Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

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Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

We examine what the deal means for the industry.

Kimberly-Clark to Acquire Kenvue

Kimberly‑Clark said on Nov. 3, 2025 that it is planning to acquire Kenvue, the former Johnson & Johnson unit and maker of major United States brands like Band-Aid and Tylenol, for approximately $48.7 billion (1).

In the immediate aftermath of the announcement, Kimberly-Clark shares dipped sharply; Kenvue has 

 of US Health and Human Services Secretary Robert F. Kennedy Jr. for purported links between the use of acetaminophen—the active ingredient in Tylenol—by pregnant women, and the prevalence of autism spectrum disorder and/or attention-deficit hyperactivity disorder in children (1,2).

"This validates how easing rate expectations are fueling large, transformational mergers," Kimberly Forrest, chief investment officer at Bokeh Capital Partners, 

 (1). "Both companies sit side by side on store shelves, so the scale and distribution logic make sense even if the Tylenol overhang remains a shadow any buyer would rather avoid."

Here are some other key considerations of the deal for pharmaceutical industry professionals:

What happens to brand portfolio upstream sourcing?

The merged company’s large product portfolio means upstream sourcing of active ingredients, excipients, and packaging materials may shift significantly, affecting suppliers who service both consumer health and pharmaceutical markets.

How might this influence regulatory risk tolerance?

Litigation involving Kenvue that has resulted from the acetaminophen-autism claims has highlighted how even consumer-facing health products carry regulatory and reputational risks (1). Compliance demands may amplify as sector boundaries blur.

Will manufacturing footprints consolidate or diversify?

With targeted cost synergies and integration benefits cited in the transaction, manufacturing sites for both consumer health and pharma-adjacent products could either be consolidated or repurposed; that may affect manufacturing contract dynamics (1).

Does this signal acceleration of consumer health and pharma convergence?

This deal reinforces the idea that pharmaceutical players may increasingly look to consumer health-adjacent markets for growth, making it essential for drug development teams to monitor consumer health trends and regulatory pathways.

How will supply chain resilience be revisited?

As large-scale acquisitions logically tend to prompt reviews of supply chain robustness, more stringent expectations may be set for dual-use suppliers and end-to-end traceability.

In sum, while the Kimberly-Clark–Kenvue deal resides in the consumer health space, its ripple effects extend into drug discovery, development, and manufacturing, underscoring the importance of cross-sector awareness and adaptive strategy.

Kimberly-Clark Bets $40 billion for Kenvue Despite Tylenol Controversy.

Acetaminophen and Autism: Industry Impacts of the White House Statement.

Videos

The planned Kenvue acquisition, expected to close in the second half of 2026, has notable implications for pharmaceutical R&D and manufacturing professionals.

Kimberly-Clark to Buy Tylenol Maker Kenvue: Analyzing Risks and Rewards

In a three-part interview (view those videos 

 coverage, Maggie Saykali, Director – Specialty Chemicals, Cefic (European Chemical Industry Council), reviewed her presentation at the conference, “The Critical Medicines Act: Game-Changing Opportunity for a Sustainable and Resilient Supply Chain?” The discussion focused on the origins, development, and core goals of the 

European Union’s proposed Critical Medicines Act

 (CMA); the necessary structural shifts for the European biopharmaceutical manufacturing sector; and the significant geographical shifts occurring in pharmaceutical manufacturing.

PharmTech: Can you provide an overview of the CMA?

Maggie Saykali: The CMA took a long time to elaborate; the idea for it originated during the pandemic. During the pandemic, we witnessed quite a few shortages that illustrated the existing situation that we all knew about: due to years of offshoring from Europe to Asia, we were very dependent on other regions for the supply of some of our critical medicines, especially generics. From 2020 until 2022, the situation was obviously exacerbated, and it became clear that a solution must come. The European Commission worked with major stakeholders—active pharmaceutical ingredient (API) manufacturers, generics manufacturers, branded medicines manufacturers mainly, but also patient associations, pharmacists, and member states—to identify the root causes for the shortages and find drastic solutions to alleviate or reduce them.

That process began with establishing a methodology to determine what makes a medicine critical. The Commission developed a methodology using a rather complex matrix with different factors, such as the therapeutic family of the medicine, the structure of its supply chain, and the number of suppliers. This helped identify critical medicines and differentiate them from medicines that might be short but do not qualify for criticality. In 2023, the idea arose that Europe needed a Critical Medicines Act, similar to the models for chips or raw materials.

This idea was really pushed hard by a few member states together with the European Commission. A Critical Medicines Alliance was formed, involving about 200 stakeholders. The steering board of this critical alliance included the associations mentioned, plus representatives of patients, pharmacists, and member states. We worked on the possible solutions, and then the Commission compiled this information. In March 2025, the CMA was published by the Director General for Health (DG SANTE)—the directorate in the European Commission responsible for health—with support from the directorates for industry and medical emergencies.

Since then, the CMA has entered the European decision-making process, which involves consultations with the European Parliament and the Council (the European member states). The council, the commission, and the parliament are currently discussing the Act. We think the final vote will happen at the end of this year or the first quarter of 2026, after which it will hold legal value.

What opportunities can the Act bring to EU manufacturers of APIs, intermediates, and starting materials?

We see today a situation in procurement that is completely based on cost and price only, meaning one winner takes the whole tender. This approach provides no guarantees on quality, security of supply, or adherence to environmental or social norms. This is detrimental to European manufacturers, because we have a set of standards (the European regulatory frameworks) that we must comply with. Some suppliers from other world regions do not abide by these standards, resulting in different cost structures.

By addressing the criteria used for procurement, this might give European manufacturers better possibilities to be competitive. By including environmental criteria, as we requested, value will be given to the fact that we produce according to very strict and tight environmental, social, and governance requirements. This means that we will not be penalized because of it, but that it will rather become an advantage for us. Furthermore, we are asking for multi-winner tenders, instead of the "one winner takes it all" approach, which would also be an advantage for those who manufacture in Europe.

