The 5th Annual Operationalize Expanded Access Programs (EAP) Conference, held in Boston this March, once again brought together industry leaders and key stakeholders to discuss the evolving landscape of expanded access and post-trial access programs. Our team had the opportunity to attend, engage in meaningful dialogue, and contribute to the ongoing conversation around how Sponsors, regulators, and access program vendors, like WEP, can continue to work together to better align patient access with regulatory and commercial strategy.
Having worked in the EAP space for nearly a decade, I wanted to share my thoughts and highlight some key takeaways from the conference.
The Evolution of EAP Discussions
The growth of the Operationalize EAP Conference is a strong signal of industry’s continued commitment to expanding patient access to medicines. While many core questions persist year after year, the range and depth of the discussions have evolved. We’re beginning to see more collaboration and strategic problem-solving than we have in years past. There’s now a greater focus on patient-centered solutions, indicating a collective effort to approach access more holistically and build solutions that have a greater number of patients in mind – not just the perfect subjects in a clinical trial.
Real-World Data: A Hot Topic with Growing Complexity
During the conference I presented on the topic of – Aligning Patient Needs with Commercial Goals: The Value of Collecting Real World Data in EAPs. My goal was to highlight the opportunity expanded access and post-trial access programs present to collect data that can be used to help drive drug development and commercialization efforts.
The topic elicited great conversation and lots of questions from the audience. This highlights that, while regulatory flexibility around data collection has improved and Sponsors are more aware of the topic, confusion still remains around what data can be collected, how it should be collected and interpreted, and what the data ultimately can be used for. At this stage, it is clear that execution still lags behind opportunity.
Doing Data Collection Well: Ask the Right Questions
There is no one-size-fits-all solution to RWD collection in EAPs. Success begins with strategic intent: understanding what gaps exist, what objectives the data will support, and what limitations need to be considered. For some Sponsors, the path forward may be to collect what’s feasible now, with a view to future utility – provided it’s done in a way that doesn’t overburden sites or compromise patient care. It is critical that the Sponsor involve key stakeholders across multiple internal groups to align and agree on the data points that will be collected.
A key enabler to succeed in this area? Choosing the right partner with the tools and experience to guide the process effectively.
“It Depends”: Embracing the Uncertainty
A recurring theme at this year’s conference – both humorously and seriously – was the phrase “It depends.” In the world of EAPs, it’s a common and often frustrating term that’s used. For me, I think it reflects the reality of a space that is in constant flux. Whether it’s regulatory requirements, supply chain logistics, or data governance, every program is subject to dynamic variables that will evolve and change over time. Sponsors must strike a balance between strategic planning and operational flexibility.
There’s no perfection in EAPs – but that doesn’t mean we can’t reduce ambiguity through strong planning, clear ownership, and cross-functional alignment.
Regulatory Uncertainty: No Central Source, But Tools Exist
When it comes to navigating global EAP regulations, attendees were eager for a one-stop repository of reliable information. Unfortunately, that doesn’t exist, yet. Instead, Sponsors must draw on a combination of expert partners, internal teams and databases, AI tools, and local consultants to stay up to date.
The key lies in not only understanding today’s regulatory landscape, but proactively monitoring and adapting to changes as they arise. Things are constantly evolving and the regulations of today won’t always be the same in 5, 10, 20 years’ time. It’s about being good stewards of regulatory strategy – keeping programs aligned with today’s realities, while anticipating tomorrow’s changes.
Choosing the Right EAP Partner: More Than Just Expertise
With the vendor landscape becoming increasingly competitive, Sponsors must look beyond capabilities and evaluate partners based on communication, organizational culture, management style, shared values, and long-term vision.
My advice? Choose a partner who shows up consistently – in good times and bad – and who aligns with your organization’s mission and future. Remember, you need a vendor that will do right, in the here and now, for your patients and for you as a clinical company. But don’t forget that someday you are going to continue to grow and become a commercial company. So, make sure your vendor is able to think strategically about your tomorrow – a partner that grows with you and is willing to have the hard conversations.
Final Thoughts
This year’s Operationalize EAP Conference made it clear: the conversation around expanded access is maturing, but many of the foundational challenges remain. Progress is being made, especially in areas like data collection and cross-functional collaboration. But the path forward will continue to be nuanced, regionally diverse, and ever-evolving.
We left Boston encouraged by the energy, engagement, and openness shared across the industry – and more committed than ever to working collaboratively to improve patient access around the world.
