Christopher Cole

A look back at the top 10 PharmTech videos of 2025 reveals several overarching themes dominating the pharmaceutical industry landscape, primarily centered on advancing complex therapeutic modalities, navigating stringent regulatory environments, and accelerating development through technological integration. A significant focus across these videos was on specialized medicines, including gene therapies using 

high-concentration biologics formula tion

 for targeted cancer treatment. These advanced therapies necessitate novel manufacturing strategies, 

such as the adoption of the "CGT 2.0" paradigm for cell and gene therapy (CGT)

, which emphasizes flexibility, scalability, automation, and data analytics to overcome bottlenecks and ensure commercial viability.

Crucially, these advancements are underpinned by a strong emphasis on 

regulatory compliance, and digital transformation

. Discussions throughout the year addressed common regulatory hurdles, such as responding effectively to FDA warning letters regarding insufficient Quality Control units, and the complexity of ensuring drug safety by performing rigorous 

. Furthermore, the industry is increasingly leveraging 

artificial intelligence (AI) and machine learning

optimize various workflows, including in silico compound screening, predictive manufacturing controls, and accelerating discovery by generating novel hypotheses

. This dual focus—on cutting-edge biological science and the application of modern data technology—reflects the industry’s push toward faster, safer, and more personalized medicine in 2025.

Let’s take a look back at our top 10 videos of 2025:

1. Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics, Billion Dollar Deals Push Further Consolidation or Collapse, and an Analytics Wish List

Episode 24 of Behind the Headlines investigated the latest trends and factors driving pharmaceutical news, including a round of "mega-deals" fueled by “big Pharma” patent cliffs and the necessity of acquiring diverse technological expertise for manufacturing complex advanced therapy medicinal products. Panel discussions focused on major acquisitions, such as AbbVie's purchase of Bretisilocin and the collaboration between Enlaza Therapeutics and Vertex Pharmaceuticals. Significant time was spent analyzing the $17.5 billion Waters-Becton Dickinson deal, concluding that Becton Dickinson’s recurring revenue and regulatory knowledge in diagnostics and precision medicine were the main attractions.

Advancing Radiopharmaceutical Development

In this interview, Juliana Maynard, PhD, head of Translational Imaging, at Medicines Discovery Catapult (MDC), discusses what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer. Radiopharmaceuticals are a unique class of medicines that incorporate a radioisotope for both diagnosing and treating cancers, known as a "theranostic" approach, Maynard explained. These treatments offer precision by targeting radiation directly to tumors, significantly reducing the radiation dose to the rest of the body compared with traditional cancer therapies, thus sparing healthy tissue and lowering side effects, she noted. However, development faces challenges, including securing a reliable global supply of radioisotopes, complying with high regulatory and quality standards, and managing the logistics of manufacturing products with short half-lives that often require same-day injection.

PharmTech Weekly News Roundup – Week of September 29, 2025

This roundup of all our news from the week ending on Oct 3, 2025, covered pharma news on AI's role in drug development, new FDA/EMA guidance, clinical advances, MFN pricing agreements, and ongoing quality control challenges. The news items discussed included:

FDA Draft Guidance’s Impact on Clinical, CMC Strategies

FDA’s Remibrutinib Approval and the Future of BTK Inhibitors

, looking at clinical trial progress for multiple myeloma and breast cancer, Merck's FDA approval for a subcutaneous formulation of Keytruda, and Pfizer's acquisition of Metsera to enter the weight-loss drug market.

How AI Is Accelerating Pharmaceutical Development

Drug Digest: Patient Preference Drives Solid Dosage Trends

This Drug Digest video features Lonza’s Adi Kaushal summarizing the current market state and emerging trends in oral solid dosage (OSD) formulation. The discussion confirms that patient preference is the driving force behind solid dosage trends. A major theme was how contract development and manufacturing organizations leverage their experience and expert techniques to overcome key challenges for developers, particularly focusing on improving OSD bioavailability.

In the wrap-up of the 2025 Parenteral Drug Association (PDA) Regulatory Conference, Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joined PDA CEO Glenn Wright and Melissa Seymour, Executive Vice President, Global Quality, Eli Lilly and Company to highlight several "hot topics," including quality culture, import alerts, artificial intelligence, and transparency. Wright noted that the topic of complete response letters proved exceptionally popular and required an extended session, underscoring the substantial industry interest in the number and percentage of these letters being issued.

