Antibiotic resistance is the third leading cause of death, globally, claiming almost 5 million lives every year, with this projected to increase …
The Hidden Complexity of Global Early Access: Lessons from the Field
The Hidden Complexity of Global Early Access:
Lessons from the Field
By Estelle Canazilles, Senior Program Manager
When I tell people I work for a company that’s specialized in early access to medicines, I find that the easiest way to describe what we do is that there is a patient in need, a medicine available, and we are the bridge between the two.
In reality, that bridge spans continents, regulations, ethics, and time zones, and every step must be perfectly aligned to deliver hope safely.
As someone who has spent 8 years managing global early access programs (EAPs), I’ve learned that what looks like a straight path on paper is, in fact, a delicate network of moving parts. Each program involves multiple stakeholders: sponsors, physicians, regulatory authorities, logistics providers, all working together under immense pressure to make a difference to patients and their family.
The Challenge Behind the Mission
Early access programs (EAPs) are designed to provide potentially life-saving treatments to patients before full commercial approval. But implementing them globally is far from straightforward.
Every country interprets “early access” differently. Regulatory timelines vary, documentation requirements change, and local ethical standards must be carefully respected. Aligning these variables while maintaining compliance and speed is like conducting an orchestra where each musician plays from a slightly different score.
Then comes the human layer. Physicians want to help their patients as soon as possible. Sponsors are under pressure to deliver safely and responsibly. Regulators must balance compassion with control. It’s a landscape where empathy and structure must coexist and both are non-negotiable.
Lessons from the Field
After years of coordinating EAPs across regions, a few lessons stand out, not just about project management, but about people, purpose, and perspective.
1️⃣ Clarity beats complexity. In fast-moving, high-stakes environments, ambiguity is the enemy. I’ve seen how a single misunderstanding about documentation or shipment timelines can cascade into weeks of delay. The more complex the program, the more essential clear communication becomes, across teams, time zones, and languages.
2️⃣ Cultural intelligence matters. Global programs mean global mindsets. Understanding how urgency, hierarchy, or compliance are perceived in different countries changes everything. What feels like efficiency in one culture may come across as pressure in another. The ability to listen and adapt is just as valuable as technical expertise.
3️⃣ Empathy drives excellence. When the pressure mounts (and it often does), remembering why we do this work keeps everyone grounded. Behind every physician’s request and approval is a real patient. Precision and compassion are not opposites; they’re partners.
The Bigger Picture
Early access programs aren’t just logistical exercises. They are lifelines, ensuring that innovation reaches those who need it most, even before full market authorisation.
Each successful program is proof that when science, regulation, and purpose align, we can bridge the gap between discovery and access. And while the process is undeniably complex, it’s that very complexity that makes the work meaningful.
Because in the end, early access isn’t just about delivering medicines early. It’s about delivering hope responsibly.
I’d love to hear from others who’ve worked on global healthcare programs: How do you balance urgency, compliance, and compassion in your work?
Antibiotic resistance is the third leading cause of death, globally, claiming almost 5 million lives every year, with this projected to increase …
Antibiotic resistance is the third leading cause of death, globally, claiming almost 5 million lives every year, with this projected to increase …