About Event
What Was in Store at the Inaugural Operationalize: Expanded Access Programs West?
An escalating stream of companies are launching programs to enable access to investigational and pre-approval therapies to patients in need. However, as more programs launch, the complexities of intricate regulatory and operational nuances prove immense challenges. But with no centralized guidance on opening, managing, and exiting programs on the global stage, it has never been more important to find your community.
Experts turbocharged their understanding of the Expanded Access landscape, whether the focus is on Real-World Data, Post-Trial Access, Reimbursement Opportunities or Cell and Gene Therapy, this event gave you the tools and insights to increase your program implementation and stay ahead of the curve.
Are you seeking to connect with pioneering senior leaders in the Expanded Access space, including experts in Pre-Approval Access, Clinical Operations, Medical Affairs, Clinical Supply and Patient Advocacy?
This exclusive community joined over three days to explore the complex regulatory landscape, assess the potential of Real-World Data to support regulatory approval, gain hard-won lessons on exiting your programs, and unlock the full potential of their company to implement effective Expanded Access to patients in need.
Companies Who Spoke on the Program:
What Your Peers Have to Say:
“With so many industry professionals in one place, I learned about numerous aspects of managed access and met experienced vendors who can provide support. On a personal note, this meeting has a noncompetitive atmosphere, where different companies can learn from one another’s best practices, ultimately making it better for patients around the world” - Gilead
(Attendee at the 5th Operationalize: Expanded Access Programs Summit 2025)
“The openness and collective sharing were invaluable. Hearing from different sized companies with varied histories around access really helped pressure test options and philosophies that could be implemented” - Biogen
(Attendee at the 5th Operationalize: Expanded Access Programs Summit 2025)