Behind the Headlines Episode 27

Ask the Expert

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

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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.

Articles

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.

Videos

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.

The key, again, like I said before, with with the answer about how you arrange partnerships is, you know, really understanding what your pain points are, and then how to solve those and so, and where vertical integration matters, and where special specialization is more beneficial. And so, for example, for early stage development, when you want to bring a product into first in human testing, manufacturing and regulatory interactions are almost always on the critical path. How am I gonna get my ind in how am I gonna be able to start up my clinical trial as quickly as possible? And so, you know, for a typical cell therapy, there are a number of different manufacturing components that need to be brought together. For your typical viral based cell therapy, you need to secure plasmid, secure virus, figure out how you're made the cell therapy, put that all together in a regulatory filing, know where you're going to run the clinical study, and then put that all together in a package and get the clinical study up and running. So I think vertical integration of those activities for a standard. I think what's great about the industry now cell therapy, that really is only eight, nine years old. If you think about like the first commercial car T, is that we can say standard, standard cell therapy. It's no longer like totally new. So if we think about a standard car T or something, and you need to bring those components together. They really benefit from vertical integration. We see a lot of partners try and be in the middle again, of doing all of those and arranging all of those interactions that I just mentioned. And it just becomes hard for them to set up these, you know, for the first time, and for one off, I do think for those, some of those different components, as you move later in development and you have more time to plan and scale, is more important that say plasmid or viral vector manufacturing can be more more specialized sites. But I still. Think. And I'll take, if I, if you can indulge me, I'll take a little deeper dive on the relationship between the clinic and the manufacturing. I think will persist, not only through that and the benefits of arranging that properly, but will carry forward, not only through the first human study, but throughout clinical development, and even I would argue commercial development, one of the big debates in Cell Therapy fields is decentralized versus centralized manufacturing. And I think what we're right now, where we are, is a lot of centralized manufacturing. You know, there's one or two big sites for the commercial products, and that's how they're produced. There's a lot of initiatives, mostly coming out of academic centers, of trying to do some small amount of manufacturing very locally, because cell therapies will always have this special relationship between the patient and the manufacturing, because each batch is made for a particular patient in really in a very unusual circumstance, the patient is the source of the starting material, and so taking that into account, when you shape the supply chain, really seems fit for purpose right now, and you can only do that when you move away from centralized manufacturing. So what we have now currently with commercial the main commercial cell therapies, centralized manufacturing, distributed raw material supply, basically the patients are everywhere, literally everywhere in the world and ship their products to a center, ship that starting material, the patient's blood, often to a centralized manufacturing facility that then does the manufacturing, and then ships it out to every place in the world for on demand manufacture in real time, where the patient, you Know, for oncology, doesn't have that much time because their disease is so severe, typically at this stage. And so to me, that's like using our traditional approaches to try to solve the current challenges in cell therapy. And I don't think it's fit for purpose. I think long term, what will be successful is a relationship between a regional manufacturer and various clinical centers, and that then sponsors or commercial suppliers will basically tap into these regional networks and say, for example, this manufacturing site already has a relationship to produce cell therapies for let's, I mean, let's just use it, since it's in my background for the Texas Medical Center, where there's more patients treated in this area than any other geography, small geography In the world, and there'll be a regional manufacturing that will have a short supply chain, short transit time, and a pre existing relationship with those hospitals. And I think long term, that's a different kind of supply chain shape than it for traditional where, again, the biopharma is sort of in between, and the hospital never really interacts at all with the manufacturing site. I think these manufacturing sites will almost turn into cell therapy pharmacies, where the doctor, rather than ordering up something from the pharmacy, will just say, hey, I want to prescribe this cell therapy for my patient, and I'm going to basically order it from the manufacture, the local manufacturing facility. I think long term, you know, that's not going to happen next week or next year, but long term, I think having the supply chain built in consideration of the raw materials for the patients will be the long term solution for Cell Therapy, which is very different structure than what a lot of people envision, and definitely different than how other modalities are typically supplied,