This applies to finished dosage forms, active pharmaceutical ingredients, and excipients. We should not forget excipients because many medicines, whether generics or branded, depend on excipients for their mode of action. If we have a shortage of excipients, we are at the same point where we cannot make the medicine. The goal is to make sure there are no causes for vulnerability throughout the supply chain and no possibilities for shortages or delivery of faulty or substandard quality ingredients.

How can the Act help enhance innovation and competitiveness of the industry?

Competitiveness and innovation are very important for European manufacturers. This is the way they can create an added value compared with production in other regions of the world that might still use older techniques or older manufacturing processes and have lower environmental requirements. By valuing and giving an advantage to these criteria, we are pushing for innovation and for more efficient, environmentally friendly processes, such as better control of emissions and better recycling of solvents. Innovation is pushed by the need for competitiveness, so the two go together. Since we cannot compete on salaries or costs, we must compete on quality and innovation.

What will be the global implications of the Act?

We observe that other world regions, such as the US, are adopting something very similar to encourage national production. They are advancing in parallel with the EU. This is the solution if you want to have control over your supply chain and guarantee that whatever crisis happens, you have what is needed to address the crisis. Crises are unpredictable by definition. The essential notion here is not that you should have a stockpile of what is needed, but that you should have the equipment and the infrastructure to produce what you need when you need it. If Europe does not maintain its current level of industrialization and manufacturing for the pharmaceutical supply chain, this ability to produce what is needed when it is needed will dwindle, causing a problem. This is more or less where the US is now, because they have lost a lot of their manufacturing capability and are now more vulnerable even than Europe.

How else is the industry reimagining supply chains to protect against global disruptions?

The CMA addresses this really well, as it includes a chapter on preparedness and a chapter on international cooperations. If you want to be crisis-ready, which is the final purpose of what we are doing, you need to act on both. You need to be able to encourage local production at the best and highest standards of quality possible to be able to make what you need when you need it. But you also need to secure international alliances and cooperations for times of crisis, when you need to have other options as well. By having only one option at the moment, we are making ourselves vulnerable. We saw this during the early phases of COVID, when some supplies failed to arrive in Europe, illustrating a real issue in the delivery of some ingredients needed to make medicines. The pandemic truly highlighted some of the issues that could happen if we don't prepare.

How does the industry plan to maintain competitive advantage as patent cliffs, rising generic competition, and pricing reforms intensify margin pressures?

I can only answer from my perspective, which is that for us, the only way to go forward is to truly put value on something other than just the price. We must push for innovation and technological advances that will give us this competitive edge. If we don't do that, we lose the battle, and that is obvious. In some ways, we have to ask ourselves, “Can we afford to continue as we have always done, and can we afford to only rely on cheap medicines?” They are cheap for a reason.

Articles

The European Union's proposed Critical Medicines Act (CMA) aims to enhance the sustainability and resilience of the pharmaceutical supply chain by addressing shortages and dependencies on non-European regions. Originating during the pandemic, the CMA seeks to redefine procurement criteria, emphasizing quality, security, and environmental standards, thus benefiting European manufacturers. It encourages innovation and competitiveness by valuing advanced, eco-friendly processes. Globally, similar initiatives are emerging, highlighting the importance of local production capabilities. The CMA also emphasizes preparedness and international cooperation to mitigate global supply chain disruptions.

Maggie Saykali reviews the key points of her CPHI Frankfurt presentation on the potential game-changing opportunities of the Critical Medicines Act.

How the Critical Medicines Act Aims to Optimize European Pharma Competitiveness and Resilience

J.D. Mowery, Bora, says global sustainability standards are good, AI implementation demands data cleansing, and outsourcing must mature.

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 

*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.

Dosage forms, especially new innovations in oral delivery, are discussed.

Frank Romanski CPHI Interview - Part One

As part of its coverage of CPHI Frankfurt 2025, 

, PhD, vice-president of Strategic Growth & Revenue Management and head of Global Pharma Solutions at 

. Romanski’s presentation at the conference, “From Molecule to Market: Scalable Enteric Solutions for Accelerated Clinical and Commercial Success,” was delivered on Wednesday, Oct. 29, 2025.

In the first part of this interview, Romanski tells PharmTech Group that while the field of oral 

 has not grown as fast in recent years as biologics and cell and gene therapy, he foresees an imminent change in the direction and popularity of oral delivery.

“Simple fact, adults don't like [using] needles,” Romanski says in the interview. “Children don't like [using] needles. Eighty-four percent of biologics are actually parenterally administered, and about two-thirds of people that take pharmaceuticals really, really despise the needles. And in fact, there are very large fractions of the population that will just avoid it entirely.”

However, he cautioned, formulation challenges remain, and those must be reckoned with in a number of different ways—due to distinct factors that require unique solutions.

“You have poor solubility, you have poor absorption, you have netting that out into poor bioavailability,” Romanski says. “You have a need for these formulations to now have a variety of different things in there.”

Check back for part two of Romanski’s conversation with PharmTech Group. In that segment, Romanski turns his attention to regulatory and quality challenges, including the importance of maintaining stringent current good manufacturing practice standards.

Lonza Capsugel can be located at Booth 8.0S76 at CPHI Frankfurt 2025.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Frank Romanski. I head the Strategic Growth and Revenue Management group and I'm also the head of the Global Pharma Solutions business at Lonza Capsugel. I have a PhD in chemical engineering with a focus on drug formulation, and I've held a number of different roles in life sciences, spanning from R&D to marketing to production to product management, global strategy, and business management. My passion is taking science and converting it into real, commercial processes and working on different drugs that ultimately benefit patients around the world.

