Christopher Cole

Doctor technology AI integrates big data analytics with clinical research, enabling precise treatment plans tailored to individual patient needs and genetic profiles | Image Credit: © Suriyo - stock.adobe.com

 by Dineli Ranathunga, PhD, scientist III, Research and Development at Thermo Fisher Scientific, at 

, held Nov 9-12, 2025 in San Antonio, Texas, investigators sought to use in-silico modeling to identify the best formulation approaches for use with poorly soluble drugs in order to support early decision making. Dr. Ranathunga, Thurman Falk, scientist III, Early Development at Thermo Fisher Scientific; Tom Reynolds, PhD, manager, Research and Development at Thermo Fisher Scientific; Nairuti Milan Mehta, scientist II, Research and Development at Thermo Fisher Scientific; Thomas Yonker, VP of Operations at Cerevance; and Sanjay Konagurthu, PhD, senior director, Science and Innovation at Thermo Fisher Scientific conducted the study based on the premise that the pharmaceutical industry faces persistent hurdles in bringing new treatments to market, particularly when dealing with compounds that are difficult to dissolve.

Currently, between 70% and 90% of drug candidates under development are categorized as poorly soluble (1). This widespread issue necessitates the early integration of appropriate formulation technologies into the development pipeline to prevent expensive delays later in the process, according to Dr, Ranathunga and team. Their work demonstrates how integrated predictive modeling can be leveraged to guide these critical, early-stage decisions for poorly soluble drugs, they stated.

The approach utilizes computational tools to rapidly identify optimal solubilization methods. As a case study, the researchers evaluated the poorly soluble compound CVN424. The study began by assessing the chemical structure and physicochemical properties of the compound, using in-house artificial intelligence (AI) and machine learning (ML) models to predict properties when experimental measurements were unavailable. All computational work, including quantum mechanical calculations, molecular dynamics simulations, and statistical modeling, was performed using the Quadrant 2 program.

How can predictive modeling streamline formulation selection?

The initial step in this systematic approach involved applying the Developability Classification System to categorize CVN424 based on its inherent characteristics. A combined framework of AI, ML, and statistical algorithms was then employed to steer the formulation technology choice. This framework analyzed several critical drug characteristics, including lipophilicity (Log P), pKa, melting point, dose, solubility, precipitation kinetics, and thermal stability. The analysis generated recommendations for the most effective solubilization technologies designed to enhance both solubility and bioavailability.

Following the selection of initial technologies, further computational studies focused on identifying appropriate excipients. The selection of suitable excipients is vital, the study team noted, as it reduces the time and expense associated with the typical empirical screening of the vast number of commercially available excipients. High-level quantum mechanical calculations were used to perform a conformational distribution analysis of CVN424. Advanced quantitative structure-activity relationship models, incorporating AI and ML, generated molecular descriptors (such as electrostatic potentials and hydrogen-bond donors/acceptors). These descriptors, combined with molecular interaction energies derived from molecular dynamics simulations, helped analyze drug–excipient interactions. By comparing these analyses against an extensive excipient database, the study predicted suitable polymeric dispersion excipients. Furthermore, molecular dynamics simulations were conducted at varying drug loadings to evaluate how CVN424 dispersed within the excipient matrix and to calculate the maximum feasible drug loading for each promising excipient.

What formulation strategies were recommended and tested?

The results of the predictive modeling provided specific recommendations. For instance, the findings displayed the predicted success likelihood for various formulation technologies across three dose ranges (Table), recognizing that the dose amount significantly impacts the formulation strategy, particularly when exact dosing is still unknown. The study specifically recommended lead excipients and their calculated maximum drug loadings for use in amorphous solid dispersion formulations, such as those created via spray drying. Snapshots from the molecular dynamics simulations visually represented the dispersion behavior of CVN424 within the excipient matrix as a function of drug loading.

Based on these computational predictions, Dr. Ranathunga and team selected spray-dried formulations and nano-milled suspensions for further evaluation. Spray-dried intermediate formulations were manufactured using five polymers—HPMCAS-H, HPMCAS-M, HPMC E3LV, Eudragit L100, and Soluplus—chosen based on the insights from the modeling and initial screening. Nano-milled suspensions of CVN424 were also developed; these suspensions were subsequently isolated using a spray-drying process. The feasibility of the chosen formulations was assessed using such methods as physical characteristics, chemical and physical stability, and 

 performance, including biorelevant two-stage dissolution performance.

This work highlights the utility of an integrated predictive approach in accelerating the formulation process for compounds like CVN424. By identifying suitable excipient candidates and solubilization strategies through computational means, the study efficiently guided the selection of spray-dried and nano-milled formulations for later evaluation. Ultimately, this process minimizes reliance on empirical trial-and-error, demonstrating the clear potential of predictive modeling to accelerate the overall development timeline, according to the poster presentation.

