I also asked Donley to speak to us more broadly about his experiences with CDMOs over the years, and to provide some advice to Outsourced Pharma readers regarding relationship building, and the current lay of the outsourcing land.
No Fault Of Yours
“With regard to the ongoing nature of a relationship with a CDMO – and this applies generally to any outsourcing that has strategic bearing on what you're trying to do as a business –you need to find a service partner that can align with your ambition,” Donley starts his thoughts.
However, he quickly adds, when a positive drug-sponsor/CDMO relationship starts to deteriorate, “it’s often because the CDMO gets stiff-armed.”
As in: “They aren’t given close access to information they need. They don't have the full context. They are kept at a distance.”
Donley says with access and context missing, the working relationship can devolve into an us-versus-them attitude.
“I saw that happen years in the past, mostly in the earlier stages of outsourcing in our industry,” he says.
But today, he and Aurinia represent a more mature breed of outsourcer, demonstrating advanced – and some ground-breaking – arrangements with CDMOs. (again, see part one.)
“There're a lot of people working in our industry today who understand the real value proposition. The CDMO is an involved part of your strategy for how you will fulfill that development and manufacturing part of your business remit,” Donley says.
“And people like me believe if a partnership is not working, the first place you should be looking is at your own team.
“You carefully selected a strategic partner; if that relationship is not working, it's incumbent upon you to figure out why, and try to make it work. This is a complex business we're in; there are a lot of things that can go wrong.
“To the extent you have a working strategic partnership, you're finding solutions together. What you don’t want is to be throwing dirt clods at each other.
“If it gets to that stage of pointing out who's at blame and who's at fault, from my perspective it’s now a failure of leadership and management.”
So, dear readers, no stiff-arms or dirt clods.
Instead, says Donley, stay clear in your communications with your service providers about what you are working toward – together.
“That clarity maintains an environment where issues aren't hidden until the last minute,” he explains, “or until the worst scenario arises and you start running through the lawyers every time there needs to be something sorted out.”
What, then, typifies the strength of an ongoing outsource relationship, according to Donley, is “active, open, and frequent communication.”
“If it's some minutia in terms of figuring out why a certain gelatin is behaving this way or that,” concludes Donley, “or something much larger, for example, with regard to an urgent need to toggle output in response to changing demand dynamics, you have to manage it in that manner of a ‘we,’ not an ‘us-versus-them’ attitude.
And That Goes Round The Globe
Furthermore, nothing changes when the strategic partnerships are practiced worldwide.
Globalism, to paraphrase Donley, is simply how it works in the modern biopharma industry. And it’s been that way for quite a while. He finds that as matter-of-fact as the very need to outsource at all.
“Fundamentally, our industry is structured that way: the capability and capacity resides where it resides, and you go to meet it.
“COVID, hopefully, is a once in a century dynamic. We've navigated it really well. Absolutely we were concerned, continue to monitor it, and adjust if necessary.
“But I mean, you've always got geopolitical dynamics to deal with. You’ll have certain international complications, for example Brexit, and events you must contemplate.
“Heck we have to manage snowstorms. That's just part of the biopharma dance today.”
“All these things are in fact navigable. It all holds up first-and-foremost because of an ease of communication. The relatively open nature of global commerce remains fully viable. The global model is pervasive.
“It's the norm in biopharma – and the norm in almost all commercial businesses.”
Stay Out Of The Weeds
Donley reminds us of the overriding consideration of a biopharma executive, and the entire biopharma organization.
“We often get into the weeds about how we do what we do, and sometimes we miss why we do it,” he explains.
Specifically about Aurinia’s newly announced strategic relationship with Lonza – and the citing of a “monoplant” at that CDMO dedicated to Aurinia:
“This type of partnership represents one of many that affords us the opportunity to do something that biopharma does when it's at its best: We're bringing treatment to patients desperately in need.
“Lupus nephritis is an awful disease. We have taken a 20-year journey here at Aurinia to develop something that's going to bring patients hope – around the world – and a way out of dialysis clinics, and avoiding potentially fatal consequences.
“And these meaningful medical breakthroughs coming from startup companies are enhanced by strategic outsourcing partnerships.
“So the ‘why’ we do what we do is the important element to consider in our partnerships; it’s been central to our ability to fulfill our ambition.”
“Years ago when I started with MedImmune, we were smaller than Aurinia is now. But the biotech industry had a deficiency of manufacturing capability. So what did we do? We built a facility – which may still be one of the largest buildings in the state of Maryland. It was a massively expensive stainless-steel, clean-steam, biologics-manufacturing plant.
“And by the time it came online, the industry was migrating to partnered manufacturing. New, dedicated production capability was coming online with folks who are really good at it – the CDMOs.
“They now had the depth of expertise. It wasn't a bolt-on function – it was their central focus. And we know this is a fungible strategy for manufacturing. It's more efficient.”
If, that is, you enjoin and correctly nurture your strategic partnerships.
“You end up with leverage that allows smart, scientific organizations to realize the potential of their efforts,” concludes Donley.
“It's an awesome time we are in as drug developers and commercializers. And for our CDMO partners.”