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Ask the Expert

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Behind the Headlines Episode 28

How AI, Machine Learning, and Large Language Models Enhance Bioanalysis

Artificial intelligence (AI), machine learning (ML), and large language models are tools that are seeing increasing use in a variety of pharmaceutical development and manufacturing areas. 

® spoke with Long Yuan, PhD, director, Department of Drug Metabolism and Pharmacokinetics, 

, to find out more about how these technologies can enhance 

“There is significantly increased interest and a great potential for AI to make a significant impact on various aspects of bioanalysis, including improving the quality, efficiency, compliance, and also reducing human errors,” Dr. Yuan says.

He believes these tools can be utilized to enhance bioanalytical method development, such as using AI to predict optimal conditions for bioanalytical assays. “This will be especially useful for assays that require significant method development, like the kind of trial-and-error type of method development, for example, for nick and binding assays, the optimization of capture and detection regions conditions,” he says.

He also points to the benefit of using AI in data processing and interpretation. “For example, AI can help to do the automated peak detection integration, calculate and generate the concentration data, and even integrate with the downstream report generation process,” he explains. AI can also be used to create study protocols and validation reports.

The specialized form of ML, large language models, can also be used to enhance the automation of biomedical workflows as well as streamlining and integrating various bioanalytical tasks, according to Dr. Yuan. “For example, we can help streamline and automate the whole biomedical process, including sample preparation, instrument calibration, routine sample analysis, data processing, documentation, and even reporting of the data,” he explains.

Dr. Yuan will be moderating the symposium, “Oligo Bioanalysis, Platforms and Methods” on Wednesday, Nov. 12, 2025 at 9AM in 221 AB at 

, which is being held from November 10–12 in San Antonio.

Long Yuan, PhD, Director and Head of the Bioanalytical group in the Department of Drug Metabolism & Pharmacokinetics at Biogen

Long Yuan, PhD, is currently the Director and Head of the Bioanalytical group in the Department of Drug Metabolism & Pharmacokinetics at Biogen. He leads a group of scientists to provide bioanalytical support for diverse modalities including small molecule drugs, oligonucleotides, biologics and AAV gene therapies, in drug discovery and development. Long received his B.S. in Medicinal Chemistry from Fudan University (Shanghai, China), and his Ph.D. in Medicinal Chemistry from the College of Pharmacy, University of Illinois Chicago (IL, USA). Before joining Biogen, he worked in the Department of Bioanalytical Sciences at Bristol Myers Squibb (NJ, USA). His research focuses on developing bioanalytical methodologies for various molecules, with recent emphasis on oligonucleotides, including ASO, siRNA and antibody-oligonucleotide conjugates. He has published over 50 peer-reviewed papers, including 7 book chapters.

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 Long Yuan. I'm currently the Director and Head of biomedical group in Biogen DNPK, so I'm needing a group of scientists to provide bionic support for different mortalities, including small molecule drugs, oligonucleotides, biologics and AV gene therapies.

PharmTech: How can artificial intelligence and machine learning be used to enhance bioanalysis in bio/pharmaceutical development and manufacturing?

 AI and machine learning is still in a relatively early stage for the application in Bioanalysis. However, I do see there is significantly increased interest and a great potential for AI to make a significant impact on various aspects of biomanac sales, including improving the quality, efficiency, compliance and also reducing human errors. Here are some examples, I think they may be applied first is to enhance bioanalytical method development. For example, AI can predict optimal conditions for bioanalytical assays. This will be especially useful for assays require significant method development like that, kind of trial and error, type of method development, for example, for nick and binding assays, the optimization of capture and detection regions, conditions. The second area is the data processing and interpretation. For example, AI can help to do the automated peak detection integration, calculate and generate the concentration data and even integrate with the downstream report generation process. The other area is like to generate the study protocol, Biennale reports, validation reports to improve the compliance with regulatory.

How can large language models be applied to bioanalytical workflows?

