for it in translational research. When you’re dealing with a relatively rare form of cancer or the eligibility criteria for a trial is competing against a fairly robust standard of care, you need to be able to access large populations. You also need to keep in mind that the regulatory agencies are asking for clinical trials with broad geographies to ensure that different ethnicities are appropriately represented so that we don’t end up with a situation where we have a drug that works for certain ethnicities but may not be understood very well in others.

This is one of the reasons why Q² Solutions has the global laboratory footprint that it does. But we need certain core technologies to support the biomarker strategies that our clients have. And among those core technologies that are increasingly in demand are genomics. That’s why we are looking at various platforms to deploy globally.

What type of assays do you expect to start running on the Genexus System?

PH: The biggest areas of interest for us on Genexus include comprehensive cancer profiling research assays, both for solid tumor and circulating free nucleic acid. We’ve been doing a lot work with immune repertoire sequencing and we’re looking forward to the introduction of those assays. Given the flexibility of the system, we can enter the workflow on the instrument from various points, including from prepared libraries. That means some of the panels we have in flight right now are things that we would potentially be interested in transitioning over to Genexus.

“When you can essentially take a sample, even pre-analytically, and work with very little hands-on time all the way to a reporting capability, I think that’s something that’s really critical”

What was your reaction when you first received a briefing of the Genexus System’s capabilities?

PH: Clearly it was a very thoughtful design. Thermo Fisher listened to their customers in terms of what the pain points were for sequencing and responded in-kind. But the thought process from sample to answer is very well sorted out and is really a major leap. I have five attributes that I think are addressed well by the Genexus System.

The first is content. This is something Thermo Fisher does a really good job of identifying the genomic content that’s going to be critical.

Second is what I refer to as reagent overhang. That’s the phenomena where in a quick-turn testing setting, you need to be able to run these assays quickly, but depending upon what your sample uptick is like at an given moment, you may not have the wherewithal to be able to run as many samples as you would like to make optimal use of your reagents from a cost perspective. So, by ensuring stability of reagents on the deck of the instrument and by splitting the sequencing chip into multiple lanes, it really makes it feasible. Working with a solution that doesn’t cost all of our reagents for a single run, I think, is a key attribute.

Third is the streamlined workflow. When you can essentially take a sample, even pre-analytically, and work with very little hands-on time all the way to a reporting capability, I think that’s something that’s really critical. And I think it’s going to be a very attractive feature for our pharma partners who are interested in developing future diagnostic assays as companions to their therapeutics.

Fourth, it’s an integrated solution. When you have a very good solution covering substantially the entire workflow, that means that from a training and global deployment standpoint, it is much more straight-forward. And that’s important because so many of the studies we’re supporting have worldwide presence, and we want to be able to deploy assays with quick turnaround times in our global laboratory footprint.

Finally, I really liked the built-in flexibility. This allows us to use prepared libraries directly on the deck, rather than having to go through the entire workflow to enable our research. This affords us the ability to intermix different library types in a single run and have the instrument take care of that intelligently.

What role do regional regulatory guidelines play in your decision to take up this NGS System?

PH: It’s great to work with companies that are aware of the regulatory environment. Ultimately, we’re going to do our due diligence, and knowing that we can potentially deploy in all the geographies that are of concern to us, including China, is very important. We’re a global company. We like to work with global companies that have a global perspective.

“Thermo Fisher has been a good partner. They understand the markets that we work in well. They are building solutions that are responsive to that market”

How has your experience been working with Thermo Fisher, and how has the relationship helped Q² Solutions better serve its customers?

PH: Thermo Fisher has been a good partner. They understand the markets that we work in well. They are building solutions that are responsive to that market. We have a very productive relationship in that we’ve provided Thermo Fisher with very honest feedback and they’ve done the same with us and it makes both of our organizations better. From a global standpoint, obtaining instrumentation, whether it’s in the UK, EU, the US or in China or Asia Pacific, it’s been very straight forward to work in each of those geographies, which is something we really appreciate.

*The Genexus System is for research use only. Not for use in diagnostic procedures.