Nexelis: An Agile Approach to Bioanalysis

Benoit Bouche | CEO | Nexelis

There is a unique strength in numbers. We understand more and more easily together, and the ongoing pandemic underlines the crucial position of international cooperation on science and technical frontiers. In recent months, our doctors, clinicians, scientists, and medical experts from all walks of life have collaborated relentlessly to tackle the pandemic of coronavirus in a spirit of cooperation that is beyond precedent.

The necessity for both simultaneous attempts to generate several prospective candidates and the need for fast, large-scale production and global delivery are crucial to the evaluation of vaccinations for every type of disease. And that’s what our edition The 10 Most Trusted Vaccine Solution Providers, 2020 is all about. We are on an adventure to extract out all the companies making revolutionary developments in the industry.

And we can’t be more pleased to commence this issue with Nexelis, a preferred partner of choice for companies working on the vaccine development.

Despite being a relatively young Contract Research Organization (CRO) firm, Nexelis has become the preferred partner in vaccine development in no time. With its roots deep in vaccine research, with many of its experts originating in GSK vaccines, Nexelis is a dynamic and motivated company dedicated to apply its knowledge, agility and drive to further support vaccine efforts against diseases like COVID-19, as well as servicing other areas in immunology where new therapies are urgently needed to save lives.

“An inspiring mission is the most powerful motivator there is. And at Nexelis, we are part of overcoming some of the world’s most difficult healthcare challenges.”

The CRO firm brings its unrivalled expertise in immunology to the industry. With assay development and advanced laboratory testing, the company provides services to companies seeking solutions in the infectious diseases, metabolic diseases, and oncology arenas. Nexelis has become a testing lab of choice for top 10 global pharmaceutical, innovative biotechnology companies, and governmental or non-governmental organizations funding the development of vaccines targeting emerging countries, which use the CRO’s services to help develop lifesaving innovations.

The Inception Saga

The company came into existence as a meeting of minds, when NEOMED-LABS was spun-off from GSK Vaccines in 2015, partnered with Ampersand Capital in 2018, acquired Pacific Biomarkers the same year, and PairImmune in 2019. This group combines over 10 years of bioanalysis, 20 years of vaccine, and 25 years of biomarker experience. Through new strategic acquisitions, Nexelis continues to grow and bring in important areas of expertise, solidifying its leadership position in the immunology field.

Earlier this year, Belgian specialty immunogenicity and immuno-oncology testing ImmunXperts and Indianapolis based bioanalytical ligand binding and mass spectrometry laboratories joined the group, further extending its portfolio of services. These acquisitions also provide Nexelis a global presence with 3 sites in North America: Laval, QC; Indianapolis, IN; Seattle; WA and 2 sites in Europe: Gosselies, Belgium and Porton Down, the UK (through a partnership with PHE, Public Health England). We understand that the company will add a third site in Europe in the months to come through another acquisition to be announced before the end of the year.

A passionate leadership team

Benoit Bouche, the CEO of Nexelis, has spent over 30 years growing in the healthcare business. His dual professional background in both science and business has provided him with an in-depth knowledge of all aspects of a healthcare venture stage company. As an entrepreneur, investor, advisor, and board member, he has honed his expertise in dealing with the challenges that arise when a company experiences a growth spurt. It is his experience that has proven invaluable for the meteoric rise of Nexelis.

Bouche joined NEOMED-LABS in 2017. His assignment was to transform a 55-person vaccine R&D unit, into a global services provider for immuno-centric advanced lab testing. With an MBO backed by Ampersand Capital in July 2018 and a number of organic and inorganic initiatives, the company more than sextupled its size in two years and a half.

He says, “At Nexelis, we offer a distinctive approach centered on this openness to creativity and innovation which allows us to be very flexible in our pursuits. This approach, in turn, generates enthusiasm from our scientists, collaborators, and clients. Personally, I view politics and lack of transparency as the main roadblocks to efficiency in a corporation. That is why I have always tried to promote this culture, whereby we encourage our specialists to exchange freely with colleagues and partner with clients in a spirit of collaboration and transparency. As a result, there’s no overlong process or heavy hierarchy at Nexelis. We get things done!”

