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Maggie Saykali, Cefic, emphasizes the importance of competitiveness and innovation for European manufacturers to create added value and maintain environmental standards.

Maggie Saykali on the Critical Medicines Act and the Mandate for Local Production

In this part 2 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), offers strategic insights into the necessary structural shifts for the European biopharmaceutical manufacturing sector, focusing on competitiveness, innovation, and crisis preparedness. Her analysis centers on the premise that the European industry cannot effectively compete on salaries or basic costs, necessitating a fundamental pivot toward quality and technological advancement to ensure long-term resilience and secure critical supply chains.

Saykali stresses that innovation is driven by the mandate for competitiveness, arguing that manufacturers must create added value compared to other regions that may use older techniques or processes with lower environmental requirements. By valuing criteria, such as implementing more efficient and environmentally friendly processes, achieving better control of emissions, and improving the recycling of solvents, Europe actively pushes for the technological advances that yield a competitive edge.

Furthermore, she argues that the approach to security and crisis readiness must evolve beyond simple stockpiling and instead focus on maintaining robust, adaptable production capacity. This strategic focus on maintaining industrialization is critical because if Europe loses its current level of pharmaceutical manufacturing capability, the ability to produce necessary medicines will inevitably dwindle. Saykali provides a crucial strategic overview of why production capability is paramount for crisis readiness:

“Crises, by definition, are unpredictable,” Saykali says. “It's not that you should have a stockpile of what is needed. The essential notion here is that you should be able to produce it when you need it, and actually that you should have the equipment and the infrastructure to produce what you need when you need it”.

She notes that other regions, such as the US, are adopting similar models to encourage national production, often because they have already lost significant domestic manufacturing capability, leaving them potentially more vulnerable than Europe. The proposed Critical Medicines Act addresses this dual challenge by emphasizing both preparedness (encouraging local production at the highest standards) and securing international alliances and cooperations for times of crisis, according to Saykali. Relying on only a single option for supply creates vulnerability, a risk clearly demonstrated during the early phases of the COVID-19 pandemic, when the delivery of key ingredients to Europe was disrupted. Ultimately, Saykali emphasizes that stakeholders must actively "put value on something other than just the price" to push for the innovation necessary to maintain this competitive edge, prompting the industry to question whether it can afford to rely solely on cheap medicines moving forward.

 and Part 3 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.

Competitiveness and innovation are two very important things for European manufacturers. This is the way that they can create an added value compared to production in other regions of the world that still use maybe older techniques or older manufacturing processes and lower environmental requirements. So by giving an advantage and valuing this, these criteria, actually, we are pushing for innovation and pushing for more efficient, more environmentally friendly processes, better control of emissions, better recycling of solvents, things like that. So innovation is pushed by the need for competitiveness. So the two go together, and we cannot compete on salaries or costs. We will compete on quality innovation, and that's it.

Well, we see that other world regions are actually adopting something very similar. I mean, look at the US. Everything that is happening to encourage national production is actually happening more or less on the same model as what is happening in the EU. I mean, it's not one acting on the same model as the other. They are advancing in parallel, because that is the solution if you want to have control on your supply chain and have the guarantee that whatever crisis happens, that you have what is needed to address the crisis. Crises, by definition, are unpredictable. So it's not that you should have a stockpile of what is needed. The essential notion here is that you should be able to produce it when you need it, and actually that you should have the equipment and the infrastructure to produce what you need when you need it. And if Europe does not maintain the level of industrialization and of manufacturing that we have for the pharmaceutical supply chain, then this ability to be able to produce what is needed when it's needed will dwindle, and therefore we have a problem. And this is more or less where the US are at now, because they've lost a lot of their manufacturing capability and are now more vulnerable even than Europe.

The Critical Medicines Act actually saw it really well. You have the chapter on preparedness, and you have the chapter on cooperations and international cooperations. And I think that if you want to be crisis ready, which is the final purpose of what we're 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 alliances and cooperations for times of crisis, when you need to have other options as well. By having only one option for the moment, we are making ourselves vulnerable. And we have seen it during the early phases of COVID, where some supplies were not arriving to Europe, that there was really an issue in delivery of some of the ingredients to make the medicines that we needed. Actually, the pandemic really highlighted some of the issues that could happen if we don't prepare.

It's a very difficult question to ask, and one that I don't think I have all the information to answer it. I can only answer from my perspective, which is that for us, the only way to go forward is to really put value on something other than just the price, and to push for innovation, push for technological advances that will give us this competitive edge. If we don't do that, we lose the battle, and that is obvious. So we in some ways, have to ask ourselves, “Can we afford to go along as we have always done, and can we afford to only rely on cheap medicines?” They are cheap for a reason.

Videos

Nigel Langley of gChem discusses the company’s DMSO, proactive pharma strategies, and more in part 1 of a 2-part interview related to his presentation at CPHI Europe 2025.

Why Sound Science Is Pharma's Best Defense Against Regulatory Shifts

*Access a full transcript of the video interview below

In this part 1 of a 2-part interview regarding his presentation, “Challenges to the Sustained Availability of Excipients” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, Nigel Langley, Global Technical Director of Life Sciences at gChem and immediate past chair of IPEC-Americas, discusses gChem's offerings at the conference, regulatory challenges facing excipients, and how the pharmaceutical industry can respond to them.

At CPHI, gChem is presenting its Procipient dimethyl sulfoxide (DMSO), a high-purity, pharmaceutical-grade product with applications as both an API and an excipient. This product is supported by a type two drug master file with the FDA in the US and a type one file in Canada. In addition to Procipient, gChem will promote two other DMSO grades: a synthesis grade for API and peptide synthesis, and an American Chemical Society analytical grade for laboratories and diagnostics.

Langley identifies the most pressing regulatory challenge as the "daily shift" in focus on different safety concerns for traditional excipients. He cites numerous examples, including issues with titanium dioxide (TiO2), potential nitrosamine connections, microplastics, and PFAS (per- and polyfluoroalkyl substances). More recent scrutiny in the US has targeted synthetic color additives and talc, keeping industry organizations like IPEC busy. This constant stream of emerging concerns makes it difficult for the industry to keep up.

Regarding how pharmaceutical companies can better anticipate these challenges, Langley acknowledges that it is difficult to be proactive. He stresses that the industry's response should be rooted in sound science. He criticizes how isolated or questionable scientific papers can sometimes used to drive regulatory decisions. Langley points to the industry's successful response to the proposed ban on TiO2 in Europe as a model for future action. The industry countered by presenting strong scientific evidence, highlighting the potential for massive drug shortages and the lack of viable alternatives. This fact-based, non-melodramatic approach ultimately prevailed. Langley believes this method of presenting robust scientific facts is how the pharmaceutical world should proactively tackle future regulatory challenges.

