Expanded Access is a reality in today’s clinical development environment. An Expanded Access Program (EAP) is a formal plan under which preapproval access to an investigational drug is provided to a group of patients. There are practical issues relevant to EAP decision making, particularly around implementation considerations. There are a multitude of considerations of when to initiate an Expanded Access Protocol and guidance on the proper exit strategy. Some, but not all, pharmaceutical companies have embraced EAPs. This session will provide valuable insight into the considerations, risks and commitments that will enable a company to decide whether it is right to go ‘all in’.
Learning Objective : 1. Overview of the regulatory tools and schemes available to drug developers to help augment patients access
2. Address key areas such as access versus evidence trade-off, using lessons learned from the Adaptive Pathways Pilot
3. Focusing on parallel HTA advice - that drug development, pre- and post-licencing must address questions relevant to all stakeholders
Stakeholder Tools to Facilitate Patients Access: A Trade-Off of Uncertainties?
Richard Huckle, MSc
Senior Consultant, Regulatory Affairs
Pope Woodhead and Associates Ltd, United Kingdom