Oral delivery is a really interesting area, and it's probably, arguably, one of the oldest technologies in pharmaceutics. It's one that, compared to the rise of biologics and cell and gene therapy, has been one that probably has not grown nearly as fast in recent years. But that's really starting to change, and I think the rise of the GLP-1s [glucagon-like peptide-1 drugs] and the new blockbusters, if you will, that are coming out, is really drawing a lot of attention towards oral delivery once again.

You have to keep in mind that many of these new modalities and different chemistries are a little bit more challenging to work with. In the case of GLP-1s, small peptides, and live biotherapeutics, they're very challenging to formulate. They have a tendency to have an extremely low absorption, extremely low bioavailability. They tend to be very sensitive to things like water and oxygen, and certainly inside the stomach as well. So you really have to target them to get into the right part of the gastrointestinal tract, and ultimately get the payload to where it needs to go, because you're talking very, very tiny percentages of absorption, and that's very, very important.

Now, what's really driving all of this? It's really about patient compliance. Simple fact, adults don't like [using] needles. Children don't like [using] needles. 84% of biologics are actually parenterally administered, and about 2/3 of people that take pharmaceuticals really, really despise the needles. And in fact, there are very large fractions of the population that will just avoid it entirely.

So this is the market that many of our clients and pharmaceutical companies that we work with are going after. They want to have an alternative to many of the injectable dosage forms that are out there, and this is spurring a whole degree of technology to overcome the challenges of taking these small peptides, for example, that may be very sensitive, and getting them into an oral administrative form that can be delivered to these markets and these patients.

I think it's important to say that a lot of the ‘easy’ drugs are done. The days of taking a small-molecule chemistry and mixing it up with some MCC [microcrystalline cellulose] and creating a tablet through direct compression are largely over. And a lot of these molecules that we were just discussing, some of the GLP-1s, the small peptides, etc., they can be a real formulation challenge. And it all really starts with that formulation challenge. You have poor solubility, you have poor absorption, you have netting that out into poor bioavailability. You have a need for these formulations to now have a variety of different things in there.

One example would be penetration enhancers. You may also have different excipients that are in there to protect it from oxygen, or from specific enzymes. All of this has to be thought about pretty early from the formulation development timeline, and that keeps getting pushed back, it feels like. Now, one of the strategies associated with that is to start with a technology that actually can scale from the clinic all the way through commercialization. And I'll give you an example that we work a lot on. We have a product that we have developed and launched called Enprotect. This is a unique, dual-layer capsule that actually has built-in, enteric protection. And what that means is it will bypass the stomach and go directly to the GI [gastrointestinal] tract where the payload needs to be delivered.

There isn’t anything more complicated to a formulator than taking that formulation and encapsulating inside an Enprotect capsule. And in fact, we have even as small as a size 9 capsule, which is very, very tiny. It's actually used in pre-clinical studies to animals, even as small as rats. And you can use that same technology all the way to human trials and ultimately, to commercialization, using the same technology. So you're not scaling and changing unit operations and worried about different changes to the formulation as you go through it.

And not only that, here at Lonza, we not only do work with products like Enprotect, we can fully customize them. So for example, we work with a number of our clients that have challenges with the standard product. We can fully customize it. We can change some of the polymers that are in there. Certainly things like size and color and print, those are obvious, but I'm talking really about the formulation technology that allows us to get those drug developments to the final clinic.

Finally, we also have a CDMO [contract development and manufacturing organization]. The CDMO is based in Tampa, Fla., and we can go end-to-end, fully commercializing from the clinic all the way to commercial manufacturing of these drug dosage forms. So we're trying to offer our clients a lot of different areas of optionality to improve these formulations, all the way from the excipients and capsule design itself through commercial manufacturing.

Patient compliance is driving the emergence of new modalities, as Frank Romanski of Lonza Capsugel explains in the first installment of a two-part discussion.

Dosage Form Innovations: A CPHI Frankfurt Conversation with Lonza’s Frank Romanski, Part One

As a part of its CPHI Frankfurt 2025 coverage, 

, PhD, executive director and head of Diagnostics, Software Medical Devices & Packaging Development for 

Banerjee gave a keynote address at the conference on Tuesday, Oct. 28, 2025, entitled “The Future of Packaging: How Smart and Connected Technologies Are Enhancing Consumer Interaction.”

The full interview with Banerjee can be viewed 

 How do smart, connected packaging solutions enhance the consumer experience?

 If we take a step back here, many of these smart packaging solutions were first introduced in the consumer industry, and then subsequently [they] evolved and took different shapes and forms in the pharmaceutical industry, with the first being introduced as—and if you take again a step back here—there are different levels of smart packaging. Obviously the QR code is something, what we would call an ‘entry level’ of smart packaging, where someone can scan the QR code and it takes them to a web page which can have information, or it can have gamification, or anything of that nature as well.

The second level goes into the NFC [near field communication] technologies, which are, again, used for some of these instances where you can tap, and again, it either takes you to the web page, but NFC also offers a one-way or a two-way communication as well. And obviously, as you progress more, you can have the Bluetooth and the cellular system networks as well. Depending on what you want to achieve, many of these technologies provide different features in some of these elements, including recording features and so on and so forth.

As I was mentioning, many of these things were first evolved in the consumer space and then moved into the pharmaceutical space. In the pharmaceutical space, one of the first instances of use was in the clinical studies, by using smart caps for the clinical study program, where it helped the adherence towards the clinical program in terms of dose taking by the patients and the subjects. And subsequently, again, there were solutions which were found in terms of QR codes connecting to e-leaflets and also providing information about the patient's dosing regimen.

So as things evolved in the pharmaceutical space, smart packaging has been a patient support system, whether it is through adherence or through information, and it has been well received over the last couple of years now.

How can these innovations improve patient adherence?

