Overcoming Regulatory Barriers to Market Access

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.