Luc Gagnon, VP Vaccine Sciences

Armed with over 20 years of experience, Luc Gagnon is in charge of scientific operations at Nexelis in the vaccine field. He is responsible for developing assays supporting vaccines and biologics through the various phases of the clinical trials. Since its very beginnings, Luc has worked as VP of Vaccine Sciences, making the transition from the pharmaceuticals to a CRO following GSK ‘s 2015 spin-off.

GSK exchanged the oncology business in 2015 with the business of Novartis vaccines. As a result, GSK had to abandon the Laval facility in Canada for so many R&D sites worldwide. However, the pharmaceutical industry was conscious of the tremendous potential of the Laval experts and sponsored their conversion into a single CRO.

Luc says, “At the Laval GSK site, we almost had the full chain of vaccine testing available, from the early discovery of new antigens up to the pre-GMP production, and even a clinical site where human samples were tested to assess immune responses. We were able to take all that expertise and convert it into a new CRO venture. ”

In the first three years, Nexelis-initially called NEOMED-LABS-has begun to tr a vel and was given the buildings and all the instruments and $25 million in financing. 55 workers entered the newly established organization in terms of professionals, all of them with more than 15 years of vaccine evaluation experience.

“As I always say to potential partners: we’re a young CRO with an old soul, thanks to our very experienced staff. The core team was highly versed in analyzing samples generated in phase I up to phase IV clinical trials. Furthermore, we have access to the best equipment. We have fully automated systems that can tackle large series of clinical samples while maintaining both the integrity and quality of the testing being performed, ” he adds.

He further continues with “In terms of quality, we also stay true to our pharma roots. The first time we were audited to obtain our GCLP certification, we were told we were overly engineered. Usually, companies need to take action to reach a certain line, but we were already way above the line! So, we have the whole package, combining our eye for quality with the scientific expertise and the instruments. This makes us one of the best players for vaccines and immunology specialty labs in the market.” Nexelis has complete assay packages that allows collaborators to produce all data required to submit for new vaccines. Their collective strategy is one of the keys for Nexelis growth. They follow the approach of a collaborator instead of a customer support provider during projects.

Luc asserts, “In every project, we strive to be an extension of our partner’s lab. We’re not a CRO where it’s ‘our way or the highway’. We’re always willing to further improve on the science, process, or performance of the assay. Working as partners also means that we can openly discuss things without being afraid to challenge each other on important decisions. We are confident that our opinions matter and that our input is beneficial to our partners, as our scientists are so experienced. This collaborative relationship lets us achieve the best possible outcome without the risk of any caveat or grey zone. We’re not only executing; we’re also providing advice based on our experience in the vaccine field.”

The SARS-CoV-2 soon began to disperse across the world at the beginning of 2020. This challenge has been recognized by the Nexelis team early and committed collaborators have begun to search into solutions. In battling this deadly pandemic, the organization has played a leading role.

“We were able to very quickly develop new assays that measure the extent to which candidate vaccines elicit an immune response to SARS-CoV-2. Because we already had a general approach to developing such assays, we were able to fast-track the development. This is something we are capable of doing for any new health threat that arises unexpectedly. It’s an important lesson we’ve learned from this crisis: we all need to develop more generic approaches and stay vigilant for potential new pandemics, so we can start developing tools in time like we managed to do for the COVID pandemic. Our assays are now becoming the gold standard, used around the world. I’m also proud to say that we initially funded this work internally and obtained the support of the Bill and Melinda Gates Foundation in this initiative, out of a desire to quickly help tackle this pandemic issue,” cites Luc.

The Nexelis SARS-CoV-2 research forced several businesses and industries to invest in COVID-19 vaccinations and therapies at the front and center of the market.

