Pre-Conference Workshop Day

Tuesday 21st March 2023

10:00 – 12:00 Workshop A – Introduction to Expanded Access Programs

  • Annmarie Galli Head of Global Medical Affairs Research, Compassionate Use & Managed Access Programs Oncology, GlaxoSmithKline

Synopsis

This interactive workshop is designed to offer introductory topics for companies and individuals at the start of their foray into using EAPs/CUPs. If you’re just getting started, join us for an end-to-end guide, and set yourself up for the next few days ahead!  

 

Covering topics such as: 

 

  • Summarizing the role of EAPs and differentiating between different terminologies  
  • Overview of each stakeholder their roles and responsibilities within EAPs  
  • Submitting expanded access requests and reports to regulatory agencies  


1:00-3:00 Workshop B –Effectively Execute a Global Expanded Access Program

  • Ashling Dion Manager, Clinical Trial Mgmt GMA Oncology, Daiichi Sankyo, Inc.
  • Annie Drelles Director & Head of Office of Medical Access, Global Oncology & Medical Affairs, Daiichi Sankyo
  • Tiffany Kawai Director, Program Management and Operational Excellence, Global Oncology Medical Affairs, Daiichi Sankyo, Inc.

Synopsis

Every country has various regulatory requirements. To operate a program in more than one country you need to ensure that all regulatory requirements are appropriately assessed. A clear plan also needs to be developed to guarantee access for patients that are approved to receive the treatment. Therefore, navigating regulatory pathways ahead of time is vital to act on a request as soon as it comes in.  

 

Join this workshop to: 

  • Develop a country-by-country roadmap of global regulations and nuances by the time a patient is approved for access 
  • Coordinate internal teams to navigate submissions to multiple health authorities  
  • Attain import licenses quickly and efficiently  

3:30 – 5:30 Workshop C – Supporting Patients while Transitioning to a Commercial Product

Synopsis

Expanded access programs are temporary in nature, therefore, closing an EAP and moving to commercialization needs to be accounted for during the planning stages of an EAP. Companies have an important duty to the patients that may have benefited from the treatment and should consider a plan for ongoing treatment. 

 

Join this workshop to: 

 

  • Develop a post-trial access strategy  
  • Close an EAP in a country where the drug will not be commercialized  
  • Manage reimbursement and post-trial access  
  • Gathering data from patients to aid commercialization