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Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real World Evidence

March 28-29, 2018
  • Washington, DC

CBI’s Expanded Access Programs conference 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.

Join This Interactive Dialogue Addressing:

  • Examine practical application steps needed to launch and sustain these programs and identify the calculated risks and challenges
  • Understand transparency reporting responsibilities around Expanded Access Programs and the 21st Century Cures Act
  • Consider ethical considerations of providing unapproved promising drugs available to terminally ill patients
  • Ensure fair patient selection criteria and fair patient enrollment practices
  • Review industry trends in the collection of real world data in expanded access programs
  • Navigate pricing, payment and reimbursement policy for expanded access programs
  • Optimize strategies to forecast and establish supply
  • Share best practices and review comparable processes and regulations between U.S. and Global expanded access programs
  • Explore the challenges and opportunities of the Right to Try bill

Previous Attendee Acclaim:

After 10 years in the expanded access space, I learned something new and heard a lot from the patient’s perspective

Associate Director, Expanded Access, Tesaro

March 28-29, 2018 | Washington, D.C.

Expanded Access Programs 2018

Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real World Evidence

CBI’s Expanded Access Programs conference 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.

Join This Interactive Dialogue Addressing:

  • Examine practical application steps needed to launch and sustain these programs and identify the calculated risks and challenges
  • Understand transparency reporting responsibilities around Expanded Access Programs and the 21st Century Cures Act
  • Consider ethical considerations of providing unapproved promising drugs available to terminally ill patients
  • Ensure fair patient selection criteria and fair patient enrollment practices
  • Review industry trends in the collection of real world data in expanded access programs
  • Navigate pricing, payment and reimbursement policy for expanded access programs
  • Optimize strategies to forecast and establish supply
  • Share best practices and review comparable processes and regulations between U.S. and Global expanded access programs
  • Explore the challenges and opportunities of the Right to Try bill

Previous Attendee Acclaim:

After 10 years in the expanded access space, I learned something new and heard a lot from the patient’s perspective

Associate Director, Expanded Access, Tesaro

March 28-29, 2018 | Washington, D.C.