In July 2024, leaders from Bridge Biotherapeutics, AriBio, and Novotech gathered in Seoul to discuss the regulatory and operational challenges of conducting clinical trials in Europe. Theis roundtable focused on selecting trial locations based on cost, time, and quality, while offering insights into Europe’s Clinical Trials Regulation (CTR) and the importance of partnering with experienced CROs to navigate local complexities.
Understanding European Regulatory Changes
For Korean biotech companies looking to expand into Europe, understanding the continent's regulatory framework is critical. The European Medicines Agency (EMA) provides clear communication and strong intellectual property protections, but managing the high costs and regional differences across the continent can be challenging. As regulations harmonize under the Clinical Trials Information System (CTIS), conducting clinical trials in Europe is becoming more streamlined, but local regulatory nuances remain.
Managing Costs and Timelines in European Clinical Trials
One key takeaway from the roundtable was the growing attractiveness of Central and Eastern Europe (CEE) for clinical trials. Regions like Poland and Hungary offer lower costs and access to diverse patient populations, making them ideal for trials. However, panelists like Yooni Kim of Novotech and James Jungkue Lee of Bridge Biotherapeutics emphasized that inflation and recruitment difficulties still pose significant barriers, particularly in these regions.
Korean biotechs need to carefully assess site startup times and inflation’s impact on their budgets, while considering local expertise and cost-effective strategies to ensure trial success.
Choosing the Right European Locations
Selecting the right trial location in Europe is essential for Korean biotechs. Panelists highlighted the importance of balancing patient recruitment, cost-efficiency, and quality. Eastern Europe offers cost advantages but faces recruitment challenges, while Western Europe can provide access to more established healthcare systems, albeit at a higher cost. Ensuring that Principal Investigators (PIs) have a proven track record in conducting trials is crucial for success.
Partnering with CROs for European Success
Navigating Europe's regulatory landscape is complex but partnering with a CRO that understands local and regional requirements can be a game-changer. A CRO like Novotech provides expertise in overcoming regulatory hurdles, ensuring compliance, and expediting site startup processes. Korean biotechs aiming for faster patient recruitment and smoother trial operations will benefit greatly from such partnerships.
Patient Recruitment Strategies in Europe
One of the critical challenges for clinical trials in Europe is patient recruitment, especially for rare disease research. Central and Eastern Europe offer diverse and treatment-naïve patient populations, which is a significant advantage. However, the limited pool of patients in certain regions and recruitment difficulties can delay trial timelines. The roundtable emphasized the need for tailored recruitment strategies to ensure smooth trial progression.
Conclusion
For Korean biotechs expanding into Europe, understanding the region’s regulatory and operational challenges is key to trial success. By selecting the right locations, managing costs, and partnering with experienced CROs like Novotech, biotechs can navigate these hurdles more effectively, ensuring successful clinical trials and faster market entry.