When Batches At The CDMO Go Kaput
By Louis Garguilo, Chief Editor, Outsourced Pharma
Towards the end of my conversation with Michael Kelly, CEO, NervGen Pharma, I solicit an example, drawn from his years in the industry, of how to handle a serious issue that occurs at a CDMO.
His has been a storied career, starting in established pharma, moving successfully through smaller biotechs and commercial launches.
It takes him a moment to collect his thoughts. “I’ll give you an example where I was on the executive team of a company, and my colleague was responsible for a critical CDMO relationship,” he eventually replies.
No Shame On You
“I was running our North America commercial operations, and my colleague was delivering the product to me through an external partnership he’d established.
We ran into some manufacturing challenges – batch failures – at the CDMO that were going to cause serious challenges for us.
It presented us, as these cases will, with a fork in the road.
One path was to flip to a backup manufacturer, where we could see if we could alleviate the problem. However, a mentor of mine way back in my career gave me advice I’ve always remembered:
‘You have to go see the partner. Meet face-to-face. You can't rely on people at varying levels within their organization who are below the executive level to simply manage a relationship, or a process, when something occurs. You have to build relationships throughout the organization – at all levels, including executive level whenever you can.’
That's what this mentor taught me, and thankfully, that's how my partner immediately approached the challenge.
Just like within your own company, there are different levels of manufacturing going on if you're outsourcing manufacturing, and there are different levels of responsibility within those activities.
If you're not making connections at all of those levels so that folks on both sides can appreciate what's going on in the other organization, then when you have a challenge, you typically are stuck.
It’s so much easier if you have built and maintained those vertical relationships. Depending on the situation, you can tell your counterpart at the appropriate level of their organization, ‘Here’s what’s happening to our business. What's going on with your business? Can we work out some type of mutual fix to this problem?’
If you have not built those relationships throughout the organizations, that's when you typically end up going to another organization – the relationship effectively ends because the challenge can’t be overcome.
In this example, my colleague had effectively made those relationships. He dropped everything, hopped on a plane and flew across the country. He held a number of meetings within their organization. Importantly, he was welcomed by them.
He explained the situation from our perspective, and came to understand the situation from theirs. The two sides came up with a mutual solution. It was the fastest way we could resolve the problem, and it also was a long-term solution. It was a disaster avoided.
Earlier in our conversation you asked if I had been lucky in my outsourcing experiences. I guess I've been lucky in that I've not allowed disasters to occur. But that's because I've worked my tail off to make sure that challenges didn’t turn into bigger problems.
Back to this situation I’ve described, my colleague was also trained by a mentor, one who made two points.
First, if you're not talking to all levels of the external organization, and at the same time you aren’t clearly relaying to that organization that you are relying heavily on them to support you as a partner, then shame on you.”
What Failed?
I ask Kelly what exactly was the issue with those failed batches. Equipment breakdowns? Operator errors? Quality controls? Something else?
“I'd describe it as more of an overall personnel issue,” he replies.
“They had recently switched some staff, as I recall. They were growing fast. It's the same as the problems sponsors may have when we grow too fast. There is not a sufficient transfer of knowledge from the experienced professionals that have been there to the new ones coming into the organization.
It takes time to come up to full speed. And typically, mishaps occur during that period of time when somebody is doing something they think they know how to do, but they don't necessarily – they’ve missed something, some understanding or experience is omitted.
So I believe it was a growth challenge at that CDMO. And because we talked it out so we could learn specifically what the problem was – and we told them how our plans were impacted by this as well – we avoided having to jump start the production with somebody else.
While we may have had the choice to move to another CDMO, in many cases you really can’t just up and move on. You have to fix the problem where it exists. The best and fastest way to fix it almost always is with getting all the expertise from both sides in the same room to face it.”
How was the challenge overcome?
“Training. It just took them to implement a detailed plan, and a dedication, to more and continuous training.
"And slowing down a bit on our end. We agreed to ease the batch demand. We had to work with them, and we knew the faster we made them go, the worse we made the problem.
"Subsequently, there were other solutions implemented, where, for example, you work out the addition of another production line, so you're not stressing out the one line we were dependent on. You work together with the CDMO to build redundancies in a timely manner.
Altogether, it was a wholesome learning experience – by that I mean we learned and the manufacturer learned how to fix these problems together.
They're running a business just like we are. They're not going to make those improvements or investments in your business – such as adding capacity or capabilities – unless they understand you are willing to work with them, and have a long-term commitment.”
On all levels.