PharmTech Weekly News Roundup – Week of October 6, 2025

This roundup of all our news from the week ending on Oct 10, 2025, covered the pharmaceutical industry’s recent developments and current regulatory landscape. The news items discussed included:

Building in Flexibility and Commercial Viability Early in CGT Scaling

AstraZeneca’s US Expansion Highlights AI, Automation, and Policy Pressure

Collaborating on the Development of Radiopharmaceuticals

Schreiner MediPharm Launching RFID-Embedded Label at CPHI Frankfurt

DemeRx’s Neuroplastogen Candidate Signals New Alcohol Use Disorder Approach

RedHill's $1.8M Middle East Deal Signals Global Demand for Effective H. pylori Treatment

AAPS National Biotechnology Conference 2025: High-Concentration Biologics

The formulation of high-concentration biologics presents significant challenges, despite the growing need for patients to administer these drugs at home using devices like pre-filled syringes or autoinjector cartridges, according to Lun Xin, associate director at WuXi Biologics, in this video interview. Biologic drugs typically require higher dosages than small-molecule drugs, he noted, adding that since the subcutaneous volume limit is approximately two milliliters, developers must concentrate protein therapeutics to several hundred milligrams per mL to deliver the necessary dose.

Ask the Expert: Studies for Extractables and Leachables

In this episode of the Ask the Expert video series, Schniepp talked to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

In this Ask the Expert episode, Schnieep and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit. Schmitt explains that receiving a warning letter means the company's initial response to the observations on Form 483 was considered inadequate or incomplete by FDA. The essential response strategy involves admitting the shortcoming and providing a complete and convincing remediation plan that the authorities will accept.

AAPS National Biotechnology Conference 2025: AAV Vector Production

Noah Kopcho, field application scientist at Gyros Protein Technologies, addresses the challenges involved in the production of Adeno-associated virus (AAV) vectors, which are commonly used in gene therapies. A key difficulty is that AAV often exhibits lower titers compared with other vectors, creating problems for scalability, he says. The workflow for production and purification must maintain strict purity, requiring careful monitoring of several different contaminants.

Articles

The pharmaceutical industry in 2025 is characterized by advancements in complex therapeutic modalities, regulatory navigation, and technological integration. Key areas of focus include gene therapies using AAV vectors, high-concentration biologics, and radiopharmaceuticals for targeted cancer treatment. These therapies demand innovative manufacturing strategies like the "CGT 2.0" paradigm, emphasizing flexibility and automation. Quality systems, regulatory compliance, and digital transformation are crucial, with AI and machine learning optimizing workflows. The industry's dual focus on biological science and data technology aims to deliver faster, safer, and more personalized medicine.

The top 10 PharmTech videos of the year cover advanced therapies, high-concentration biologics, major mergers and acquisitions, AI use, and regulatory challenges.

The Top 10 PharmTech Videos of 2025

2025 Pharma Tariffs and Supply Chain Disruption

The year 2025 was defined by escalating global trade tensions that fundamentally reshaped the pharmaceutical supply chain, forcing major companies to commit billions to domestic manufacturing to avoid crippling import tariffs (Infographic - article continues below).


2025 Tariff Timeline | Image created with NotebookLM

What was the immediate aftershock, and what major investment pledges followed?

The year opened with immediate policy shifts targeting trade partners. On February 1, the 

Trump Administration announced 25% additional tariffs on imports from Canada and Mexico, and a 10% tariff on imports from China

, citing illegal immigration and the flow of drugs like fentanyl as a "national emergency." While the tariffs against Canada and Mexico were paused for 30 days starting February 3 to allow for negotiations, China quickly retaliated with its own tariffs against the US.

The industry immediately voiced concerns about the consequences, fearing that relying on internationally sourced raw materials and critical medications could lead to "surging" prices, supply disruptions, and reduced access to essential treatments. Analyses suggested US exports of key products like vaccines and toxins could face losses in the billions.

In response to the threat of steep tariffs, pharmaceutical companies initiated massive investment commitments aimed at building out domestic capacity. On February 26, global manufacturer 

Eli Lilly and Company announced plans for four new US manufacturing sites

 intended to bolster small-molecule chemical synthesis and extend its global parenteral manufacturing network. This announcement meant Lilly’s total US capital expansion commitments since 2020 exceeded $50 billion. Weeks later, in mid-March, 

Merck offered another sign of accelerating reshoring efforts

 by unveiling a new facility to increase vaccine production capacity.

How did rising uncertainty lead to formal investigations by the US government?

