As neoantigen therapies advance into clinical development, optimising clinical trial design and operational setup becomes critical to ensuring scientific validity, regulatory alignment, and overall programme success. Careful planning of endpoints, patient stratification strategies, biomarker integration, manufacturing timelines, and site coordination is essential to minimise delays, control costs, and generate robust, interpretable data. This workshop will provide an in-depth exploration of best practices in clinical trial setup to equip you with the strategic and operational insights needed to execute streamlined, data-driven, and successful trials.

This workshop will gather experts to discuss:

• Design robust trial protocols to successfully meet regulatory requirements
• Align manufacturing timelines and supply chain logistics with clinical trial sites to ensure timely treatment delivery
• Optimise patient selection approaches to improve response rates and meet primary endpoints
• Generate mechanistic insights through immune monitoring and translational biomarker analysis
• Navigate varying regulatory requirements to support smoother global trial execution