- Determining the optimal stage for CRO engagement to maximize efficiency
- Engaging CROs in protocol development to inform strategic decisions, including country selection and trial design considerations
- Leveraging CRO expertise by fostering a collaborative, partnership-driven relationship
Archives: Agenda
CASE STUDY: Optimizing T Cell Engaging Therapies from Preclinical Study to Human Clinical Trial: Conditional Activation of T Cell in the Tumor Microenvironment by a Novel 4-1BB T Cell Engaging BsAb (Grabody T)
| · The Grabody T platform: A Clinically Validated 4-1BB Bispecific Antibody Approach to Overcome Liver Toxicity
· Grabody T Exhibits TAA-Dependent 4-1BB Activation and Strong in vivo Efficacy · Promising Clinical Activity and Favourable Safety Profile Across the Grabody T Pipeline (Givastomig, Ragistomig, and YH32367) |
Tracking Global Rare Disease Trial Trends and Preparing for 2027
- Where rare disease trial activity is growing/declining and which indications are driving this
- Geographic shifts in where trials are being conducted and emerging locations to watch
- Benchmarking trial size, duration, sites/countries and other operational metrics against industry standards
- How trial designs are evolving, including adaptive/platform approaches and strain-agnostic development
- What the current pipeline and data suggest for 2027 and beyond
END OF CONFERENCE
Managing Long-Term Follow-Up in Rare Disease and Advanced Therapy Trials
- Building sustainable long-term follow-up strategies
- Keeping patients engaged over many years
- Using registries and real-world data effectively
- Preparing sites for extended study commitments
Streamlined Biosimilar Development in Cancer
Session reserved for event sponsor
Lunch and networking
Session reserved for event sponsor
Breaking Down Silos – What Clinical Development and Drug Safety Can Learn from Each Other in Rare Disease Trials
- 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