The Key Trends Driving Supply Chain Localization and Data Scrutiny in Biopharma

In this part 1 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, offers insights into critical trends shaping the biopharmaceutical industry, drawing on his 25 years of experience in the sector. The discussion focuses on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration of artificial intelligence (AI).

Geopolitical concerns, particularly tariffs, are driving a pronounced shift toward localized supply chains. Mowery notes that many organizations are now seeking to conduct as much work as possible within the region where their clinical trials are executed. These pressures, similar to those experienced during COVID-related shipping constraints, are expected to remain relevant for at least the next three to five years. This environment underscores the increasing value of regulatory reciprocity among agencies. Collaboration and common standards help ensure therapies are treated equally across countries, delivering such benefits as cost savings and reduced global travel while allowing local regulators, who may be better equipped due to language considerations, to conduct facility assessments.

The biopharma sector has also faced a macroeconomic shift, sometimes termed the "biotech freeze," which demands more robust data to secure capital and advance clinical trials, according to Mowery. While earlier periods allowed capital raising based on less data and more philosophical ideas, the current climate necessitates therapies that are much more robust and founded on data, a development he sees as a positive outcome for the patient.

Discussing innovation, Mowery identifies AI as a transformative force, globalizing faster than electricity or the internet. When proper infrastructure is in place, AI acts as "almost passive knowledge," capable of optimizing everything from supply chain logistics and sales/marketing to drug discovery and operational efficiencies, he adds. One particularly impactful application is using AI to author regulatory submissions by distilling accumulated development and validation data rapidly, thus expediting approvals and lowering costs. Mowery stressed that AI should be viewed as an opportunity to augment human capabilities. "A lot of people are scared of AI and job displacement,” he notes. “We actually see it as an opportunity to amplify the capabilities of our people and hand them a strong tool to leverage the deep expertise they have."

Check out Part 2 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.

My name is J.D. Mowery. I'm the president of Bora Pharmaceuticals, which is our CDMO division within Bora Group. I've been with the organization a little over a year now. I've been in the sector for about 25 years. I spent half of my career as an innovator working at Genentech, Celgene Geno Therapeutics, and the other half of my career working on various CDMOs within the industry before joining Bora.

I think when we, consider the CDMO sector, the biopharma industry, and tariffs and some of those geopolitical concerns that are out there right now, you're starting to see a pivot towards localized supply chains. Many are looking to do as much within the region where they operate—where their clinical trials are being executed—as possible.

One of the things that we have the luxury of here at Bora is the ability to do that on a global scale across our different regions. We've got sites that have commonality when we think about Mississauga and Maple Grove, they're very similar. So if a country, their region of say APAC needs service, we have the ability to take care of them there, or tech transfer and be able to do it within the US region as well.

I think those pressures are going to be in place for probably at least the next 3, 4, 5 years. You never know how that's gonna play out. But I think looking at… similar to the way people reacted to COVID, to where we were trying to prevent crossing borders because of shipping constraints and things like that, I think you're dealing with a very similar situation right now in response to those tariffs.

I think when you think about the regulatory support that could come when we have constraints around tariffs or border shipping and such, I think we already understood as an industry how valuable reciprocity is for different regulatory agencies, and the common standards that can exist so that, we have modalities and therapies and treatments being treated equally within a given country. Sometimes you gotta take a look at the different countries and understand what's the right bar to measure ourselves against. The more those different regulatory bodies can work together to come up with a common standard and a common way of working, and be able to recognize what one another are doing, there's many benefits. It's a cost savings for the different countries. It cuts down on things, greenhouse emissions and things like that because they're not traveling all over the world. Many times, the local regulators are better equipped to do a proper assessment of a given facility, especially if there are language barriers. Reciprocity was always important, but I think this is another example of why it is so important.

When you think about the balance of private and public sectors and consider how that helps us, especially in the kind of macro economic conditions we're looking at. Several years ago you could have gone in to, to, whether it was a PE firm or a VC firm to raise capital, and do with probably less data, more of an idea, thought philosophy and where you were gonna head with a different therapy.

The shift in the kind of the economic conditions over the last few years, and people refer to it as the biotech freeze or the pharma freeze, has put us in a position where much more robust data is necessary to get capital, to allow clinical trials to progress.

Personally, I think that's a good thing. Because the products and the therapies that are coming out the other side of the clinical trials are much more robust. They're much more founded on data. When you look at what's happening from an ecosystem perspective, the public and private sector have the ability now to get honed in on the right therapies and make sure that they see the light of day from a commercialization perspective.

And at the end, the patient is who benefits, right? Because the patient that's laying there can have greater faith in what's happening coming out of clinical trials. I think that ability to balance the public sector, whether it's a publicly traded company, and the private sector has put us in a place where people realize that from a competition perspective, yes, it's still relevant, people are still going to be fighting for market share, but there's also an opportunity to allow people to focus on what they're really strong at doing so that others take care of what's important to them and their mission and that ecosystem.

Yeah, when you think about innovation and the opportunities that lay ahead of us, you can't ignore AI, right? If you look at AI and what's going to happen, it's being globalized faster than the internet, faster than electricity. I spoke about this last year at DCAT and we continue to be very focused on it here at Bora and the industry as a whole, as we get that infrastructure in place, the results of it, if you have the right AI system around, it's almost passive knowledge. You can use it and continue to feed data into it for anything from supply chain to sales and marketing to operational efficiencies, to drug discovery. The ability to take and process and analyze that data and put it into a useful format to make decisions in a fraction of the time with a fraction of the people or man hours that were necessary before…

I think about something as simple as the authoring of a BLA and really being able to take the information accumulated during the execution of, process validation, PPQ development, and be able to distill that down and create a dossier that can be handed over to the regulatory agencies in a fraction of the time. That allows for cost reduction, but it also allows products to flow through and get approval much more quickly.

So here we see, a lot of people are scared with AI and job displacement. We actually see it as an opportunity to amplify the capabilities of our people and hand them a strong tool to leverage the deep expertise they have. I think that's the biggest opportunity we're going to see in my lifetime, when we think about innovation.