He comments, “We are also supporting CEPI (the Coalition for Epidemic Preparedness Innovation), a global partnership launched in 2017 to develop vaccines to stop future epidemics. CEPI is now also sponsoring initiatives to accelerate the development of COVID-19 vaccines. Our assays, to determine the immunogenicity of candidate vaccines, will be transferred to six other labs around the world, which we will be managing at distance in terms of quality.”

The business has grown steadily since its creation in 2015 by integrating internal innovations and external acquisitions. The Nexelis team has quadrupled in scale in 18 months and will have sextupled in two years and a half at the end of the year 2020. Additional Nexelis locations, based on biomarker studies in Seattle, and Belgium with experience in early in vitro and in vivo preclinical development are situated in addition to the Laval location in Canada where vaccine research is carried out. Nexlis often collaborates with Public Health England – Porton Down following entering into strategic relationship in July 2019. Nexelis has become an immunocentric CRO with a robust reach.

“Despite the boom in COVID-19 vaccine research, the vaccine field remains limited to a few key players, particularly when compared to larger domains such as immuno-oncology or cell and gene therapy. With our strong background in vaccines, we have quickly become the number one partner for this field. Now, with the growing demand of other growing immunology fields, we are working hard to extend our services in other domains. The aim is, of course, to become the partner of choice for these larger fields as well. To do so, we have been investing heavily in our capability to perform next-generation sequencing and qPCR, and measure gene and biomarker expression using flow cytometry or cellular immunology. In addition to this internal growth, we’re purchasing companies that allow us to build new capabilities rapidly and incorporate further expertise in our scientific team,” he asserts.

Adding further to the sustainable future, he says, “For our vaccine business, international growth is a key focus. We’re working on setting up centralized labs in Europe and Asia, reducing the costs of shipping samples around the world. This saves not only money, but also reduces both the time and environmental impact. Our new site in Belgium already gives us a footprint in Europe, but the goal is to expand further geographically. In that aspect, we will be not only growing horizontally with different pillars, but also vertically to have a broader presence around the world. All of this growth will bring new benefits to our partners, and further cement our position as the top CRO for advanced laboratory testing services.”

Greg Kulnis, Senior Director of Customer Solutions

Greg Kulnis is the first in line for sponsors in the vaccines field as a Senior Director of Customer Solutions at Nexelis. Combining a research background with many years of business development experience, he is the perfect fit to connect the operational and commercial departments within Nexelis. Kulnis expresses some of his favorite facets of Nexelis work and his confidence in the vaccinations and medicines the organization aims to produce.

The team of Customer Service aims at supplying Nexelis consumers with the greatest consumer experience. A core component of this step is to identify what prospective customers need and link them to the right research tools inside the organization.

Greg says, “We have a number of experts in different fields, meaning we can always find a good fit for new partners. For example, we have Luc Gagnon, our VP of Vaccine Sciences for all vaccine related projects. For preclinical development, we can rely on Danielle Poirier, who leads our preclinical team in Laval, or Bassam Hallis of Public Health England. For early in silico or in vitro immunogenicity assessment, we leverage the insights of Sofie Pattijn from our newly acquired division in Belgium.”

I worked in the lab for a number of years prior to moving to the commercial side, and I’ve always appreciated being able to establish a conversation between two well-aligned experts. For a new client, it’s important that we are confident in all of the business areas, but what really instills trust in our organization is connecting the experts and allowing them to engage in those in-depth exchanges. It helps demonstrate our competence and instils confidence in our ability to deliver the project in exactly the right way and according to the desired timelines.

Nexelis is set up to foster cohesive cooperation across the globe. The organization is built so that each of the sites has their own specialty without significant overlap in expertise.

Our biomarker experts in Seattle remain our biomarker experts. If we have a vaccine-based project that’s looking to assess a biomarker, we don’t rely on the resources in Laval, but instead, reach out to the team in Seattle where that is their true core expertise. The same applies for mass spectrometry which is the core expertise of the Indianapolis team led by Shelby Anderson. This way we ensure that our clients are accessing the top experts at all times, no matter the area and geographical location,” says Greg.

