Archives: Agenda
Afternoon refreshments and networking
NETWORKING DRINKS
Clinical trials surged in H1 2025! What happened and what you must know to stay ahead
GlobalData’s clinical trials data indicates that new trials initiated in H1 2025 has increased significantly over previous years. In addition to surprising Wall Street, this has shaken up the biopharma competitive landscape and created major opportunities for CROs, CDMOs, Pharma Tech, and consultancies. Behind the headlines, clinical trial reporting lags, shifting start dates, and withdrawals make it easy to miss where the real growth is happening.
This session breaks down what drove the surge, where the next wave is coming from, and how early signals can give you the edge on predicting future market shifts. Whether you run trials, manufacture at scale, or advise life sciences companies, this is about being prepared, before your competitors are.
T-cell immunotherapy: trends and insights shaping clinical development
• Overview of the T-cell immunotherapy landscape
• Trends in regulatory approvals and designations impacting trial timing and logistics
• Market outlook and projected growth through 2031 and the implications for supply planning
• Clinical trial insights, including leading countries and key challenges affecting trial execution
Using PMPF to expand intended purpose and strengthen clinical claims
- Designing general-purpose PMPF studies to validate new settings, claims, or patient population
- Addressing gaps from initial submissions and identifying emerging risks
- Using PMCF outcomes to support intended purpose expansion or claim updates
Q&A session: lessons learned from former Notified Body expert
- See how to align robust clinical evidence for MDR from an NB perspective
- Bridge the gap between reviewer expectations and sponsor realities
- Optimize clinical trial design and submissions for smoother approval