Archives: Agenda

• The biggest misconceptions Clinical Development and Drug Safety have about one another, particularly in complex rare disease programmes
• Practical lessons from your six-month role swap and how it changed the way you approached collaboration
• How a better understanding of each function’s responsibilities can strengthen decision-making when working with small patient populations and limited clinical data
• Simple ways organisations can encourage closer cross-functional collaboration and improve rare disease study delivery

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

Moderator: Suzanne Abdulwahed, Senior Director Global Regulatory Affairs, BioNTech

• 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