Vilem Guryca
Director, Expanded Access, Global Medical Affairs BeOne Medicines
Vilem Guryca is Director of Expanded Access within Global Medical Affairs at BeOne Medicines, where he leads the strategic direction, governance, and operational delivery of global access programmes. With a background spanning R&D, portfolio management, and medical affairs, he brings deep expertise in integrating patient access into broader business and scientific strategy. Vilem specialises in leading cross-functional global teams, designing sustainable and compliant access models, and navigating complex regulatory and operational landscapes to ensure patients receive timely access to innovative therapies.
Seminars
Tuesday 20th October 2026
Responding to New FDA Expanded Access Guidance & MFN Pricing: What Has Changed & What Access Teams Must Do Now
2:00 pm
- 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
Wednesday 21st October 2026
ia4ma: Achieving Global Impact Through a Non-Profit, Independent Association
1:45 pm
- Establishing a shared vision and foundation for Managed Access, aligning on ethical principles and industry standards to reduce fragmentation and enable sustainable global pathways
- Delivering value for patients, industry and stakeholders by accelerating equitable access, improving operational efficiency, and enabling meaningful peer and regulatory exchange
- Driving system level impact beyond individual programs by shaping policy, fostering multi stakeholder collaboration, and strengthening global trust in Managed Access