Large language models are a specialized form of machine learning.These large language models, like ChatGPT, can significantly enhance the biomedical workflow by automating, streamlining and integrating various tasks for Bioanalysis. For example, we can help streamline and automate the whole biomedical process, including sample preparation, instrument calibration, routine sample analysis, data processing, documentation and even reporting of the data. It can also help to improve the regulatory compliance the QC, QA, large language models can help review electronic lab load books and audit trails to ensure the compliance with FDA or EMA guidelines. It may also help to connect to the new system or year end systems to pull the data, to prepare the report and draft the SOPs like those type of tasks. One unique features for large language models is it can also serve as it can be also more interactive with human. It's more like a real human. So so energies can interact with large language models to get guidance and assistance on troubleshooting a regular biological workflow, those type of tasks.

Videos

Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, explains how artificial intelligence, machine learning, and large language models are used in performing bioanalysis.

Feliza Mirasol is the science editor for 

PharmSci 360 will spotlight AI advances, gene therapy progress, and leading pharma research insights this year, says programming chair Mei He.

2025 PharmSci 360 to Highlight Next-Gen AI for Drug Development

American Association of Pharmaceutical Scientists

, in San Antonio, Texas, from Nov. 9–12, highlighting cutting-edge innovations shaping the bio/pharmaceutical sector. 

, Chair, 2025 PharmSci 360 Scientific Programming Committee, and associate professor, University of Florida College of Pharmacy, shares an exclusive preview of this year’s agenda and discusses the transformative role of 

 (AI) and advanced technologies in bio/pharmaceutical research with the 

What are the key trends shaping the 2025 annual meeting?

This year’s conference brings together leading researchers to discuss trending topics, including basic research 

, and the clinical-to-translational research pipeline, Dr. He emphasizes. She notes that more than 800 abstracts for posters and over 200 oral presentations have been submitted, reflecting rapid advances in the industry.

A central theme this year is the integration of AI into all aspects of bio/pharmaceutical research. “You will find a lot [of] interesting topics in this year’s annual meeting…we have a lot of spotlights for the scientists to present in [the] meeting,” Dr. He notes.

AI-powered analytics and manufacturing processes are set to take center stage, along with emerging technologies, such as spatial transcriptomics and 

The event will host opening and closing plenary speeches from renowned scientists, fostering high-level discourse on research philosophy, scientific trends, and future directions, she adds. The conference is further expanding engagement with hot-topic sessions and spotlight speakers, encouraging greater inclusivity and participation from top experts. With AI and 

 trends at the forefront, the 2025 meeting offers an essential platform for scientists aiming to stay ahead in bio/pharmaceutical innovation, Dr. He asserts.

Mei He, PhD, Chair, 2025 PharmSci 360 Scientific Programming Committee and Associate Professor, University of Florida College of Pharmacy

Dr. He is a senior member of the National Academy of Inventors, and chair of the American Association of Extracellular Vesicles scientific program. She is also an editorial board advisor for the journals 

 and the Royal Society of Chemistry’s (RSC’s) 

. Dr. He’s research innovation has led to more than 20 pending and issued patents, of which most have been licensed and launched as products on the market by multiple companies. Dr. He received the National Institutes of Health’s Maximizing Investigator’s Research Award and the RSC’s 

Hi everyone. I'm associate professor from the University of Florida, College of Pharmacy, and serve as the chair of the certificate program of the AAPs and especially for this year, AAPs 2025, annual meeting in San Antonio. My research expertise focused on the drug delivery, formulation, the gene therapy and theoretical development, especially, we use the latest modality of the actual cellular vesicles for gene therapy treatment.

This is a great question, and well, this year especially, we have quite a few hot topics in the APS meeting. And every session that we have mainly focused on the six of the same we have the basic research discovery and the formulation drug delivery by analytics and the manufacturing and the clinical size, translational research and with all those different theme and we can see the AI Artificial Intelligence actually plug into the each application very tightly from this year, and they catch up the latest development. And using artificial intelligence, and using the AI approach to develop for each application, and especially their hot topic, is from the translational research session, and also from the formulation drug delivery session, and even in the manufacturing session, we also have the AI plug in to develop the artificial intelligence, and they enhance the manufacturing process. So all those could be very interesting and cutting edge.