As spring progressed, the administration continued to introduce broader tariffs. 

 included a 25% tax on auto imports, a 20% import tax on China, and 25% tariffs on steel and aluminum. Earlier, on March 26, the Biotechnology Innovation Organization (BIO) released a survey showing that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products, anticipating that European Union (EU) tariffs could lead to surging manufacturing costs and force roughly half of companies to delay regulatory filings.

April brought significant volatility. After President Trump announced a 10% baseline tariff on imported goods—sometimes referred to as "Liberation Day" tariffs—on April 9, reciprocal taxes were levied on various countries, 

only to be followed by a 90-day pause later that same day

, causing temporary stock market disruption.

The threat against the pharmaceutical sector formalized on April 14 when the US Department of Commerce initiated a 

 into imported pharmaceuticals, APIs, and their derivatives. Commerce Secretary Howard Lutnick indicated that a tariff model would soon be implemented for pharmaceuticals to encourage reshoring. This led to a surge of exports from Ireland to the US in February 2025, suggesting the US industry was attempting to stockpile pharmaceuticals.

By July, international trade experts confirmed that "

sectoral tariffs" under Section 232 were proceeding on an accelerated timeline

, with decisions expected as early as August 1. Threats of high rates persisted; President Trump suggested pharmaceuticals could be tariffed at a "

." Experts noted a phased approach might be used, starting with a low tariff and gradually increasing it, reflecting the complexity of the pharmaceutical market and the significant capital investment needed for reshoring.

. In late July, AstraZeneca announced a $50-billion investment, signaling confidence in its ability to domestically produce nearly all its drugs for the US market.

How did the industry adapt to trade threats, and what was the impact of the 100% ultimatum?

Throughout August, the industry demonstrated how it was actively adapting. A survey conducted by 

nearly half of respondents (49.4%) anticipated tariffs would significantly affect their operations or supply chains

. In response, companies prioritized increasing investment in trade compliance (48.3%) and diversifying their supplier base (37.9%), aiming to balance domestic reshoring with supply chain flexibility.

Mid-August brought some clarity to international relations when the White House and the European Union finalized a trade deal that set a 

15% cap on pharmaceutical imports from the EU

However, the most forceful policy move of the year came in late September. On September 25, President Trump announced a new trade policy imposing a 

100% tariff on all imported branded or patented pharmaceutical products

, effective October 1, 2025. Crucially, this tariff could be avoided if a company had initiated the construction of a manufacturing facility within the US. This "invest-or-tariff" ultimatum was supported by regulatory changes, as the FDA had launched its PreCheck initiative on September 3 to streamline the approval process for new manufacturing sites in the US.

 that tariffs were driving up costs for raw materials, APIs, and finished drugs, leading to increased operational expenses and squeezing profit margins, which often resulted in reduced spending on research and development. 

Generic drug manufacturers, in particular, faced acute pressure

 due to thin margins and static reimbursement rates, risking drug shortages if they were forced to exit the US market.

What was the long-term pivot in the pharmaceutical supply chain strategy?

By November, industry analysis confirmed that the primary response to tariffs was the reshoring of manufacturing to domestic markets, leading to new investments and supply chain localization. This trend toward onshoring was generating 

, including improved quality control, reduced miscommunication, and less reiterated work, despite potentially higher initial costs compared to outsourcing to Eastern markets.

Ultimately, the pharmaceutical industry called for stable, predictable trade policies that would eliminate tariffs on critical inputs like APIs and excipients, coupled with robust government support for innovation and R&D. Faced with perpetual policy uncertainty, the industry prioritized resilience and security, viewing diversification, inventory optimization, and enhanced operational efficiency as necessary strategies to strengthen medicine supply security for the future.

Global trade tensions in 2025 significantly impacted the pharmaceutical supply chain, prompting major companies to invest heavily in domestic manufacturing to circumvent import tariffs. The US government imposed tariffs on imports from Canada, Mexico, and China, leading to retaliatory measures and concerns over supply disruptions and increased costs. Pharmaceutical giants like Eli Lilly and Merck announced substantial investments in US facilities. The US Department of Commerce initiated investigations into imported pharmaceuticals, and a 100% tariff on imported branded drugs was introduced, pushing companies to prioritize reshoring and supply chain diversification.

US pharma tariffs in 2025 forced companies to invest billions in reshoring manufacturing, mitigating rising costs, supply chain strain, and R&D delays.

