Advancing Point-of-Care Multi-Omics & AI in Clinical Practice: Regulatory Readiness Across Medical Devices and Pharma

Description: Point-of-care multi-omics approaches, spanning genomics, transcriptomics, proteomics, and metabolomics, are beginning to move from research into clinical application. Artificial intelligence (AI) is emerging as the key to making these technologies actionable at the bedside, integrating complex data to support earlier diagnosis, predict treatment response, and enable personalized patient management. The convergence of AI and multi-omics holds enormous promise for transforming clinical practice through applications such as early cancer detection, treatment response prediction, and real-time patient stratification. However, regulatory frameworks are still adapting to this rapid innovation, and challenges around data quality, validation, algorithm transparency, and ethical use must be addressed.

This session will explore how regulatory professionals can anticipate and navigate the challenges of bringing omics-driven, AI-enabled platforms into clinical practice. Both device and pharmaceutical regulatory perspectives will be considered. Participants will gain insights into current on-market point-of-care solutions and their regulatory strategies, evolving expectations for data quality, validation, and reproducibility, and how these intersect with patient safety and ethical considerations. The session will also highlight regulatory trends in Europe and globally, including how agencies are approaching complex datasets, algorithm transparency, and real-world evidence integration. We will examine the potential for regulatory approval of large language/omics models.

To ensure practical insights and real-world relevance, the session will feature contributions from an industry representative of a company providing CE-marked multi-omics solutions at the point of care, alongside experts from pharmaceutical regulatory affairs. This mix of perspectives will show how device and pharma regulatory domains can be bridged in practice, offering participants a comprehensive view of regulatory readiness for emerging technologies.

By bridging the device and pharma regulatory divide, this session provides participants with actionable strategies to engage across domains. Attendees will be better prepared to guide their organizations in adopting next-generation omics-based and AI-enabled tools while ensuring compliance and patient safety.