This year, we have more than 800 abstract submission and for poster. And we have more than 200 of the submission for the simplest and we also have the hot topics and the rapid fair. And all those sessions are catch up the change in the frontier of the pharma industry and research developments, and especially for the submission trending using the new techniques, and some techniques like artificial intelligence and also the spatial transcriptomics And the gene therapy and AI designed drug so all they use the into therapeutic development, which are the trending right now? So if you want to catch up the frontier of the former development and know what's new of the technology, definitely, you will find a lot interesting topic in this year annual meeting

for today of the top scientists, and we have a lot of spotlights for the scientists to present in APS meeting, and especially for the opening plenary speech, and also for the closing plenary speech, we have those top scientists to present in the to catch up their philosophy and also the research development and also share their experience and the perspectives and during those opening remarks. And we also have hot topics that we are going to develop this hot topics and the spotlight speakers and more and more in the future of the APS annual meeting, which actually have much more engagement of the speakers compared to the past few years. And this also will open the submission for the hot topics and also spotlight speakers, and we want to be more inclusive to accept the more top scientists to be engaged in our meeting.

AAPS PharmSci 360 will spotlight AI advances, gene therapy progress, and leading pharma research insights this year, says programming chair Mei He.

2025 AAPS PharmSci 360 to Highlight Next-Gen AI for Drug Development

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

We conclude our CPHI discussion with Thermo Fisher Scientific.

Jennifer Cannon Interview Part Two

, PhD, president, Commercial Operations, Pharma Services at 

, at CPHI Frankfurt 2025, the discussion shifts from artificial intelligence (AI)—typified by Thermo Fisher’s recently announced strategic collaboration with OpenAI—to the results yielded by the company’s Accelerator Drug Development platform in its first year of offering the formally integrated contract development and manufacturing organization (CDMO), contract research organization (CRO), and clinical supply services.

“We're getting to the point where we've got so much experience in doing it that we want to move more toward an outcome-based contracting, where we commit to a certain timeline that is significantly faster than the fragmented supply chain where customers use different vendors throughout their CMC (chemistry, manufacturing, and controls) and clinical trials and testing,” Cannon says in the interview.

This experience, she says, naturally builds trust between Thermo Fisher and its partners.

“Just speaking about the development in the manufacturing side, there's going to be bumps in the road, through your development, as you're approaching commercialization,” Cannon says. “You want to work with a partner that's going to help you through those bumps in the road.”

Cannon also spoke about the annual experience of CPHI and how it has evolved over the last decade-plus.

“I've been to CPHI for 13 years, and it was always historically very small-molecule modality-based,” she says. “Now we're seeing a lot more customers, of course, coming in with large-molecule and emerging cell and gene therapies.”

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 Jennifer Cannon. I head up the commercial organization for Thermo Fisher’s CDMO, contract manufacturing. We call it the Pharma Services group.

We've actually mapped that out. We continue to lean on the Tufts Center for the Study of Drug Development and Design, and they use our data as well as data that that models out, if we're working with a customer in Phase I or II, they're modeling out, if that molecule continues on, what that benefit will be long-term. And so it's some of their data and our data combined.

For Phase III programs, that's where we see the bigger return on investment, just because the cost of the trial [and] the number of patients involved in the trial is so much more significant. And so the cost and time savings benefit[s are] that much more significant. We're seeing between a 20- [and] 100-fold return on investment. The net present value of these are quite significant. We're getting to the point where we've got so much experience in doing it that we want to move more toward an outcome-based contracting, where we commit to a certain timeline that is significantly faster than the fragmented supply chain where customers use different vendors throughout their CMC (chemistry, manufacturing, and controls) and clinical trials and testing.

When we make that commitment, we're actually providing a guarantee to performance. Imagine if you're a biotech, you have limited funding, you know then that you can advance your IND (investigational new drug) filing, or you can move to your next Phase II or Phase III that much faster. It's a pretty bold commitment that we're making, but it's because we've got enough of these trials under our belt, both on the CMC and the clinical trial side, that we're ready to introduce this in 2026.