The Year of the Tariff: Pharmaceutical Supply Chain Reimagined in 2025

Top 10 neon blue and yellow light text on empty red brick wall banner. Bright sign of top ten list winners at night. Design template of modern signboard or advertising | Image Credit: © olhakibec - stock.adobe.com

Our top 10 articles for the year track seismic shifts across the pharmaceutical landscape, from high-level trade policy and drug pricing to fundamental regulatory stability and quality control. They highlight policy upheaval, regulatory complexity and quality control, and market disruption in both economics and therapy development. The industry faced intense pressure this year to adjust its global supply chains due to unprecedented tariffs, while simultaneously navigating new government efforts to mandate lower drug prices through most-favored-nation (MFN) deals. Regulatory bodies were defined by internal instability, such as abrupt leadership changes at the FDA, and renewed scrutiny on manufacturing quality (Figure), exemplified by recurring Form 483 citations. Finally, therapeutic innovation continues to accelerate, with massive market growth projected for emerging areas like Metabolic Dysfunction-Associated Steatohepatitis (MASH).

2025 Regulatory Shake-Up | Image created with NotebookLM.


Following is a closer look at each of the top 10 articles.

Competition in MASH Is Heating Up as GLP-1s Gate-Crash the Party

The market for treating MASH, a condition affecting more than 250 million people globally, is experiencing a surge in competition. The MASH market was projected as of Sept 15, 2025 to grow significantly, from $7.9 billion in 2024 to $31.8 billion by 2033. Recent regulatory approvals include Madrigal Pharmaceuticals’ orally active thyroid hormone receptor (THR)-β agonist, Rezdiffra, approved by the FDA in March 2024, and Novo Nordisk’s injectable weight-loss drug, Wegovy (semaglutide, a GLP-1RA), approved by the FDA in August 2025 for MASH patients with moderate to advanced liver fibrosis.

AstraZeneca Is Next to Reach MFN Deal with White House

AstraZeneca became the second of 17 major pharmaceutical companies, following Pfizer, to agree to the most-favored-nation (MFN) pricing protocols put forth by President Donald Trump. Through this agreement, AstraZeneca will offer drugs at reduced, MFN prices to US patients, including Medicaid recipients, via the forthcoming federal platform, TrumpRx.gov, which is expected to launch in 2026. Separately, AstraZeneca announced a $4.5 billion investment in a new US manufacturing facility near Charlottesville, Virginia, which will support enhanced manufacturing capability for a wider range of medicines, including cancer treatments.

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Vinay Prasad, MD, MPH, abruptly departed his role as director of the Center for Biologics Evaluation and Research (CBER) in July 2025, less than three months after his appointment. His brief tenure was characterized by a push for stricter regulatory standards for vaccines and cell and gene therapies, marking a shift from the previous emphasis on regulatory flexibility. Prasad's conservative regulatory decisions, including increased scrutiny of gene therapies for rare diseases and a clash with Sarepta Therapeutics over its product Elevidys, drew significant criticism from industry stakeholders and political commentators. Following his exit, George Tidmarsh, MD, PhD, the new head of the Center for Drug Evaluation and Research (CDER), was appointed as the acting director of CBER. Then, a little over a week later, 

EMA Looks to Include Patient Perspectives in Drug Regulation

The European Medicines Agency, or EMA, published a draft reflection paper in September 2025, which is open for public consultation, encouraging drug developers to collect and use patient experience data throughout a drug’s lifecycle. The paper emphasizes that patient perspectives—such as prioritizing quality of life over certain clinical endpoints—offer "great value" and play a "complementary role" to scientific data in regulatory reviews. The reflection paper provides principles for generating, collecting, and analyzing this data, derived from sources like clinical trials and post-market real-world evidence.

FDA 483 Cites Contamination and Safety Issues at Novo Plant

An FDA inspection conducted between late June and mid-July 2025 resulted in a Form 483 citation for a Novo Nordisk pharmaceutical manufacturing plant in Bloomington, Indiana. The facility, acquired by Novo Nordisk through its purchase of Catalent operations in late 2024, was cited for significant quality concerns, including contamination and unresolved equipment problems. Inspectors documented the presence of “atypical extrinsic particles,” such as human and cat hair in vial stoppers, along with pest infestations in classified areas. Reports indicated recurring complaints of contamination dating back several years, with investigation failures to determine root causes or assess potential impact on upstream batches.

