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Linking Pre-Approval Access with Drug Development Strategy

March 27-28, 2019
  • 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 shifting legislative landscape.

Join This Interactive Dialogue Addressing:

  • Identify calculated risks and challenges in launching sustainable expanded access programs
  • Discuss pricing, payment and reimbursement policy for expanded access programs from a multi-stakeholder perspective
  • 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 and potential use of real world data in expanded access programs
  • Optimize strategies to forecast and establish supply – Managing the complexities and the inherent risks of executing global expanded access programs
  • 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 – Consider the implications of multiple pathways of access
  • Garner support for increasing cohort expanded access programs
  • Investigate strategies to break down barriers to access for physicians and clinicians – Increasing access by building centralized infrastructures of support for physicians/clinicians
  • Strategize how to encourage harmonization of processes for expanded access globally

Previous Attendee Acclaim:

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

Associate Director, Expanded Access, TESARO

Great insights from a variety of perspectives including the patients, regulators and manufacturers, who all addressed real issues.

Vice President, AmericansourceBergen

Definitely, a must-attend.

Director, Global Medical Services, Med Communications

The conference really brings together like-minded professionals, in a non-competitive nature, sharing lessons learned, as well as wishes to see, in the Early Access framework for the
benefit of the patient and industry.

Program Manager, Ultragenyx Pharmaceutical

Expanded Access Programs 2019

Linking Pre-Approval Access with Drug Development Strategy

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 shifting legislative landscape.

Join This Interactive Dialogue Addressing:

  • Identify calculated risks and challenges in launching sustainable expanded access programs
  • Discuss pricing, payment and reimbursement policy for expanded access programs from a multi-stakeholder perspective
  • 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 and potential use of real world data in expanded access programs
  • Optimize strategies to forecast and establish supply – Managing the complexities and the inherent risks of executing global expanded access programs
  • 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 – Consider the implications of multiple pathways of access
  • Garner support for increasing cohort expanded access programs
  • Investigate strategies to break down barriers to access for physicians and clinicians – Increasing access by building centralized infrastructures of support for physicians/clinicians
  • Strategize how to encourage harmonization of processes for expanded access globally

Previous Attendee Acclaim:

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

Associate Director, Expanded Access, TESARO

Great insights from a variety of perspectives including the patients, regulators and manufacturers, who all addressed real issues.

Vice President, AmericansourceBergen

Definitely, a must-attend.

Director, Global Medical Services, Med Communications

The conference really brings together like-minded professionals, in a non-competitive nature, sharing lessons learned, as well as wishes to see, in the Early Access framework for the
benefit of the patient and industry.

Program Manager, Ultragenyx Pharmaceutical