Dmitry Sharov, founder and CEO of OCT, shares the state and prospects of the clinical research market in a recent interview.
— The primary goal is to advance strategic pharmaceutical partnerships. The forum was conceived as a platform for direct dialogue among pharma and biotech companies, government representatives, research sites, and investors. The first forum in 2023 was organized with the support of Russia’s Ministry of Industry and Trade. The second followed a year later. Both proved highly relevant. The format with panel sessions allows participants to establish business connections and discuss key topics: clinical trials, drug registration, and import/export of medicines.
— Over the past three years, collaboration between pharma companies in both countries has intensified. Russian pharma shows strong interest in Chinese developments, regardless of their clinical trial phase. Chinese manufacturers seek to register drugs in Russia and the EAEU. For us as a company who provides a full range of high-quality CRO and drug registration services, participating in this initiative is essential. The forum is a practical tool for finding partners, strengthening cooperation with promising pharma projects.
— Initially, the market barely existed. My partner and I partnered with a St. Petersburg research institute to conduct trials on their premises facilities and began faxing proposals to pharma companies. Russia had excellent scientific and clinical infrastructure — the challenge was organizing the application process. Demand grew, and we started receiving requests from Europe and the US. One early project involved testing a surfactant for newborns with undeveloped lungs for an American sponsor. The developer proposed administering a special fluid via lavage tubes to expand the lungs. We obtained the approval from the Health Ministry, contracted 12 maternity hospitals in Moscow and St. Petersburg, and began the trial. The outcome was — 50 of 75 infants survived, a major success given the high mortality rate for this condition at the time. The drug was registered and remains in clinical practice today.
Whenever I reflect on what keeps me in this demanding industry, I think first of the children’s lives saved. It reaffirms that our work matters.
To date, we’ve conducted over 400 trials involving 50,000+ patients and volunteers, including cancer patients who received innovative therapies.
— Previously focused on Central and Eastern Europe, we’ve concentrated on Russia and CIS countries in recent years. We offer end-to-end clinical research services — designing study protocols, selecting sites, obtaining regulatory approvals, collecting data via advanced software, performing statistical analysis, and preparing registration dossiers. If required, we guide clients through the entire registration process — up to drug approval. In Russia alone, we work with 500 clinical research sites staffed by experienced investigators and top-tier physicians. We don’t develop drugs but ensure objective, precise research compliant with international standards.
In clinical trials, what’s at stake is human life. We are paid not just for results, but for the truth.
Our 20-year portfolio spans 400+ projects across all phases and therapeutic areas. This expertise lets us identify and mitigate risks during project planning.
— Clinical trials are the final stage of a multi-step drug development process. After lab research and animal testing (typically mice, sometimes primates), human studies begin. Phase I focuses on safety evaluation, Phase II involves expanded safety, efficacy, and dosing assessments, and Phase III is a large-scale multicenter trial with a large patient population. Following successful completion of these phases, the drug undergoes regulatory approval and is made available for sale. In some instances, studies may continue to monitor the long-term effects.
— Innovative drugs average 10 years; generics may take months; biosimilars — from 3 to 5 years. Participant numbers vary by phase and requested population (healthy volunteers or patients). Early phases involve dozens to hundreds; late-stage trials may require thousands.
— OCT actively tested COVID-19 therapies. We conducted a trial of a Chinese vaccine, enrolling 5,000 volunteers rapidly. The Russian Direct Investment Fund also contracted us to evaluate Russian COVID vaccines for registration in the EAEU and beyond, ensuring dossiers met EMA and WHO standards. This proved our team’s readiness for urgent demands.
— We work with different companies, including government agencies (e.g., FMBA, Ministry of Industry and Trade) running clinical trial tenders, but most clients are private Russian pharmaceutical companies and foreign developers seeking marketing authorization in Russia or including our region in global large-scale studies.
— Our core team is stable. We have a low turnover, with many members in the company 10–15 years. Our cohesive team of experts combines thorough market knowledge with scientific and regulatory expertise. We’ve launched educational initiatives like lectures at Sochi’s Sirius Center and internships for MSU medical students to train the next generation.
— What are OCT’s strategic further goals?
— Expanding internationally, strengthening our global presence, and growing educational programs to nurture young pharma professionals.