The Impact of Europe’s Decision on the Use of Titanium Dioxide

In August 2025, the European Commission (EC) announced it would continue to allow the use of titanium dioxide (TiO2) in medicinal products. This decision followed a 2021 finding by the European Food Safety Authority that TiO2 was unsafe as a food additive due to genotoxicity concerns. The EC concluded that fully replacing TiO2 in all 91,000 affected drug products is not technically feasible without potentially disrupting global supply chains or slowing investment in new treatments.

Pharma Implications of Paul Offit’s Removal from Vaccine Advisory Committee

Changes in federal vaccine policy under HHS Secretary Robert F. Kennedy Jr. resulted in the abrupt removal of key advisory figures, including pediatrician Paul Offit, from the FDA’s Vaccines and Related Biological Products Advisory Committee in early September 2025. This removal, alongside the firing of all 17 members of the CDC’s Advisory Committee on Immunization Practices, signaled a potential erosion of scientific oversight and created ambiguity around future vaccine candidate assessment, raising concerns among industry stakeholders about regulatory predictability and the potential restriction of vaccine availability.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

Pharmaceutical and medical device companies serving the US market frequently receive FDA Form 483s—inspectional observations—or warning letters following FDA inspections. These inspections, which can be surveillance, for-cause, application-based, or follow-up, often occur overseas due to the extended global supply chain. When inspections result in a Voluntary Action Indicated (VAI) or Official Action Indicated (OAI) classification, the issuance of a 483 or warning letter can cause reputation damage, delay new drug approvals (NDAs), and disrupt business operations until the identified systemic issues are fully resolved.

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

A significant trade policy, announced in September 2025, mandates a 100% tariff on all imported branded or patented pharmaceutical products, effective October 1, 2025. The stated goal is to incentivize domestic production. Crucially, the policy includes a provision: the tariff can be avoided if the company has initiated the construction of a manufacturing facility within the US. This ultimatum has accelerated a trend of major pharmaceutical companies committing vast capital to US infrastructure; for example, AstraZeneca announced a $50 billion commitment, while Johnson & Johnson and Roche committed $55 billion and $50 billion, respectively. This pressure point directly intersects with supply chain security efforts and necessitates strategic re-evaluation of global manufacturing footprints.

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

The FDA published draft guidance in January 2025 providing recommendations for complying with 21 

 ) 211.110, which governs the sampling and testing of in-process materials and drug products for human drugs and biologics. The guidance stresses that robust product and process development are essential for establishing and maintaining control strategies to ensure quality attributes are obtained. Manufacturers must employ a scientific- and risk-based approach to control processes, identify critical quality attributes, and monitor performance throughout the product lifecycle. The document also addresses quality considerations for drugs utilizing advanced manufacturing technologies (AMTs) and references the new Advanced Manufacturing Technologies Designation Program, designed to encourage AMT adoption.

The pharmaceutical industry, as evidenced by these top articles, operates like a complex ecosystem: shifts in the political climate (tariffs and MFN deals) immediately change the manufacturing topography (onshoring investments), while changes in regulatory leadership (FDA exits) ripple through the innovation pipeline (gene therapy oversight). Concurrently, focused competition in disease areas like MASH demonstrates that therapeutic breakthroughs constantly redefine the economic priorities of the industry.

The pharmaceutical industry is undergoing significant transformations, driven by policy changes, regulatory shifts, and market dynamics. Key developments include the expansion of the MASH treatment market, AstraZeneca's MFN pricing agreement, and leadership changes at the FDA affecting biologics oversight. The EMA is incorporating patient perspectives in drug regulation, while FDA inspections highlight ongoing quality control issues. Trade policies are prompting domestic manufacturing investments, and new FDA guidance emphasizes robust quality control in drug production. These changes underscore the industry's adaptability in response to evolving economic, regulatory, and therapeutic landscapes.

Our top 10 articles of 2025 covered pharma tariffs, MFN deals, FDA leadership changes, 483 quality issues, and a soar in MASH competition.

PharmTech’s Top 10 Articles of 2025

Mike Stenberg, LGM Pharma, outlines how GLP-1s, AI, and 505(b)(2) delivery shifts are driving pharmaceutical innovation.

How GLP-1s, Digital Tech, and 505(b)(2) Strategies Are Reshaping the CDMO Landscape

 recently spoke with Mike Stenberg, Vice President – Business Development, LGM Pharma, to get his perspective on trends that shaped pharmaceutical development and manufacturing in 2025 and where things are headed in 2026. In this part 2 of our three-part interview, Stenberg, explores the primary trends reshaping the pharmaceutical industry, specifically focusing on the transformative impact of GLP-1s, the practical integration of AI, and strategic shifts in drug delivery.