Like a sharp blade, Nexelis uses its limited scale and professional scientists to perform the utmost. The company’s emphasis on immunologic tests, usually for large molecular molecules, has been improved over the years. The business has taken on a strong leadership role in this region due to its long-standing expertise. The reduced scale of the organization often helps the team to handle consumer initiatives much more flexibly than the bureaucracy-laden activities of the bigger, broader CRO.

He says, “Since we are rather specialized in what we do, and we don’t try to cover a large number of other disease areas, we are able to house all services under one roof and still be very nimble in our approach to client studies. We are not bogged down by the corporate machinery of larger companies, where the requirement to conform to standard processes causes delays for clients. We’re adaptable and very flexible in serving the needs of our clients. As a company grows, you need to make more of a concerted effort to maintain that agility, which has definitely been the case with the Nexelis leadership team.”

The strengths of Nexelis include the firm’s contribution to rigorous research and performance. The preservation of these expectations ensures that the finest research minds are drawn, a challenge for which the Nexelis team has a variety of cards up its sleeve.

Greg asserts, “One of the key opportunities we offer researchers who join our team is being able to interact directly with the top scientific minds in the companies we work with. For instance, if we’re talking to a large pharmaceutical company, a Nexelis researcher would likely be working with a principal scientist in their immunology group, and when we’re working with smaller partners, our researchers are often personally engaging with their CSO. This opportunity, to liaise and exchange ideas directly with the world’s top experts, is a real plus of working at Nexelis as it is not usually possible for most researchers at larger CROs.”

“The diversity of the projects that our researchers get to work on is also a real motivator. When I started my career at Merck, I worked on the rotavirus vaccine for 5 years, without any variation. Whereas within the span of 5 days, a scientist developing new assays at Nexelis could be working on a meningococcal, pneumococcal, rabies, and a chikungunya vaccine, just to name a few. This diversity of assays leads them to really have a deeper understanding of different infectious disease agents, and not be pigeonholed within a particular assay. They are able to build a tremendously broad expertise and translate that into projects that are geared towards saving lives.”

Nexelis operates in a large variety of bacterial and viral disease environments, where people require successful vaccinations urgently. The organisation also built a toolbox for the wide spectrum of pathogens that is appropriate for the differing needs of multiple researchers.

He cites, “Right now, some of the biggest areas that we are focusing on are bacterial targets like pneumococcal and meningococcal vaccines. However, we have also been working on viral diseases for a number of years, like RSV for example. All of these diseases are severe issues that urgently need vaccines to protect the vulnerable. RSV is particularly pressing, as the disease is literally the second most common cause of death for children under the age of one, only beaten by malaria.”

While Nexelis’ disease foci are typically client-driven, some developments are funded by the company itself.

“Our chikungunya efforts were actually self-funded, a development that we then offered to different commercial partners. We chose to fund this particular project upfront as chikungunya is a neglected tropical disease, primarily affecting people in the world’s poorer regions, spread by mosquitos in Africa, Asia, and India. Because for us it is not just about serving client needs; it is also about making a positive difference to people,” says Greg.

This ability to adjust their assays to address widely varying diseases is a real strength of Nexelis’.

He adds, “Having the flexibility to shift team members between projects and possessing a core expertise in different methodologies is significantly beneficial to both Nexelis and our clients. One of the great things about the infectious disease model and the assessments that we perform is that they are pathogen agnostic, so they can be used for a range of different diseases. Whether it’s E. coli or Shigella, they do remarkably similar things at the immunological level. Naturally, with a bacterium, you are going to be measuring some different things than you would with a virus, but that’s why we have our specialized teams in place to make sure we’re addressing what’s needed in each case. Transferring the assays from one bacterium to another also takes some work, but you’re not trying to completely understand the biology of the different pathogens every time; you’re just trying to measure the body’s immune response to it, which is usually a welldefined process by the time you get to a vaccine candidate.”

Having a full portfolio of services in-house enables Nexelis to respond rapidly to emerging health threats. The ongoing SARS-CoV-2 pandemic has proved to be an excellent example of the company’s capabilities.

