Demonstrating the Value of Expanded Access Programs: Patient, Clinical, Regulatory & Commercial Impact
4:00 pm - Wednesday 24th March 2027
- Combining company sponsored compassionate use via spINDs with a five-year Expanded Access Protocol to demonstrate meaningful impact across 200+ patients
- Managing the operational and financial components of a large-scale Expanded Access Program from a small early-stage Biotech footprint: impact of design, partnering and proactive stakeholder engagement
- Creation of real-world data sets supporting clinical strategies and regulatory filings with a direct impact on business development and partnering efforts