 build versus buy, is often the number One question a near clinical phase or a late stage pre clinical company will start to ask themselves, what mainly goes into this is oftentimes a risk based approach. From a CMC perspective, there is obvious benefit in owning your supply chain upfront, right, in having control over your your raw material inputs, or your drug manufacturing. But of course, it's extremely expensive standing up GMP manufacturing is a very, very expensive and, quite frankly, often risky business to get into. So that's why people do often turn to cdmos, right when you look at early phase clinical companies and think, you know, biotech and biopharma companies that I. Have a very strong candidate, but are looking for funding or support on the manufacturing side using a well established cdmo is, is a very nice option to reduce your risk from a financial standpoint when it comes to building out manufacturing or or, of course, buying companies that are doing the manufacturing while kind of partnering with a company that has good quality systems, a well established manufacturing platform and an area that really can help support some of the difficulties of of GMP manufacturing or clinical manufacturing. And so you can think companies that that maybe have a few early phase assets, there's always the risk of building and spending quite a bit of money that could be spent elsewhere without the Surefire thing of having a clinical success and a commercial success. So cdmos really can step in and help support that right. We can help support the the infrastructure needed for GMP manufacturing and help reduce some of the financial risk that's associated with building out or buying through M and A parts of the supply chain that you currently don't control.

Now, I feel that one thing we perhaps do not look at too closely are the partnerships that are on strategic licensing, especially when those deals are based on foundational technologies. So from a biopharmaceutical technology perspective, what are the key technical and intellectual property considerations when entering into licensing agreements for platform technologies that impact the fundamental properties of the advanced therapeutic that is in development or that will be moving towards commercialization

With these advanced therapies, especially cell therapies, a lot of the innovation goes on in the engineering aspect. You know, how you structure the car? What other elements do you put on when you try and armor the car? But you know, you think like an armored car is like one of our more advanced things, or even a logic gated car that may have two different binders, and there's some logic between those. So most you're expressing like, three different proteins, and those are pretty complicated, and yet, what's really interesting about cell therapy is you're putting those into a vehicle of a T cell that is expressing many, many, many orders of magnitude more proteins there, you know, 10,000 different proteins, all regulated in different ways. And clearly, how you grow those cells, how you do the engineering. One little aspect that we can look at is that aspect that we've engineered, and we're starting to get better tools at looking at the rest of the scaffold, essentially, that you're attaching that car to. But it has vastly more impact on the efficacy of that treatment, the safety and the efficacy profile of that treatment than for other modalities, like, for example, we're making a capsule, okay, yeah, sure. We're going to take some powder, take an API, and that API is going to have a certain structure and everything, we're going to lyophilize it and then, but then we're going to put it into a capsule. That capsule probably has very little to do with the overall efficacy of the product. You know, maybe, let's say, 5% 2% you know, an antibody. You know, when you have the basic backbone of an antibody, it's really this CDR domains that are the binding domains that confer the real efficacy and safety profile of that but for cell therapies, it's really bringing these two components together. And there's a huge amount on the scaffold, if you will. And so for companies, oftentimes their technology is focused on the engineering component, yet finding partners who have a really solid like you said I liked your word you used about foundational technologies, how to produce things. So you know one thing, the most clear example, maybe at least a clear example in cell therapy is actually tills. Car TS get a lot of play, but tills, which the first commercial till, was approved last year, these are tumor infiltrating lymphocytes. I think it's undeniable that how you produce the tills is equally, if not more, important than how you engineer them. And so there's been a number of different approaches on how to engineer those cells, but for those companies to partner with, you know, it's hard for them to build both of those capabilities in house, to be like, Hey, we were going to develop a best in class till manufacturing process, and we're going to have all this understanding and know how around an IP, around an engineered the engineer, and so where we've seen the most success is companies who focus on the engineering aspect, have IP around that, and then, you know, partner with companies so that that scaffold does justice, to be honest. To how you engineer the product to give you the best safety and efficacy profile. And I think we've seen examples companies who actually have really great engineering but haven't paid as close attention to the scaffolding and have said, like, oh, we could just do that ourselves too. Those products have failed. Like, there's been a little bit of a graveyard of specifically, tills in the field. And we don't honestly know, is that because that engineering wasn't the right engineering to do and didn't have the desired effect, or was it the platform that they chose to bolt their engineering on top of my overall advice to companies is figure out where your expertise is, you know, and if you're really, if your expertise is really in the engineering aspect of it, the construct, then, rather than trying to do it all yourself, find a partner who has that foundational technology so that and That's clinically validated, so that then your engineering aspect can demonstrate its full potential. So

