Is 2026 The Year We End The "Culture Wars" Between Sponsors And CDMOs?

By Louis Garguilo, Chief Editor, Outsourced Pharma

We’ve spent years scrutinizing the operational cultures of CDMOs. The standard question sponsors have come to ask is: “Does the CDMO’s culture fit ours?”

2026 should be the year we flip the script.

Biotechs and pharma alike should ask a different question: “Does our culture enhance –  or inhibit – the outsourcing experience?”

Becoming Better Customers

In a 2025 review, I highlighted CDMOs focusing on reinventing the customer service aspect of their operations.

But real transformation in outsourcing relationships won’t happen unless sponsors also consider how to be better partners.

Among other things, that means building an organization that respects and integrates internal and external CMC expertise.

Recently, I spoke with a director of CMC who decided to leave her biotech because neither investors nor management thought seriously about CMC. “They were hardly thinking about it at all, and it was growing late in our product cycle,” she says.

Although confident that the therapy would eventually be approved, she believed when that happened they wouldn’t have the drug supplies needed to fill the patient market. She also honestly feared they could be heading for trouble with the FDA because of a lack of controls.

This might seem an extreme case, but in fact is not a rare one.

At biotechs, enthusiasm tends to stem from and through discovery, and then most attention is on clinical trial results. The actual clinical material production and subsequent manufacturing, by contrast, is compartmentalized to a few professionals.

No wonder their’s friction with CDMOs. If anything, they are all about the realities of processing and manufacturing.

This gap is the biotech’s cultural blind spot.

The professional mentioned above said she actually had to caution her boss from using terminoloy auch as “widget builders” to describe manufacturers.

“That attitude trivializes the complexity of pharmaceutical production, and erodes trust between sponsor and partner,” she says.

Sponsors cannot afford to perpetuate this mindset. Manufacturing – do we really have to spell this out? – is not a peripheral activity. Rather, it’s the manifest reality between discovery and doses to patients.

And consider: You have outsourced that central element to an external organization.

A recurring lament from CDMO leaders is that leadership at many sponsors don’t even attempt to wrap their heads around understanding the CDMOs they are working with.

A lack of interest manifests in the demanding of unrealistic timelines, incomplete technology transfers, and starting out with adversarial negotiations. When challenges arise (as they will), the cycle of misunderstanding spirals.

Instead, biotechs not familiar with manufacturing should invest in educating yourselves about CDMO realities, e.g., their facility and equipment trains, capacity gyrations, regulatory oversight, the intricacies of GMP and scale-ups, and indeed the CDMO business model.

Our industry should insert manufacturing expertise into earlier stages of biotech growth – even when the biotech views itself primarily as an R&D engine. Otherwise, development success will find the biotech’s team ill-prepared to work productively with material suppliers.

Sponsors that do get to see their therapy move through the clinic should have already considered establishing and structuring later-stage development and manufacturing relationships.

And by the way, a biotech who has done this will find it facilitates the outlicensing or sale of assets to bigger fish to commercialize, if that is the business model.

A final forewarning. Large-scale outsourcing is often managed through procurement-style transactions: volumes, schedules, price per units. Obviously, those are vital elements in contracts, but a supply-chain expert says that while that model “might suffice for office supplies, it mostly undermines collaboration in drug manufacturing.”

Correcting Oversight

Here’s a culture quizz for sponsors:

How do you approach manufacturing oversight?

For example, let’s talk about person-in-plant (PIP) arrangements.

Yes, some CDMOs are reluctant or restrictive to this practice. Do you take no for an answer? Or do you demonstrate that your organizataional culture demands that level of involvement; you view this activity as crucially as the CDMO does.

On the other hand, and although above we speak to the lack of interest at some biotechs in the contract manufacturing site, your PIP should not behave like a caffeinated auditor, or even a “meddler” as I heard this once described.

An outsourcing culture calls for engaging as collaborators — ready to triage problems, share responsibility, and celebrate wins – and trusting as partners.

And sponsors can set the tone. Invest in building relationships with the leaders, operators, engineers, quality and other staff at the CDMO. Learn of and give recognition to their expertise and experience.

If there’s little trust, you’d probably be better off finding a new CDMO.

Manufacturing Truce

These attitudinal shifts can be profound, and they lead to realistic expectations.

And your expectations should be delivered as a component of proper behavior towards your manufacturer.

Here’s what cancelling the “culture wars” looks like:

• Respect for manufacturing as a strategic discipline, and not a late-stage obligation.
• Recognition of your CDMO professionals as skilled workers directly influencing your chances of clinical and commercial success.
• Constructive oversight to ensure quaility and build relationships.
• Structuring an environment for joint decision-making and challenge-solving.

If you are a virtual or lean organization, and simply do not have outsourcing-experienced professionals intimate with working with CDMOs, hire consultants that do. Or recalibrate and consider hiring in experience.

In any case, go to the horse’s mouth: lean into your CDMO with questions, ideas, and concerns. The point is to get educated, learn to work together, and monitor your own behaviors.

Certainly no two cultures meld perfectly, but between any sponsor and CDMO lies a certain culture of manufacturing outsourcing that both sides should recognize.

If 2025 was the year CDMOs focused on their customer service, let 2026 be the year sponsors do the same on your side.