Introducing Vantage BioTrials, a CRO focused on operational excellence with a lean and holistic approach to each project, Vatché Bartekian, president and co-founder, also advocates for greater visibility for Canada on the international stage and an increase in collaboration within the pharmaceutical industry and regulatory bodies.
Vantage BioTrials celebrated its tenth anniversary last year. What gap did you identify in 2007 for Vantage BioTrials to fill?
“What we can observe in Canada is a very diverse CRO landscape, in which each player has found its own specialty.”
2007 was an interesting year given the sudden economic downturn. When we opened in April 2007, we did not foresee that, but in many ways, we hit the right timing with our launch. The crisis helped in streamlining our offering, that of a simpler solution to clinical trials management. Our functioning had to be as lean as possible and we have since upheld this goal of lean operational management with delivering “just in time” services.
I had worked in Big Pharma before, at a time when the approach was very siloed, which was unfortunate, as the departments did not communicate enough. This caused delays in getting things done, and in clinical trials, losing time is costly. After two years with a “Top three Pharma”, I wanted to create a company that addressed that issue by focusing on the question of how to do things more efficiently with the right people and achieve better results.
Our name illustrates our philosophy and business model: we conduct research on humans, hence “BioTrials”. “Vantage” comes from a vantage point; whereby from a high point atop the mountain you see the valleys, trees and horizon and are enabled a more holistic view. We wanted to be a big picture company, one that acknowledges the forest for the trees and yet find the most direct route to the problem, minimizing obstacles and risks along the way.
How does Vantage BioTrials differentiate itself with its business model from other CROs?
What we can observe in Canada is a very diverse CRO landscape, in which each player has found its own specialty. Our niche lies within our operational excellence. Yet, even though we have the ability to cover a large array of therapeutic areas, this does not mean we are spread thin. We have built a business model allowing us to keep a small core team of project managers, clinical research monitors, CTAs and auditors, that we can expand accordingly if one of our clients requests extra project resources for instance. Thanks to Canada’s breadth of diverse specialty vendors, we can partner with companies employing data managers, bio statisticians, or enhance our team with independent monitors in other provinces to realize the full scope of one project.
When taking on a new area where we have not ventured before, we ask of ourselves whether we have the capacity to address all the requests, and take a decision accordingly. We dare but with caution; this is how we came to conduct a medical device study for the first time in 2009. Even though this was a first for us, taking all aspects into consideration, we were confident we could master guidelines and regulations and were rewarded with success: our client got 510k FDA approval within a few short months from project completion, and was later acquired by Medtronic.
We do focus on rare diseases to a degree, having undertaken several projects in that field and currently conducting a post-market observational study on a rare dermatologic condition. But more than the field, we see repeat business and client feedback as gauges of our ability to differentiate ourselves. Vantage BioTrials stresses collaboration with its client on all levels as essential. We believe we have to identify the right path and then move forward on it together.
What makes Canada an attractive place to conduct clinical trials?
Firstly, the regulatory environment is conducive to being an excellent testing center. I would like to add that there is an ease of working with Health Canada these days that was not there a few years ago, they act as an approachable body that remains open to discussion and advice.
Furthermore, different provinces—namely Quebec, Ontario and British Columbia—have streamlined their ethics review committee processes. It has become much faster on a specific province level to work with only one ethical review board as a reference, and obtain authorization from all other boards involved in the province automatically. This has cut down the timeline from six to two and a half months on average for most multi-center trials.
Often mentioned, the talent pool for research to be conducted in Canada is excellent. However, I am cautious with praise, as we do have many great researchers from academia, but on the clinical operational side, I find that universities could do more to help prepare students for the “real world” and the array of possibilities awaiting them. The university education we see is good for an academic or private laboratory setting, but is lacking in the more concrete part of preparation for recent graduates in seeing all that is out there: clinical research, pharmacovigilance, regulatory, data management, consulting etc.
What do you identify as the most pervasive challenges currently impacting CROs in Canada?