The way it improves patient adherence is, one, if you take the example of a smart cap, it provides [an] alert to the patients in terms of missed dose or scheduling the time to take doses. It records the dosing. It helps care providers in terms of guiding the patients or dosing the patients at the right time, because we know globally, there is a big population of aging people. So overall, it helps in maintaining adherence in terms of taking the medication on time.

As we progress further, some of these new-age medications or therapeutic areas are complex, which means the dose has to be taken at a particular time. Some of these dosings are also titrated, which means that it is not necessary you do the same dosing every day of the week and so on and so forth. So with some of these complexities in the therapeutic areas, smart packaging actually helps in adherence and guiding the patients.

What takeaways does this provide pharma companies with for the future?

Where this helps, as I said, obviously it helps in the clinical studies. You can very clearly understand which of the subjects have been taking the medications on time. It helps in the PK [pharmacokinetic] studies, in the clinical studies as well, because now you know that if the patient has taken the medication on time, how does it reflect in the efficacy and the safety profile of the drug?

So that is, I would say, one use case in terms of the pharmaceutical industry. The second use case is, again, in terms of complex medications. It enables these types of technologies, enables the pharmaceutical industry to ensure that the efficacy and the safety of the medication is maintained, because in certain cases, you also do not want the patient to be overdosing on something just because that patient might think they might have forgotten to take the medication. So it enables a lot of benefits, I would say, towards the healthcare industry as a whole, and not only impacting whether it's the patient or the pharmaceutical industry. It takes a higher view in terms of the healthcare industry per se, which includes the healthcare professionals, the patients, and the pharmaceutical company.

How do these changes deepen the connection between brands and consumers?

Currently, if we try to see the big picture, pharmaceutical companies have been providing the molecules to the healthcare system, which has been benefiting the patients. However, if you see from an overall patient centricity and product standpoint, technologies including smart packaging actually help in terms of patient engagement, patient adherence, patient understanding, whether it's [an] e-leaflet, or anything of that nature. Therefore, it provides a much more holistic experience to the patients throughout the treatment and the medication journey.

Smart, connected packaging solutions, initially developed in the consumer industry, have been adapted for pharmaceuticals to enhance patient interaction and adherence. Technologies like QR codes, NFC, and Bluetooth facilitate communication and information access, supporting patient adherence and engagement. These innovations are particularly beneficial in clinical studies and complex therapeutic regimens, ensuring proper dosing and improving pharmacokinetic study outcomes. By integrating these technologies, pharmaceutical companies can strengthen their connection with consumers, offering a more comprehensive and patient-centric experience throughout the treatment journey.

Sriman Banerjee of Takeda Pharmaceuticals says patient adherence is improving thanks to technologies that offer a more personalized approach.

Takeda’s Sriman Banerjee Discusses Smart Packaging at CPHI Frankfurt 2025

J.D. Mowery, President, Bora Pharmaceuticals

In an 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 in the sector. The discussion focused on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration, but also the operational hurdles, of artificial intelligence (AI), the necessity of establishing global standards for sustainability, and the need to increase trust in outsourcing partnerships.

PharmTech: How is the sector reimagining supply chains to protect against rising tariffs, geopolitical shocks, and global disruptions?

J.D. Mowery: When considering the CDMO sector, the biopharma industry, and geopolitical concerns like tariffs, we are seeing a pivot toward localized supply chains. Many organizations are looking to execute clinical trials and conduct as much work as possible within the region where they operate.

At Bora, we have the advantage of executing this strategy on a global scale across our different regions. For instance, our sites in Mississauga and Maple Grove have commonality, allowing us to serve the APAC region there or conduct a tech transfer to handle services within the US region. These pressures—similar to how people reacted to COVID and constraints on crossing borders—are expected to remain in place for at least the next three to five years.

What role should regulatory harmonization play in ensuring timely access to critical medicines during cross-border disruptions?

Regulatory support is crucial during constraints like tariffs or border shipping issues. As an industry, we already understand the value of reciprocity among different regulatory agencies and the importance of having common standards so that treatments and therapies are treated equally within a given country.

The more regulatory bodies work together to achieve common standards and recognize one another's work, the greater the benefits. This cooperation results in cost savings for countries, cuts down on factors like greenhouse emissions (by reducing travel), and ensures that local regulators, especially where language barriers exist, are better equipped to perform proper facility assessments. Reciprocity was always important, but current disruptions further exemplify why it is essential.

How can public–private partnerships be structured to not only address immediate shortages but also incentivize long-term resilience in pharmaceutical supply chains?

The economic conditions of the last few years, sometimes referred to as the "biotech freeze" or "pharma freeze," have shifted the landscape. Several years ago, capital could often be raised with less robust data, sometimes based more on an idea or philosophy. Now, much more robust data is necessary to secure capital and allow clinical trials to progress.

This requirement for robust data is viewed as a positive development because the resulting products and therapies are stronger and more data-founded. This ecosystem now allows the public and private sectors to focus on the right therapies and ensure they reach commercialization. Ultimately, the patient benefits because they can have greater faith in the outcomes derived from clinical trials. While competition for market share remains relevant, there is also an opportunity for entities to focus on their core strengths.

Where do you see the greatest potential for innovation that could safeguard medicine security without significantly increasing costs?

The greatest potential for innovation lies with AI. AI is being globalized faster than electricity or the internet. If the correct AI system is implemented, it offers "almost passive knowledge" that can be continuously fed data. AI can be leveraged across all areas, including supply chain management, sales and marketing, operational efficiencies, and drug discovery. AI's ability to process, analyze, and synthesize data into a useful format allows decisions to be made in a fraction of the time, requiring fewer man hours than previously needed.

For instance, AI can be used for something as simple as authoring a Biologics License Application. It can distill the information accumulated during process validation and PPQ development to create a regulatory dossier much faster. This speed leads to cost reduction and allows products to flow through and gain approval more quickly. We view AI not as a threat of job displacement, but as an opportunity to amplify our employees' capabilities by providing a strong tool to leverage their deep expertise. I believe this is the biggest innovation opportunity we will see in my lifetime.

