Day Two

• Understanding how personalized and patient-specific mRNA products are being approached by EMA and MHRA
• Learning from ongoing oncology-focused mRNA trials navigating the current patchwork of global expectations
• Discussing gaps in guidance for non-infectious mRNA indications and how companies are addressing them

• Explore how regulatory sandbox models can provide early, flexible engagement with agencies to de-risk novel mRNA therapeutic development
• Understand how platform-based regulatory strategies can streamline approvals by leveraging prior data across multiple products
• Learn from emerging case studies on how these frameworks have reduced timelines, improved regulatory predictability, and enabled faster patient access

• Comparing how EMA, FDA, and MHRA currently define and assess mRNA-based therapeutics
• Understanding where regulatory definitions diverge (e.g., biologic vs. ATMP) and how to plan accordingly
• Learning how companies are building global regulatory strategies that reduce friction and misalignment

This networking session is your opportunity to get face-to-face with many of the brightest minds working in the mRNA field and establish meaningful business relationships to pursue for the rest of the conference

• Understand best practices of safety monitoring during clinical trials to ensure robust safety oversight
• Learn how post-marketing studies and close interaction with health authorities shape ongoing patient safety and regulatory compliance.

• Explore how barcoded nanoparticles generate high-resolution datasets to map RNA delivery efficiency across tissues
• Learn how machine learning algorithms decode complex delivery patterns to optimise formulation design
• Understand how this approach accelerates the translation of RNA therapeutics with improved targeting and efficacy

• Accelerating Neoantigen Discovery – How AI integrates genomic, transcriptomic, and immunological data to rapidly identify and prioritize tumor-specific targets
• Optimizing Vaccine Design – Using predictive models and adaptive strategies to anticipate immune response and iteratively refine personalized formulations
• Translating Innovation into Impact – Case studies where AI platforms have shortened development timelines, improved patient outcomes, and opened new horizons for immunotherapy

• Discovering how saRNA and circRNA are redefining RNA’s potential with longer lasting expression, lower dosing, and expanded therapeutic applications
• Understanding the scientific and clinical implications of modality-specific challenges, from immunogenicity to delivery complexit
• Learning from pioneering case studies translating next-generation RNA formats into viable therapies across oncology, rare diseases, and beyond

• Explore how CycloPhore™ and SemaPhore™ overcome delivery barriers to enable the extrahepatic delivery of circular RNA and mRNA
• Understand the platform’s potential for improving stability, targeting, and translational efficiency of RNA therapeutics
• Learn how patented delivery technologies are advancing the development of novel RNA modalities

• Explore how viral-like particles (VLPs) enable efficient delivery of large circular RNA constructs for gene expression
• Review preclinical data showing improved stability and expression outcomes compared to linear RNA formats
• Understand the translational potential of VLP–circRNA systems for advancing nextgeneration gene editing therapies