Overcoming Regulatory Barriers to 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.
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.
