Takeaways from Operationalize Expanded Access Programs 2024
We had a great time at the Operationalize Expanded Access Programs Conference in Boston last week. The conference focuses on learnings for sponsors providing access to pre-approval medicines for patients with unmet needs.
Common themes
Data
Data - the collection and use of it - remains a major topic. We heard about the challenges of collecting data from EA programs using existing systems along with questions about how much data is appropriate to capture. There’s an increasing interest in information which can provide insight into trends or signals about treatment. Regardless, a reliable, GxP compliant system is a must.
Efficiency & oversight
Many attendees talked about the time and complexity required to respond to inquiries, and the difficulty of coordinating stakeholders, both internal and external. Supporting clinicians who are trying to obtain treatment for their patients requires ensuring that they know exactly what they have to do. Conversely, the clinician often knows how to navigate the processes to help a company get a treatment into a new country. Ensuring that communication is transparent to everyoneand that the status of a request is easily accessible is crucial.
Global programs
There were many presentations about how to run programs around the world, from working in the Middle East to an overview of delivering humanitarian aid into war zones. It’s impressive to see the lengths to which companies will go to get treatment to the patients who need it, often under very difficult circumstances.
The flip side of this is the difficulty companies face in tracking and complying with regulations around shipping treatment into countries, many of which have very different requirements, which are often not terribly well documented. Using a system with the flexibility to set up and manage programs by country can help ameliorate these changes.
Takeaways
As a technology company enabling access to pre-approval medicine, we focus on the places where we can help address these challenges. There are clear areas where our platform provides solutions to these pain points:
providing a secure and flexible platform for data collection
structuring workflows to help ensure that regulatory requirements are met
enabling collaboration
providing a checklist to ensure visibility
automating reminders
We left the show excited about where we are and with many ideas for what needs to be done next!