Look for Part 2 of this interview and access all our 



 Hi everyone. My name is Nigel Langley. I'm the global technical director of Life Sciences at gChem. I'm also the immediate past chair of IPEC-Americas, and the two roles actually provide the opportunity to be involved in the industry from the excipient side. So, for gChem, I help to support our customers and formulators in those companies with their challenges for formulation, supporting their work with our pharmaceutical grade dimethyl sulfoxide, which is DMSO, which is known as Procipient.

At CPHI this year, we will be presenting and promoting our Procipient dimethyl sulfoxide product, which is our high-purity, pharmaceutical-grade DMSO. And that has both an API and an excipient application. We support this with a Type II Drug Master File in the US with the FDA, and a Type I Drug Master File in Health Canada.

But it's also an excipient, so it has multiple functions. In addition to Procipient, we will be also promoting two other grades of DMSO that we have in our portfolio. One is our synthesis grade, which is targeted towards API synthesis as a solvent, and also peptide synthesis, which is a growing market and growing area.

And the third being our ACS grade, which is our analytical grade, which is really focused and targeted towards laboratories for reagent grades, for diagnostics, etc.

The most pressing challenge that we see, and particularly through IPEC-Americas and IPEC in general, is the daily shift in what to focus on next. We've had issues around safety concerns around quite a lot of the traditional excipients, like titanium dioxide, for example. We've had issues with nitrosamines and the possible connection with excipients, as well as drug products.

We've had issues in, with challenges with microplastics, with PFAS. There's a lot of impurities or that type of issue that's come through, some of which have been driven from Europe, some of which have been driven from the US. More recently in the US, there's, an opportunity, if that's the right word, of actually looking at color additives and synthetic ones that there's an initiative to scrutinize those and to ban certain colors. There's also more recently, talc is being on the microscope. And it's, it's really keeping IPEC busy, and the industry itself busy.

I think this is a difficult one because I think it's quite challenging for pharma companies to know how to react and be proactive in these types of instances. I think really, the science should prevail, the wealth of science in a particular area should be more compelling. I think what's happened more recently is isolated scientific papers are being cited that may be not representative of the bulk of the knowledge about a certain topic, and decisions are being made based on that type of science. And you can question whether that science is strong enough to actually warrant that type of discussion. This was an example that came from TiO2 [titanium dioxide].

The way that the industry responded to that, and, again, that came from Europe. The concern that TiO2 was banned in food and it looked like it was going to be banned in pharma products, in the pharmaceutical area. Well, if that happened, there would’ve been 90,000 drug products in Europe that would've had to be reformulated.

And, of course, a lot of those wouldn't have been reformulated because economically it wouldn't make any sense to do that. And there's no good alternative for TiO2. So how the industry responded, and it responded very well in my opinion, and took the science and questioned and challenged the citations that were being presented in Europe.

And although that took some time to actually re-present what's safe, and the world seemed to be divided on what was safe. The FDA actually saw no issues with the safety of TiO2. But in certain European countries, they did. The actual common sense, in my opinion, actually won the day in the end.

So, my point is I think the way that the pharma companies tackled that particular issue, because the impact of the patient could have been dramatic, you know, drug shortages if you have to reformulate, and as I mentioned, a lot of those products would probably not… the generics wouldn't have been reformulated because there's no economic gain to do it.

And they would've had to be reformulated with an inferior excipient to TiO2. It wasn't a simple case of just interchangeability with something else. The way that they reacted was a very positive way and not melodramatic, but just presenting the facts and the good science in that particular case. So I would imagine that's how, proactively, if this comes through, and I'm sure it will, another issue, how the pharma world will actually tackle that type of challenge.

white pill capsule isolated on white background | Image Source: ©F16-ISO100 - stock.adobe.com

pened today, October 28, with conference sessions on a variety of topics and a wide range of companies exhibiting their products and services. Contract development and manufacturing organization (

, chose CPHI Frankfurt to showcase the expansion of its services in Europe with the anticipation of shorter lead times, more robust supply chains, and local support from pharma manufacturers. In particular, the company’s Croatian operations, is one of Europe’s largest capsule production sites, according to the company (1).

At stand 8.0T60 Zone Excipients, ACG is also exhibiting its gelatin capsule portfolio, which is now manufactured in Europe, and includes inhalation capsules, TiO

-free options, liquid-fill formats, and a cellulose-based capsule with a pH-independent profile for moisture-sensitive formulations. The company’s range of high- and ultra-high barrier blister packaging is also on display.

“ACG is driving sustainability through PVC free and design for recyclability thermoforming options, PVC and halogen free cold forming material and lighter weight materials. ACG’s CelluPod, a paper-based blister and Bio D, a biodegradable PVC film. ACG’s packaging materials are produced from premium and traceable raw materials and are fully compliant with global regulations, provides reliability and consistence in product quality,” Jochen Scheil, ACG’s Vice President Global Sales & Business Development said in a press release (1).

“Our focus is on being in Europe, for Europe, combining global expertise with local presence to deliver real value for our customers,” said Selwyn Noronha, CEO of ACG Capsules, in the release (1). “By strengthening our operations in Croatia, we’re increasing capacity, shortening lead times and enhancing supply chain resilience. Together with our integrated solutions and deep understanding of European standards, this investment ensures we remain a trusted partner, always at our customers’ side.”

How will innovation in outsourcing be discussed this year?

, a CDMO that specializes in formulation development, clinical and commercial manufacturing, and packaging, will be exhibiting and presenting this year. Bora CDMO president, J.D. Mowery, is participating in a panel discussion on the future of CDMO innovation. 

Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation

 explores the emerging trends shaping CDMOs and is scheduled for October 30 from 11:35 a.m. to 12:15 p.m.

2-part interview with Mowery to post on Thursday.

The company will also be announcing the expansion of its fill/finish capabilities in the CDMO Zone at Booth 6.0C90. In addition, the company’s Chairman and CEO, Bobby Sheng is a finalist for “CEO of the Year” in the 

. Sheng won “CEO of the Year” in 2020.

“Bringing leaders and ideas together under one roof to collaborate is critical to the future growth of our industry,” said Mowery in a press release (2). “This has been an exciting year at Bora, marked by global growth and strategic investments across our business. We’re eager to make the most of the connections and collaboration at CPHI and carry those insights back to our customers to further strengthen the value we deliver.”

