Expanded Access in Practice: Turning Demand into Strategic Opportunity
Time: 11:30 am
day: Pre-Conference Workshop Day
Details:
- Discuss the role of Expanded Access (EA) in the treatment journey and its strategic importance for early-stage biopharma companies
- Analyze key regulatory frameworks and ethical considerations shaping EA, including recent legislation and expectations for transparency and accountability
- Assess internal capabilities and stakeholder dynamics required to manage EA effectively, including governance, resource planning, and external pressures
- Develop integrated strategies that align patient access through EA with long-term business sustainability, regulatory compliance, and strategic growth
