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?


  • 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


  • 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


• 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


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


• 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


• 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?

  • Ruth Rostron Director of EAP Program Management, Durbin Plc.


  • 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

  • David Stein Director, Medical Operations, Regeneron Pharmaceuticals Inc
  • Maggie McDermott Senior Specialist, Global Medical Operations, Regeneron Pharmaceuticals Inc


• 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


• 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

4:30 pm Chair’s Closing Remarks

4:40 pm End of Conference Day Two