I'll start with the technical aspect of licensing. So ideally, there would be a proof of concept study to demonstrate the value of the technology, the reproducibility of the technology, the scalability, manufacturability, the analytical methods that gets used with the technology is also very important. An example would be, oftentimes, one test we offer that customers for using a V's come to us for is analytical Ultra centrifugation testing to look at field versus empty capsids, and this kind of very unique testing is needed to know if the technology you are using to create the capsids is good or not. So when you are evaluating a technology for licensing, knowing how good the analytical methods is and the data you are seeing is really going to translate to larger scale is very important. The overall product, quality, safety, platform, adaptability, when you are looking at for your disease, indication, therapeutic area, etc, is also very important, IP wise, obviously, freedom to operate, we need to understand and internationally, both regulatory and legal landscape varies, so understanding the actual IP state of the Technology and being able to operate in different countries in the way you want to operate, if that flexibility is there is very important exclusivity or non exclusive licensing, understanding. Those are very important as well as one of the key things we see is as the technology improves from from the company that will licenses it out ownership and accessibility to the upgrade of the platform. Where does that reside? If you are licensing in the technology, do you get the upgrade as well? Is also important. In our case, we license our select System line technology, and we see licensing as a process of creating long term partnership. So our model is not just the licensing as a only step, but longer term support of our partners. And that also has built in some incentives for the partner to work with us for clinical and commercial manufacturing, yet the partner has full flexibility. However, they want to do the cell line development using our technology.

How do you balance the tension between being a one stop shop and being a specialist?

 It's a great question. You know, there are several aspects of the one stop shop that are seen as highly preferable. You can combine contracting, you can combine quality systems. But I think the reality of what we've seen is that often in these scenarios, it ends up not being as one stop shop, as folks think. You know, it is extremely important. And we have decided that there are, there are parts of the supply chain when it comes to CGT manufacturing that are extremely important to focus on at trilink and MJH, we focus on the drug substance part, and our goal is really to provide the highly pure drug substance, whether that is guide RNA or an mRNA to fit into the CGT workflow, and we feel that that is the area, one of the areas that is extremely important for understanding whether or not your therapy will be successful. Now we totally recognize the one stop shop area, and so we've done quite a bit of diligence in partnering with other companies externally to make sure that we can facilitate the rest. Of the supply chain. And so that's kind of the key here is that, you know, we have these partners in the industry, and these are very strategic decisions to make sure that we are appropriately not only providing the singular solution of what we manufacture, but we're providing a net of solutions for for our partners and our customers. So, you know, really looking at this across the board? Yes, there is, there is something to be said about the One Stop Shop mentality. There's also something to be said about building a network of the suppliers out there and then providing that as a singular solution as well. And we think that that gives our customers and our partners the best shot for success. Really, right is is getting the best out of each area. So whether that's the best drug substance manufacturer paired with the best drug product manufacturers, we want to provide an ecosystem that really fits that bill, rather than getting a total jack of all trades approach.

Well, that's all the time we have. Thank you to our speakers for being on today's episode and sharing their insightful perspectives. I'd also like to thank our sponsors, biovectra, Ecolab, Eppendorf, Fujifilm, biotechnologies, lab Vantage solutions, the parenteral Drug Association and piramal pharma solutions, for supporting today's episode. You can catch all our drug digest videos@www.pharmtech.com thank you for watching until next time.

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J.D. Mowery, Bora, says tariffs localize biopharma supply chains, the "biotech freeze" mandates robust data, and AI rapidly optimizes operations.

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 

*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.

Maggie Saykali, Cefic, explains that Western pharma vulnerability stems from market loss to Asia, caused largely by short-sighted offshoring due to environmental costs.

US and European Pharma Manufacturing Face Diverging Paths to Resilience

In this part 3 of a 3-part interview regarding the presentation “The Critical Medicines Act: Game-Changing Opportunity for a Sustainable and Resilient Supply Chain?” at 

, held Oct 28-30 in Frankfurt, Germany, Maggie Saykali, Director – Specialty Chemicals, Cefic (European Chemical Industry Council), addresses the significant geographical shifts occurring in pharmaceutical manufacturing, drawing on data shared with the European Commission during the elaboration of the 

. The discussion focuses on the pronounced loss of market shares for both the United States and Europe in the manufacturing of small molecules, while China and India have gained corresponding ground. The market share data reveal a critical disparity: Europe currently maintains approximately 33% to 34% of the market for small molecules, whereas the US market share has fallen to around 10%, according to Saykali.

This erosion of manufacturing capability carries significant implications for supply chain resilience, she continues. The US, despite remaining powerful in the creation of innovative molecules, faces overwhelming dependence on external sources for generic drugs, with reliance exceeding 90%, states Saykali, adding that a market share as low as 10% indicates a severe loss of infrastructure, talent, and know-how, leaving the country highly vulnerable and requiring substantial financial investment to achieve a sustainable position.

