Archives: Agenda

During the Think Tanks session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Think Tank 1: How Can Sponsors Make Rare Disease Trials More Attractive for Sites?

Think Tank 2: Where Are Oncology Studies Losing Time Between Protocol Finalisation and First Patient In?

Think Tank 3: What Is the One Rare Disease Trial Requirement You Would Remove or Redesign?
Hosted by: Frank Tennigkeit, Senior Director Pediatric Development Rare Diseases, UCB

Think Tank 4: Preparing for Regulatory Submissions Dos & Don’ts
Hosted by: Harald Enzmann, Head of European and International Affairs, BfArM, Former CHMP chair

• Understanding where AI genuinely adds value across clinical development
• Validating AI recommendations through expert oversight
• Avoiding over-reliance on plausible but incorrect outputs
• Maintaining accountability while integrating AI into regulated environments
• Lessons learned from implementation across sponsor organisations

• Common challenges during early oncology development to prepare for long-term success
• Choosing the right indications from the outset
• Building meaningful clinical outcome assessments into protocols
• How early strategic decisions influence later stages of development
• Bridging early and late-stage thinking to improve long-term programme success
• Practical lessons and key takeaways for development teams

• Designing studies around the realities of patients and caregivers
• Reducing travel and logistical burden for families
• Supporting long-term participation throughout the study journey
• Building family-centred approaches into protocol design from the outset

Reserved for EUPATI

• Deciding which activities should remain in-house
• Selecting specialist CROs and niche vendors
• Managing oversight without increasing internal headcount
• Building long-term outsourcing partnerships