The application of in-silico modeling in drug formulation is akin to using a sophisticated digital blueprint before laying a single brick in construction, the investigators stated. Instead of blindly testing hundreds of materials and combinations, the predictive technology narrows down the most structurally sound options, saving immense amounts of time and resources before physical experimentation even begins.



1. Ranathunga, D; Falk, T; Reynolds, T; Mehta NM; Yonker, T; Konagurthu, S. 

AI/ML Model Informed Early-Stage Drug Development

. AAPS PharmSci 360 Poster Presentation. Nov 12, 2025.

Articles

In-silico modeling is being utilized to address the challenge of poorly soluble drug candidates, which constitute 70-90% of drugs under development. This approach integrates AI, ML, and statistical algorithms to predict optimal solubilization methods, as demonstrated with the compound CVN424. The study employed computational tools to recommend formulation strategies, such as spray-dried and nano-milled formulations, minimizing empirical trial-and-error. This predictive modeling accelerates the drug development process by efficiently identifying suitable excipients and solubilization strategies, ultimately reducing time and resource expenditure.

In a poster presentation at AAPS PharmSci 360, by Dineli Ranathunga, PhD, indicates that AI/ML in-silico modeling can accelerate poorly soluble drug development.

Using AI and Molecular Dynamics to Overcome the Poor Solubility Challenge

AI is transforming pharma R&D, bioanalysis, and manufacturing. The industry faces intense competition (obesity wars) and FDA regulatory instability

PharmTech Weekly News Roundup – Week of November 3, 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.

Two major themes cut across the week’s news: the profound integration of advanced technology, particularly Artificial Intelligence (AI), and the complexity of the modern pharmaceutical business landscape, characterized by intense competition and regulatory uncertainty.

The AAPS PharmSci 360 2025 (AAPS) annual meeting, held Nov 9-12 in San Antonio, 

will center on the transformative role of AI

, highlighting its integration into every facet of bio/pharmaceutical research, including basic discovery, analytics, formulation, and manufacturing. Cutting-edge topics like AI-designed drugs, spatial transcriptomics, and gene therapy progress will also be featured at this essential platform for pharmaceutical innovation.

Ahead of his presentation at AAPS, Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, tells us that 

liquid chromatography–mass spectrometry (LC–MS) is becoming the preferred tool for bioanalysis

 of complex molecules like protein-based biologic drugs and oligonucleotide therapeutics, offering benefits over traditional ligand binding assays. This shift occurs as LC–MS actively addresses past sensitivity challenges and helps mitigate issues related to critical reagents used in immunoassays.

The pharmaceutical landscape is currently defined by significant regulatory uncertainty, stemming from an accelerating loss of expertise and a fractious organizational structure within the FDA’s vaccine center, according to our 

. Intense corporate battles dominate the lucrative obesity drug market, exemplified by major lawsuits and massive revenue guidance increases for key industry players.

, Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, explains that AI, machine learning, and large language models are poised to significantly enhance bioanalysis, promising improvements in quality, efficiency, compliance, and reduced human errors. These technologies are utilized to automate tasks, predict optimal assay conditions for method development, and streamline the entire biomedical workflow, including data processing and report generation.

planned acquisition of Kenvue by Kimberly-Clark for approximately $48.7 billion

, which underscores the convergence of consumer health and pharmaceutical markets. This deal necessitates reviews of supply chain resilience, may influence regulatory risk tolerance due to ongoing Tylenol litigation, and could lead to manufacturing footprint consolidation.

Videos

AI is transforming pharma R&D, bioanalysis, and manufacturing. The industry faces intense competition (obesity wars) and FDA regulatory instability.

Syringe with a needle and various pills on a blue background | Image Credit: © R R/Wirestock Creators - stock.adobe.com

A recent analysis of FDA’s 505(b)(2) regulatory pathway approvals that was presented at AAPS PharmSci 360, held Nov 9-12, 2025 in San Antonio, Texas, provides detailed insight into current trends in pharmaceutical formulation and manufacturing. For a study, Manasa Singirikonda, PhD-candidate, Long Island University, and Ahmed Abu Fayyad, PhD, RPh, examined approval data from 2024–2025 aimed to provide a comprehensive understanding of the characteristics of these reformulated drugs, including their therapeutic targets and the challenges inherent in developing them. Their investigation focused specifically on identifying the approaches used to overcome technical hurdles, such as stability, palatability, and manufacturing consistency, alongside meeting specific pharmacokinetics and bridging requirements. Data from FDA’s public database and corresponding product labels were processed to document relevant attributes, including dosage form, physicochemical properties, and patient-centric considerations like compliance, ease of use, and dosing accuracy.