What barriers exist to wider adoption of AI in bio/pharma?

A major challenge is that many organizations do not fully appreciate how dispersed or disparate their systems and data are until they begin the implementation journey. Significant effort—or inertia—is required upfront to consolidate and cleanse the data before it can be leveraged to get the full benefits of AI. Companies often realize they are further away from starting than anticipated once they assess their systems.

This difficulty can make it challenging for organizations to defend the investment, as they are often looking for the ROI as quickly as possible. This situation is comparable to the introduction of electronic batch records: converting poor paper records to a digital format simply results in a poor digital format. Therefore, companies must undertake the "housekeeping and cleanup" to establish a solid foundation, focusing on data cleansing, data hygiene, and creating a good, solid data lake before they can fully realize the benefits of AI.

How can industry and governments simultaneously improve resilience and meet environmental targets?


Implementing set global standards is crucial. Operating facilities, supply chains, and shipping all impact the environment, and if everyone measures themselves against a single set of goals, it will be very important for progress.

Standardization simplifies the process for the biopharma sector when choosing CDMO partners, ensuring they operate against the same environmental criteria used in the biopharma companies' own facilities. Whether applying standards across innovators and CDMOs or across different countries and regions, this harmonization allows everyone to be "on the same sheet of music" regarding environmental impact and sustainability. When people measure using multiple scales, initiatives, and methodologies, it becomes very difficult to compare and contrast performance.

Achieving standardization is a heavy task, requiring deliberate effort. It involves getting people aligned and understanding the value of harmonization. Just like regulatory bodies striving for reciprocity, the process requires identifying the "right bar," selecting the best practices from the best actors, and creating one primary set of standards that most entities are comfortable working with.

Talk about your CPHI Frankfurt presentation.

The presentation will be an opportunity to discuss how we can better serve the sector. Other industries, like the automotive and computer industries, are much more mature when it comes to outsourcing compared to biopharma. From a cost perspective, the biopharma industry should be outsourcing more, allowing CDMOs to distribute overhead costs across multiple customers and SKUs, rather than companies building facilities to manufacture only one or two drugs.

The primary reason this hasn't happened is that the CDMO sector is still working to gain the trust of the biopharma industry. At Bora, we focus on building this trust by maintaining an extremely strong "on time in full" performance, with most of our sites exceeding 95%. Biopharma companies rely on this trust to ensure they have their product when needed for commercial distribution or clinical trials. Gaining this trust will be a key point during the presentation.

The biopharmaceutical industry is undergoing significant transformation, driven by evolving supply chains, regulatory harmonization, and the integration of AI. Localized supply chains are becoming crucial to mitigate geopolitical risks, while regulatory cooperation is essential for timely access to medicines. Public-private partnerships are adapting to economic shifts, emphasizing robust data for capital acquisition. AI presents vast innovation potential, enhancing efficiencies across various domains. However, data consolidation challenges hinder AI adoption. Establishing global sustainability standards is vital for environmental goals, and building trust in outsourcing partnerships remains a priority for industry growth.

J.D. Mowery discusses boosting pharma supply resilience through localized manufacturing, AI innovation, and critical regulatory standardization.

Standardizing Operations to Meet Global Sustainability and Resilience Goals

We highlight the week’s industry news in an easy-to-consume, fun format.

PharmTech Weekly News Roundup — Week of October 27, 2025

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

What are the best practices for AI adoption?

In an interview regarding “The State of AI in Next-Generation R&D” at CPHI Frankfurt 2025, 

 that artificial intelligence (AI) platforms must integrate R&D data to overcome silos, necessitating a centralized strategy and rigorous change management. Furthermore, automation in the "wet lab" is critical for capturing harmonized data, which provides the high-quality basis needed to "close the loop" for better predictive R&D. The strategic collaboration 

between Thermo Fisher Scientific and OpenAI,

 announced at CPHI Frankfurt, aims to save 25% to 60% of time in clinical trial document authoring, enhancing decision-making speed.

Where are supply chain localization and data scrutiny trending?

Geopolitical concerns are driving a pivot toward localized supply chains, where organizations seek to execute clinical trial work within the operating region, according to J.D. Mowery, president of Bora Pharmaceuticals, 

 at CPHI Frankfurt. Dr. Weite Oldenziel, CEO of Ofichem, 

 that the pharmaceutical sector is conservative and slow to change, meaning structural supply chain reimagining moves slowly, primarily affecting high-priced, proprietary APIs rather than large-volume generics. Christian Dowdeswell of Arcinova noted that 

 from single, end-to-end contract development and manufacturing partners who mitigate complexity and allow direct communication between drug substance and drug product teams.

What innovations are being made with excipients?

Novel excipients are urgently needed to keep pace with increasingly complex drug modalities, but major barriers remain, including the risk perception that combining a new API with a novel excipient creates a "double risk," 

 in his CPHI Frankfurt presentation discussion. Langley also detailed how regulatory scrutiny of traditional excipients like titanium dioxide and talc demands robust scientific defenses, while Peter Freed of Roquette 

 that the move towards plant-based excipients supports bio-based sustainability goals.

How is AI impacting the workforce and hiring?

 at CPHI Frankfurt detailed that the industry's accelerated shift toward data-intensive operations requires aggressive, continuous upskilling, with skill refreshes now shortening from years to "every six to 12 months." The speakers also agreed that to manage technological gaps and compete for high-tech talent, smaller players must strategically leverage partnerships for "the technology pieces.” Human oversight remains crucial for interpreting complex results and making decisions in areas with scarce data, as AI cannot be relied upon in the same way as in well-researched domains.

AI-driven pharma trends: R&D acceleration via data integration, supply chain localization, excipient innovation, and rapid workforce upskilling.

