Pre-Conference Workshop Day
Tuesday, March 18, 2025
7.30: Registration & Coffee
Opening Your First Expanded Access Programs
8:30 am Guiding Principles for Successfully Establishing & Managing an Early Access Program (EAP)
Synopsis
- Delving into the essential considerations for planning and executing an EAP that aligns with your company’s vision, product pipeline, and patient needs
- Exploring strategic approaches to managed access, including identifying critical requirements, anticipating common challenges, and understanding the core principles needed from program inception
- Address system development strategies, providing insights on what can be achieved and how to implement effective solutions
Advanced Challenges in Expanded Access Programs
8:30 am Navigating Regulatory Requirements in Transitioning from Free-of-Charge to Commercial Programs
Synopsis
- Understanding the key regulatory considerations and compliance issues when moving patients from free-of-charge programs to commercially available treatments
- Identifying the stakeholders who should be engaged in this transition process to ensure a smooth and compliant shift
10.30: Morning Break
11:00 am EAP Procedures: Stakeholder Management, Internal Alignment & Ethical Considerations
Synopsis
- Deciphering which stakeholder will be involved in setting up programs and the key roles of each function
- Setting up a singular tracking system and portal to ensure cross-functional alignment
- Exploring stakeholder engagement, including best practices for gaining internal buy-in, cross-functional collaboration and CRO management
- Identifying the ethical considerations that need to be taken into account
11:00 am Operationalizing Post-Trial Access: Planning & Running to Ensure Continued Access to Medicines
Synopsis
- Analysis factors that need to be taken into account when deciding whether to execute a PTA study and what are the alternative options?
- Highlighting the ideal time to start having conversations around running a PTA program
- Exploring are the labelling and supply requirements for a PTA depending on the country you are running it in
- Deciphering the data requirements for a PTA depending on the country you are running it in
- Evaluating whether to use commercial or clinical supply for PTA and what are each countries guidance on this
1.00: Lunch
2:00 pm Strategic Exit Planning for Transitioning Patients from EAPs to Commercial Products
Synopsis
- Providing critical insights into crafting effective exit strategies, ensuring a seamless transition for patients to commercially available treatments
- Exploring the key drivers for program termination and learning how to plan exit strategies in advance
- Addressing the complexities of handling multiple programs across different countries, considering local regulations, management challenges, and financial constraints, laying out various scenarios for transitioning patients from ongoing programs to commercial access
2:00 pm Examining Nuanced Scenarios for Transitioning Patients from EAPs to Commercial Products
Synopsis
- Highlighting several scenarios of hurdles that might arise when planning and executing an transition strategy, including no reimbursement, delayed reimbursement, and changes in companies’ strategy
- Brainstorming strategies to support end-to-end access for patients, navigating reimbursement approval timelines, local regulations and managing off-label requests
4.00: Afternoon Break & Networking
4.30: Workshop Run by myTomorrows
