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Faster, Flexible and Affordable: Mikhail Groubman on Building a Global Legacy in Clinical Research in an Untapped Market
Dec 21, 2024, 10:09

Faster, Flexible and Affordable: Mikhail Groubman on Building a Global Legacy in Clinical Research in an Untapped Market

Interview with Mikhail Groubman, By the Editor-in-Chief of OncoDaily, Gevorg Tamamyan

Mikhail Groubman is the CEO of Atlant Clinical, a leading international provider of clinical studies and healthcare support services. Since joining the company in 2012, he has transformed Atlant from a small local CRO into a prominent global organization. Under his leadership, Atlant Clinical continues to expand, delivering high-quality clinical research and accelerating time-to-market for innovative therapies.

In this interview, Mikhail Groubman shares the story of transforming a small local CRO into a respected international player. Starting in a market dominated by global giants, Atlant faced significant challenges—from overcoming international skepticism to proving that Russian clinical research could meet the highest global standards. Mikhail discusses how the company leveraged its unique workforce, adapted to market demands, and built a reputation for delivering fast, flexible, and high-quality services.

 

Overcoming International Skepticism

Mikhail Groubman began by describing the early days of Atlant Clinical when CROs were largely dominated by international giants. “We definitely started the company at a time when there were very few CRO companies,” he explained. “The majority of them were international, and we were among a relatively small group of Russian companies.”

The primary challenge was gaining the trust of international clients, particularly those from the United States. “The majority—about 95%—of our clients were from the U.S., with fewer from Europe,” Mikhail shared. “We had to convince them that the quality of work provided by Russian investigators met international standards, like GCP and the requirements of the FDA and EMA.”

For Mikhail and his team, proving that a local company could deliver services comparable to global players was no small task. “The main challenge was to start those discussions and convince clients that we were in a position to provide better and faster services than many big international CROs,” he said.

 

Turning a Challenge into Strength

What might have seemed like a staffing challenge in a country with limited clinical research infrastructure became one of Atlant Clinical’s greatest strengths. Mikhail Groubman described Russia’s situation at the time as unique, with many highly skilled professionals looking for opportunities outside traditional paths.

“There were many doctors who couldn’t afford a living if they continued working in clinical practice,” he explained. “They had to quit medicine and search for better opportunities.” However, clinical research provided an appealing alternative, allowing these medical professionals to stay connected to their field.

Beyond medical doctors, Mikhail recognized an untapped pool of talent in the scientific community. “As I’m not a medical doctor—I’m a biochemist by background—we also started hiring people with scientific backgrounds: biochemists, chemists, and biologists,” he shared. Many scientists were similarly drawn to clinical research due to limited opportunities in academia. “We found a lot of people ready to quit scientific work for the same reasons, and they joined our team.”

The result was a workforce unlike any other. “About 95% of our staff traditionally have a scientific background, and more than 15% hold a PhD,” Mikhail revealed. This level of expertise and education gave Atlant Clinical a significant edge. “It’s a unique situation globally. In countries like the United States or Europe, medical doctors would typically continue to treat patients rather than join CROs. But we were lucky to get people with great education and a deep understanding of medicine.”

This highly qualified team enabled Atlant Clinical to provide exceptional services and meet international standards, helping the company earn its reputation for excellence. “That’s why the level of services we could provide was excellent,” Mikhail said proudly.

 

Building Trust with Global Leaders by Being FASTER, MORE FLEXIBLE, and MUCH MORE AFFORDABLE

From its early days, Atlant Clinical set its sights on working with global pharmaceutical leaders. Mikhail Groubman proudly highlighted their partnerships with some of the largest players in the industry. “We worked a lot with GSK, we had global provider status from Merck—MSD, as it’s called here. We worked with Takeda, Astellas, AstraZeneca, Alexion, OctaPharma, and many other pharmaceutical and biotech companies,” he shared.

Earning the trust of these international companies required meticulous attention to detail and an unwavering commitment to quality. “To give you a flavor, when we started to work with Merck, it took us one year of constant audits—reviewing all our standard operating procedures and processes—along with interviews with the majority of our staff,” Mikhail explained. That rigorous preparation paid off. “Once we did start working with them, we succeeded because we were MUCH FASTER, much MORE FLEXIBLE, and, frankly speaking, MUCH MORE AFFORDABLE and RESULT-ORIENTED than the global players.”

For Mikhail, maintaining a stellar reputation is paramount. “What I always tell my team is that we cannot fail. Our reputation is much more important than anything else,” he stated. This focus on reliability led Atlant Clinical to adopt a risk-sharing approach, which sets them apart from most global CROs.

“What we do at the very beginning is tell the company: here is our proposal. If you do not change your requirements, we will fulfill the budget. If my team fails to calculate something, it’s my problem—it’s on me,” he explained. This approach shifts accountability onto the CRO and reassures clients that budgets and expectations will be met.

Mikhail Groubman also emphasized the importance of timelines in clinical research. “Timelines are crucially important—for Wall Street if you’re a publicly traded company, for other investors, and finally for humanity,” he said. He underscored the urgency of faster clinical trials, particularly in fields like oncology. “The faster we do the trials, the faster people will get new treatment options and, potentially, life-saving treatments.”