“Our collaboration with Bora Pharmaceuticals for sterile fill and finish services truly distinguishes us from other biologic CDMOs,” Marc Goemans, chief commercial officer of Bora Biologics, emphasized. “It streamlines the client experience by allowing them to sign a single agreement to work with one team on one timeline, ensuring expedited project success from start to finish—consolidating expertise and rewarding collaboration to de-risk every project."

will be announced at the event’s opening ceremony on October 28 (3).

ACG. ACG Showcases Strengthened European Capabilities and Croatia Expansion at CPHI 2025. Press Release. Oct. 28, 2025

Bora Pharmaceuticals. Bora Pharmaceuticals Joins Global Pharma Leaders at CPHI 2025. Press Release. Oct. 27, 2025.

Mirasol, F. CPHI Frankfurt Reveals 2025 Pharma Awards Finalists for Bio/Pharma Development. PharmTech.com. Sept. 18, 2025. 

https://www.pharmtech.com/view/cphi-frankfurt-reveals-2025-pharma-awards-finalists-for-bio-pharma-development

Articles

CPHI Frankfurt commenced with diverse conference sessions and numerous companies showcasing their offerings. ACG highlighted its European service expansion, focusing on reduced lead times and enhanced supply chains, particularly through its Croatian capsule production site. ACG's exhibit includes a range of gelatin capsules and sustainable packaging solutions. Bora Pharmaceuticals is participating in discussions on CDMO innovation and expanding its fill/finish capabilities. The event emphasizes collaboration and innovation, with Bora's CEO being a finalist for "CEO of the Year" at the CPHI Awards, which will be announced at the opening ceremony.

ACG showcased the expansion of its European presence, and Bora Pharmaceuticals participates in a discussion about CDMO innovation.

Day One at CPHI Frankfurt Sees Announcements from ACG and Bora Pharmaceuticals

Eva-Maria Hempe, NVIDIA, says bio/pharma must centralize AI strategy, tackle silos, prioritize process integrity, and balance quick wins with long-term drug design goals.

Centralizing AI Strategy, Ensuring Process Integrity, and Balancing Quick Wins with Long-Term Drug Design in Bio/pharma

In this part 2 of a 3-part interview regarding the presentation “The State of AI in Next-Generation R&D” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, Eva-Maria Hempe, Head of Healthcare & Life Sciences, NVIDIA, explains that the successful integration of Artificial Intelligence (AI) within the bio/pharmaceutical sector requires addressing organizational, technological, and cultural challenges, according to an analysis of strategic imperatives for AI adoption. She notes that the adoption of AI is posited as a fundamental shift that permeates the entire value chain, encompassing applications across research and development, manufacturing, and commercial activities. Her primary recommendation for industry leaders is to solidify AI as a core central business function rather than treating it as a decentralized or non-essential add-on.

According to Hempe, the current barriers to widespread AI implementation are diverse, including pervasive organizational and data silos, outdated legacy IT systems, and fragmented AI strategies. Additionally, she says organizational compute capacity is a significant bottleneck, often manifested as GPU scarcity, which limits project scalability; this issue is frequently linked to a lack of centralized strategic oversight for infrastructure planning. To sustain AI momentum, Hempe advises organizations to strategically balance highly ambitious, long-term goals—such as shifting drug discovery toward intentional design—with short-term "quick win" projects. While transformative drug discovery requires timelines exceeding ten years, immediate impact can be achieved through applications like automated regulatory filing, clinical writing, and optimized recruitment for clinical trials, she adds.

Overcoming these obstacles mandates a significant focus on change management and culture shift, elements often grossly underestimated, according to Hempe. This involves comprehensively educating both staff and leadership on the capabilities and limitations of AI. Furthermore, process integrity is a critical prerequisite for meaningful digitization, she says, summarizing the necessity of focusing on foundational improvements as "if you digitize or standardize or automate broken processes, you get broken automated processes." Successful AI deployment, therefore, relies on improving standardized ontologies, data interoperability, and ensuring robust compliance frameworks, Hempe concludes.



 We already talked about silos, namely data silos, but I think there's also a lot of organizational silos. So, I think the big barriers to adoption are organizational silos, legacy IT systems, fragmented AI strategies, and then also change management is really massively underestimated. It's not just you're doing now AI and everybody's going to jump at it.

You have to find the right quick wins, which are helping people to buy into the opportunity. I also actually see is often GPU scarcity. So there is often just not enough compute for people to run what they would like to run. And that ties back to the centralized or the fragmented AI strategy. If you don't have a centralized AI strategy, you don't really have a good overview of what you need in terms of also infrastructure to run your most important AI projects for the organization. So, the first thing that I hope is going to be addressed, I would recommend people to address, is to really have a centralized AI strategy and have that as a core business function and not just an add-on somewhere.

This is just something that permeates across the entire value chain, and we are seeing use cases from research and development all the way to manufacturing and commercial. So this has to be a core central business function.

The second thing, which I already alluded to, is to really balance quick win projects with more ambitious initiatives. We all hope, and we are all working towards, making drug discovery less a serendipitous discovery and more an intentional design. But that's really hard, and the timelines are just 10 years plus. You still have to run through all the steps of clinical trials. Again, AI can help with clinical trials, but in a way, if you take a drug for six weeks, it's just going to take six weeks. Or if it takes two months or three months if you want to show a long-term survival, it just takes time. So this is the long-term parts of the portfolio, but there are so many also quick wins, which are returning impact immediately. They might not be as sexy as solving drug discovery, but with things like clinical writing, automated filing for regulatory, as well as better recruitment for clinical trials, you can win a lot on a very short time scale, and that's going to allow you to sustain the momentum as well for those more long-term and more ambitious initiatives.

And then I think the last thing, which I also said before, is really change management. So it's educating staff, educating leadership. One of the things about AI is that it's at the same time incredibly powerful and incredibly non-powerful. So you need to understand what it can do to basically also be able to judge what you do with the outputs.

Yeah, really driving that change management process, driving the culture shift, driving process improvements as well. We said before garbage in, garbage out. And another of these sort of sayings is that if you digitize or standardize or automate broken processes, you get broken automated processes. So doing all of those things is a real prerequisite to fully tapping into the power of AI. And then of course some of the more technical challenges like data interoperability, standardized ontologies, and then compliance. But there we are also seeing frameworks emerge and we're working with partners on a lot of these fields.

React4Life’s Silvia Scaglione emphasizes how organ-on-chip tech and AI are reshaping drug testing, personalized treatment, and the future of bio/pharma innovation. 

How Organ-on-Chip Tech and AI Are Transforming Drug Development

, Silvia Scaglione, PhD, director of research at the National Research Council in Italy and founder of React4Life, an Italy-based biotech company specializing in organ-on-chip technology, spoke about the advancement of organ-on-chip platforms in 

. Her insights reveal a transformational period in translational research and drug development, with the potential to reshape preclinical testing and personalized medicine globally.

