Archives: Agenda

• 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

• Moving beyond transactional outsourcing toward integrated partnership models​
• Mitigating operational unpredictability with clear governance, escalation,​ and proactive engagement​
• How CROs differentiate through delivery consistency and functional expertise

• Exploring how regulatory and economic shifts disrupt timelines
• Supporting teams to adapt while protecting patient access
• Strengthening readiness for rapid pivots in study delivery

Moderator:

Mary MacDonald, Director, Clinical Quality Assurance, Eisai

• Exploring lessons from shifting between outsourcing models
• Supporting clearer expectations between sponsors and CROs
• Strengthening RBQM alignment across portfolios