To align incentives, Atlant Clinical incorporates timeline guarantees into their contracts. “If we are slower than promised, we lose money. If we’re much faster, we gain additional money. My clients see this as a very fair approach, something they rarely see in global CROs,” Mikhail added.

 

Joining Forces: Global Expertise with Local Excellence

In 2020, Atlant Clinical entered a new chapter when it was acquired by Agenus, a U.S.-based, publicly traded biotech company and a global leader in immuno-oncology innovation. Mikhail Groubman, CEO of Atlant Clinical, shared the motivations and opportunities behind this strategic partnership, highlighting how it has accelerated growth while maintaining the company’s global focus.

“It was our strategic decision,” Mikhail explained. “We wanted to find a suitable partner to continue our global development, but we also really wanted to contribute to bringing medicines to patients much faster than before.” This alignment of purpose made Agenus an ideal partner. “We share the same spirit with Agenus because what they do is try to be as efficient and as fast as possible, finding better solutions and innovative medications for the patients,” he added.

Since 2020, Atlant Clinical has supported Agenus’ clinical trials while maintaining its work with other international pharmaceutical and biotech companies. “Not only do we support Agenus clinical trials, but we continue to work with other international players. That is extremely important,” Mikhail Groubman emphasized. This dual approach allows Atlant Clinical to combine its expertise in Eastern Europe with the rigorous standards of Western markets, particularly the U.S.

Mikhail proudly described how Atlant Clinical’s collaboration with Agenus showcases their ability to meet the highest global regulatory standards, including those set by the U.S. Food and Drug Administration (FDA). “We are a unique company in Russia that would efficiently work with the FDA,” he stated. “Our biostatistical team, our data management team, and our medical writers work together with the Agenus teams to provide the data and documentation submitted to the FDA, which proves that the level of professionals we have here is truly global.”

Atlant Clinical

 

Russia’s Pre-2022 Role in Global Clinical Trials

Mikhail Groubman began with a historical perspective, emphasizing Russia’s importance in global clinical trials before 2022. “Based on FDA data, Russia was the number two contributing country to global patient enrollment, second only to the United States,” he explained. This was particularly significant in oncology, where Russia played a leading role in providing high-quality data.

One of the driving factors behind this prominence is the high unmet medical need in Eastern Europe. “The healthcare systems here are not as developed as in the United States or Central Europe,” Mikhail noted. For many patients, clinical trials provide the only opportunity to access novel treatments, guaranteed standards of care, and high-quality medical attention. “Patients here want to participate in clinical trials,” he added.

Russia’s clinical trial landscape offers unique benefits, particularly for oncology research. Mikhail Groubman highlighted the availability of treatment-naive patients—a challenge in developed markets like the U.S. and Western Europe. “It’s very hard to find naive patients for oncology in the United States, but here you can find them faster,” he explained.

Additionally, labor costs in Russia remain significantly lower compared to Western countries. “Doctors here are not paid even close to what their counterparts in the developed world earn,” Mikhail said. This creates an incentive for investigators to engage actively in clinical trials. “Investigators in Russia take clinical research very seriously. They are committed to collaborating with global peers, participating in publications, and contributing to international research,” he observed.

Mikhail Groubman also emphasized the professional pride Russian investigators bring to their work. “They are much more involved in clinical research than principal investigators in many countries globally,” he said, noting feedback he’s received from CROs and pharmaceutical companies worldwide.

Since 2022, many global companies have halted new trials in Russia due to geopolitical concerns. However, Mikhail pointed out that clinical research remains exempt from sanctions. “The United States has clearly stipulated that clinical research is not under sanctions because it has a humanitarian aspect,” he explained.

While international activity has declined, the demand for clinical research remains high. “Currently, 99% of the market in Russia consists of trials performed by Russian pharmaceutical companies, along with a few Indian, Iranian, and Chinese firms,” Mikhail stated. He sees this shift as an opportunity for companies bold enough to continue working in Russia.

“Patients are still here, and there’s a huge social demand for clinical research,” he emphasized. Companies that act now can access patients faster, generate high-quality data, and accelerate their clinical development timelines. “The FDA and EMA still analyze data from Russia, and ongoing trials initiated before 2022 continue to submit their results,” Mikhail Groubman explained.

 

A Personal Passion for Clinical Research

Mikhail Groubman also shared his personal journey, underscoring his passion for clinical research. “When I joined, Atlant was a small local company with 15 employees,” Mikhail recalled. “In the last 12 years, we’ve built an international company with over 100 employees, and we continue to grow.”

For Mikhail, clinical research is more than a profession—it’s a mission. “I love the social impact this industry brings to the world. Our mission is to accelerate time-to-market for companies innovating to improve people’s lives,” he said.

As the conversation closed, Mikhail Groubman extended an invitation to global companies: “Russia currently creates great opportunities for international companies to access patients, generate high-quality data, and accelerate development timelines—especially in oncology.”