Just speaking about the development in the manufacturing side, there's going to be bumps in the road, through your development, as you're approaching commercialization. You want to work with a partner that's going to help you through those bumps in the road. And so as we come to CPHI again, we've built really strong relationships. We've managed through some difficult supply chain issues.

For customers that have been working with us for many years, even pre-COVID, so much has to come together to be ready for commercialization. Might be through the process development status, the procurement of materials, the readiness of the line. Being able to have very open and transparent discussions and using data during it, we use [the] MySupply [platform]—that was something we rolled out about a year and a half ago, which we give our customers full access to. Not many CDMOs will do this. MySupply allows a customer to go in and see, did my batch start filling? Is my batch on track for on-time delivery? Is my batch in full? How does the yield look? If there’s a particular—if it's in the red, if a program's not performing as originally planned between the partner and Thermo Fisher, what actions are we doing, which are on a glide path, and how are those actions being implemented to ensure we get back on track? So we believe a lot in data, and we believe in full transparency to our customers.

We also really appreciate and value when our customers come to our sites and work with us and understand the complexity of what we're delivering together.

Thermo Fisher’s Jennifer Cannon reviews the first year of the company’s Accelerator Drug Development suite of services and the overall experience of attending the CPHI conference.

Building Trusted CDMO Relationships: A CPHI Conversation with Thermo Fisher Scientific, Part Two

We conclude our CPHI conversation with Lonza Capsugel.

Frank Romanski Interview Part Two

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

® about the importance of adhering to current good manufacturing practice (cGMP) guidelines in a world in which regulatory shifts and an ongoing push for digitalization are constantly keeping companies on their toes.

“This is really a license to operate in this space,” Romanski says in the interview. “This reduces risk, this manages product recalls. We're ensuring consistent product quality, simplifying regulatory approval processes, and ultimately saving costs and conserving resources in drug manufacturing.”

The move to digital recordkeeping in particular, Romanski says, is in many ways unavoidable for pharmaceutical companies—and it is crucial.

“The world of regulatory and quality has a tendency to be very heavy on the paperwork side of things,” he says. “And if you're not leveraging the digital technologies that we have today, I think it's a missed opportunity.”

Of course, contract development and manufacturing organization (CDMO) partners must align on these standards, making quality even more paramount, according to Romanski.

“Once you get downstream and you start talking about the CDMO sites that we manage, this is something that's, of course, absolutely critical to what we're doing,” he says in the interview. “We really embed quality into every step of our manufacturing processes, all of the interactions that we have with our clients, and with any agencies that they're in.”

My name is Frank Romanski. I head the Strategic Growth and Revenue Management group and am the head of the Global Pharma Solutions business at Lonza Capsugel.

I know that your audience in particular knows the criticality of cGMP manufacturing. This is really a license to operate in this space. This reduces risk, this manages product recalls. We're ensuring consistent product quality, simplifying regulatory approval processes, and ultimately saving costs and conserving resources in drug manufacturing.

For us at Lonza Capsugel, let's talk about two different pieces of this. We of course have the drug product manufacturing facilities, which always operate under the appropriate cGMP. But I want to talk a little bit about the capsule side of the business, the excipient side of business, if you will. Our manufacturing facilities are independently certified for the appropriate cGMP standards, and we do that across our entire network. We have a network of sites that go in all of the major different markets, and we operate each one of them at the appropriate cGMP standards. And we set a global bar so that there's interchangeability and there's robust supply chains that can be brought to our customers.

We also offer to our customers comprehensive regulatory support, compliance support, to help drug developers navigate these pathways all the way from the concept into the clinic, into the commercialization pathway, and we have a very strong track record of commercial drug manufacturing.

One other thing that I think is really important that we're putting a lot of emphasis on is digitalization. The world of regulatory and quality has a tendency to be very heavy on the paperwork side of things. And if you're not leveraging the digital technologies that we have today, I think it's a missed opportunity. So what we have done is we've taken a lot of our paperwork that [is] needed for our clients, with which to interact with regulatory authorities, quality agencies, etc., and we've put that all online in our ACHIEV portal. And this enables people to have a one-stop shop, [you] don't need to call somebody on the phone, you don't need to use a fax machine or some of these technologies that are long outdated. You can get everything online. It's always up to date. You get notifications when things change, etc.

