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.

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