I see Canada somewhat lagging behind in technology adoption, especially compared to the US or South Korea. Technology adoption is crucial to making good progress and forging a strong path ahead. We need to ensure we are aware of what type of upcoming technologies are out there and how to utilize this to maximum effect. For example, augmented and artificial intelligence can play an important role in helping choose drug candidates that have been shelved or forgotten and essentially bring these drugs back to life by examining the therapeutic effect or usage for other indications they could have. We have also witnessed a company leveraging on artificial intelligence as a tool to boost patient recruitment. We cannot afford to wait and need to identify future trends today, so as to implement innovative technologies as soon as possible, because the effect is for new therapies to reach patients faster.
How do you think Canada should position itself in an increasingly competitive global clinical research market?
I believe Canada’s potential lies with very targeted, specific trials, in rare diseases for instance. This is why Vantage BioTrials has chosen to move in that direction. Canada has in general got to do more to attract investment in research, although it has to choose wisely which formats it wants to attract.
Affiliates of large pharmaceutical companies in Canada face the same challenge in advocating for allocation of research to Canada. Canadian CROs can help support these advocacy efforts, by issuing studies for the pharmaceutical companies, showcasing the lower cost of conducting research in Canada than in the US for instance.
The larger CROs attract the larger studies and this is only natural. But if we partner with them, we can act in a complementary way. I see opportunities here, and have been confirmed when large global CROs have approached us for local expertise or the need of bilingual monitors on a specific trial. I think that we have to be more open-minded about collaboration. Because by considering other CROs as collaborators and partners, we follow the principle of stronger together and are able to enlarge our offering, rather than wasting time battling for market shares.
It is evident that science is becoming more and more complex, hence regulators are collaborating more and more with CROs to look for real world evidence. How can Vantage BioTrials partner with the various stakeholders in the industry in this regard?
We have not yet undergone partnerships with regulatory bodies such as the FDA or Health Canada. However, I believe there definitely is opportunity to investigate overlapping interests and work and advance together without hindering research. In the end, it all boils down to the right management, the right human resources with knowledge of the industry. Communication is key, and in such partnerships, it is even more crucial as budget plays a central role. As industry representatives, we have to make sure regulators understand that doing things right and in a timely manner has a certain cost attached. As always, important upfront investments are seldom pleasant but avoid cost overruns and change orders.
On the subject of real word evidence, we have been approached by larger pharmaceutical companies wishing to partner with us as they have been attracted by our activity in post-market observational trials. They require expertise in conducting studies with a clear management of centers and sites, timelines and budgets. We have thus had the opportunity to collaborate with such players, working on innovative patient recruitment strategies, for example.
What is your approach to team management and leadership?
At Vantage BioTrials we want to hire people who think outside the box, but we see that our task does not stop at hiring. It is essential we train our employees, so that they perform as we expect them to. We want them to adopt the same holistic approach with which we approach business. Beyond their day-to-day work, they have to have the capacity to think analytically and to tackle the issues they might encounter when managing a project. It is our responsibility to provide them with the tools to be innovative in their approach to solutions and the right mindset to dare and ask questions when needed. Especially in our interaction with clients, we realize time and again that people are often stuck in their tunnel vision, but that triggering them with the right questions to make them see the whole picture, works wonders in improving advancement.
You were selected Emerging Pharma Leader in 2011. Seven years later, how do you feel has leadership in the life sciences ecosystem in Canada evolved?
It was a moment of great pride to be selected as Emerging Pharma Leader in 2011 by Pharmaceutical Executive, especially since we were that year the only Canadians featured. I think, that Canadians should be more visible and present on a global stage when it comes to promoting leadership skills. We have so much talent especially young talent in this country, I wish for them to be recognized on a global level. And just as importantly, I wish for more women in leadership positions in the pharmaceutical industry. In clinical research at project management level we have a majority of women often, but then this is not translated into upper management. More opportunities for women leaders should be created, I am a strong advocate of that.
What key priorities will you be pursuing over the coming years?
Vantage Biotrials will diversify its collaboration with technology companies in order to stay ahead of the curve. Furthermore, we will continue to advocate for Canada’s visibility within the international community. While the provinces have picked up, I think that as a nation, we should do a better job in marketing ourselves. This is one of the reasons why we have launched the “Canada Talks Pharma” series of conferences. The third edition will be held in May in Toronto this year, and we have met great success with this initiative. Every year, we gain market intelligence as we invite speakers from Canada and abroad to bring a fresh perspective on what is animating the industry. I think it is essential to keep the conversation going.