And finally, as we're producing our products and our services, we're always building quality-by-design into those products themselves, and we're leveraging a tremendous amount of technology to make sure that we are consistent always with those highest standards.

When it comes to making drug product, it really starts with a lot of the raw materials that are being used. And something that, of course, at Lonza Capsugel, we can speak very intelligently about is the capsules themselves. In order to make them to the highest standards, we really have to start with the quality of the raw materials. And we work with all of our partners in the supply chain when we're sourcing things like gelatin or HPMC (hydroxypropyl methylcellulose), which are the bedrock of the capsules that we're ultimately producing.

We have really robust quality management systems, and really, we set the bar in terms of industry-leading standards across our network. We're also a founding member of EXCiPACT, which is an independent third party that really sets the standards for excipient manufacturing. And that's something that has been really quite important of late, because as most manufacturers are also manufacturing excipients for different parts of different industries, it's really important that on the pharma side, that we're all following the appropriate cGMPs.

In addition to that, we continue to really focus on the processes that we have. We document everything that's there. And once you get downstream and you start talking about the CDMO sites that we manage, this is something that's, of course, absolutely critical to what we're doing. We really embed quality into every step of our manufacturing processes, all of the interactions that we have with our clients, and with any agencies that they're in.

Frank Romanski of Lonza Capsugel dives into the excipient side of manufacturing and the emerging prevalence of digitalization.

Regulatory, cGMP, and CDMO Challenges: A CPHI Conversation with Lonza Capsugel, Part Two

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

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

In Episode 28, Miroslav Gasparek, Lizzy Lawrence, and Joe Lewis go behind the headlines.

Behind the Headlines Episode 28: Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines bi-weekly episodes examine the ongoing trends, factors and fashions that cause pharmaceutical news to happen. Panelists are a mix of consultants, venture capitalists, scientists, patient advocates, journalists, and editors. Each episode talks about the current headlines of the preceding weeks that are on everyone’s lips but seeks to highlight the more enduring lessons that hide behind these headlines.

In Episode 28, Miroslav Gasparek, CEO and co-founder, Sensible Biotechnologies; Lizzy Lawrence, FDA reporter, STAT; and Joe Lewis, managing director, Deloitte Consulting, focus on an accelerating loss of expertise at FDA’s vaccine center. While 

, the organizational structure is fractious at best (some say unstable), as 

, officially as “resigned,” along with many others. This creates “uncertainty on top of uncertainty,” one of our panelists exclaimed. It is a highly charged moment for the organization but also for all industry stakeholders, including patients.

The same day as recording, as if to emphasize this point, the seemingly certain approval of UniQure’s Huntington disease (HD) candidate AMT-130 suddenly seems unlikely (1). UniQure described the feedback as a "key shift from prior communications," and said the timing of its plan to ask for approval of AMT-130 now looks bleak. Leerink Partners analyst Joseph Schwartz said the news is a "confusing" and "unexpected" twist (2). "QURE has been thoroughly aligned with the FDA over the past year, has breakthrough therapy designation and the data update QURE presented in September was very strong," he said in a note. So, while patients look likely to wait longer for improved therapies, the upshot for Uniqure is a plummeting share price, dropping nearly 50% at close of the stock market day. The HD community has been enthusiastically hopeful about what AMT-130 could mean for HD treatment, with key HD opinion leaders calling these results 'game-changing,'" Schwartz said. "So we expect there could be a rallying effort on that front to support QURE in the coming weeks."

As a discussion point, the panel noted a LinkedIn post from Amedo Vetere, senior group leader, Arena BioWorks, that reads “the obesity wars are getting spicy” (3). Pfizer isn’t just suing Novo Nordisk, they’re going after Metsera too. Breach of contract. Fiduciary duty. Interference. All because Metsera said “thanks, but no thanks” to Pfizer’s $7B and leaned toward Novo’s $9B counteroffer… The science is hot. The business is cutthroat. And in this arena, who gets to treat obesity may depend less on biology…and more on who survives the merger. All the while, Eli Lily raises guidance to $65Billion, on the back of a stronger-than-expected US revenue increase of 45% “driven by Zepbound and Mounjaro, despite a 15% price decline due to a one-time adjustment in Q3 2024. European revenue increased by over 100% in constant currency, bolstered by Mounjaro uptake and a $380 million milestone benefit (4). Revenue for Japan, China, and Rest of World grew 24%, 22%, and 51% respectively, with Mounjaro volume as the primary driver.”

