Asembia's AXS26 Summit: Are Regulatory Policies Impacting Early-Stage Portfolio Planning?

In a conversation with Pharmaceutical Executive at Asembia’s AXS26 Summit, Kim Plesnarski, vice president, strategic market access and patient support, Syneos Health^® emphasizes the elevated market access to a central pillar of the overall go-to-market strategy.

Companies can no longer simply ask where to launch to maximize volume; they must now consider how global launch sequencing and pricing decisions will affect U.S. pricing, profitability, and gross-to-net under MFN-type frameworks. The IRA, she explains, further reshapes the landscape by creating a shorter window of value capture for small molecules, which face price negotiations after seven years, compared with eleven years for biologics. This discrepancy forces manufacturers to ask whether it is even viable to invest in certain categories, and if so, how to accelerate the path to growth before negotiation periods erode returns.

Plesnarski warns that these dynamics can ultimately harm patients and the broader market, as promising therapies might be deprioritized, and stresses that companies must be more precise, strategic, and proactive at launch to preserve value without undermining access.

Noting how new technologies are impacting patient adherence, Plesnarski returns to the theme of two-way digital communication. She notes that programs leveraging secure, bidirectional communication, combining chatbots for simple, 24/7 support with access to clinical educators and patient navigators, are seeing approximately a 20% improvement in persistency. What once felt like “old news” is now being meaningfully upgraded through always-on support and richer interactions.

She also underscores the expanding role of wearables and data harvesting, using this information to refine the patient experience and drive better health outcomes. Finally, Plesnarski highlights predictive, just-in-time outreach, such as secure text messages and portals that reach patients in the exact moment of need, rather than relying on constant, generic reminders that can become intrusive or annoying.