Responding to New FDA Expanded Access Guidance & MFN Pricing: What Has Changed & What Access Teams Must Do Now

• Interpreting recent FDA expanded access guidance on broader eligibility, sponsor responsibility, and proactive access planning – and what this changes in practice
• Understanding how MFN pricing dynamics are extending time to launch and increasing reliance on early and managed access pathways
• Aligning expanded access planning with pricing driven launch uncertainty without creating open ended access commitments
• Evaluating whether existing access governance, resourcing, and supply models are fit for increased regulatory expectation and prolonged pre commercial access

Speakers:

Pedro Franco

Senior Director & Head of Europe Global Regulatory & Scientific Policy,

Merck KGaA

Vilem Guryca

Director, Expanded Access, Global Medical Affairs

BeOne Medicines

Ramona Reichenbach

Head Managed Access & Medical Policy

Novartis AG