My Kingdom For A Horse! Or At Least A CDMO
By Louis Garguilo, Chief Editor, Outsourced Pharma
The crown of commercialization depends more than ever on specialized technologies and skilled workmanship, inducing an arduous search throughout the kingdom of development and manufacturing for external partners. Alas, we had thought we’d entered a golden age of outsourcing.
A golden age would be described as abundant optionality and refined internal-external partnerships realizing expectations of heightened returns on supply-chain investments (spread strategically across a global network).
And our “horse,” of course, is a CDMO of impeccable breed.
“What biopharma clients of all kinds typically and specifically come asking us to provide them is our ‘preferred list of manufacturing contractors’ that fit their criteria,” says Ken Shultis, CEO of Rondaxe, with whom we got a start on this subject in part one.
A Lust For Lists
But think about this a moment: With so much information readily available to sponsors, and seemingly so much optionality in outsourcing, doesn't it feel odd that in 2024, this is still the top request of consultants today?
Yet even the most experienced biotech professionals profess the search for CDMOs – through attending conferences and other events, sifting through marketing, websites and information online, direct solicitations, and word of mouth – is far less productive than it should be.
An aggravating factor we pointed out earlier: Emerging biotechs today are led by entrepreneurs with more pharma-industry experience than those in the past, but that prior experience was rarely gained in the realm of manufacturing.
Less so in outsourcing manufacturing. The CDMO search goes on.
Who’s Hot, Who’s Not
“The reason biotechs and pharma visit consultants and demand our ‘lists’ is because we, on the other hand, have worked with the manufacturing arms of the CDMOs,” explains Shultis. “We can provide insights valuable to them.”
Those insights include understanding of something increasingly important: Who's hot and who's not.
Shultis says today CDMOs themselves are more fluid; their operating circumstances change (e.g., via M&A), investments in equipment and upkeep ebbs and flows, personnel move around (incessantly, some would say). It’s difficult to keep up with all the gyrations.
“Clients foremost want a view of all this,” he says.
“If they have worked with certain people in the past and like them, they will go back to that facility. But all these contractors undergo changes, and those can lead to some major disappointments for repeat customers.”
To be fair here, CDMOs do need to adapt to keep up with the needs of clients. M&A can work for the better for service organizations and those they serve.
Combining assets or operations brings additional experience, and those new skillsets and technologies sponsors are looking for. There's also the advantage of introducing new geographic locations.
“But the point remains,” says Shultis. "They are not really the same organization anymore. That is important to understand.”
“And so,” he adds, “sponsors are looking for that somebody new they can learn to love again.”
Sophistication Of A Sort
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Shultis says often at the heart of the matter is timing.
Biotechs need to know:
At this point in the development of our company and our program(s), which contract manufacturer would have the kind of skills that we're looking for?
“As they say in racing, there are horses for courses,” is how Shultis explains it.
Interestingly, within this search, Shultis says he’s discovered that neither biotechs nor established pharma trust brokers as they once might have.
“The brokers always have a point of view,” he says, and those can differ from consultant insights.
“The guys the brokers represent are always the best,” he says with a smile. While consultants, too, may have their “favorites,” consultants work with many different CDMOs "and hold no allegiance to any of them."
Let me be careful here; this is not a swipe at brokers. They certainly have their position within the industry. And for these many years, when it comes to finding international relationships, brokers have been of singular value.
Nonetheless, Shultis continues, “Biotechs today come to consultants for a viewpoint that presents, we might say, a broader objective, coupled with updated, inside knowledge of a variety of contractors."
“Therefore," he adds, "this is not necessarily an unsophisticated customer who is always searching.
“It’s a customer that knows we need to find out more before selecting our manufacturing partner. We need a source that isn't leaning one way or another, or who might be swayed when searching for external assistance.
Here let's pause for another caveat: Certainly, not all consultants are the same, and this inserts another challenge for biopharma organizations.
In fact, says Shultis, in all regards, today, sponsors are intelligently discerning, and searching for “trustworthy sources.”
Who Makes The List?
“It really depends on what you're looking for,” says Shultis. “We can provide recommendations,” he says. But first on the list for determining lists, he says, are questions like these:
- Are you looking for a first-time partner to get manufacturing started? Or a backup supplier in another geographic location?
- Are you graduating from a skilled but small-scale provider to a larger scale CDMO who you hope will become your primary manufacturer?
- Do you need a replacement to whom you look to execute an effective tech transfer from your current CDMO?
These are just some of the questions upon which provider lists are built.
But no matter your situation, says Shultis in summation, when you're looking for a manufacturer, "first of all, you should possess really good, detailed description of your process.”
“It can’t be, ‘Oh, we just copied the 3.2 S section of my IND to see if they can do this.’
“No,” we tell these clients, “you must explain to potential CDMOs exactly what you need. Give them a chance to figure out if the project is a fit or not.”
If you can get CDMOs talking to you on that level of detail, you end up with a better selection process, no matter how you go about your search.
And there’s this: Entering these detailed discussions right off the bat, affords the contractor an impression that maybe you know what you are doing.
Because don’t be surprised if the CDMOs have their preferred lists of clients they’d like to work with, too.