- 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
- Leveraging patient insights to enhance clinical trials and create life-changing value for patients
- Building a roadmap to embed Patient Engagement as a standard practice throughout the development process
- Establishing the Dev PE process, a common framework for planning and implementing Patient Engagement across projects
- 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
- Checking out what’s working and what could be better
- Looking at the difference between research done purely for research versus for commercialization, and what that means for patients given today’s