Europe, however, still retains the necessary talent, know-how, and infrastructure due to its higher market share. While the situation was drastically different 40 years ago, Europe is now facing a crucial window to act, lest it reach a point where necessary recovery costs become prohibitive, Saykali says. The core difference between the current challenges facing the two regions lies in the amount of investment required to reverse the manufacturing decline.

The shift away from Western production was initially driven by economic factors, specifically the cheaper cost of manufacturing elsewhere. "But don't forget that… 30 years ago, it was also because we started in Europe and in in the US to have very strong environmental laws… It takes a lot of money to make it clean and environmentally sustainable, so one of the options was ship it off. But that was a short-sighted decision, and we are paying the price now."



This is the interesting difference between the US and Europe. So, the study that we shared with the European Commission when we were elaborating the Critical Medicines Act shows the loss of market shares for the US and for Europe, and of course, in the case of China and India, it's a gain of market share. and you could see that the US actually are now at more or less 10% market share for small molecules. Europe is at around 33-34%, and of course China and India have picked up all the slack.

So, if you go back 40 years ago, the situation was completely different. At 30-something percent market share, we still have the talent, we still have the know-how, we still have the infrastructure in Europe. 10% is too low. There you have lost the infrastructure or big parts of it. You've lost the talent, the know-how, and you're much more vulnerable or you have to put a lot more money on the table to be able to go back to a sustainable position.

Whereas for us in Europe, it's really time to act now if we don't want to go to a point… it's not the point of no return, it's the point where the return will cost you too much. So, that is where we are now and that's the essential difference between what's happening in the US and what's happening in Europe.

And the US are still very strong in making innovative molecules, but generics, totally dependent. I think the number is above 90% dependence on external sources for generics, because essentially, it's cheaper. But don't forget that a few years ago, 30 years ago, it was also because we started in Europe and in in the US to have very strong environmental laws and some of the production of some of the active ingredients and intermediates is not… I mean it takes a lot of money to make it clean and environmentally sustainable, so one of the options was ship it off. But that was a short-sighted decision, and we are paying the price now.

As part of its coverage of CPHI Frankfurt 2025, 

, director of Product Management & Innovation—Molded Glass at 

Among the new innovations SGD Pharma is showing at the event is its flagship Sealian platform, an internal surface treatment for molded glass vials.

SGD Pharma will additionally roll out its recently launched Lab Services offering, designed to deliver analytical testing to players throughout the glass packaging space.

Mebarki says the innovations SGD Pharma will have on display at the event collectively reflect the company’s growing and ongoing commitment to sustainability and emission reduction goals.

 for all of our CPHI Frankfurt coverage. 

 to view the video version of this interview.

 One of our very important innovations is Sealian, which is a unique internal treatment that confers additional functionality to the vial, and for which we have a strong competitive advantage thanks to this internal coating. It allows for a barrier effect and hydrophobic properties.

We will also showcase Idency, our latest premium molded vial that combines high mechanical strength and chemical durability. These are vials that combine the benefits of molded glass with the same outer diameter as [standard] tubular [glass]. We have developed a full range that will be available: 6 mL, 10 mL, and 20 mL. It's aimed at sensitive parenteral drugs [such as for] biotech, oncology, monoclonal antibodies, and the immunology and lyophilization markets.

[We will also display] Sterility, our ready-to-use offer that increases speed-to-market for customers.

For oral, we have Ensiemo, which is a full packaging solution for oral droppers, and now we also have a full packaging solution for syrup.

Proseal+ is an external treatment that is on the ceiling surface and guarantees an optimal ceiling, and it protects the drug from moisture or oxygen. As you may know, 50% of medicinal products degrade because of moisture.

Velocity, which is another treatment, is an external treatment that boosts production line efficiency and reduces particulate generation up to 96%.

Finally, we will launch a new service called the Lab Services, which is a comprehensive analytical portfolio. We are a glass expert with more than a century of know-how. And this analytical portfolio covers from pharmacopeia compliance studies to more advanced investigations and more specific customer needs, and it's suitable for both molded and tubular.

How will you be building on previous CPHI interactions?

We always have a great experience at CPHI, with our customers, our prospects, and our partners as well. It's a big moment of connection with these people, but also a big moment of networking.

Of course, a big moment for business, but not just business. It's also the moment where we follow trends, where we confirm trends, where we discuss these trends with our partners.

That's our biggest event of the year, actually, so the busiest one and the biggest, but each year it's always a success, and each year it's always different in a way. But yes—a moment to connect and to share.

