7:30 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 8:45 a.m.

Welcome and Introduction by Chairperson

8:45 a.m. – 9:15 a.m.

Keynote: Learning More from Patients in Difficult Therapeutic Areas

9:15 a.m. – 10:15 a.m.

The Foundations of EAPs

In this session, you’ll learn about the development of EAPs, including historical business practices; current regulations; definition of terms; strategic considerations in implementing integrated research and treatment programs; important new state and federal legislatives; and international developments.

10:15 a.m. – 10:45 a.m.

Networking Break

10:45 a.m. – 12:15 p.m.

Handling the Challenges of EAPs

This panel will cover commercial hazards of EAPs — both real and imaginary; medical and bioethical considerations; operational planning: objectives, execution, and scale; and reimbursement and sustainability of large EAPs.

12:15 p.m. – 1:30 p.m.



1:30 p.m. – 2:30 p.m.

Maximizing the Value of EAPs

In this session, you’ll hear a discussion of a case history of data uses from large EAPs; emerging frameworks for Real World Data (RWD) collection and pragmatic trials; and integrating sample collection and multi-omics for clinical discovery.

2:30 p.m. – 3:30 p.m.

Can EAPs Improve the Drug Development Process in Breakthrough Diseases?

This is an interactive session in which you and experts in the EAP field will discuss how EAPs can improve the current drug development process for serious diseases.

3:30 p.m. – 3:45 p.m.

Networking Break

3:45 p.m. – 5:00 p.m.

New Business Models for Inclusivity, Wider Access to Patients, and Data Utilization

This session covers commercial feasibility and cost recovery; patient-centric resources; crowd-sourced data; and business-to-consumer sequencing and design.

5:00 p.m.


5:15 p.m. – 6:30 p.m.

Networking Reception




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