Monday, February 11, 2019

Expanded Access Programs 2019

Expanded Access Programs 2019
March 27-28, 2019 | The Inn at Penn | Philadelphia, PA

CBI’s Expanded Access Programs 2019 focuses on the design, development and practical implementation of early access programs. The summit convenes top industry stakeholders and regulators to examine current approaches in providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes. A multi-stakeholder faculty will address key issues affecting EAPs and review the potential impact of the evolving legislative landscape.

Drug Channels readers will save $300 off of the standard registration rate
when they use code AGK946.* REGISTER TODAY!

Join Expert Thought Leaders Including:
  • Marcel van Kuijck, Vice President UltraPrograms, Global Medical Affairs, Ultragenyx Pharmaceutical Inc.
  • Tom Watson, Executive Vice President, Early Access Programs, Bionical
  • Naomi Lopez Bauman, Director of Healthcare Policy, Goldwater Institute
  • Sharon Ellison, DUHS IRB Chair; pharmacist, Duke University Hospital
  • Gretchen M. Randlett, Consultant – Clinical Trial Commercial Product Strategy and Process, Eli Lilly and Company
  • Alison Bateman-House, Ph.D., MPH, MA, Assistant Professor, Division of Medical Ethics, NYU Langone Health; Co-Director, NYU School of Medicine Working Group on Compassionate Use and Preapproval Access (CUPA)
  • Dawn Sullivan, Department Manager, Global Medical Affairs & UltraPrograms, EAPs/ISTs, Ultragenyx Pharmaceutical Inc.
  • Erika Segear, Ph.D., RAC, Associate Director of Regulatory Affairs, Duke University
Key Topics to Be Addressed:
  • Implement practical guidelines for responding to inquiries around Right to Try
  • Assess whether there is an opportunity to seek reimbursement through traditional payer channels
  • Navigate the development process of sibling Early Access Programs
  • Bring the patient voice into the development of Early Access Programs
  • Learn how global organizations are handling new legislation on patient privacy
  • Explore how crowd funding bridges Right to Try, stem cell and new frontiers
  • Discuss post-clinical trial access when a program does not meet endpoints
This multi-stakeholder event is focused on U.S. and global models for a variety of access management programs, including, but not limited to:
Expanded Access Programs, Early Access Programs, Compassionate Use Programs, Named Patient Programs and Managed Access Programs.

Visit for more information.

Drug Channels readers will save $300 off of the standard registration rate
when they use code AGK946.* REGISTER TODAY!

*Applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on workshop only or academic/non-profit registrations.

The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

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