Unlocking Strategies for Navigating the Evolving Market Access Landscape: A Pharmaceutical Commerce Peer Exchange® - Episode 2

Overcoming Regulatory Barriers to Market Access

June 25, 2025

Edward Ahn, Rob Philo, Shana Gunderson Hua PharmD, Ed Schoonveld

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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.

EP. 1: Current Perspective on Pricing and Reimbursement Models

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EP. 2: Overcoming Regulatory Barriers to Market Access

EP. 3: Delivering Value Beyond the Trial with Real-World Evidence

EP. 4: Aligning Real-World Evidence with Payer Perspectives

EP. 5: Navigating Market Entry Challenges for Orphan Drugs

EP. 6: Effective Tactics for Pricing and Reimbursement in Today’s Market

EP. 7: Designing Effective Value-Based Contracts: Timing, Evidence, and Risk Alignment

EP. 8: Planning for Market Sustainability Under New Policy Frameworks

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.