Biologics in Motion: Navigating the Clinical Trials Landscape in Europe

The European clinical trial landscape for biologics is experiencing a period of dynamic growth and transformation, underpinned by regulatory modernisation, increasing therapeutic innovation, and expanding cross-sector collaboration. This session will provide a comprehensive overview of current trends in clinical trials involving biologics across Europe, including therapeutic focuses, sponsor profiles, and the impact of new frameworks such as the Clinical Trials Regulation (EU) No 536/2014, which seeks to streamline processes and facilitate multi-national studies.

Bringing together a range of expert perspectives, the session features a pharmaceutical sponsor presenting a real-world case study from ongoing biologics trials in Europe. This will highlight operational challenges and strategic decisions from trial planning to implementation. A clinical Contract Research Organisation (CRO) will contribute field-level insights on the evolving dynamics of trial design, patient recruitment, and regulatory navigation. In addition, a French clinical centre will provide a focused examination of the regulatory landscape as experienced by investigative sites, offering practical commentary on ethics approvals, regulatory submissions, and institutional readiness within the current framework.

By integrating these diverse viewpoints, the session aims to equip stakeholders with actionable knowledge and a nuanced understanding of the opportunities and challenges shaping biologics trials in Europe today.