Pre-Conference Workshop Day

Tuesday February 15, 2022

All times shown in EST

Workshop A: Developing a Managed Access Strategy for an Individual Program, and Across Programs

Tuesday, February 15 | 10:00am-12.00pm

A successful Managed Access program takes forethought and planning. There are often multiple stakeholders’ whose collaboration is essential. Managed Access programs do not have standard ways of working, and there is an industry wide lack of guidance for
establishing and running these program. In this interactive workshop you’ll gain an understanding of how to be prepared before your first request compassionate use comes in, and how having an early strategy aligns all stakeholders to respond quickly to physician requests and ensures equity of access for patients.

• Discuss how and when to set up a strategy for Managed Access for a medicine in development
• Understand who needs to be involved in program design and strategy
• Learn how and when to build a cross departmental team to address expanded access program requests
• Design an equitable, patient-first expanded access program

Workshop Leaders

Annmarie Galli
Sarah Misenko
Sandrine Fontaine

Annmarie Galli
Head, Global Medical
Affairs Research and
Compassionate Use/
Managed Access

Sarah Misenko
Senior Manager, Office of CMO, Oncology

Sandrine Fontaine 
Head of CMO Office Management and Oversight Office of the Chief Medical Officer

Workshop B: Ensure Global Regulatory Compliance in Your
Expanded Access Programs

Tuesday, February 15 | 1:00pm-3.00pm

Global differences in definitions and regulations of expanded access programs present a
continuous challenge for everyone working in this field. These programs all have unique set
of rules when it comes to their implementation, management and data collection. In this
interactive workshop we will explore how to navigate these fast-evolving regulations in
different countries and how to maximize the success of your expanded access programs.

• Investigating the varying terminologies for expanded access programs
• Understanding the differing regulatory requirements for countries to ensure compliance
• Addressing data collection questions

Workshop Leaders

Sara Radenovic_photo

Sara Radenovic
Associate Director, Managed Access Programs 

Karen Photo

Karen Frascello
Director, Global Medical Affairs, Early Access
Alnylam Pharmaceuticals

Workshop C: Addressing key challenges in Expanded Access
Programs; what can happen and how to fix it

Tuesday, February 15 | 3:30pm-5.00pm

Ensuring patients receive life-saving treatments in a timely manner is vitally important to a successful expanded access program BUT the road to success is filled with obstacles that must be conquered. In this interactive workshop, you’ll learn how to tackle these challenges effectively.

• What patients will be treated, in which countries?
• How to get the drug supply you need.
• Do you have enough resources?
• How to say no.
• What happens when the drug is approved?

Workshop Leaders

Stephanie Petrone

Stephanie Petrone
Navigate Clinical