- Building redundancy into supply chains to mitigate risk from production, transport, or equipment failures
- Managing complex customs, import/export, and radioactive materials regulations across trial countries
- Ensuring quality control and radiopharmaceutical stability testing within extremely narrow time windows
- Embedding patient voices into research, development, and lifecycle management
- Building a structured framework to gather, evaluate, and apply patient insights
- Enhancing clinical outcomes through patient-driven innovation
- Success story: Transforming the patient journey with an on-body injector for chemotherapy care
- Unpacking the challenges and complexities inherent in the full pharmaceutical supply chain journey, from production to final patient delivery
- Navigating regulatory demands and ensuring ongoing compliance across the chain
- Reviewing the practical strategies used to enhance performance and quality across the entire supply chain
- Identifying the right point for CRO involvement to improve efficiency and execution
- Leveraging CRO insights to optimize protocol design, country selection, and study feasibility
- Establishing clear communication, shared accountability, and collaborative ways of working
- Global market trends and US FDA regulatory perception
- Establishing a strategy for New drug development in line with updated guidance from US FDA
- FDA engagement strategy: pre-IND/IND and accelerated clinical programs