Feliza Mirasol is the science editor for 

In this episode of Drug Digest, the discussion centers around the optimization of biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

Drug Digest: Strategic Alliances and Technology Integration in the Evolving Biopharma Landscape

The biopharma industry is actively navigating an evolving landscape through strategic partnerships and advanced technology integration. Collaborations are crucial for market expansion, while some companies are leveraging artificial intelligence (AI) for the discovery of novel therapeutic modalities and for manufacturing efficiency. Experts evaluate partners for their AI capabilities, focusing on data integration and validation challenges. Manufacturing, licensing agreements, and supply chain strategies are also paramount. This episode of 

 will explore these trends and how partnering can lead to success in bringing new biopharmaceutical modalities to market.

Sigma Mostafa, Chief Scientific Officer, KBI Biopharma

Cory Smith, Senior Product Manager, Nucleic Acid Services, TriLink Biotechnologies

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

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.

MJH, pharmaceutical technology presents drug digest, a tech talk with the pharmaceutical technology editors all about emerging opportunities, obstacles and advances in the pharmaceutical, biopharmaceutical and biotech industries. Join us as we discuss with industry experts the research, development, formulation, analysis, upstream and downstream, processing, manufacturing, supply chain and packaging, as well as business strategies and regulatory issues.

Hi and welcome to the junk digest video series. I'm feliza mirasol, the science editor for pharmaceutical technology, pharmaceutical technology Europe and BioPharm International. In this episode, I'll be talking with industry experts about navigating biopharma's evolving landscape for strategic partnerships and AI innovation. Our discussion will center around the optimization of bio manufacturing and supply chain efficiency through mastering AI data integration and critical validation challenges. Joining me, this episode will be subject matter experts from CTMC, KBI biopharma and trilink biotechnologies.

This episode of drug digest is sponsored by Biovectra, Ecolab, Eppendorf, Fujifilm Biotechnologies, Lab Vantage solutions, the Parenteral Drug Association and pyramal pharma solutions.

Whether embarking on their journey into clinical trials or navigating the critical Commercial validation phase, biopharmaceutical companies choose biovectra, a full service cdmo, with a commercial supply record of more than 20 years and five decades of experience with multi step API chemistry for their biologic small molecule nucleic acid and fill finish needs.

ecolabs, global life sciences sector comprised of eco labs, bio processing and purification technologies and pharma slash personal care businesses, is responsible for delivering value to pharmaceutical and biotechnology customers with innovative, downstream purification products and manufacturing decontamination solutions.

Let's bio process together. Eppendorf aims to support you with your specific challenges, whether you are developing cell and gene therapies, antibodies, vaccines, modern food or other products, by providing scalable bioprocess systems and encompassing software solutions, all orchestrated to optimize process, control, automate tasks and harness the power of data.

Fujifilm biotechnologies, a subsidiary of Fujifilm Corporation, is the world leading cdmo For biologics, vaccines and advanced therapies.

Lab Vantage solutions, a leader in enterprise laboratory software dedicates itself to improving customer outcomes by transforming data into knowledge by supporting more than 1500 global customer sites in the life sciences, pharmaceutical, medical device, biobank, food and beverage, consumer packaged goods, oil and gas, genetics, slash diagnostics, forensic and healthcare industries,

the parenteral Drug Association is the leading global provider of science, technology and regulatory information, and since its founding in 1946 as a nonprofit organization, has been creating awareness and understanding of important issues facing the pharma community and delivering high quality, relevant education to the industry, as well as scientifically sound, practical technical information and expertise to advance pharma manufacturing, science and regulation.

Piramal pharma solutions a cdmo and part of pyramidal pharma Ltd offers end to end development and manufacturing solutions across the drug life cycle, serving customers through a globally integrated network of facilities in North America, Europe and Asia. Now, without further ado, let's meet our guest speakers.

I have about 25 years experience in small, medium and large size biotech and biopharma, mostly developing products, bringing products from research side into the clinic, and then I've been fortunate to be involved in bringing several products through clinical development, through global commercialization, with peak market sales projected At more than three and a half billion dollars. Over the last five years of my career, I've really turned my attention to cell therapies, which have a tremendous amount of potential, and yet I think one of the keys to realizing that full potential is coming up with fit for purpose. But. Development and manufacturing strategies, and that's what I really focus on, my attention on today as CEO of CTMC. CTMC is a joint venture between MD Anderson Cancer Center National resilience, where, with a differentiated model, we help biotech companies develop and manufacture their impactful cell therapy products and basically increase access to patients for those products. 

I'm sigma Mostafa. I'm Chief Scientific Officer for KBI biopharma in my role as CSO, I'm responsible for our cell line process development and all analytical services, that's about 40% of our business. And I'm also responsible for all of our new technical offerings, as well as digital service offerings. I have been with the company for over 15 years. My role right before I became CSO. Was a scientist for two of our largest sites, and being involved in clinical and commercial manufacturing, I have commercialized multiple drugs, as well as taken into clinic upward of 200 molecules. I started my career at Eli Lilly after finishing my PhD from Northwestern in chemical engineering. I was in Lily for about seven years, then with Mark, a subsidiary of Mark organ on biosciences, before joining KBI. Overall, my my expertise is in building and sustaining large technical and operational organizations and being able to bring key unique value proposition through those organizations.

 My name is Corey Smith. I work at trilink bio technologies, part of Marvi Life Sciences. Been at this company for six years now, working on the cdmo side. I've held various roles across the organization, but currently manage the GMP service or cdmo service portfolio at trilink, been working in the RNA field across a couple of different modalities for about 10 years now at innovator companies developing therapeutics, as well as now at the on the cdmo side, it's great to be here today

 On AI integration for novel therapeutic modalities. How are biotechnology experts evaluating potential partners for their AI capabilities in drug discovery, particularly around identifying and optimizing novel modalities? What are the specific data integration and validation challenges?

