David Setboun
Chief Operating Officer Alkeus Pharmaceuticals, Inc.
Seminars
Wednesday 25th March 2026
Fireside Discussion: Navigating Global Differences & Business Decisions in Expanded Access Programs
11:30 am
-  Compare regulatory frameworks and access pathways across the US (FDA), Europe (EMA), and other national systems such as France’s ATU
- Explore how approaches to expanded access differ between large pharma and smaller biotech organizations.
- Examine how companies assess the business case and operational feasibility of launching programs in emerging regions, including the Middle East and Latin America
