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Choosing a CDMO When You’re Still Figuring Out Your Program

  • Writer: Sarah Sink
    Sarah Sink
  • Aug 21
  • 3 min read

Let’s be honest, most biotech teams don’t have everything buttoned up before talking to CDMOs.


Maybe the formulation is still being finalized. Maybe the tox timeline just shifted. Maybe you’re still raising funds and trying to gauge how far this next batch needs to take you.


Sound familiar?


You’re not alone.

But here’s the challenge: even when the program isn’t fully defined, you still need to make manufacturing decisions. And that often means evaluating CDMOs before you have all the answers.


So how do you move forward responsibly without locking yourself into something that could hurt you down the line?



Strategic Fit Matters Even More When Things Are Unclear


When your program is fully baked, you can match it to a very specific service provider. But when you’re still refining your CMC plan, you need a CDMO that can flex with you, not one that rigidly quotes what you thought you needed three months ago.


This is where strategic fit comes into play. It’s not just about what services they offer; it's about how they think, communicate, and adapt.


Ask yourself:


  • Are they curious about how your program might evolve?

  • Do they have room to pivot with you?

  • Are they willing to scope with “known unknowns” in mind?


If the answer is no, you may end up with a partner that locks you into the wrong path, or worse, penalizes you for changing direction.



Common Mistake: Delaying CDMO Outreach Until Everything’s Final


It’s tempting to say, “Let’s wait until the formulation is locked” or “We’ll engage CDMOs once we get our next funding tranche.”


But waiting too long can limit your options. By the time you’re “ready,” your ideal CDMO may not have capacity, or your timelines may require a rushed tech transfer.


Instead, think about engaging early with the right kind of CDMO, one that knows how to collaborate during early-phase ambiguity and can help you make smarter decisions upstream.



5 Questions to Ask CDMOs When Your Program Is Still Evolving


These aren’t your standard capability questions. These are strategic alignment checks:



1. How do you handle evolving scope?


Look for examples of other clients who changed formulations, adjusted timelines, or shifted batch size after award. How did they respond?



2. Do you offer phased proposals?


Some CDMOs can structure proposals in stages, quoting initial feasibility work first, then layering in larger scopes once more is known. This helps reduce rework and improves flexibility.



3. Can you help pressure-test our assumptions?


A good CDMO will ask thoughtful questions about your process and not just take your assumptions at face value. That input is incredibly valuable when your team is still locking details down.



4. How do you define program success for early-phase clients?


Are they focused on getting your batch done, or helping you de-risk and move forward? Listen closely to how they talk about value during early-phase work.



5. Who will be in the room for the early conversations?


If your formulation and strategy are still evolving, you want access to SMEs early, not just a BD rep with a standard slide deck. The right people in the room make all the difference.



Use Smart Tools to Guide a Fluid Process


When things are still evolving, structure helps.


That’s why I created several tools specifically for biotech teams navigating this gray zone:



If your team is still working through scope, risk, or readiness, my course How to Get Internal Alignment Before Engaging a CDMO is built to help you frame the right questions and engage with more confidence.


These aren’t generic vendor checklists. They’re built from the trenches, for teams who are working through real-time ambiguity.

You Don’t Need to Have It All Figured Out, But You Do Need the Right Partner


There’s no perfect moment to engage a CDMO. Programs shift, timelines move, formulations evolve. That’s biotech.


What matters is having a partner who gets it, and who’s structured to support you, not slow you down, as you make decisions in real time.


If you’re still figuring out your program and wondering how or when to engage CDMOs, don’t wait for perfect clarity. Instead, start smart with the right questions, the right tools, and the right mindset for flexibility.



For more insights and personalized support in navigating the biotech-CDMO landscape, visit my website: www.yourpharmagirl.com and follow Your Pharma Girl on LinkedIn. Whether you need strategic guidance, tailored BD solutions, or expert advice on building lasting partnerships, I'm here to help you and your team succeed at every stage of development.

 
 
 

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