SGD Pharma is showcasing its innovative Sealian platform, a unique internal surface treatment for molded glass vials, at CPHI Frankfurt 2025. The company is also introducing its Lab Services for analytical testing in the glass packaging sector. These innovations underscore SGD Pharma's commitment to sustainability and emission reduction. Other products on display include Idency, a premium molded vial, and Proseal+, an external treatment for moisture protection. The event serves as a key networking and trend-confirming opportunity for SGD Pharma.

SGD Pharma’s Najet Mebarki provides an overview of more than a half dozen services, products, and treatments, including ready-to-use solutions.

Vial Packaging Innovations from SGD Pharma at CPHI Frankfurt 2025

We spoke with Nigel Langley, Global Technical Director of Life Sciences at gChem and immediate past chair of IPEC-Americas, regarding his presentation, “Challenges to the Sustained Availability of Excipients” at CPHI Frankfurt 2025, held Oct 28-30 in Germany. Langley addresses major industry concerns, including regulatory scrutiny over traditional excipients (such as titanium dioxide and talc), strategies for enhancing supply chain security and sustainability, and the urgent necessity of overcoming barriers to novel excipient innovation.

PharmTech: What is gChem exhibiting and promoting at CPHI 2025?

Langley: At CPHI this year, we will be promoting Procipient dimethyl sulfoxide, which is our high-purity, pharmaceutical-grade DMSO. Procipient has applications as both an API and an excipient. We support this product with a Type II Drug Master File in the US with the FDA, and a Type I Drug Master File in Health Canada. In addition to Procipient, we will also be promoting two other grades of DMSO in our portfolio:

1. Synthesis grade: Targeted toward API synthesis as a solvent, and also peptide synthesis, which is a growing area.

2. ACS grade: Our analytical grade, which is focused towards laboratories for reagent grades and diagnostics.

What is the most pressing regulatory shift currently threatening excipient availability?

The most pressing challenge, particularly seen through IPEC-Americas and IPEC in general, is the constant shift in deciding what to focus on next. There have been concerns regarding the safety of traditional excipients, such as titanium dioxide (TiO2). There have also been issues concerning nitrosamines and their possible connection to excipients and drug products, as well as challenges related to microplastics and PFAS (per- and polyfluoroalkyl substances). These issues, some driven from Europe and some from the US, involve various impurities. More recently in the US, there is an initiative to scrutinize and ban certain synthetic color additives. Talc is also currently "on the microscope". Dealing with these continuous issues keeps IPEC and the industry busy.

How can pharma companies better anticipate the next regulatory challenge?

It is challenging for pharma companies to know how to proactively react in these situations. Ideally, the science should prevail, and decisions should be based on the wealth of science in a particular area. However, recently, decisions have been made based on isolated scientific papers that may not be representative of the bulk of knowledge on a certain topic, leading to questions about the strength of the science cited.

A successful proactive strategy was demonstrated by the industry's response to the TiO2 concern that came from Europe. When TiO2 was banned in food, it looked like it would be banned in pharmaceutical products. If that ban had occurred, 90,000 drug products in Europe would have had to be reformulated. Many of these products, particularly generics, would likely not have been reformulated due to a lack of economic incentive, potentially leading to drug shortages. Furthermore, there is "no good alternative for TiO2," meaning reformulations would have required an inferior excipient.

The industry responded effectively by challenging the citations presented in Europe using sound science. Although the safety of TiO2 was debated (the FDA saw no issues, while certain European countries did), "common sense" ultimately prevailed. The appropriate proactive strategy is to present the facts and good science to tackle the challenge, rather than being melodramatic.

What proven strategies exist for strengthening excipient supply chains against global disruptions?

All pharma companies must consider the risks of single sourcing for raw materials, including excipients. To overcome this, supply opportunities should be provided, either by using a company that manufactures the same product at multiple global sites or by maintaining safety stock in different parts of the world to compensate for potential supply chain challenges.

Regarding sustainability, I see an opportunity for DMSO (gChem’s product) as a much safer, greener solvent alternative because it is a Class 3 solvent. This contrasts with Class 2 solvents currently used in drug synthesis and formulation, such as dimethylformamide (for API and peptide synthesis) and N-methylpyrrolidone. In terms of sustainability, there is no reason for formulators to choose more toxic Class 2 solvents in the future when a safe alternative exists, meaning sustainability can be rectified by alternative, safer materials that lead to much better patient outcomes.

Where are the best opportunities to integrate sustainable practices into excipient production without compromising performance?

