Archives: Agenda

• Questioning whether current AI tools are overpromising and underdelivering in real clinical operations
• Exploring where AI implementations are stalling due to data quality, integration and change-management challenges
• Examining regulatory, validation and inspection readiness concerns that are slowing adoption

• Embedding patient-reported outcomes (PROs) early to streamline oncology trial operations and control cost: How PROs in Phase I/II can deliver clearer tolerability and patient-experience data, supporting faster decisions and more efficient Phase III planning
• Operationalizing digital endpoints (eCOA) for speed, quality, and patient-centricity: Practical strategies for configuring eCOA to accelerate startup, and reduce patient burden
• Using digital endpoints to enable risk-based oversight and phase-to-phase continuity: How continuous, real-time eCOA data supports centralized/risk-based monitoring, and robustness of regulatory and scientific outcomes

• Exploring how communication styles, cultural mismatches and unspoken assumptions derail trials more than processes or systems
• Supporting teams by aligning expectations, roles and behaviour before contracting, not after issues emerge
• Strengthening long-term partnerships with transparent conflict resolution models and joint decision-making practices

Moderator: Peter Barschdorff, Vice President, GlobalData

• Exploring why innovations stall at pilot stage
• Supporting organizations to scale meaningful improvements
• Strengthening alignment and accountability across teams

Moderator

John Seman, CEO, Revitale Pharma

• Transforming Protocol to Execution: How AIKA uses advanced AI to streamline protocol generation, enhance feasibility analysis, and reduce study start-up timelines
• Data-Driven Decision Support: Leveraging real-time operational insights and predictive analytics to improve trial performance and risk mitigation
• Scaling Clinical Operations: Practical examples of AIKA in action, from automated task orchestration to cross-functional collaboration that drives efficiency and quality

• Understanding patient expectations when a treatment shows clear benefit during a trial
• Managing continuation pathways once a study ends and the therapy is not yet commercially available
• Exploring where sponsors, sites, and physicians struggle to align on responsibility and feasibility

• Baselining the magnitude of China Biotech & Pharma
• Understanding the shift for the broader industry
• Reflecting on China market realities
• Implications for agencies, contractors, and vendors
• The way out