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This article reviews industry data that highlight the reality facing various stakeholders in Europe when it comes to access to new medicines, and why an early access program (EAP) is an important component for future commercial success. The premise and key foundational element of early or expanded access is to allow patients with serious or […]

Imagine that your loved one is diagnosed with a rare disease. The first thing you do is to go to the internet to understand what you can about this disease including how the disease is treated. You learn that, as for most rare diseases, no approved medicine exists

It’s important for pharma and biotech companies to think about how various stakeholders interact with publicly available information about the company’s medicines in development.

I have been associated with expanded access or named patient programs for innovative medicines for nearly 25 years, both on the sponsor side and on the service provider side. These access programs provide opportunities for patients to get access to a lifesaving or life-changing medicine when they cannot participate in a clinical trial, or the