In particular, organ-on-chip technology (such as React4Life’s platform) facilitates growth and analysis of patient-derived tissue samples. This capability enables researchers to potentially drastically reduce time, cost, and failure rates typically associated with traditional preclinical studies, Dr. Scaglione emphasizes.

How is organ-on-chip technology revolutionizing drug testing and personalized medicine?

“For the first time, it’s possible to reduce the time and cost typically spent during the preclinical stage, and, moreover, we can also reduce the failure in [the] clinical stage due to the wrong experimental setup,” Dr. Scaglione notes.

An important aspect of organ-on-chip technology is the ability to connect multiple organ models—such as gut, brain, and skin—which allows researchers tomimick complex human physiological interactions. This multi-organ connectivity enables researchers to assess drug efficacy holistically, observing not just local but also systemic impacts, Dr. Scaglione emphasizes.

The integration of the microbiome within the organ-on-chip system further enhances disease modeling, offering critical insights into how gut health influences drug responses, especially in cancer therapies, she explains.

Dr. Scaglione also champions the role of AI and in-silico methods in streamlining drug candidate selection. By combining machine learning with organ-on-chip platforms, companies like React4Life aim to set new benchmarks for accuracy and efficiency in drug discovery.

Dr. Scaglione spoke at CPHI Frankfurt on Oct. 28 in the session “

Lightning Talk: Innovating the Future of Biologics R&D

.” CPHI Frankfurt runs Oct. 28–30, 2025.

Silvia Scaglione, PhD, Director of Research, CNR, and Chief Scientist, React4Life

Since 2010, Dr. Scaglione has been a permanent researcher at the National Council of Research in Italy, becoming a senior researcher in 2021 and leading the tissue engineering team. In 2017, she founded React4Life, an Italian biotech company that develops organ-on-chip technologies to accelerate translational research and improve the reliability of drug testing. React4Life has won several international projects and awards, including the EU Innovation Radar Award for Best Health Technology and the CPHI Award in 2023. Dr. Scaglione is also an ambassador for the European Innovation Council. She received her PhD in bioengineering from the University of Genoa (Italy) and was a visiting scientist at the University Hospital of Basel (Switzerland).

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

 I'm Silvia Scaglione. I'm a director of research at the National Research Council in Italy, and I also founder and chief scientist of React for Life, which is an Italian deep tech biotech company which developed and commercialized an organon a chip platform for translational research and drug testing.

 What impact does the industry see from using dynamic human tissue systems in preclinical testing as alternatives to traditional in vivo methods?

 The impact is really huge and amazing, because the use of dynamic human organ energy platform are really changing the use of and the adoption of alternative experimental model during pre clinical stage. Indeed, for the first time, it's possible to reduce the time and cost typically spent during the pre clinical stage, and moreover, we can also reduce the failure in clinical stage due to the wrong experimental setup. Moreover, we have also introduced something related to the personalized approach, because we can really host and grow personalized the patient derived tissue samples and testing different therapies for selecting the best therapy for that patient, for that disease. Soit's really a revolutionary impact.

 How crucial is the ability of advanced models to enable precise controlover factors such as barrier function and mucus production and increasing the reliability and predictability of drug permeation data?

 It's really important to have the possibility to control and quantify the readout during the use and adoption of organism platform, because just an example, when you use a gut on a chip platform, you have the possibility to measure the barrier function of the gut, and at the end, you can discriminate if you are working with a healthy tissue model versus an IBD or clone disease intestinal models, so the possibility to properly control measure and quantify the readout, enable to control the experiment, to decouple different behaviors and to discriminate healthy versus pathological diseases, And of course, related to these there is a possibility to properly quantify the efficacy of new treatments by analyzing the effect of this therapy on the tissue

 Now, from an industry perspective, how does the integration of tissue models into multi organ systems, such as simulating the gut–skin axis, reshape the approach to testing efficacy for oral treatments?

 It is really important to have the possibility to work with multi organ connections. Connection. That is what is possible using how our vivo, proprietary organ energy platform, because we can fluidically connect multiple organs like that versus skin, but also gut versus brain or gut cancer. And this is amazing, because for the first time, you can control and observe the effect of the therapy, not only on the localorgan, but using a holistic perspective, so analyzing, for instance, a therapy orally administered, but also evaluating its effect on a target tissue, it which might be far from the gut. And in this case, we can introduce a systemic approach, which is revolutionary for increasing the reliability of the readout.

 Beyond accelerating general drug screening. What are the primary ways that validated tissue platforms are currently supporting innovation in the development of microbiome-based therapies?

 Well, the microbiome modulates a lot of biological and pathological things in our in our body, so the possibility to introduce microbiome within the organon chip enable to unlock new testing and new complex disease modeling. Just an example. We have co culture gut microbiota into the gut on a chip platform, which was critically connected to the cancer model, and we have successfully demonstrated what it is observed in clinics, that is the fact that the dysbiosis in the gut might drastically reduce the efficacy of the anti cancer drug treatment, and this is due To the cross talk between microbial with local and systemic organs. I just

 How is the biologic sector reimagining supply chains to protect against rising tariffs, geopoliticalshocks, and global disruptions?

 This is really a critical point, because we have understanding that the geopolitical situation might also drastically affect industrial decision. What we have done in reactor Life is to internalize completely the supply chain. Soat the moment, the product of React for Life is fully made in Italy. So we have decided to select our supplier among the supplier of the Italy ecosystem, in order tofacilitate a more robust and stable relationship. I don't know if it's the same choice of pharma company, but for sure, this is what we have done.

 And what role do AI and digital technologies play in accelerating drug discovery and improving manufacturing efficiency, and what are some unresolved barriers to full adoption of these technologies?

 AI definitely is a key point, and in some cases, I will say alsoit's a buzz word used just because it's important and mandatory to be used in the drug testing. What, what is my experience is that it's really important to adopt also in silico approaches like machine learning AI based approaches, but also in the past, before the AI massive adoption drug testing has adopted in silico solutions during the drug testing to accelerate and improve the reliability of the selection of the niche and lead candidates.

Maggie Saykali, Cefic, reviews how the EU’s proposed Critical Medicines Act aims to curb supply dependence and shortages by reforming drug procurement.

