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Feature|Videos|June 25, 2025

Navigating Regulatory Barriers within Market Access

A panel of industry leaders emphasize the importance of early engagement with payers, real-world evidence, and value-based endpoints to ensure successful access, pricing, and long-term market viability—especially in a more complex, globally integrated reimbursement landscape.

Episodes in this series

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.

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