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Tuesday, June 26 • 10:30am - 11:30am
#237: Expanded Access: Where Are We Now?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-581-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Anne B Cropp, PharmD

Speaker

Stakeholder Tools to Facilitate Patients Access: A Trade-Off of Uncertainties?
Richard Huckle, MSc

Global Patient Access Process
Sarah Alummootil

Global Patient Access Process: Advocate Perspective
Jennifer McNary


Speakers
avatar for Sarah Alummootil

Sarah Alummootil

Expanded Access Coordinator, Early Access Care
Sarah Alummootil joined Early Access Care as an Expanded Access Coordinator in 2017. In this ever adapting pharmaceutical industry, Sarah strives to prioritize the patient during their interaction with each stage of the drug development process. Prior to Early Access Care, Sarah was... Read More →
avatar for Anne Cropp

Anne Cropp

Chief Scientific Officer, Early Access Care
RH

Richard Huckle

Principal Consultant, Pope Woodhead
Regulatory affairs professional with drug development experience spanning 25 years in the consulting/CRO industry and biotech/pharma companies. With a broad technical understanding of pre-clinical, quality, clinical and regulatory procedures. Richard leads Pope Woodhead’s (now Huron... Read More →
avatar for jennifer McNary

jennifer McNary

Manager, J McNary Consulting
Jenn McNary is the mother of two young men with a rare disease and a consultant in the biotechnology space with an expertise in caregiver/patient engagement, including bringing the patient voice to drug development and solving barriers to access. Her other activities include serving... Read More →

Tuesday June 26, 2018 10:30am - 11:30am EDT
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session