Many companies are already working on sound ways of assessing their carbon footprint of manufacturing. Sustainability on raw materials sourcing is critical. This requires having excellent communication with suppliers and knowing where the material is being made and where the raw materials used by the excipient company are sourced.

The move toward safer solvents is also a key area of sustainability. In my opinion, the safer approach avoids Class 2 solvents, as they potentially face future bans. For instance, dichloromethane (a Class 2 solvent) has been banned, and dimethylformamide is now being banned in certain industries and by REACH in Europe. If there is a threat that these solvents will not be available in the future, they are not sustainable, especially given that many drug products are formulated with them.

How can novel excipients be introduced quickly while still ensuring safety and efficacy?

Novel excipients are needed now more than ever, but there are still very big barriers to their implementation. Without excipient innovation, the industry faces a major problem because drug modalities are increasingly complex, yet companies often rely on excipients that are 60, 70, or 80 years old. It is difficult to mold these older excipients into the desired functionality when what is truly needed is something designed fit for purpose.

Excipient innovation has not kept pace with drug innovation. There was hope three years ago when the Prime process was introduced by the FDA, as it offered a potential mechanism for new chemical entities used as novel excipients to be reviewed independently from the drug product submission. However, IPEC has not received confirmation from the FDA on whether this pilot program will proceed, and it is suspected to be either on hold or stopped.

To foster innovation, pharma companies need to have a much closer collaborative relationship with excipient suppliers. Suppliers should not be viewed merely as a vendor or a source of excipients. Collaboration requires early communication regarding formulation challenges and the specific need for an excipient to meet that challenge.

Academia has an important role in developing new chemical entities for future drug formulation, but the translation and commercialization of these ideas remain difficult. New materials must undergo the tox cycle and safety aspects before being adopted by a pharma company. Currently, pharma companies tend to be "first to be second," waiting for another company to successfully take a novel excipient through to completion (Phase III and drug approval). This is because a novel excipient is perceived as a significant risk; if a company already has a new API, adding a novel excipient is almost a "double risk". Much closer collaboration between the two parties is the way to combat this perceived risk.

Nigel Langley, Global Technical Director at gChem, highlights key challenges in excipient availability, including regulatory scrutiny and supply chain vulnerabilities. He emphasizes the importance of scientific evidence in addressing regulatory shifts, as seen in the titanium dioxide debate. Langley advocates for sustainable practices, such as using safer solvents like DMSO, and stresses the need for innovation in excipient development to keep pace with complex drug modalities. He calls for closer collaboration between pharma companies and excipient suppliers to overcome barriers to novel excipient implementation and ensure safety and efficacy.

Excipient Innovation and the Regulatory Tug-of-War: Navigating Threats to Availability and Safety

Big data technology and data science illustration. Data flow concept. Querying, analysing, visualizing complex information. Neural network for artificial intelligence. Data mining. Business analytics | Image Credit: © NicoElNino - stock.adobe.com

In an interview regarding his presentation “Harnessing AI in Clinical Practice to Drug Development and R&D. From the Bedside to Benches” at 

, held Oct 28-30 in Frankfurt, Germany, Gustavo Ferrer, MD, CEO of Dr. Ferrer BioPharma and Moxie Health Group, discusses how artificial intelligence (AI) is rapidly reshaping how drug development and pharmaceutical manufacturing operate, compressing timelines, reducing costs, and enabling unprecedented real-world data integration. He explores how platforms like Moxie-Link—an AI-powered, Fast Healthcare Interoperability Resources (FHIR)-compliant clinical and research platform—are turning every clinical encounter into actionable intelligence, all while navigating the remaining barriers to wider AI adoption and maximizing innovation through cross-disciplinary collaboration.

PharmTech: How is AI supercharging drug development, discovery, and manufacturing?

AI is revolutionizing drug development and pharmaceutical manufacturing by compressing timelines, reducing costs, and integrating real-world data. Platforms like Moxie-Link transform clinical encounters into actionable intelligence, enhancing protocol optimization, decentralized trials, and manufacturing efficiency. AI excels in pattern recognition, extracting insights from unstructured data to refine protocols and identify trial candidates. Real-world impact is measured through enrollment velocity, data fidelity, diversity, and operational efficiency. Cross-disciplinary collaboration with centralized governance is crucial for innovation. Barriers to AI adoption include regulatory ambiguity, data fragmentation, trust, and workforce readiness.

Gustavo Ferrer, MD, explains how AI accelerates drug development and manufacturing, streamlining clinical data into actionable pharma insights.

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