Boris Karsakov: From Startup to Global Pharma Market Subtitle – A Pharmaceutical Business Expert Explains How to Avoid Regulatory Pitfalls—and What Sets the US, EU, and Asian Markets Apart

According to Evaluate Pharma, by 2026, over 60% of the revenue of the world’s largest pharmaceutical companies will come from international markets. However, entering the global arena presents a range of regulatory complexities and communication barriers. Boris Karsakov, a pharmaceutical business expert who consults startups and HealthTech companies on international expansion, believes that effective engagement with regulators like the FDA goes beyond paperwork—it’s also about understanding business culture and the differing approaches to pharmacology across countries.

Karsakov’s path is unique: from critical care physician to a recognized international expert in guiding pharma companies into global markets. He has developed a unique framework for assessing how reimbursement mechanisms in different countries impact access to therapy. His analytical methods are applied at all levels—from startups to national health policy planning.

Boris conducts in-depth business assessments, advises startups on scaling internationally, and consults on pharma development strategy for both public agencies and non-profits. Among his recent projects is an AI-based tool for predicting hospital readmission risks, supported by leading European innovation network EIT Health.

In this Discover Health interview, he shares his approach to evaluating companies, identifying regulatory flexibility in clinical trials, and spotting the most promising segments in HealthTech.

Boris Karsakov

— You’re often called on to assess how ready medical startups are to enter global markets. How do companies adapt their products and processes to meet various international requirements?

Entering international markets in the pharmaceutical sector demands special attention to regulatory frameworks, local medical practices, and logistics. Beyond legal compliance, it’s critical to understand the region’s clinical and epidemiological profile—what diseases are prevalent, how physicians approach treatment, and which medications are trusted by patients.

The competitive landscape and maturity of the distribution infrastructure also play a vital role. This includes not only choosing reliable transport partners but also setting up local warehouses where needed and building efficient distribution networks.

Product and process adaptation is an ongoing task. It affects not just the product itself, but internal workflows. In some cases, companies may need to change dosage, formulation, or even the composition of a drug to align with local standards.

— This year, you consulted two HealthTech teams that successfully entered international accelerators in Europe and the US. What are the key factors driving successful global expansion today?

In my view, success today comes down to a combination of factors: deep knowledge of local regulatory demands, the ability to tailor the product to specific market needs, and flexibility in logistics.

Technology is especially critical. Digital tools allow for end-to-end supply chain management, and ensure compliance with GDP and GMP standards, while enabling quick responses to changes. Another essential factor is a company’s ability to partner with local players and rapidly reconfigure its internal processes to meet a given country’s demands.

Ultimately, succeeding globally requires strategic foresight, precise planning, and technological maturity.

— You instruct nonprofits and government agencies on pharmaceutical access and reimbursement models. What are the major differences between the FDA and other regulators? How do companies adapt?

The key difference lies in the approach to risk and approval processes. The U.S. FDA is known for its strict, detailed, and often prescriptive standards. European regulators, like the EMA, are also rigorous but may offer more flexibility when evaluating the benefit-risk balance—especially for innovative treatments or orphan drugs.

There are also differences in how clinical trial data is accepted, labeling requirements, and manufacturing quality controls.

Most companies follow a global strategy with localized execution. That means developing a core regulatory dossier aligned with international standards, and then customizing it for specific country requirements.

— As an external expert supporting companies during FDA submissions and international go-to-market strategy, what methods do you use to help ensure success?

I usually step in at the early stages, helping teams shape their product and regulatory roadmap. My role is to guide them in building a realistic, compliant pathway to the clinic or market.

I use several hands-on tools: evidence-based audits, reimbursement model assessments, and accelerator preparation. We start by evaluating whether their current data meets FDA expectations, and identify weak points—often, projects have strong tech but poorly defined clinical endpoints, so we fix that early.

Next, we map out how the service will be reimbursed—through CPT codes, direct purchasing, insurance models, or grants. This is crucial for entering both U.S. and EU markets.

Finally, I run a “technical pitch audit”—we test their presentations from regulatory, business, and go-to-market angles to ensure they’re solid in front of accelerator panels or potential partners.

— This year, you also conducted an analytical project on medical reimbursement across several countries. What regions have the strictest requirements for clinical research?

Clinical research standards vary widely in terms of evidence depth, study design, and regulatory oversight. The strictest, traditionally, are the FDA and EMA, where multicenter, randomized, placebo-controlled trials with extensive data monitoring are the gold standard.

Some countries in Asia, the CIS, and Latin America allow more flexibility—such as accepting foreign data or smaller sample sizes, especially for local approvals. However, companies aiming for global markets usually follow international ICH and GCP guidelines to align with multiple regulators at once.

— You’ve evaluated project hypotheses in a number of AI-based medical startups. Which areas of HealthTech seem most promising right now?

The most promising areas in HealthTech today include personalized medicine, digital therapeutics, telemedicine, and AI-driven solutions for analytics, diagnostics, and clinical trials.

I’ve advised a startup working on AI to predict hospital readmission risks, and another developing a home monitoring device for patients with chronic obstructive pulmonary disease.

There’s growing interest in combining big data and machine learning to improve drug development and predict side effects. Remote patient monitoring is also evolving quickly—it boosts treatment adherence and provides pharma companies with real-world, actionable insights.

— More broadly, which digital technologies are shaping the global pharmaceutical ecosystem, and how are they changing business expansion strategies?

Technologies that enhance transparency, speed, and control across the drug development and distribution cycle are having the biggest impact. These include data management platforms, big data and AI in clinical trials, electronic regulatory submissions, and supply chain tracking systems.

AI is revolutionizing molecule discovery—it can analyze vast genomic and chemical datasets. In personalized medicine, AI helps tailor treatments based on a patient’s genetics, lifestyle, and medical history.

Internet of Things and Internet of Medical Things are also growing rapidly, enabling continuous patient monitoring and direct communication with physicians. These tools can also track the pharmaceutical supply chain—monitoring temperature, humidity, and location to ensure integrity from manufacturing to the pharmacy. That’s especially crucial for temperature-sensitive drugs.