Rapid deployment of a compassionate use program

During the peak of the COVID-19 pandemic, a global compassionate use program (CUP) was urgently needed to provide compassionate use of a promising treatment. The program required rapid deployment across multiple regions to support hospitalized patients. 

• Designing and implementing a global EAP under extreme time pressure
• Navigating global regulatory complexity and process requirements to expedite drug shipments – Coordinating among diverse stakeholders during a global health crisis
• Ensuring 24/7 operational readiness for case intake and document review 

To overcome the challenges of deploying a global Expanded Access Program (EAP) during the height of the COVID-19 pandemic, a unified and collaborative approach was adopted. ICON, the sponsor, the FDA, IRB, and various vendors worked together as a team, streamlining communication and decision-making. A strategic “sun-up/sun-down” model was implemented to ensure continuous coverage for case intake and essential document reviews across time zones. 

A centralized program platform was developed, incorporating agreed-upon metrics to monitor progress and ensure transparency. Internal coordination was facilitated through global managers across North America, Europe, and Asia Pacific, enabling seamless cross-regional communication. Additionally, a governance structure was established with a strong emphasis on risk management, ensuring regulatory compliance and operational integrity throughout the program.

• Rapid start-up: Achieved a 5-day turnaround from final protocol approval to first patient dosing.
• Swift activation: The first country (EU) was activated just 9 weeks after the award.
• Real-time monitoring: A portal was launched to provide daily enrollment metrics.
• 24/7 case review: Enabled continuous case processing and essential document review to expedite global drug shipments.
• Global impact: The data collected supported global regulatory approvals for the treatment of hospitalized COVID-19 patients.