How to Get Specialty Drug Launches Right from Pre-Launch to Patient Access

At Access USA 2026, Pharmaceutical Commerce sat down with Kristine McGaughey, vice president of Implementation at ConnectiveRx, to explore what it really takes to get a specialty therapy launch right—before, during, and after approval. With deep experience guiding both emerging biopharma companies and established pharmaceutical leaders, McGaughey offers a pragmatic view of how launch strategy translates into real-world patient access.

In the conversation that follows, she underscores the importance of timing as a defining factor in launch success. From her perspective, the difference between a smooth day-one patient experience and a friction-filled rollout often comes down to how early teams align on critical decisions—particularly across market access, patient services, and pricing. She highlights the 18–24 month pre-launch window as a strategic “sweet spot,” while also cautioning that waiting until the final months before approval can severely limit a manufacturer’s ability to course-correct without impacting speed to therapy.

McGaughey also draws a clear distinction between the needs of first-time launchers and seasoned pharma organizations. For emerging biopharma, success hinges on building foundational capabilities from scratch with the right strategic partner, while larger companies benefit from refining and accelerating established playbooks. Across both, she emphasizes the central role of early, data-driven decision-making—particularly when designing hub models and specialty pharmacy networks—warning that delayed insights can lock teams into suboptimal pathways that are difficult to unwind post-launch.

McGaughey’s insights offer a roadmap for minimizing friction, aligning cross-functional teams, and ultimately ensuring patients can access therapy as quickly and seamlessly as possible from day one.

A transcript of her conversation with PC can be found below.

PC: What does an optimal pre-launch engagement calendar look like for market access, patient services, and pricing and contracting teams, and at what point does a manufacturer typically engage too late to course-correct without it affecting day-one patient access?

McGaughey: An optimal timeline is 18 to 24 months. So you want to be able to pull in the right stakeholders such as market access, patient services, your hub teams, and really start to map out what that patient journey looks like. Everything from what coverage pathways look like to your patient journey workflows to ultimately your execution of how to get that patient on therapy as quickly as possible. And that is beyond just your coverage determination. You really want to get in front of when that prescription is before it's written in that HCP's office. So that 18 to 24-month window is your sweet spot because you want to design a strategy that prevents friction at the point of prescription to patient-on therapy. Where it starts to become a really tight window is within that six to nine-month window where really you've already started to have these key decisions made. So what is your patient journey workflow? What is your pharmacy strategy? And when you aren't engaged prior to those windows, you have very little time to pivot and make those changes without creating additional friction for your time to therapy at the time of your approval.

How does ConnectiveRx's Launch Excellence framework adapt for an emerging biopharma on its first specialty launch versus a large pharma company that's done it many times before?

So the exciting thing about an emerging biopharma is we're really coming in as that strategic partner. We're starting from the ground up. So we're sitting with you elbow to elbow going over what are those building blocks that we need to think about. What are your market access strategic imperatives? What does your design workflow need to look like? Really building on that so you have no friction or reduced friction at day one. Whereas when you think about large pharma, it's less about the building blocks, and it's more about refining and being, and building on those lessons learned and those strategic playbooks that you've already developed. So you're bringing market access together, hub operations, the pricing teams, and you're working together to build on those to ensure that it's a smooth launch, more consistency, and a faster launch to market.

How early should market access analytics be informing hub model design and specialty pharmacy network strategy — and what decisions get made wrong when that data comes in too late?

You should be thinking about the data in that pre-launch strategy. So the first and foremost piece is when you think about pre-launch strategy is before that prescription is written. So you're wanting to look at those analytics early and often of what do I need to know before the drug is approved, how do I support that patient journey design, and what will I need to do in the post-launch phase to keep patients on therapy, not abandoning therapy, and working through any of those potential hurdles that you'll face in that post-approval process for your drug.