About Event

What You Missed at the 4th Operationalize Expanded Access Programs Summit

In response to a significant surge in pressure from the FDA for biopharma to establish Expanded Access Programs (EAPs) and accommodate global demands for drug access and real-world data on safety and efficacy, the imperative to launch and optimize an EAP became more apparent than ever before.

In 2023, we witnessed a wave of enthusiasm and progress, yet persistent challenges remained. Navigating the evolving landscape of global regulatory policies, defining clear exit strategies, and standardizing approaches across the supply chain were among the hurdles faced. Additionally, questions arose about the role of Real-World Evidence (RWE) in EAPs and the optimization of collaboration with physicians.

Over 25 experts in managed access, medical strategy operations, clinical supply chain management, physicians, patients, and vendors delved into these pressing issues, sharing their latest experiences and insights to identify potential solutions for advancing early access programs. Their contributions aimed to streamline access to life-changing therapies, maximize vendor selection, and enhance operationalization, ultimately benefiting as many patients as possible.

Unmissable Highlights Included:

Successfully streamline the process of setting up your EAP with Alexion, Argenyx and UCB by developing your EAP policy, establish a framework to reach physicians and patient advocates, understand the necessary workflows required and strengthen cross-functional relationships

Leverage the learnings from long-running global EAPs with Novartis, Daiichi Sankyo, Eli Lilly, The PBC Foundation and Her ALS Story to mitigate operational hurdles, understand the approach towards post-trial access and explore methods to effectively involve patients in the set-up of your EAP

Facilitate treatment access for patients across the globe with Sanofi, Biogen, Regeneron, Novartis, and SpringWorks Therapeutics by strategically designing your EAPs to balance the benefits Vs risks in the US, LATAM, and Middle East

Deep dive into crucial conversations with physicians from the University of Michigan and Riboscience to understand their pain points, views on real world data collection and unique solutions to overcome challenges with engagement

Chart the path forward for clinical supply excellence with GSK and Alexion by reviewing multinational labelling requirements and seeking guidance for optimal interpretation to ensure continued drug supply to patients in need

Who Attended?

HW231109 41514 – 4th Operationalize Expanded Access Programs Summit brochure v4