UniQure Plummets 49% On A 'Confusing' And 'Unexpected' Twist For Its Gene Therapy

UniQure’s FDA submission for its Huntington’s disease therapy thrown into question

Lilly Raises 2025 Revenue Guidance to $63–$63.5B with 54% Q3 Growth and Major Pipeline Advances

In Episode 28, Miroslav Gasparek, Sensible; Lizzy Lawrence, STAT; and Joe Lewis, Deloitte, go behind the headlines.

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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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.

We take a look at what was most on the minds of key opinion leaders.

Building Resilience in Pharma: Our Top 10 Questions from CPHI Frankfurt

The COVID-19 pandemic brought light to the global importance of vaccines and ensuring they are manufactured to quality standards for every region in which they are used. 

Vishal Mukund Sonje, Vaccine Manufacturing Lead at the Coalition for Epidemic Preparedness Innovations 

(CEPI), discusses some of the challenges faced for vaccine manufacturers, especially those working hard to get these products to remote regions, including complex regulatory requirements.

PharmTech: How do complex global regulations and legal rules inhibit or help vaccine manufacturing?

 Development and manufacturing regulations for vaccine development are quite stringent. However, these requirements are essential, since it ensures product safety and efficacy. The main regulatory bodies [FDA and European Medicines Agency] enforce rigorous standards from maintaining high quality of vaccines, and this is essential, since vaccines are injected into healthy individuals.

There are also efforts to harmonize regulatory standard across countries, for example, ICH [International Council for Harmonisation] guidance, WHO [World Health Organization] pre-qualification. These guidances ensure that there is streamlined approval and global distribution possible, mainly in the LMIC [low- and middle-income] countries.

Are there specific manufacturing issues pharmaceutical companies should consider when manufacturing a vaccine that will be used globally, especially in areas where the vaccine may be most needed?

Vaccine manufacturing involves complex bioprocessing, and it needs years, if not decades, of experience to develop technical depth and know-how. It also involves significant CapEx [capital expenditure] investment. Apart from that, knowing post-pandemic COVID periods, it is essential [that] each region enables different platforms that can be used in a pandemic situation. The platforms that can be used are mainly categorized into recombinant protein, viral vector, and mRNA [messenger RNA].

Thirdly, manufacturers need to keep in mind [the] overall ecosystem and external environment that could have [a] large impact on the success of manufacturing capabilities, for example, maturity of the regulatory authority, input material, supply chain, cold chain infrastructure, finished goods supply chain. For example, shortage of critical components could be challenging to manage and can have detrimental effects on the planning of manufacturing. These factors are essential for any region or manufacturer to keep in mind before moving into vaccine manufacturing.

For these reasons, there are some advantages for manufacturers in certain regions like global north or Asian economies, like India and China, while it is challenging to set up new facilities in new LMIC regions, such as Africa or [the] Latin American region.

Are manufacturers moving to patient-centered manufacturing for vaccines and creating modular manufacturing centers closer to where the vaccines are specifically needed?

The COVID-19 pandemic underscored the critical role of vaccines and the necessity for stringent manufacturing standards globally. Vaccine manufacturing faces challenges, particularly in remote regions, due to complex regulatory requirements. Harmonization efforts, like ICH guidance and WHO pre-qualification, aim to streamline approvals, especially in LMICs. Vaccine production requires significant expertise, investment, and consideration of external factors like supply chains. While personalized medicine is trending, vaccine manufacturing remains region-focused, with efforts to develop capabilities in LMICs using platforms like viral vector, recombinant protein, and mRNA.

Vishal Mukund Sonje, Vaccine Manufacturing Lead, CEPI, talks about the challenges that arise in the manufacturing of vaccines in various global regions.