Greg asserts, “We quickly recognized SARS-CoV-2 as a major event that we needed to act on. Together with Benoit, Luc, and the support of our Board of Directors, we decided to self-fund the efforts to develop assays to determine if vaccine candidates could elicit an immune response. We rapidly got these up and running and offered them commercially to the various sponsors. Thanks to that quick decision making, our assays are very advanced compared to others and have been adopted by the global community. The choice to self-fund their development was however more of a humanitarian decision than a commercial one. Getting these candidate vaccines to market faster will be a great benefit to everybody.”

“In developing the SARS-CoV-2 assays, we were able to benefit from the breadth of our own services. For example, in the early stages of the outbreak, it was exceedingly difficult to obtain a commercial source of the different SARS-CoV-2 antigens that we needed. They are critical for the assays and, thanks to our protein engineering team, we were able to develop all those materials in-house. This allowed us to act faster than when having to wait on a commercial supplier. Producing the antigens in-house also prevented the risk of supply chain breakdown, which would have slowed down the process. We were just able to walk it down the hall, turn it over to our immunochemistry team and say: “Here you go, please start developing your ELISA.”

“Another key factor in our success was a lot of sacrifice, hard work, and long hours by the team. Because the team has worked together for almost 20 years now, we could really leverage our best practices, allowing us to push these assays forward in an extremely accelerated timeframe without jeopardizing the quality. It was really through the dedication of the team, that these assays were made possible.”

Kulnis says the pandemic has also changed the nature of some client projects.

“Because of the urgency of the pandemic, we’re getting involved in COVID-19 projects at a much earlier stage than we typically would. Sometimes the companies don’t even have their antigen selected yet, or they don’t know what their formulation is going to look like. Even so, they already want to start talking about the assays, to understand what our capabilities are and make sure that we are the best partner for their clinical development program. It’s a testament to our team’s agility that it is able to rapidly recalibrate to work in such a different way. And I think it is evidence of Nexelis’ reputation for excellence that these companies are reaching out to us so early, trusting that our experts will be able to meet their needs.”

Kulnis believes that the global response to the widespread health threat of COVID-19 has triggered a drastic change in how companies conduct their work. It remains to be seen if these changes are temporary, or the dawn of a new era of increased cooperation.

He says, “In the past, companies went at it on their own, trying to ‘win the race’ for a new drug or vaccine out of a desire to be the first on the market. However, with the urgency of this pandemic, everyone is inclined to work together on collaborative projects. The focus seems to be less on profits, and more on saving lives. It’s understandable: everyone has been affected by this disease in some way, meaning that we are all have a personal incentive for trying to fight it.

Companies like Sanofi-Pasteur and GSK, Pfizer and BioNTech, and Medicago and GSK are working together in their response to the ongoing pandemic. It has been an interesting situation, because the level of secrecy and ownership of various aspects of the development process have been stripped away. A lot of people have understood that, in order to accelerate the timelines, they need to be more collaborative. There has been more willingness to share information, from general knowledge to technology. Furthermore, the speed at which licensing agreements have been processed has been absolutely amazing! We’ve also seen an increase in the sharing of materials needed to benchmark how your product is performing compared to others.

Philanthropic agencies like CEPI and the Bill and Melinda Gates Foundation are also providing further incentives for cooperation by funding collaborative projects. I think this general spirit of increased collaboration will be a lasting improvement, even if companies will likely revert a little bit when it comes to certain proprietary information. At Nexelis, we definitely see this as a really positive change in the industry, in line with our own mission of making a difference to patients.”

People’s Health at Core

People’s health is at the heart of the Nexelis’ mission, with the company contributing to lifesaving efforts by supporting pharmaceutical and biotech companies in the development of vaccines and large molecules. With a firm grasp of the needs of both sides of the client/CRO relationship, Nexelis has been instrumental in the development, qualification, validation, and largescale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and soluble large molecules.

Nexelis’ versatile team of scientists, using advanced technology platforms, supports work ranging from preclinical to clinical Phase I – IV, meeting the ever-growing demand for techniques to assess humoral, innate and cell-mediated immunity induced by candidate vaccines and immunotherapies.