The CMA: Transforming Procurement to Ensure API and Excipient Supply Chain Resilience

In this part 1 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), provides insight into the origins and development of the 

European Union’s proposed Critical Medicines Act

 (CMA). The push for the CMA originated during the 2020–2022 pandemic, during which medicine shortages underscored Europe's deep dependency on other regions—particularly Asia—for critical medicines, a situation aggravated by years of pharmaceutical offshoring. The core goal of the legislation is to identify the root causes of these shortages and drastically reduce them, explains Saykali.

The European Commission, working with major stakeholders, including API manufacturers, generics and branded medicine producers, patient associations, and member states, first developed a methodology to define what constitutes a "critical medicine." This methodology relies on such factors as a medicine’s supply chain structure, therapeutic family, and the number of suppliers. The concept of the CMA itself emerged in 2023, modeled after similar European legislation focusing on raw materials or semiconductors. This process involved the formation of a Critical Medicines Alliance, which included approximately 200 stakeholders. Published in March 2025 by the Directorate General for Health (DG SANTE), with assistance from the directorates for industry and medical emergencies, the act is now undergoing consultation with the European Parliament and Council, with a final vote anticipated by the end of this year or the first quarter of 2026, according to Saykali.

A primary focus of the CMA is reforming procurement practices. Currently, procurement is often based solely on price, resulting in a "one winner takes the whole tender" system that lacks guarantees regarding quality, security of supply, or adherence to environmental and social norms. This setup is detrimental to European manufacturers who must comply with strict EU regulatory frameworks. By reforming procurement criteria, introducing multi-winner tenders, and embedding environmental standards, the CMA seeks to ensure that compliance with stringent requirements becomes an advantage rather than a penalty for European producers. Furthermore, vulnerabilities must be addressed throughout the entire pharmaceutical supply chain. Saykali emphasized the often-overlooked components:

"We should not forget excipients because a lot of the critical medicines, generics or branded, actually depend on the excipients for their mode of action,” says Saykali. “And if we have a shortage and excipients, we… cannot make this medicine."

 and Part 3 of this interview and access 



My name is Maggie Saykali. I am the director of the European Fine Chemicals Group, and that is the trade association that represents the European manufacturers of active pharmaceutical ingredients, excipients. Intermediates and the key inputs, in fact. So our members are mostly CDMOs or some of them also make finished dosage forms, but mostly they are CDMOs and manufacturers of excipients or active pharmaceutical ingredients.

So the Critical Medicines Act is something that took a long time to elaborate. It originated during the pandemic, the idea of it. During the pandemic, we were witness to quite a few shortages that illustrated actually the existing situation that we all knew about, that for some critical medicines and with the offshoring that has been going on for years from Europe to Asia due to different factors that we were very dependent on other regions for the supply of some of our critical medicines. And this is more acute in generics of course, so we can go into the numbers behind that, But so, during the pandemic in 2020 until 2022, it was very obvious that the situation was exacerbated and that the solution must come. The European Commission worked with major stakeholders, meaning us as active pharmaceutical ingredient manufacturers, the generics manufacturers, and the branded medicines manufacturers mainly, but also patients associations, pharmacists, and member states to come up with a solution, first of all to identify the root causes for the shortages, and then, of course with the purpose of finding solution to alleviate them or to reduce them drastically.

So that started with a methodology to determine what is actually a critical medicine, what makes for the criticality. And the commission came up with a methodology with different factors based on the structure of the supply chain of a medicine. It's therapeutic a family factors like the number of suppliers, et cetera.

So there was a rather complex matric that would then identify what is a critical medicine and what is and differentiated from medicines that might be short but not qualify for the criticality. After that, in 2023, the idea came that we need a critical medicines act for Europe on the same model as the one for the chips or for raw materials, et cetera.

And this idea originated with a few member states that pushed it really hard together with the commission, European Commission, and there was a Critical Medicines Alliance formed. With the stakeholders, there was about 200 stakeholders, but the critical alliance board, steering board was these associations that I mentioned, plus representatives of patients, pharmacists, et cetera, and member states.

And we worked on what were the possible solutions. And then the commission went to work, put this all together. And in March, 2025, the Critical Medicines Act was published, and it was published by the director General for Health (DG SANTE). So the directorate in the European Commission that is responsible for everything that concerns health, but it was also helped by the directorate for industry and the one for medical emergencies.

So since then the Critical Medicine Act entered the European decision-making process, which involves consultations with the European Parliament and the council, meaning the member states, the European member states, and this is where the process is now. The council, the commission, and the parliament are discussing, and the final vote will happen we think, at the end of this year or first quarter of 2026. And then it'll be it'll have legal value.

First of all what we see today is a situation, for instance, in procurement that is completely based on cost, a price only meaning one winner takes the whole tender and it's only based on price. Meaning there are no guarantees on quality, on security of supply, on any other factors on the fact that it's produced, respecting environmental norms or social norms, all of that doesn't enter into account.

And is actually detrimental to European manufacturers because we have a set of standards, environmental, social that we have to comply with. That's normal. These are the European re regulatory frameworks. And some of the other suppliers from other world regions are not abiding by these, and they have different cost structures.

By addressing the issue of the criteria for procurement, this might give European manufacturers better possibilities to be competitive. Plus in putting environmental criteria in there as we asked for, that will give value. To the fact that we produce according to a very strict and very tight ESG requirements.

And this means that we will not be penalized because of it, but that will become rather an advantage for us. Plus then we are asking for not to go for the one one winner takes it all. But to have multi-winner tenders, which will put at an advantage Also people who manufacture in Europe.

Be it finished dosage, forms, active pharmaceutical ingredients excipients, et cetera. We should not forget excipients because a lot of the medicines critical or sorry, generics or branded actually depend on the excipients for their mode of action. And if we have. Shortage and excipients. We are at the same point that we cannot make this medicine.

So the role throughout the supply chain, we have to make sure that there are no causes for vulnerability and no possibilities for shortages or delivery of faulty or not up to standard quality ingredients.

Eva-Maria Hempe, NVIDIA, explains that accelerated computing, data governance, and “lab in the loop” are key to bio/pharma’s AI strategy for transforming drug discovery and R&D.

AI and Accelerated Computing Propel the Biopharma Ecosystem Forward

In this part 1 of a 3-part interview regarding the presentation “The State of AI in Next-Generation R&D” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, Eva-Maria Hempe, Head of Healthcare & Life Sciences, NVIDIA, discusses the pivotal role of artificial intelligence (AI) and accelerated computing in transforming the bio/pharmaceutical ecosystem.

A core challenge and competitive strength in this sector stems from the prevalence of siloed and proprietary data. Leading organizations are tackling this by adopting advanced AI platforms designed to integrate, process, validate, and harmonize these complex, disparate data sources, Hempe explains. She adds that specialized tools operate atop these platforms, including Parabricks for genome sequencing, MONAI for medical imaging, and BioNeMo for biological language models, all aimed at accelerating analysis and extracting rich insights from often unstructured data.

