- Addressing recent site performance concerns and rebuilding trust when site credibility is questioned
- Identifying common gaps in oversight, governance to avoid actively monitoring site work
- Understanding policies and competing with limited resources at sites
- Enhancing site staff training, culture and accountability of clinical research
Archives: Agenda
Lunch and networking break
KEYNOTE: Demystifying Artificial Intelligence in clinical trials: Turning promise into practice
- Overcoming the hype: Moving from pilot projects to real-world applications of AI in pharma
- In a conservative and cautious industry, are we ready for AI?
- Reskilling for the AI Age: Preparing today’s workforce for the future, equipped with data-centric skills
- Unveiling but disparaging AI myths in clinical research
PANEL DISCUSSION: Study start-up challenges in a competitive environment
- Overcoming financial constraints when budgets are limited and resources tight
- Fierce site competition: How start-ups can compete with established companies for sites
- Utilizing effective planning to improve study and program efficiency without compromising patient safety
- Agile and adaptable: Being prepared to adjust your strategy and approach as needed
The 2026 biotech landscape: Perspectives and projections
- Trends observed during the JP Morgan Healthcare conference
- Navigating geopolitical complexity, regulatory shifts, and a more selective funding environment
Sponsor’s oversight responsibilities on regulatory submissions for outsourced clinical trials – Integrating the Target Product Profile
- Sponsor Accountability: Ultimate responsibility for regulatory submissions remains with the sponsor.
- Target Product Profile Integration: Acts as a strategic anchor for submission quality and alignment.
- Effective Oversight: Governance, communication, and risk management ensure compliance in outsourced settings.
Beginning with the end in mind: Building effective long-term follow-up strategies in complex therapy trials
- Emphasize the critical role of LTFU in cell and gene therapy trials and why early planning matters
- Outline key logistics and operations considerations (site readiness, patient tracking, communication pathways) that minimize follow-up costs and support successful LTFU models
- Highlight the importance of early patient education and engagement and use of remote or virtual visits to improve retention and compliance
- Share broad learnings from past programs where proactive LTFU planning facilitated compliance and improved cost predictability
Chair’s introductions
PRIZE DRAW
Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!