I'm going to pivot a little bit from discovery to more development, where I think there has been a lot of hype, as in almost every industry, about AI, we focus mostly on working with companies once they've gone through that early discovery point and have Clinical candidates, and need to bring those into the clinic and develop them through the clinic. And I think there's a really important role for digital systems overall in that, and they've this has been contemplated for seemingly for decades, but I think cell therapy is a modality where this digitalization, and in some ways you do, which is a adjacent to AI, is not a nice to have, but is like essential, and it's going to be a key driver going forward, with the difference being that with a lot of traditional modalities, whether it's small molecules or, let's say antibodies, the way we scale is we scale up and we make bigger batches, batches that can produce hundreds of 1000s of doses per batch. And so even for very successful commercial products, the number of batches you produce a year is fairly manageable, maybe on the order of 1050 and while those that type of production benefits from digitalization, It's not essential you can get by making 10 batches a year on on paper, based systems and looking at all that data on an Excel table and plotting it a couple different ways, but with cell therapies. Even for a phase one study, you're making 2530, batches. For a phase three study, you're making potentially 300 batches. And for commercialization, we're talking 1000s of batches, 10s of 1000s of batches a year. And so doing that in a paper based system is just not possible. And so the and yet, a lot of the. Industry hasn't like pushed that fully yet, and so the first phase is just getting this information to be digital instead of paper based. But then I think the really next important step, which is also critical, is integrating these digital systems to talk to each other. So for example, lots of groups have and they're utilized electronic Batch Records. You essentially have a screen, and it lets the operators put the information directly into a digital system, which is good, very important advance from paper. But still, that batch record typically doesn't connect into a LIM system, or doesn't connect into a training database, or doesn't connect into your ERP system for materials management. And so what we're doing, and really trying to push the envelope, is have a very integrated, holistic digital environment where, when that operator goes into the batch record and starts to enter in information, first, they'll check the training database and say, is that person qualified to run this step? Oh, no, their training isn't up to date. Then they can't even run it. Hey, they're scanning a barcode on a raw material before they bring it into the hood to add it to the to the cells. Is that material fully released? Has it met all its testing requirements? Yes. Okay, proceed. No. Oh, and I think why that's critical is this will start to rather than have a paper trail to document mistakes, will create a system that prevents mistakes from happening in the first place. And I think for for manufacturing, that is a critical difference, to preempt these mistakes, reduce quote, unquote operator error and the like. And then as we get all this information into digital systems, that's when we can start really utilizing AI to collect that data, analyze it, optimize it as we scale to 1000s, 10s of 1000s, hopefully hundreds of 1000s, of batches. So I know that answer is a little bit different than pure AI for discovery, but I think it's an under appreciated area that needs great solutions, and is still a challenging area, but is critical for the scaling of cell therapies.

So at a high level, when we are looking at building partnership with AI, different AI companies, one of the primary things to look at is, is their technology truly novel, and is it bringing value compared to others in the field, right? Because there are quite a few options out there. What we need to look at is the uniqueness of their technology, the data assets that they are using for their modeling, their actual R and D experience. Because oftentimes what happens is, biopharmaceuticals like us have a lot of data, and the AI companies may not have a lot of clinically relevant data, so what they're developing versus what you need, there might be a bit of a mismatch, right? So that proprietary data assets that they have is important, and during the due diligence process, being able to look at how they have done their scientific validation, the transparency of the data, how they can take multi modal, multi omics data and be able to incorporate in Their platform, what's the core IP, the scalability of the data sets and its applicability. Have they really tested it, how, how specific and obviously the accuracy of the data? Or if we are talking about particular biologics, we can even think about generative AI, which is now being used both in the CGT and in the biopharmaceutical side, for developing novel molecules with very unique attributes, right very targeted attributes. So being able to handle large volume of data, and in the proof of concept stage, being able to take, perhaps your data set and showing the actual value is very important. Otherwise, there is a gap in what the technology says it can do versus its application in your therapeutic field.

Now, in light of discussions surrounding MNA activity, what are the primary Manufacturing Technology? Integration challenges and strategic considerations for biopharma companies that are engaging in acquisitions or partnerships within the complex and rapidly evolving CGT landscape.

 I think complex is a great way to describe the CGT landscape right now, there are quite a few choices that developers need to make, both on the technology side and the modality that they're choosing, as well as the partners they choose, either on the manufacturing side or the technology side. One of the key first challenges, of course, is determining what type of editing or cell therapy technology you would like to use. You can look at in vivo editing technologies, your traditional CRISPR, CAS systems, you can look at ex vivo editing technologies or ex vivo cell therapies. Think cell engineering, car T or other ex vivo editing technologies both have risks and benefits. Both have significantly different aspects and roles that they play when it comes to partner selection. But the key thing here is that you want to choose a partner that is is certainly specialized and experienced on either side. You want to have a partner that's worked through the the difficulties of of ex vivo cell therapy manufacturing when it comes to the biologic side, as well as the drug substance or raw material manufacturing side, and for in vivo gene editing, you need to have a partner that really produces very, very highly pure product. Quality is key in the CGT space. Gene editing requires extremely so that you can safely and effectively edit your specific target and any kind of lack of specificity, whether that's on the technology side, so that the drug development side, or on the partner side, the manufacturing side, can have pretty drastic side effects when it comes to things like off target effects, unwanted editing in the patients and eventually, of course, clinical trial failures or major hurdles in clinical trials. So choosing the right systems from a technology standpoint is extremely important, but choosing the right partner as well is extremely important as well, and I think we really want to make sure that when we're looking at modalities and making choices as drug developers and cdmos, we have the right services to meet the needs of each specific market segment in the CGT space