According to Hempe, success in AI hinges directly on data quality and integrity, adhering to the principle that "garbage in garbage out is just a matter of fact." This necessity drives the implementation of robust data governance frameworks, such as ALCOA (attributable, legible, contemporaneous, original, accurate), alongside rigorous automated validation routines and training, she says. These AI platforms support safe model development practices by allowing the tracing of data provenance.

Hempe notes that the single greatest operational opportunity identified is what is termed the “lab in the loop”—the seamless integration of the wet lab (experimental work) and the dry lab (computational analysis). By automating wet lab processes, high-quality, repeatable data is generated, complete with necessary metadata. This reliable data then feeds computational models, which in turn predict the optimal next set of experiments to run, thereby accelerating the entire research workflow, she states. This systematic, data-driven exploration is essential given the immense scope of chemical possibilities. Speaking to this scale, Hempe notes, "This is more than sand grains in the universe." Furthermore, foundation models, such as Evo 2, are being deployed to deepen the understanding of genetic mutations at scale, predict their functional impact, enhance candidate selection, and encourage crucial cross-disciplinary collaboration.

Check out 



I'm Eva-Maria Hempe and I lead Healthcare and life Sciences for NVIDIA in Europe, Middle East, and Africa. What this means is we're working with the whole ecosystem, so both healthcare and life sciences. I sometimes joke I do everything from genomics over direct discovery, surgical robots all the way to helping physicians and nurses to do their job better. But that's a bit the span we're covering. We're working with companies of all different sizes. We're working with both established companies as well as startups and really helping them to use AI to the fullest and avoid reinventing the wheel and really tapping into the potential of accelerated computing.

It's one of the big strengths or big competitive advantages actually in this field is that there is, you can call it siloed, you can call it proprietary data, but of course it is something that has to be managed. And in general, the way we see is that leading organizations have advanced AI platform, which really allows them to integrate the data, to process the data, and to validate the data.

And then on top of such a platform, we're offering specialized tools like, for example, Parabricks for genome sequencing or MONAI for medical imaging or BioNeMo or biological language models, as well as some kits for agentic AI that then enable accelerating data analysis and really reducing the manual input and you really get this rich insights from these complex data sets, which are just, they're just a matter of fact, this ius nothing we're going to be changing in a way, that is the richness of this field, is the unstructured data, is the multitude of data. And so these platforms are then really supporting centralization without really having to repackage everything and the harmonization of those disparate data sources.

The question of data quality is actually really important, and integrity. So, the old proverb of garbage in garbage out is just a matter of fact. So, it's really about enforcing compliance at the data lifecycle and having a really robust data governance framework. So we're seeing concepts like ALCOA (attributable legible, contemporaneous, original, accurate) or other frameworks being rolled out. Then it's really about having the right processes on audits, training, and as well automated validation routines. And we can help with that by having, again, a platform that allows us to trace data provenance and to really have safe model development practices that you can rely on as as a basis for the more behavioral aspects, which I just outlined.

I think the greatest opportunity really is what we call the lab in the loop or bridging the wet lab and the dry lab, and that has kind of AI challenges on both sides. In the web lab, it's really about automation, so you want to have data, which is, as you said before, high quality. So you have to have the right metadata, and you want to have a really repeatable loop, a really repeatable workflow here. So we are seeing companies working in that space who are, automating the entire wet lab, like all the processes of transferring plates between different machines and capturing all that data in a harmonized form. And that data then provides the basis for better predictions of what experiments we should be running, and then you're basically closing the loop. So you're having the wet lab, which is the validation, which gets you the real data in a good quality thanks to automation, and that data quality then feeds models which can predict which experiments to do next. I think that's once this flywheel, you get to go, it can really accelerate things because the chemical space is just so huge. I mean, this is more than sand grains in the universe. And so far we've just been looking at where we felt comfortable in a way, looking at where we've been always looking. And with this more data-driven approach, we can really explore that space in a much more structured and systematic way.

And I think there's another opportunity. So these are foundation models like Evo 2, that's to really dive deeper into genetic mutations at scale and understand and predict the functional impact of that. And then, again, this allows better candidate selection and, again, drives cross-disciplinary collaboration.

CPHI Frankfurt 2025: The Current API Market

APIs are a prominent and important part of a drug product. Pharmaceutical companies often source these materials from global API manufacturers, and qualifying these suppliers is integral to good manufacturing practices and regulations. A secure supply chain for these materials is also imperative.

With a variety of potential disruptions that may result from the current geopolitical climate, Dr. Weite Oldenziel, CEO of Ofichem, gives his perspective on why API suppliers should be qualified and how the current API market is handling the political landscape.

“Changes [in the API market] are always present, and we have to conclude that by far the majority of the APIs [are] being produced in Southeast Asia and predominantly in the countries India and China,” Oldenziel says. “There is a lot of talk about, say, reshoring, onshoring, near shoring. It is very difficult to substantiate this, to which extent this is happening. It is also very important to realize that no two APIs are alike. A low-volume, high-priced, proprietary API is completely something different than a large-volume, low-priced, generic API.”

“So, how is the sector reimagining supply chains? In general, I would say not that much,” Oldenziel says. “Things in the pharmaceutical supply chain are moving relatively slow. It is quite a conservative market where strict compliance with rules and regulations is very important. So, processes just move slow, and they can't anticipate on incidents in the world markets. Only when an incident has a more structural character… you will see that supply chains are affected.”

Ofichem will be exhibiting at CPHI Frankfurt 2025, which is happening from Oct. 28–30 in Frankfurt, Germany. You are welcome to visit their stand, number 11.0A89, zone API.

Click on the link about to watch the interview.

Dr. Weite Oldenziel is CEO of Ofichem, a fully integrated pharmaceutical company, both in drug substance and in drug product. He is a pharmacist and has a PhD in neurochemistry.

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 Weite Oldenziel from a background. I'm a pharmacist and did a PhD in neurochemistry, and since almost 20 years, I'm now the CEO of the Ofichem Group, which is a fully integrated pharmaceutical company, both in drug substance and in drug product number two, sorry, yeah, very important for pharma manufacturers, of course, is the technical part. So the API supplier should fulfill all kinds of regulation. That's a no brainer. You things like GMP, things like an API registration, things like an asmf or a CEP. That's crystal clear. However, also very important, which is actually not part of the official supplier qualification, is that an API supplier also should be proactive. Should be supporting the pharma manufacturer should help and guide them, because only when they work together, the pharma manufacturer and the API supplier, they can bring the medicine to the market.

