From Clinical to Commercial: A Playbook for Scalable Readiness

Bringing a therapy from clinical development to commercial reality is one of the most complex (and least forgiving) transitions in the product. What begins as a highly controlled, often manual clinical supply chain must evolve into a scalable, globally coordinated operation capable of consistent patient delivery under strict regulatory expectations.

For emerging and established biopharma companies alike, the challenge is to build the operational discipline, infrastructure, and cross-functional alignment required to sustain that growth. From establishing standardized processes and real-time visibility to managing global logistics networks and performance metrics, commercialization demands a different approach.

According to Bianca Gustafson, Senior Director of Program Management at Cryoport Systems, success in this transition hinges on treating commercialization as a strategic, program-driven effort that begins early in development. With extensive experience overseeing clinical and commercial programs, Gustafson brings a practical perspective on how disciplined program management and scalable partnerships can help organizations navigate increasing complexity and deliver reliably at scale.

In this Q&A, Gustafson shares insights on how companies can bridge the gap from clinical proof of concept to commercial readiness and the critical role that structured program management plays in making that transition successful.

Contract Pharma: What are the most common supply chain risks companies underestimate when moving from early-phase trials to commercial readiness?

Bianca Gustafson: From a program management standpoint, the most underestimated risk is the shift from coordination to orchestration. What we repeatedly see is underestimating how much the operating model has to change. In early clinical, you can get away with a lot of hands-on coordination with people jumping in and solving problems in real-time.

But once you move to commercial, that just doesn’t scale. You need defined processes, clear escalation paths, and real-time visibility across a much bigger network.

I think teams also underestimate how quickly that complexity compounds. As you build more shipments, more geographies, more partners, the risk escalates exponentially. Without strong program-level oversight, those interdependencies become a real risk.

CP: How does Cryoport Systems help clients bridge the gap between clinical proof of concept and commercial operational readiness?

Gustafson: We focus on taking what worked in clinical and building the structure around it so it can scale.

From a program management perspective, that starts early with kickoff alignment and process mapping to set up standardized workflows and templates so there’s consistency from the beginning.

We also can put dedicated program and implementation resources in place who are tracking everything, whether it be timelines, milestones, or performance. It’s also about keeping all the stakeholders aligned. It’s less about reinventing the system and more about maturing it into something repeatable and controlled.

CP: What systems or controls are essential to maintain consistency as volumes, geographies, and stakeholders expand?

Gustafson: At scale, consistency comes down to visibility and execution discipline.

You need systems, like a centralized order and tracking platform, that standardize how work gets done. And then you need the program structure around it with clear workflows, defined escalation paths, and ongoing performance monitoring.

For us, a big part of it is also staying very close to the data, so tracking KPIs, managing courier performance, and using regular business reviews to keep everything on track. It’s not a “set it and forget it” environment.

CP: What new challenges arise when therapies move from regional trials to global commercial distribution?

Gustafson: Everything just gets more complex very quickly.

You’re now dealing with different regulatory environments, varying infrastructure, multiple time zones, and more stakeholders in every shipment. On top of that, expectations are higher because you’re delivering commercially, often directly tied to patient treatment timelines.

From a program standpoint, you really have to shift into active, real-time management by monitoring shipments, adjusting routes, coordinating across partners, and stepping in proactively when something looks off.

The focus shifts from managing individual shipments to running a coordinated global operation.

CP: What major shifts are you seeing in how biopharma companies approach commercialization planning today?

Gustafson: The biggest shift I’m seeing is that companies are no longer treating commercialization as an endpoint or something that only happens at the end—they’re starting much, much earlier.

We’re seeing teams bring in program management, logistics strategy, and even commercial supply chain design during clinical development and not waiting until after approval. That’s a big change.

There’s also a move toward more structured, programmatic thinking in defining processes and building out governance. They’re putting systems in place early so they don’t have to rebuild everything later.

And I’d say the other big shift is around partnerships. Companies are relying more on integrated partners who can scale with them, rather than managing a lot of disconnected vendors. That continuity really helps when you’re trying to go from a handful of shipments to a global network.

CP: How should companies think about aligning manufacturing, storage, transportation, and clinical sites at commercial scale? 

Gustafson: At commercial scale, alignment requires viewing the supply chain as a single, connected system rather than separate functions.

In clinical, it’s common to see manufacturing, logistics, and sites operating a bit independently. But that approach doesn’t hold up when volumes increase and timelines tighten.

You need shared planning, shared data, and very clear communication pathways across every node. So, manufacturing schedules need to align with transportation capacity, storage availability, and site readiness.

From a program management perspective, our role is to orchestrate that alignment and ensure timelines are synchronized and there’s a defined way to escalate and resolve issues.

It’s about making sure the entire system works together to deliver to the patient reliably and that cannot happen if you’re only optimizing one part of the chain and not looking at things holistically.

CP: What industry trends are having the biggest impact on global pharma supply chains right now?

Gustafson: The biggest one is definitely the continued growth of cell and gene therapies, which are much more complex to manage. They require tighter, stricter controls and significantly more real-time oversight.

We’re also seeing a major push toward real-time visibility and proactive management and not just tracking shipments, but actively monitoring and intervening before issues happen.

Another trend is the increased focus on performance metrics and accountability. Companies want more transparency into how their supply chain is performing, so everything from courier reliability to exception handling.

And then, of course, there’s the ongoing expansion into global markets, which adds layers of regulatory and operational complexity when you start getting into regional differentiation and customs clearance.

All of that combined is really driving the need for stronger program management structures because managing these supply chains today is less about moving products and more about running a highly coordinated, data-driven operation.

CP: What best practices help ensure a smooth transition from first commercial patient to sustained global delivery?

Gustafson: The teams that do this well treat commercial launch like a program, not an event. They’ve already done the groundwork with a kickoff alignment, process definition, system setup and escalation planning.

Then they pressure test it with scenario running, lane qualifications, workflow validations and ensuring everyone has a role. 

During launch it’s about fast decision making and clear communication across the network.

Post launch, the focus shifts to disciplined monitoring through metrics, reviews and continuous improvement.

CP: How do your customers measure success beyond on-time delivery once they reach commercialization?

Gustafson: On-time delivery is an important milestone, but it’s only one measure of success.  Customers are really looking at the program holistically and how it performs overall. So, how well exceptions are managed and how reliable their courier network is. They’re looking at whether they’re meeting contractual commitments and SLAs. They’re constantly wanting to review quality metrics like deviations and investigation timelines. 

From a program perspective, success is about consistency and control over time, not just individual wins.

CP: If you could offer one piece of advice to emerging biopharma companies planning their first commercial launch, what would it be?

Gustafson: Build your program infrastructure EARLY.

Don’t wait until you’re close to launch to figure out processes, roles, and systems. Define your workflows, escalation paths, and communication model upfront and make sure you have the right people in place to manage it.

Once things scale, you don’t have time to figure it out. You need to already be operating in a structured, controlled way that can support growth.