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Expanded Access: Where Are We Now?
Session Chair(s)
Anne Cropp, PharmD
Chief Scientific Officer
Early Access Care LLC, United States
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 : Describe the complex considerations faced by a clinical team when deciding whether to embark on an Expanded Access Program; Describe risks, ethical considerations of an Expanded Access Program; Review key considerations for a thoughtful and responsible exit strategy.
Speaker(s)
Stakeholder Tools to Facilitate Patients Access: A Trade-Off of Uncertainties?
Richard Huckle, MSc
Osiris Pharma, United Kingdom
Regulatory and Development Consultant
Global Patient Access Process
Sarah Alummootil
Early Access Care LLC, United States
Global Patient Access Process: Advocate Perspective
Jennifer McNary
Canary Advisors, United States
Co-founder and Principal
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