So yeah, what does the current API market look like? Of course, changes are always present, and we have to conclude that by far the majority of the APIs being produced in Southeast Asia and predominantly in the countries India and China. There are a lot of talks about, say, reshoring, on shoring, near shoring. It's very difficult to substantiate this, to which extent this is happening. It's also very important to realize that one API is not the other one. A low volume, high priced, proprietary API is completely something different as a large volume, low priced, generic API. So maybe not from a technical point of view, this API is different, but certainly from a commercial point of view.

So how is the sector re imaging, supply chains? This is quite a difficult question. In general, I would say not that much overall, and that has to do with the fact that things in the pharmaceutical supply chain are moving relatively slow. It's quite a conservative market where compliance and to remain in compliance is very important. So processes just move slow and they can't anticipate on incidents in the world markets, so only when an incident gets more like a structural character, yeah, then you really can see that supply chains are affected. What, for example, you've seen a few years ago when development. Proprietary APIs. More was reshored back to Europe and US. Or what you see now is at the Trump administration that there are more initiatives for maybe reshoring to US soil. But at this moment, that's not very tangible yet.

I'm very much looking forward to the cphi with enthusiasm. It's always very nice to reconnect with old friends and with acquaintances and to talk about the pharmaceutical world, which is our work, and which I'm really passionate about.

Pharmaceutical Technology® spoke with Dr. Weite Oldenziel, CEO of Ofichem, before CPHI Frankfurt 2025 to get his perspective on the API market and why it is important to qualify API suppliers.

As part of our conference coverage, we hear what Takeda Pharmaceuticals will be presenting.

Sriman Banerjee CPHI Interview

In its continuing coverage of CPHI Frankfurt 2025, 

, 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.”

In his talk, and also in this video interview, Banerjee addressed how smart and connected packaging technologies have transformed the ways in which consumers interface with pharmaceutical products, leading to more personalized experiences and health information delivered in real time.

What this trend has done, Banerjee says, is not only improve patient adherence, but also provide valuable insights to pharmaceutical companies.

“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,” Banerjee says in the interview. “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.”

The full interview with Banerjee can be viewed above, with a transcript following below.

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.

I am Sriman Banerjee. I head the diagnostic software devices and packaging at Takeda Pharmaceuticals, based out of the greater Boston area. I have been with Takeda for six years now, and prior to that, I was with GlaxoSmithKline and a couple of other companies.

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, et cetera.

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.

The way it improves patient adherence is, one, if you take the example of a smart cap here, 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.

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.

It is also a part of the patients. So 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.

CPHI Europe

Patient adherence is improving thanks to technologies that offer a more personalized experience, deepening the connection between consumers and healthcare brands.

Takeda Talks at CPHI Frankfurt 2025 About Smart Pharma Packaging Impacts

The Benefits of End-to-End Services

Smaller biopharmaceutical companies that own the molecules in early clinical development and outsource most of their development and manufacturing operations, often have limited resources, according to Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company, and therefore might benefit from a contract development and manufacturing organization (CDMO) that offers end-to-end services.

“They perhaps have limited number of people who are really going to be in a position to manage their service providers. So that really brings you to the first benefit, where having a single partner actually reduces the complexity you have in managing multiple partners, you have a single point of contact across the continuum,” Dowdeswell explains. “There can actually be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without any barrier to communication because they're part of the same company, there's no confidentiality issues. It also means that maybe there's some work that can be overlapped. So, you can start work on drug product before you've finished all the work on drug substance, which might not be quite so easy when you have separate parties.”

Arcinova, a Quotient Sciences company, will be exhibiting at stand 5.1D104 , zone Contract Manufacturing and Services, at CPHI Frankfurt, being held Oct. 28–30, 2025.

Click the video above to watch the interview.

Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company.

Christian Dowdeswell is an experienced commercial leader in the CDMO industry. A former scientist with a PhD in organic chemistry and a long track record in CDMO organisations, most notably VP Head of Commercial, Small Molecules at Lonza & Chief Business Officer, Drug Substance at Siegfried. His current role as Head of Arcinova builds on his extensive experience in Early Phase development across Drug Substance and Drug Product gained in prior roles.

Hello. So I'm Christian Dowdeswell. I am the MD of Arcinova, which is a part of quotient science is limited.

I used to be a scientist, but moved into commercial roles some 20 years ago, and have been in commercial leadership roles at a number of cdmos, most notably Lonzo, where I was head of commercial for the small molecules business for nine years. Spent some time as chief business offers Officer at seafree, before deciding that I wanted to return to where I started. So back with much smaller cdmos, which is in a roundabout way, led me to this new role leading Arcinova, which is an early phase drug provider, drug development provider, offering services across drug substance, drug product, global clinical trials, supply and answer adjacent services.

How is early development of drug products enhanced by a cdmo that offers end to end services?

I think to some extent, this depends a little bit on who you're doing the work for. So if I was to take a small biopharma company, for example, and they're important because they own the majority of clinical molecules in early clinical development, typically, that sort of company has limited resources

to conduct that sort of work themselves. So they outsource heavily. They perhaps have limited number of people who are really going to be in a position to manage their service providers. So that really brings you to the first benefit, but actually having a single partner reduces the complexity you have in managing multiple partners, you have a single point of contact across the continuum.

And actually there can be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without you having to get in the way of communication because they're part of the same company, there's no confidentiality issues.

It also means that maybe there's some work that can be overlapped. So you can start work on drug product before you've finished all the work on drug substance, which might not be quite so easy when you have separate parties.

It may be an example to bring that to life. One of the things that we find here is that we can have great communication between the team that's working on the API around the material form of the drug substance, with the drug product team who's doing the work to translate that into a viable drug product. So that interplay between, how do we optimize the drug substance, how does that feed into what we're doing with drug product that can actually bring you to stronger technical outcomes as well?

I think, I think in our particular case as well, because we're part of quotient, we're actually able to go further downstream, actually into clinical work. But, but really the main benefits of that continuity of work through a single provider brings those key benefits, reduction in complexity, especially those smaller companies, reduction in time, which you know can be, can be quite meaningful, and the reduction in the total cost of ownership. So.

What role do artificial intelligence and digital technologies play in accelerating drug discovery and improving manufacturing efficiency? And what are some unresolved barriers to full adoption?

I think there's, there's actually quite a lot to unpack within that, but so I'll try and deal with it, with it through giving some examples of things that are happening, things that we've been looking at. So one of the clearest examples of how digitalization and AI is changing drug discoveries in the use of AI to help design new molecules that target a specific protein site.