 for manufacturing integration, I'll focus on those challenges first, and then perhaps on the strategic side, some of the key things is looking at scalability and proven track record around scalability. This is potentially more true for CGT, where a lot of the operations are manual, but even for therapeutic biologics, drugs, there are a lot of open operations and manual operations which integrating those technologies. If you have your own automation platform, etc, it is very important to understand if this is going to be a seamless integration or not, the quality systems, obviously, as well as the supply chain models and logistics for those manufacturing entities is going to be key factors to look at. Otherwise, the integration may lead to more headache than actually solving, solving your gaps right the regulatory experience of the entity, as well as the quality control. In other words, the testing that gets done are those similar is something that has to be looked at, because if you're completely using different tests or with similar products, getting different results, etc, integrating the manufacturing component would be very difficult in terms of strategic considerations, the due diligence and the technical assessment has to be extraordinarily robust. We know of many mergers where it ultimately did not give the efficiency, the time savings, the cost savings, because there were such differences in in the technologies, also in terms of the cultures of the companies, and the post merger integration portion is also very important in terms of how do you build Your strategic commercial plan so that you can execute and deliver on it a lot of times, the merger may be successful, but over time, having a fully integrated end to end plan is hard to develop, and again, differences in technology, automation, etc, may make it difficult, and you end up not being able to make it a success.

What is really interesting about cell therapy and in terms of creating partnerships, is, I think it up ends, or has the potential to upend, or if you want to, maybe to read more specific. Specific if you want to be really efficient in how you develop cell therapies, reconfiguring the traditional structures of partnerships can be very beneficial. So what do I mean by that? Right? Typically, there's a biopharma or biotech. They do. They develop a product, they hire a CMO to manufacture that product. They contract with different clinical sites to run trials for that. And the biopharma then hires a CRO, clinical CRO to, like, run those sites and to basically, you know, hires the CMO. They make a bunch of product, they ship it out to the pharmacy, and then, then they, you know, run a clinical trial. So that's what traditional modalities, right? We can store the product on the shelf and just take it off the shelf when you need it. With cell therapies, and especially autologous cell therapies, these trials are all on demand manufacturing. There's a different relationship between the clinical trial, because as you enroll the patients, you need to engage the manufacturer. And so you very arm in arm the manufacturing in the clinical site are arm in arm to the clinical study, as opposed to being decoupled in traditional manufacturing, traditional modalities like antibodies, and so as I was looking at this field, a lot of companies try and basically force this different kind of relationship, or this different kind of structure into the traditional partnership models. Okay, biopharma is going to hire a CRO and these and then, you know, to run an autologous clinical cell therapy trial. You know, every day of the week you're calling up your clinical sites saying, hey, when do you have patients? Oh, I have a patient coming in on Wednesday. Then that company is calling the CMO and saying, Hey, can you take this patient batch on Wednesday? Oh, no, we can't take it Wednesday, but we can take it Tuesday, going back and forth on the logistics of the trial with the biotech or right in the middle. And so one of the things that I think is an opportunity is to change that structure and have the manufacturing in the clinical very tightly aligned, and then providing that solution to a biotech. When a biotech comes to us with a new product, we say, hey, we can develop your process. We can manufacture that product. We can actually handle regulatory interactions for you too, and we can handle all the clinical trial logistics and operations for trials run in MJH. And so all of that will be transparent to you as a biotech, but you won't have to be involved with it. And so I use this as an example feliz of like a different way of arranging the pieces on the board to be more efficient for that biotech. And so they don't have to hire because we're doing this every day with mjhnderson and negotiating slots, and when patients can come, and when manufacturing lines up with clinical we handle all of that for them, as well as the shipping logistics and so that allows companies to be much leaner and capital efficient, because they don't have to build out all of this infrastructure to manage that whole operation. And so I use that as an example of, I think, in these new and advancing modalities really thinking from first principles about what the fit for purpose solution is, what is the what's the challenge, and not just defaulting for the way we've always done things with other modalities. And I think there's real opportunities there to streamline things and make things more capital efficient or time efficient, reduce risk and reduce costs. So that's overall what we look for, and when we figure out how to structure partnerships, is, how can we do all those things I just mentioned in order to increase value?

Now on vertical integration versus specialized manufacturing partnerships, given recent moves in the biopharma industry, how are experts assessing the benefits and risks of vertical integration versus specialized contract manufacturing partnerships to secure critical components and expand niche manufacturing capabilities within The biopharma supply chain?

So I'll start with the benefits of Article integration, right? Obviously, it gives you better control over the entire supply chain. It gives you better quality oversight across the value chain. Theoretically, it reduces. Is timeline and reduces cost, and it enhances the supply chain reliability. You are not dependent on some unique raw materials and you don't know when it will arrive, etc. Now the risks are usually it's very capital intensive and therefore substantial cost, as well as the overall exposure in terms of market volatility. This is more true for cdmos that look at end to end, versus having some specific areas that they're very good in because now you have married yourself to certain technologies. Let's say in context of antibody drug conjugates, if you are doing your drug substance production, but you are also doing your ligand production and your payload production, then you are married to that particular technology now, and the customers will come only based on if they want that particular technology, as opposed to creating partnership with a third party. So you have more flexibility, essentially. So there is more exposure if you don't have the demand for that end to end, and it has ultimately led to more hybrid models, I would say, for KBI, what we have done is we acquired a cell line provider selects is a premium cell line provider, and we create highly successfully. Were able to integrate them to create a shorter timeline while maintaining their unique culture in Switzerland, and they're very much R and D focus and yet integrate into our cdmo. On the other hand, when we looked at field finish, we decided to partner with equally technically good company, Argonaut, and we are looking at other partners as well, similar things for ADCs, I would say where end to end drug substance and the conjugation may be beneficial, but we are also seeing companies that are now focusing on just on the conjugation portion and not On the drug substance, whereas we bring in drug substance. So we are looking at a model, because we have lot of customers whose portfolio is changing to antibody drug conjugates to support them as they want to stay with us, we are looking at offering those services, but being able to also have partner do this through partnership, as opposed to a one stop shop.

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