Why Attend the 4th Operationalize Expanded Access Programs Summit?
Your one-stop shop to capturing industry’s latest case studies in setting up a program globally, reaching physicians and patients, collecting real-world data, and maximizing vendor selection to improve the operationalization of EAP and streamline access to life-changing therapies.
Following a momentous increase in pressure from the FDA for biopharma to run EAPs, global requests for access to drugs and data on safety and efficacy, the need to open an EAP and subsequently enhance its operationalization is more evident now than ever before.
We’ve witnessed an upwelling of excitement and advances in 2023, but challenges remain – how do we navigate evolving global regulatory policies? What is the role of RWE in an EAP? How do we define a clear exit strategy? Can we standardize the approach across the supply chain? How can we work better with physicians?
25+ experts in managed access, medical strategy operations, clinical supply leads, physicians, patients, and vendors will deep dive into your burning questions by sharing their latest experiences to pinpoint potential solutions for advancing your early access programs to help as many patients as possible.
Unmissable Highlights Include:
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