Expanded Access Programs 2019

When: March 27, 2019 - March 28, 2019, 8:00 am - 5:00 pm
Where: Philadelphia, PA, Philadelphia, PA

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.

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

Learn more »

Connect With Us

Blog Facebook LinkedIn Twitter