By adhering to a strong focus on rigorous scientific discipline and robust protocols, supported by cutting-edge technological platforms, the firm addresses even the most demanding client requirements. Unlike huge generalized CROs who focus on global coverage and logistic capabilities, the scientific leaders at Nexelis focus on versatility and ingenuity, enabling the company to provide highly specialized laboratory testing services.

At Nexelis, all projects are run in a collaborative client-centric way, and the agility of Nexelis’ team means that urgent projects can be tailored to meet expedited timelines. By avoiding overlong processes or heavy hierarchy, Nexelis’ specialists exchange ideas with colleagues and partner with clients in a collaborative and transparent manner.

Consequently, the company is recognized for its scalable operational model, resulting in optimal flexibility for its clients and high throughput capabilities for supporting large, global studies.

Turning Challenges into Opportunities

Nexelis’ flexibility and work ethic has been put to the ultimate test during the COVID-19 pandemic. The company has been supporting the massive R&D efforts within the international community and has demonstrated its leadership in the infectious diseases field through multiple collaborations. Nexelis is cooperating with almost all multinational sponsors and innovative biotechnology companies combatting the SARS-CoV-2 virus.

Furthermore, the company has been selected by the Bill and Melinda Gates Foundation as the referral laboratory for all their COVID-19 grantees, representing hundreds of millions of dollars in research funding.

In an extraordinarily short amount of time, Nexelis has dedicated more than 40 scientists to new SARS-CoV-2 developments. This was achieved without pausing any other strategic vaccine development programs in fields such as meningitis, flu (seasonal and universal), Chikungunya, RSV, and malaria.

The company responded rapidly to emerging health threats thanks to the agility of its scientists and cause of its portfolio of services in-house. For vaccines and therapies for COVID-19, as for a large range of other challenging diseases, Nexelis is proud to partner with companies looking for patient solutions.

The Differentiating Factor

One of the key advantages in favor of Nexelis is agility, where an abundance of critical thinking from open minds compress time and achieve rapid results. There’s no doubt about other CRO companies being positioned to address the mainstream clinical opportunities, however, advanced laboratory testing is all on another level where companies need collaboration with companies like Nexelis.

Nexelis excels by combining robust protocols and scientific discipline with human resourcefulness to quickly tackle even the most demanding of challenges in the collaborative client partnerships. This combination of scientific, technological, and human strengths is what makes Nexelis special.

A Culture that Harbors Innovation

The team at Nexelis offers a distinctive approach centered on this openness to creativity and innovation which has rendered the company to be very flexible in its pursuits. Mr. Bouche has always tried to promote a culture that encourages specialists to collaborate freely with colleagues and partners with clients in a spirit of collaboration and transparency. As a result, there’s no overlong process or heavy hierarchy.

As a state-of-the-art CRO, scientific discipline is at the heart of every project, supported by the advanced facilities and cutting-edge technology. At Nexelis, a truly translational scope of services answers the many scientific questions that arise from the lead selection stage through to phase III clinical trials.

Nexelis’ in vitro analytical platforms include immunochemistry, cellular immunology, viral and bacterial functional assays, as well as flow cytometry, ELISpot, and PCR/qPCR platforms. The in vitro laboratory tests are further supported by the in silico and in vivo teams (in house BSL2 and preclinical facilities) and a protein sciences group.

Every year, the firm invests millions in new systems and platforms ensuring that the labs are up to date with the latest technological advancements.

A More Collaborative Future

In the past few years, Nexelis has developed into a world-class organization. It has partnered up with the global top 10 pharmaceutical companies. And for the forthcoming years, the foundations are already in place for the organization.

With deep unyielding roots in GSK, Nexelis has already become the #1 CRO for vaccinology, and now visions to becoming the choice of partner in other areas as well. It also wants to expand the scope of services to become a one-stop-shop for companies working on anything from early development to late clinical stage.

“In every project, we strive to be an extension of our partner’s lab. We’re not a CRO where it’s ‘our way or the highway.”