Lightning Talk: Regulatory and Clinical Trial Approaches for On-Body Injectors

On-body injectors (OBIs) are revolutionising the delivery of therapies, enabling a shift from traditional healthcare settings to hospital-to-home care. These innovative devices simplify the administration of complex treatments like biologics, enhancing patient convenience, adherence, and access. However, the integration of OBIs into clinical practice and real-world settings presents unique challenges that require tailored regulatory and clinical trial strategies.

This presentation discusses current approaches in the market for OBIs, with a focus on key considerations for introducing them into clinical trials. It explores how different trial designs can help optimise the timeline for regulatory approval, while balancing the risks and benefits of earlier-phase trials. The presentation also highlights the importance of addressing device usability aspects, ensuring that OBIs meet patient needs and are integrated smoothly into real-world settings, all while maintaining rigorous safety and efficacy standards.