Christopher Cole

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.

Articles

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. 

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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.

Videos

J.D. Mowery, President, Bora Pharmaceuticals

In an interview regarding the presentation “Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, panelist J.D. Mowery, president, Bora Pharmaceuticals, offers insights into critical trends shaping the biopharmaceutical industry, drawing on his 25 years in the sector. The discussion focused on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration, but also the operational hurdles, of artificial intelligence (AI), the necessity of establishing global standards for sustainability, and the need to increase trust in outsourcing partnerships.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

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

Talk about your CPHI Frankfurt presentation.

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

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

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

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

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

In this part 1 of a 2-part interview regarding the presentation “Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, panelist J.D. Mowery, president, Bora Pharmaceuticals, offers insights into critical trends shaping the biopharmaceutical industry, drawing on his 25 years of experience in the sector. The discussion focuses on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration of artificial intelligence (AI).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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