David Stein
Senior Director - Clinical Trial Management Regeneron Pharmaceuticals
David Stein serves as the Head of Managed Access Programs at Regeneron, bringing over 28 years of expertise in Clinical Trial Management and Medical Affairs. His work reflects a deep commitment to advancing science, addressing serious unmet medical needs, and making a meaningful difference in people’s lives.
Seminars
Wednesday 25th March 2026
Case Study: Using Real-World Data from a Compassionate Use Program to Support Regulatory Filing in an Ultra-Rare Disease
2:00 pm
- Examining a practical case study of how RWD was collected and applied support a regulatory submission in an ultra-rare indication
- Highlighting lessons learned from challenges in data collection, validation, and integration across functions
- Exploring how insights from RWD informed patient access, program design, or engagement with stakeholders
- Providing actionable takeaways for translating RWD into strategies that enhance EAP efficiency and impact