How are manufacturers utilizing the 505(b)(2) pathway?

The study tracked 69 FDA-approved submissions classified as reformulations of previously approved drugs, which could involve a new dosage form, a new combination, a novel formulation, or a change in manufacturer. The most prevalent category was the Type-3 New Drug Application, which signifies a new dosage form, accounting for 41 submissions. Submissions related to a new formulation or manufacturer (Type-5) followed, totaling 24, while submissions for a new combination (Type-4) made up four approvals, and a single submission was filed for a Type-2 New Active Ingredient.

When reviewing the structure of the resulting products, injectable formulations represented the largest category, at 33.4% of the approvals (see pie chart). Oral dosage forms constituted the majority of the remaining approvals, with oral tablets (20.3%), oral solutions (13.1%), oral suspensions (10.15%), and oral capsules (8.7%) as the most common. The approvals also included various other formats, such as nasal sprays, ophthalmic formulations, oral films, pellets, granules, powders, and intrauterine systems. Furthermore, the approvals reflect an industry focus on high-priority therapeutic areas, with 8.7% of the products indicated for rare (orphan) diseases and 10.1% designated as cancer-related.

What technical challenges are driving pharmaceutical reformulation?

The effort to improve drug performance, enhance patient adherence, and ensure manufacturing reliability is reflected in the technical challenges identified and addressed in these submissions. The primary challenge tackled through these reformulations was related to stability, which was relevant to 26% of the products. Manufacturing consistency, another significant factor, was a challenge that drove 5% of the reformulation efforts.

Addressing patient comfort and ease of use remains a central theme in these new approvals. Taste or palatability was a challenge addressed in 17% of the products. Other patient-centric factors included dosing accuracy or flexibility (12% of products) and ease of use (5%). Furthermore, 10% of the products involved innovation in the device or delivery system. Complex regulatory and technical requirements, such as pharmacokinetics and bridging requirements, also posed challenges, influencing 12% of the reformulations.

To overcome these formulation obstacles, innovative technologies were recorded in the study, including the strategic use of amorphous solid dispersions and prodrug strategies. The overall pattern for 2024–2025 demonstrates the ongoing importance of formulation science in addressing stability issues and enhancing patient comfort. The increasing incorporation of sophisticated delivery systems, particularly lipid- and 3D-printing technologies, suggests promising avenues for future pharmaceutical product development. These developments offer valuable lessons that can inform subsequent candidate formulation and regulatory strategies.

The analysis of FDA's 505(b)(2) regulatory pathway approvals from 2024-2025 reveals significant trends in pharmaceutical reformulation. The study highlights the prevalence of Type-3 New Drug Applications, focusing on new dosage forms, and identifies injectable formulations as the largest category. Key technical challenges include stability, manufacturing consistency, and patient-centric factors like palatability and dosing accuracy. Innovative technologies, such as amorphous solid dispersions and prodrug strategies, are employed to address these challenges. The findings underscore the importance of formulation science and advanced delivery systems in future pharmaceutical development.

Analysis of FDA 505(b)(2) data (2024–2025) shows 69 drug reformulations, with a  focus on enhancing stability and patient comfort, utilizing new dosage forms, and innovative strategies.

New Dosage Forms and Delivery Systems Driving 505(b)(2) Success

Everything to Know About Pharmaceutical Tariffs in 2025

What should industry professionals know about pharmaceutical tariffs?

Pharmaceutical professionals need to recognize that tariffs can drive up operational costs, disrupt supply chains, create drug shortages, and alter global investment decisions (1-21). While these measures aim to boost domestic manufacturing, which is reflected in reports of US domestic manufacturing investment, and the observation that tariffs localize biopharma supply chains, they often introduce immediate and multifaceted challenges for the industry.

How do pharmaceutical tariffs impact supply chains?

Pharmaceutical tariffs raise costs, delay deliveries, and risk shortages, complicating logistics and straining inventories for hospitals and pharmacies. Companies may eventually diversify supply chains and boost domestic production, reflecting industry trends toward supply chain localization, strengthening the domestic API supply chain, and pursuing resilience goals, but immediate effects often mean reduced patient access to medicines (11-14).

Why do pharmaceutical tariffs increase operational costs?

Pharmaceutical tariffs raise operational costs by increasing prices for raw materials, Active Pharmaceutical Ingredients (APIs), and finished drugs through added taxes. The API market is a critical industry topic (15,16). This results in higher production expenses, supply chain disruptions, which directly conflicts with industry goals for resilience, and greater administrative burdens. These increased costs may be passed on to consumers, while smaller companies could face challenges absorbing them, potentially reducing research and development activities or leading to market exit.

How do pharmaceutical tariffs lead to potential drug shortages?

