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12 Mar 2019 Article

Clinigen EAP Workshop World Orphan Drug Conference (USA)

Clinigen EAP Workshop at World Orphan Drug Conference 
Wednesday, April 10th, 2019 – 1pm to 5pm 
Gaylord National Harbor Hotel, Oxon Hill MD

The Expanded Access to Commercialization Journey: Interdependencies, Operational Considerations, Strategy & Assessment Framework

Quite often, organizations running an Expanded Access Program (EAP) fail to consider the practical or strategic considerations related to the transition from an EAP to commercial availability and access. Despite being intricately linked, many organizations view Expanded Access and commercial access as two independent mechanisms. This mentality can, at times, hinder patient access which can have a significant impact on rare disease patients, in particular. In this workshop we will explore how to maximize access for these patients by examining:

  1. The Importance of the relationship between EAP and commercial access
  2. Practical / Operational considerations related to the transition from EAP to Commercial Access
  3. Strategic EAP elements that can help impact and drive commercial patient access
  4. Framework for quantifying the Strategic EAP benefits / EAP ROI

Who is it for?

  • Early Access / Expanded Access Coordinator
  • Medical Affairs
  • Clinical Development, R&D
  • Patient Advocacy / Patient Affairs
  • Commercial / Market Access
  • CEO, CMO, CBO, CCO (start-ups)

What are the benefits of attending your workshop?

  • Better understand EAPs and impact on commercial access
  • Be better prepared for the EAP to commercial transition
  • Be able to effectively plan EAP strategy
  • Understand the business and strategic value of an EAP

 

AGENDA 

Time

Topic

Moderator & Panelists

1:00 – 2:00

The Importance of the relationship between EAP and commercial access

Guiding principles behind initiating an EAP

The physician / customer journey when accessing a product via multiple mechanisms

Impact on physician perceptions and company reputation

Moderators:

Aamir Khan, Senior Consultant

Toni Williams, Business Development Manager

2:00 – 3:00

Practical / Operational considerations related to the transition from EAP to Commercial Access

Timelines and Planning

Communication strategy

Logistical considerations

Common pitfalls and key learnings

 

Moderators:

Aamir Khan, Senior Consultant

Toni Williams, Business Development Manager

 

Panelists:

Biogen

Sam Lucas, Senior Manager Global Expanded Access, Medical Affairs

Clinigen:

Karen Klein, Head of Program Management

3:00 – 3:30

Networking coffee break

3:30 – 4:15

Strategic EAP elements that can help impact and drive commercial patient access

Product perception and messaging

 Data collection and insights

Competitor and treatment landscape

 

Moderators:

Aamir Khan, Senior Consultant

Toni Williams, Business Development Manager

4:15 – 5:00

Framework for quantifying the Strategic EAP benefits / EAP ROI

Defining ROI within the EAP context

Strategic considerations for the initiation of an EAP

Key stakeholder impact assessment of a go / no-go decision

 

Moderators:

Aamir Khan, Senior Consultant

Toni Williams, Business Development Manager