Can Your Operating Model Grow? Preparing Clinical Supply For What Comes Next
By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader
Supply leaders in emerging biotech companies face a difficult balancing act: resisting the urge to overbuild in the beginning (as described in part 1 of this series) while ensuring today's decisions don’t create tomorrow’s constraints. This means recognizing when an operating model that works today may not work later.
“If you're just making a batch or two in the beginning for a clinical trial, it's not as hard. You have more time (potentially) between batches,” says Alicia Collins, of Tune Therapeutics. But supply experts should also consider the impact of increasing demand to support bigger clinical trials, or even commercial scale up.
“People tend to not think about eventually needing 10 batches a month instead of one batch a year – and how that is going to scale, operationally. Is it even going to be possible with the way you're setting things up now?” she illustrates.
Collins, vice president of technical operations at Tune Therapeutics and former vice president of supply chain and external manufacturing for the company, says that same mindset applies not only to manufacturing networks, but also to the material suppliers supporting them.
"Make sure there's a pathway to grow with your material suppliers,” Collins emphasizes. And the question is not simply whether a supplier can support the program today, but whether it can continue supporting the program as it advances.
In relation, Collins cautions not to select suppliers based solely on cost. While budget pressures are very real for emerging biotechs, lower upfront costs can create larger expenses later, including significant project delays, costly redevelopment, and potential setbacks in future partnering opportunities.
"There can be a tendency to want to go with the least expensive supplier or least expensive contract manufacturer," Collins says. "However, that can often lead to spending more than you planned at the end of the day because you're correcting for things that happened."
Quality issues, capacity limitations, or the inability to scale can quickly, for example, offset initial savings.
While redundancy may not be practical for many early-stage organizations, "ideally, you're not carrying out one part of the process at one supplier, and a different part over at another contract manufacturer,” Collins continues. “If possible, you want to design it so there's not a lot of movement between nodes.”
Some companies specialize in early phase or clinical programs, which emerging biotechs may use initially before eventually transitioning to a different CDMO. Alternatively, early-phase biotechs may hire a CDMO to execute the full process. “It’s just a matter of how you anticipate these things could slow you down as you start to grow – because the pace and dynamics are much different as you move from development to clinical to commercial,” Collins highlights.
This future focus also matters because early-stage companies often have less buffer to absorb unexpected changes. Inventory may be limited, supplier networks may be less mature, and manufacturing resupply can take significant time.
When asked where that leaves an operation most vulnerable, Collins points to supply. "Supply chain, which is part of the CMC team in general, is often managing the critical path to getting a patient dose – it’s all about how fast you can get the supply. I think that's probably the most fragile part of the system.”
That fragility is put to the test when plans change, and according to Collins, in her experience at Tune, teams are challenged less by delayed timelines than they are by accelerated ones. “Often, everything's expedited, so you have to get creative.”
Because supply often determines how quickly a program can advance, selecting the right manufacturing partners becomes one of the most important early-stage decisions.
Building A Clinical Supply Network That Can Scale
In emerging biotechs, the manufacturing strategy starts with a practical reality: "You have to decide if you're going to manufacture internally or externally," Collins says. For smaller organizations, however, the economics are often straightforward. "Building your own manufacturing facilities is extremely expensive."
That means partner selection is one of the most important decisions a company can make early in development. "Choosing the right external partner is so critical. You really, really have to vet them,” Collins cautions.
This requires a thorough due diligence process, including on-site visits to the CDMO to see the manufacturing areas and have in-depth discussions about capabilities and lead times – since problems can arise if there’s misalignment between what's needed and what can be provided.
An example would be batch sizes and scale. It's critical for the CDMO to be capable of making the smaller batch sizes often needed for supplying earlier phase trials. But if you want to retain the CDMO through later phases or even into commercial, it's important to understand how far and how fast they can scale their processes.
In addition, for Tune, the vetting process included more than just technical capability.
"We selected a partner based on their willingness to be flexible and work with us," Collins explains. "We also picked someone who understood where we're at, as a Phase 1 company." The goal was to establish a partnership rather than a transactional relationship.
That consideration also influenced how Tune evaluated larger CDMOs. "There are trade-offs," Collins says. "A CDMO might be very well-known, but you might be a teeny tiny customer compared to some of the other customers they have." As a result, smaller companies may not receive the same level of prioritization as larger programs.
The value of Tune’s collaborative partner was reinforced on one occasion when a critical dependency in the manufacturing process was uncovered that was not reflected in the original project plan – and that neither partner had initially identified.
Collins recalled, “It was like, wait a second. How are we going to do this operation before this other operation?” She added, “In your mind, you would think those operations weren’t connected, but they actually were.”
The identified issue impacted the supply timeline by extending the batch delivery date. This forced both teams to find other areas in the project plan that could be shortened, to help offset the added time.
“We took a risk-based approach,” Collins explains.
The issue was ultimately resolved through close collaboration between the teams. “We found a creative way to recover the timeline,” Collins emphasizes. “It's the art of communication when you're dealing with external partners.”
To achieve this, though, it took a rigorous approach. "It was one of those things where you go to your contract manufacturer, you sit down for 8 hours in the meeting room together, and you work through every single item on that schedule,” she elaborates.
Why Supply Chain Should Have A Seat At The Table Early
For Collins, lessons like these reinforce another belief: supply chain should be involved earlier than most organizations realize. "Specifically for autologous therapies, the earlier you have supply chain involved, the better," she says. In fact, she argues that even "early" is often not early enough. "Whatever you think it is, it's not that – it’s earlier,” she underscores.
That perspective matters because decisions made early in development can create operational limitations much later. "It will 100% come back to bite you when you can't supply because you have a constraint on capacity or you have a constraint on a material that is suddenly not adequate for whatever reason," Collins warns.
Ultimately, Collins believes successful supply organizations strike a balance between supporting current programs and preparing for future needs without overengineering systems before they are necessary.
For emerging biotechs, the challenge is balancing today's needs with tomorrow's realities. In part 1 of this series, Collins argued for building only the systems and infrastructure needed today. Here, in part 2, she extends that thinking to clinical supply: choosing partners that can support future growth and bring supply chain into the conversation early. The most successful organizations, she suggests, avoid overbuilding in the present without losing sight of what lies ahead.
Collins has 29 years of experience in the pharmaceutical and biotech industry at Merck, Genentech, BMS, and Tune in both domestic and international roles. Her experience encompasses manufacturing, supply chain, external manufacturing, strategic sourcing, and materials management. She holds a B.S. in Integrated Science & Technology with a double-concentration in biotechnology and environmental science from James Madison University.