Breaking Down The CDMO Size Barrier

By Louis Garguilo, Chief Editor, Outsourced Pharma

We recently discussed a “mutual growth” strategy for working with smaller to mid-sized CDMOs, with industry veteran Jason Cameron, COO, Orphan Drug Consulting. Now we’re on to his “bigger than you” strategies for working with what I call “Big CDMO.”

Many readers may have had positive experiences with today’s larger CDMOs despite the size difference with your organization. Others, as we occasionally document in these pages, may have had other experiences.

Good or otherwise, you’ll want to take in Cameron’s tips on how to get a Big CDMO to take on your project, and his expertise on maintaining a relationship – and access to timely capacity.

You, Too?

Cameron, who spent years at Genzyme (acquired by Sanofi in 2011) and Amicus Therapeutics before more recently joining Orphan Drug Consulting, starts us off with what you the drug sponsor are peddling to the potential CDMO:

“If you are a “me-too” product, you need to understand your challenges will start with getting the CDMO’s interest, and thus any of their capacity,” he says.

Of course, first you must have that self-realization: our product is not of novel consequence.

Yes, it is a great improvement in one or several drug-development, safety, or quality areas. Yes, it will be a valuable option to patients. And yes, there is a market for the product.

Nonetheless, is it something the CDMOs hasn’t seen before?

“Novel,” citing a Cameron example, is Gilead Sciences’ breakthrough when it developed drugs that cure hepatitis C (reference: Measure Lives Gilead Returns, And The Returns It Provides).

However, not being groundbreaking is not detrimental. In fact, it is the way our industry grows our knowledge base: incremental improvements – which can lead to more spectacular results.

“You’ll just have to spend a significant amount of time getting the right relationships at the beginning,” says Cameron. “And by that, I mean a ridiculous amount of time, building the familiarity with personal relationships,” he emphasis, and then explains:

“To build a relationship you have to be interested in getting to know people on more than a purely technical/work basis. A genuine relationship takes time and openness. It should not even be thought of as part of doing business, but more as building your professional or personal network.  

That upfront time and effort will always bring value, says Cameron. It may help you land a slot at the CDMO, and as importantly, “when things go wrong during development – and they will – it’s not left to people arguing amongst themselves.”

Instead, streamlined conversations based on familiarity can resolve challenges, “and everyone stays calm.”

Despite what he has learned works well, and the volumes provided to discussions on sponsor-provider “partnerships” and “marriages,” Cameron says he still sees that we focus too much on “contractual elements as events unfold, and not enough on the people elements.” 

He feels that’s where COVID presented the most difficulty. As much as the supply chain challenges themselves, it was the inability to go to the CDMO, visit face-to-face with the people, that in some areas disrupted the drug development and manufacturing outsourcing industry.

Color Me Novel

On the other hand, if you are bringing something recognizably new to CDMOs (it could be a technology, “platform,” completely new mechanism of action, unmet or orphan market drug) it will in all likelihood be a project of interest to a Big CDMO.

If so, use that novelty for all its worth.

The best CDMOs want to get in on new science and technologies, “so it’s a way to get significant traction.”

Cameron recalls working with “an ever-expanding, leading CDMO” on gene therapy programs.

“Overall, this was and still is a small part of their business – but it’s a huge investment area for them going forward,” he explains. The attitude when approaching the CDMO with such a program is:

“You are going to be our experts in this field that you want to become experts in. Yes, we’ll rely on you as we look at not this generation, but the generations beyond that.”

In other words, the client’s commitment and aligning of motives and directions works on any CDMO – actually no matter the scale of service provider.

“Have that scientific and technical discussion around development and what's possible, with the right people tasked with moving their organization into the future,” says Cameron.

You'll get more of their attention … and their commitment. 

Momentum Building

There is a final step in this stairway to a Big CDMO.  

It is leveraging the importance you’ve gained across the rest of the CDMO network, “where perhaps you are doing more “me-too-like” products, or when you want to bring new projects forward,” says Cameron.

“All of a sudden, more people are paying attention to everything you're doing.”

“You need to understand and communicate the value you are bringing to the company, and the specific value they are bringing that you need,” he says.

But do not overlook that there will be certain nuances to a relationship of a smaller customer and bigger CDMO. You as the customer need to understand those, and build off of them.

The foundation for that positive building? All that understanding of what you bring to the CDMO, what they bring, and those relationships you’ve put in place from the outset.

Cameron adds this as we wrap up, but makes clear it is not a tertiary thought, but an item that should already be a part of any sponsor-provider relationship.

“Have a strong patient story,” he advises. “Although we think bigger companies can be cold-hearted to a degree, bring in patient stories and demonstrate the importance of what you are doing for them. A clear purpose will build common goals helping break any size barriers.”