Navigating Regulatory Barriers within Market Access

EP: 1.Industry Voices on Current Pricing and Reimbursement Models

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EP: 2.Navigating Regulatory Barriers within Market Access

EP: 3.Effective Real-World Evidence for Adding Value to a Clinical Trial

EP: 4.Harmonizing the Payer Perspective with Real-World Evidence

EP: 5.Challenges for Bringing Orphan Drugs to Market

EP: 6.Strategies in Today’s Market for Pricing and Reimbursement Models

EP: 7.The Ins and Outs of Value-Based Contracts: Timing, Evidence, and Risk Alignment

EP: 8.How New Policies are Impacting Market Sustainability

EP: 9.Rethinking Market Strategy within a Patient-Centric Era

As international price referencing tightens and payer expectations rise, companies face a shrinking margin for error. The panel explores how clinical trial design and early payer engagement are key to meeting both regulatory and reimbursement demands across global markets. With real-world evidence (RWE) from markets like Korea and Japan in hand, forward-thinking strategies can prove valuable.

Key discussion topics include:

• Navigating international price referencing and fragmented regulatory standards.
• Why payer engagement should begin as early as clinical trial design.
• RWE as a tool for value messaging in global markets.
• The diminishing threat of generics for advanced therapies like cell therapy.