Clearing Hurdles in Sustainability, AI, and CDMO Partnerships

In this part 2 of a 2-part interview regarding the presentation “Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, panelist J.D. Mowery, president, Bora Pharmaceuticals, provides insight into pivotal operational challenges and necessary evolutions within the biopharmaceutical industry. The discussion centered on the necessity of establishing global standards for sustainability, the operational hurdles of artificial intelligence (AI) implementation, and the need to increase trust in outsourcing partnerships.

Mowery asserts that global standardization is crucial for addressing environmental impact across global supply chains and manufacturing facilities. By aligning on common criteria, both innovators and CDMOs can measure performance on the "same sheet of music," making it easier for biopharma companies to select partners who adhere to the same standards as their internal operations, he says. The current fragmentation, where people measure using "multiple different ways and there's multiple different scales," makes it extremely difficult to accurately compare and contrast performance, according to Mowery.

Implementing AI presents significant preliminary challenges, primarily related to data readiness. Organizations often do not realize the extent to which their systems are disparate or their data is dispersed until they begin the implementation journey, Mowery opined, adding that this requires substantial initial effort for data consolidation and cleansing before the full benefits of AI can be realized. He notes that, like transitioning from poor paper batch records to poor digital formats, a lack of data hygiene undermines the subsequent digital tool. Regarding this steep operational hurdle, Mowery states, "I think most organizations don't really fully appreciate how disparate their systems are or how dispersed their data is until they start to try to do something like this."

Mowery argues that the biopharma sector lags behind industries like automotive and computer manufacturing in terms of outsourcing maturity. Economically, outsourcing should be increased to allow CDMOs to spread overhead costs across multiple products and customers, he says. The main barrier to this shift is the need to gain the trust of the biopharma industry, which CDMOs must achieve by consistently maintaining high operational performance, specifically strong on-time in full delivery rates.

Check out Part 1 of this interview and access all our CPHI Europe coverage!

Transcript

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Yeah. So, you look at the different facilities that operate around the world, the supply chains, the shipping, all of those things contribute to impact on the environment. I think having set standards and global standards, and those are continuing to be dialed in to where we're all measuring against a single set of goals, will be very important.

It makes it easier for even the biopharma sector to choose the CDMOs that they want to partner with so that we can understand and be operating against the same criteria that they would operate their own facilities within. I think that standardization, whether you're talking about across the innovators and the CDMOs or if you're talking about from one country or one region to the next, it allows us to all be on the same sheet of music when we think about how we can have the most profound impact on the environment and on sustainability.

When you get people that are measuring at multiple different ways and there's multiple different scales and there's different initiatives, it's very difficult to compare and contrast how well somebody is or is not doing. So, the closer we can get to a set of global standards that everyone operates against, I think the easier it'll be for us to understand the impact we are or are not having, so we can adjust accordingly.

No, and I think, it's like any other standardization, right? There's always going to be people that are beholden to their tool, their methodology, their standards, right? It's trying to get everybody aligned on those, and I think that'll have to require very deliberate effort. And obviously people understanding the value of it on the other side, I think that's going to be your biggest challenge, because we need to go through it… it's no different than the regulations, right? And looking at regulatory bodies and trying to provide reciprocity and trust one another that you're doing it the correct way. Somebody's going to have to go help identify what is the right bar, what's the right standard, and really steal and take the best from the best and try to put together the one set of standards that everybody's comfortable working with. It's never going to be 100%, right. You're always going to have other kind of ancillary things, but if there can be a primary set of standards that we can all focus on, measure ourselves against, I think you're better off.

It's a great question. And we've started our journey this year. We've been working with an outfit out of Taiwan. We've been working with a US outfit as well to help us with that journey from an AI implementation perspective. And I think most organizations don't really fully appreciate how disparate their systems are or how dispersed their data is until they start to try to do something like this. So, the inertia that's required to get the data consolidated and cleansed and have it in a place to where you can actually leverage it to get the full benefit of AI, that's a lot of legwork on the front end. So, my guess is that some of the challenges they're facing is, when they dive in and they're ready to go do it, and they start to do the assessment of all of their systems, they realize how far away they are from actually being able to start.

If that's the case, then obviously, it makes it a little bit more difficult to, in some cases, people wouldn’t even be able to defend the investment because they're looking for that ROI as fast as possible. But, it's no different than when electronic back records first came to be, right?

The last thing you wanted was really to have just purely paper, because if you had poor paper batch records and you converted them to a digital format, you were just going to have a poor digital format. So, the housekeeping and the cleanup that has to happen before you can actually have a useful digital tool or a useful AI system, it can be a pretty heavy burden. And depending on the growth of the organization and where they are and their journey, if they haven't really been focusing on data cleansing and data hygiene and having a good, solid data lake to work from, they're gonna have to do that work now to catch up to fully leverage the benefits of AI.

The presentation will be a great opportunity for us to talk about how we better serve the sector. For me, one of the things that really… if you look at all the different sectors that are out there—automotive industry, computer industry, what have you—they're all far much more mature when it comes to outsourcing than what the biopharma industry is.

And if you take a look at the biopharma industry as a whole, and the dollars and cents of it, we should be outsourcing more, right? You should be allowing CDMOs to take the cost of producing a product and disperse the cost of that overhead across multiple SKUs and multiple customers as opposed to building facilities to manufacture one or two drugs here and there.

That, simply from my perspective, hasn't happened because we're still gaining the trust of the biopharma industry. And I think that's on us as a CDMO sector and, on us here specifically at Bora, to continue to do. We do it by way of having an extremely strong on time in full. Most of our sites are greater than 95% on time in full, and for most of your biopharma company, that's what they're looking for, right? They need to be able to trust that they're going to have their product when they've asked for it or when they're counting on it, whether it's for a clinical trial or for commercial distribution.

I think that'll be an important part as we continue this journey here at Bora and as we evolve as a sector as a whole. So, that'll be one of the things I want to touch on heavily during the presentation.