Now that is quite effective in tailoring a drug to the activity or molecules the activity you hope it will have, but it has an unexpected consequence, in that the number of synthetic steps is increased quite dramatically with that approach. So I have some data that shows around about the year 2000 there was a paper published by Pfizer and AZ, I think that showed the average number of synthetic steps to get to an API was eight, round about 2020, you do the same analysis, and you see that number of steps has almost doubled. So it's like 14 or 15.

And earlier this year, I found some more data, which suggested that the new molecules coming out of novel approaches to drug discovery have often in excess of but 30 steps of chemistry to get to the target. So that is a really dramatic step change, that over the last 25 years, you've gone from eight to 30 steps, and that's whilst that's quite an unexpected consequence, cdmos are going to have to find a way to deal with that. Now, the time that we have available for CMC is not going up, in fact, if anything is coming down. So you have more complexity, more work to do on the API synthesis. We can leave aside the problems with that you have in drug delivery beyond that. But just for the API synthesis, you have to find a way to get all of the work done on CMC and building the synthesis towards providing the small molecule API in the same time. So you have to find ways to do that much more efficiently, much more quickly.

One of the things that we've been looking at is around the use of digital twins. We're not alone in doing that, but one of the reasons we've done that work is because it gives us a really great pathway to look at how do we move from the small scale lab experiment into the initial scale up, which might be to a small kilo lab, 510, 20 liters, liters, and then take that further into the next scale, which might be one, 150 200 liter scale. And even then, how do we provide data that enables a customer or a future service provider to take that further? So we've done that work to enable us to model how the reactor is going to behave, how the kinetics of the reaction are going to behave, to enable and facilitate that scale up. And we actually did that. It was actually part of a sustainability push, originally, that we wanted to be able to do this in a in a quicker fashion, that we're using less resources to get to the same endpoint. But actually, when you tie that into the complexity part, the amount of work you've got to do, that starts to become essential. And I think your question asked about some of the difficulties, you know, the difficulty in the work that we did was to look at the data architecture, the way that you receive the data from all of the different sensors, because it's not standardized today, requires a lot of data manipulation adjustment to get it into a format where you can actually do the modeling. So here's where we're planning on bringing AI in, because AI can help do that data manipulation work in a much smarter, quicker, frankly, quicker is the key here, why that enables us to get that modeling done much more quickly, which starts to build this, then from a single product or single reaction solution into something that's much more of a platform that you can use across the board. Some of the other advantages you have is that, by how you can also look at should be operating in batch or continuous and attend on a particular stage of development, you might want to change that might be more appropriate a certain stage, stage of development, to do it continuous and later fit to batch, because that fits a large scale CD, most manufacturing assets. So there's a lot there. I think, as an industry, that's maybe a microcosm of the challenges we face. There's a, there's a there's inconsistency around the state of digitization, and that not just company to company, but acid to acid within companies, because, you know, different assets have different ages and different ability to support digitalization.

Innovation, the lack of standardized data architecture, is something that we've seen, really in a microcosm, but a macro level, I think, is something everybody faces. And I think the third one, I'm pretty sure, is an industry across the industry as well, is the is the availability of expertise. Is there a suitably qualified workforce? Do we have access to the right people that can really support and drive digital initiatives, and, in fact, even who fully understand the true potential of what could be done. I think that's one of the key challenges that as an industry, we're still coming to grips with.

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

Yeah, I think that's, that's a question I get a lot, actually, and I probably play back a little bit the the answer that I quite often give which is the quite frankly, at the moment, nobody knows there's a huge amount of change around tariffs and what's happening with some of the other geopolitical situations. And certainly I don't look to base strategy on social media posts without really understanding how actually is that going to be implemented. But I think overall, this is part of a an ongoing regionalization trend that I think has really been driving for quite some time, certainly, certainly over the last 10 years, this has been happening where, certainly for innovative Pharma. So companies working in the innovative space, their focus has moved away slightly from just being let's get things done at the lowest cost, which meant moving to Asia, to actually a realization that their success is much more dependent upon getting their drug advancing through the clinic and hopefully to market in a timely fashion. Not being first to market or being delayed is a real hit on their revenue. It's a real hit on the business case for developing the drug in the first place. So we're seeing them move away from a cost first basis to look at how do they best ensure their drug gets through that, and the way they do that is by making sure that their cdmo providers are underpinned by strong science, who are able to provide good data, who are able to execute a plan, who have no compromise on quality, who are able to really communicate them within in a very optimal fashion, depending what that means for an individual organization and overall, finding that they are able to get more security of supply, more security of delivery of what they're asked, asking for by using Western providers. And you can really see that in the last 10 years, the cdmo industry has had quite a revival, and a number of companies have that are public demonstrate that really well across Europe and US. So I see the trends, the questions around tariffs, bio secures, re emerged again. You know, the geopolitical factors around

the over dependence on China, I just see that simply accelerating that trend. Because I think our industry has been moving that way anyway. This just maybe makes people much more conscious of it. For a company that can't get Nova, which is really an early phase company, what it means for us is we have to be consistent or continually re evaluating what we offer as service, services to understand is that still addressing customer problems, what aren't we doing that we should be doing? Are we relevant? Are we going to remain relevant in the future? So really having that continuous dialog with our with our customers and future customers about what do we need to be doing to really be giving you what you need.

What are you looking forward to most at CPHI Frankfurt?

CPHI, I think have a love hate relationship with it. I've been going for 25 years, and perhaps, as I answer, you can see why I have a love hate relationship with it. I actually think the timing couldn't be better. I am less than three months in a new role with an organization that's been been rebranded is based in the organization as well, so that timing almost couldn't be better, because I get the chance to meet with a huge number of customers, and hopefully future customers, and actually other people industry, and really start to test myself firsthand. What are we doing?

Is that addressing your needs is, are we actually providing what you need to what aren't we doing that we should be doing? Basically what I talked about in the previous answer, it's a perfect opportunity to do that. I mean, it's a great place to connect with old friends, to meet up with other people in the industry who have an incredible amount of knowledge.

I think I'm not alone. I think a lot of people go to cphi and are very guilty of burning the candle at both ends. So You're up early for breakfast meetings and you're out late having having dinner and after dinner events. So it's a very tiring event, and that's why I have a love hate relationship with it. I always come back exhausted because I have burnt the candle at both ends, but it's always worth it. I always come back with with, you know, a huge amount of new information, new people met old people reconnected with so it's actually a fantastic event. It's just really tiring.

Pharmaceutical Technology® spoke with Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences Company, ahead of CPHI Frankfurt 2025 to find out what makes an end-to-end service provider beneficial to sponsor companies and how digital technologies are changing the industry.

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