Internationally dependent supply chains are vulnerable to disruptions that can raise drug prices and cause shortages. Western pharma vulnerability stems from market loss to Asia, caused largely by short-sighted offshoring (11,12). The EU’s proposed Critical Medicines Act (CMA) aims to curb supply dependence and shortages (17). Since many generics rely on ingredients like APIs and excipients from China and India, tariffs may drive up their costs (11,14,16-18). If profit margins drop too low, manufacturers might stop producing certain generics, further limiting their availability. The industry emphasizes the need to eliminate all vulnerabilities in ingredient delivery.

How do pharmaceutical tariffs cause shifts in global investment strategies?

Companies are increasingly reshoring manufacturing to domestic markets to avoid tariff costs, leading to significant new investments, particularly in high-margin drug production. This trend is reflected in the observation that tariffs localize biopharma supply chains (8,10,11)) and in reports of US domestic manufacturing investment and efforts such as SK pharmteco strengthening its domestic API supply chain with a new peptide facility (19). In response, firms are also diversifying supply chains, seeking raw materials and APIs from countries unaffected by tariffs, and establishing new regional manufacturing hubs. This supports the key industry trend driving supply chain localization. However, the rising operational costs and market uncertainty from tariffs are squeezing profit margins, often resulting in reduced spending on research and development. Investor confidence has taken a hit as well, leading to more volatile foreign direct investment—U.S. outbound investment is falling, while global firms ramp up domestic presence to maintain market access. Generic drug manufacturers, who are more sensitive to cost fluctuations, may exit or scale back, driving market consolidation. Overall, tariffs are prompting pharmaceutical companies to prioritize resilience and access over cost efficiency, reshaping the global industry landscape, a strategy frequently discussed in the context of achieving supply chain resilience and meeting global sustainability and resilience goals (5,8,11-14).

What strategies can help minimize the impact of pharmaceutical tariffs?

To mitigate the impact of pharmaceutical tariffs, companies should diversify and regionalize supply chains, aligning with the trend toward supply chain localization (5,8,11-14), optimize inventory through strategic stockpiles, and enhance operational efficiency with lean manufacturing. Contract flexibility and vulnerability analysis are key for resilient planning, especially since the industry is focused on the need to eliminate all vulnerabilities in ingredient delivery (20). Financially, firms should review invoice processing and pursue tariff engineering to reduce duty costs, while also considering investments in domestic production for long-term stability (21). Transparent communication with stakeholders and engagement in alternative policies—like subsidies or government purchasing platforms—help address price shifts for customers. Global collaboration and international agreements further strengthen medicine supply security and resilience, which is a core goal in pharma manufacturing, especially concerning API and excipient supply chain resilience (8-11,14,17).



Sullivan S, Grueger J, Sullivan A, Ramsey D. 

The Consequences of Pharmaceutical Tariffs in the United States

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Tariffs & Trade Policy: What to Watch for, Cost Impacts, and Supply Chain Strategies

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How Pharma Can Build Resilient Supply Chains Amid Trade and Tariff Shifts

Tariffs & Trade Policy: Results of a Bio/Pharma Peer Survey

PharmTech Weekly News Roundup — Week of October 20, 2025

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

Drug Digest: Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Supply Chain Challenges and Solutions Outlined in Capgemini Report

US and European Pharma Manufacturing Face Diverging Paths to Resilience

Standardizing Operations to Meet Global Sustainability and Resilience Goals

Excipient Innovation, Safer Solvents, and Supply Chain Resilience

CPHI Frankfurt 2025: The Current API Market

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

Sustainability and Stability in Excipients

SK pharmteco Strengthens Domestic API Supply Chain with New Peptide Facility

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

Pharmaceutical tariffs significantly impact the industry by increasing operational costs, disrupting supply chains, and causing potential drug shortages. These tariffs lead to higher prices for raw materials and finished drugs, complicating logistics and straining inventories. Companies are reshoring manufacturing to avoid tariffs, resulting in new investments and supply chain localization. However, rising costs and market uncertainty can reduce research and development spending. To mitigate these effects, firms should diversify supply chains, optimize inventory, and enhance operational efficiency, while engaging in global collaboration to strengthen medicine supply security.

With pharmaceutical tariffs fundamentally impacting costs, global supply chains, and more, it’s important for industry professionals to understand the basics.

In a three-part interview (view those videos 

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

European Union’s proposed Critical Medicines Act

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

PharmTech: Can you provide an overview of the CMA?

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

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

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

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

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

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

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

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

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

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

What will be the global implications of the Act?

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

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

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

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

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

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

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

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

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

Clearing Hurdles in Sustainability, AI, and CDMO Partnerships

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

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

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

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

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



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

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

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

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

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

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

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

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

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

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

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