Conference Day Two
8:25 am Check In & Morning Coffee
9:25 am Chair’s Opening Remarks
Determining the Role of Real-World Data & AI in EAPs
9:30 am Roundtable Discussion: Is Collecting Data Vital for Running a Successful EAP?
Synopsis
- Practical considerations for hospitals and patients when collecting real world data in an EAP
- What are the necessary ethical considerations and protocols needed to be in place to collect data?
- What are the different considerations for data collection for unlicensed or approved products
10:00 am How an AI Informed Global Governance Platform Can Transform Your Managed Access Programs
Synopsis
- Boost productivity with a centralized case management system powered by artificial intelligence
- Facilitate seamless collaboration amongst global teams, from Madrid to Miami
- Simplify the HCP application with automation and an easy to use interface
- Capture Real-World Data and gain AI-informed insights
10:30 am Morning Break & Networking
Charting the Path Forward for Clinical Supply Excellence
11:30 am Highlighting Practical Strategies to Successfully Deliver a Project in the Middle East
Synopsis
• Sharing previous experiences on how to navigate the regulations in the Middle East and Africa
• What are the important factors to consider ensuring it runs smoothly?
• Highlighting the lessons learnt from when it hasn’t gone according to plan
12:00 pm Panel Discussion: Ensuring Labelling Consistency Across the Supply Chain
Synopsis
As industry seeks increased flexibility for packaging and labelling to meet geographical and forecasting complexities, let's discuss:
- What factors need to be considered to allow for a streamlined labelling process?
- What are some the factors affecting your supply chain considerations when deciding on labelling and packaging solutions in today’s climate?
12:30 pm Lunch Break & Networking
1:30 pm Licence Withdrawal: Rapidly Pivoting to Ensure Continuity of Care
Synopsis
• Ensuring continued drug supply to several hundred patients
• Effective communication with HCPs and internal stakeholders
• Setting up the internal and external infrastructure to ensure streamlined approach to processing the volume of requests
Overcoming Operational Challenges & Mitigating Data Privacy & Legal Issues
2:00 pm Deep Diving into Processes & Systems for EAP
Synopsis
• Developing a platform for program management
• Partnering with digital teams and vendors
• Reporting metrics and turnarounds times
2:30 pm Access to ATMPs: Is Charging the Only Option to Achieve a Sustainable Model?
Synopsis
- Pricing: Determining how much to charge (COGS vs. reimbursable cost, variability across markets, etc.)
- Stakeholder Involvement: Bringing others to the table when revenue is generated (executive/commercial, finance, etc.)
- Patient Community: Continuing to provide access without sacrificing sustainability (equitable does not mean free)
3:00 pm Afternoon Break & Networking
3:30 pm Navigating & Successfully Setting Up an Expanded Access Program for an Ultrarare Disease
Synopsis
• How do you handle an ultrarare disease?
• How do you get drugs into countries without well-defined regulations
• How do you proceed with continuing a drug within this disease post FDA approval in different countries?
4:00 pm Roundtable Discussion: Informed Consent & Assent: Raising Consciousness About the Importance of Consent
Synopsis
• What are the best practices globally about how you do consent?
• Ensuring patients are fully aware of the risks involved
• Optimizing the circulation of data between patients, physicians, and manufacturers