Jeff Berkowitz brings a uniquely comprehensive perspective to market access, having held senior leadership roles across the pharmaceutical industry (Merck), the pharmacy sector (Walgreens Boots Alliance), and the payer landscape (UnitedHealth Group). His experience enables him to examine market access challenges from multiple vantage points—pharmaceutical, retail, and payer—offering a rare, integrated understanding of the forces shaping U.S. healthcare dynamics.

Market access is not something you can afford to address only 18-24 months before launch. Instead, it must be embedded into the earliest stages of drug development. If you don’t account for payer expectations and reimbursement challenges early on, you may face insurmountable barriers later. 

You need to ensure that your team integrates market access strategies into clinical development, pricing models, and stakeholder engagement from day one. Without this early strategic alignment, even the most promising innovations can struggle to gain traction in the U.S. market.

The U.S. represents the single largest healthcare market in the world—but for European life science CEOs like you, gaining access is anything but straightforward. The regulatory framework, market access dynamics, and reimbursement landscape are notoriously complex. These challenges have only intensified in the wake of the recent U.S. presidential election, bringing new policy shifts into focus. As the implications of these changes unfold, you can expect significant adjustments to reimbursement structures, regulatory pathways, and market access—especially if you are a non-U.S. competitor.

The key question isn’t just how to navigate the system, but how you can proactively align regulatory and market access strategies in a shifting political and economic landscape. 

And this isn’t a challenge you can delegate. As CEO, you must drive this conversation yourself. Market access and reimbursement strategy are no longer technical or functional concerns alone—they are existential, board-level imperatives that determine whether your company succeeds or stalls in the U.S. market.

For this session, Jeff will be joined by Gregory Oakes, CEO of Landos Biopharma, who successfully led the company to its acquisition by AbbVie for approximately $137.5 million, with potential milestone payments of up to $75 million. Greg will share a real-world case study on how he navigated U.S. market entry, adapted to payer expectations, and structured value-based arrangements that secured reimbursement and commercial traction. This discussion will provide practical insights on why certain strategies work—and where common missteps occur.