Stenberg identifies GLP-1s as a revolutionary force, likening their influence to the NASA moon program, for which innovations eventually spread throughout the entire sector. Beyond the medications themselves, this trend is accelerating the rise of digital health platforms, which allow manufacturers to deliver therapies directly to patients, effectively cutting out the middleman. Furthermore, GLP-1s are pushing boundaries in delivery science; the industry is 

moving toward oral solid doses with enhanced uptake

, transdermal microneedles, and subdermal options to move away from traditional injections, Stenberg adds.

Regarding AI and digital technologies, Stenberg highlights their application within the CDMO space. AI is being leveraged to vet supply chains and identify predictive processes to prevent disruptions, he notes. On the production floor, it facilitates real-time, in-process testing and predictive maintenance to reduce equipment failure. However, full adoption faces hurdles, including the current lack of structured datasets and the slow pace of change within a highly regulated industry that requires updated SOPs and extensive retraining.

To maintain a competitive advantage against patent cliffs and rising generic competition, Stenberg points to the rapid growth of the 505(b)(2) market. This strategy involves repurposing existing APIs for new indications or utilizing specialized delivery methods, such as orally disintegrating tablets or suppositories. This approach allows companies to protect margins and "buy time" while developing new molecular entities. Success in this area requires finding specialized partners with the unique equipment necessary for non-standard formulations. Overall, Stenberg envisions an industry undergoing a fundamental transformation driven by technological integration and creative delivery solutions.



Watch part 1 of the interview with Stenberg here!

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.



That all comes back to us, for example, or for our reality is really in the area of GLP-1s. So we've seen GLP-1s transform the entire industry and certainly what we're doing. That's an obvious answer, right? But when you scratch the surface a little bit, you see some other interesting developments.

One is that rise of digital health platforms. And so now we have the capability, or now there exists the capability, to deliver a therapy directly from the manufacturer or the drug company to the patient and cut out the middleman. That has been wildly popular and adopted quickly by the populace.

We've seen around GLP-1s, even the brands have started to try and do that and put together deals with digital health platforms. Some of those were successful, some of those weren't, but that system has caught on, for its ease and for sufficiency and for the speed associated with it. We don't see that going away.

Of course, GLP-1s have also created innovation in development too. They're an injectable product. People would like to move away from that. So we see this development around oral solid dose, but along with that, you need to enhance the uptake of that API in the GI system. So we see innovation around uptake enhancers being added to the oral solid dosages.

We're seeing emphasis on how we can deliver that drug differently than an oral solid dose or an injection. Can we do it transdermally? Can we do it transdermally using microneedles? Can we inject it subdermally? All of that development is going on right now, and then there's a whole attendant, microsphere of companies who are not making GLP-1s, but they're developing drugs that mitigate some of the effects or the negative effects of GLP-1s, like muscle wasting or nausea. So I think we're gonna look back at the advent of GLP-1s and we are seeing that happening now, and I think it's gonna transform the entire industry.

All the innovation going on in and around GLP-1s and in that space will eventually spread out to the entire pharmaceutical sector. It reminds me of the NASA program, all the innovations that came out of sending man to the moon spread throughout society and around the world as new innovations.

We've heard a lot about AI helping in the drug discovery process and speeding that up, but in our particular industry, the CDMO industry, we're seeing AI being used for things like helping to vet your supply chain and identify potential predictive processes, trying to predict potential supply chain disruptions in the future.

But we also see it down on the production floor as well. It gives us the ability to do real-time, in-process testing as you're manufacturing a product. It gives us the ability to start predicting potential equipment failures or deviations and avoid those, or sharply reduce those kinds of effects.

So we also see it again in the supply chain, helping us identify robust suppliers and potentially identify disruptions to the supply chain and prevent them from happening. So it has a lot of real-world applicability to the CDMO industry. But there are definite barriers to implementation. One of them is AI models rely on large, well-defined, well-structured database sets from which they can learn. Those database sets aren't very pervasive in our industry today. They're quickly being developed, but that takes time to do, and once that's done, there's also a large installed base of existing equipment and existing processes. All of those will need to be changed and updated.

We're a highly regulated industry. You can't just make a change on a turn on a dime. You have to rewrite SOPs, you have to retrain everybody. So it's gonna slow the uptake of, or adoption of, of AI. I don't think it's gonna stop it, but it's definitely gonna slow it.

What we see really exploding is the entry into the 505(b)(2) market, taking an existing API, finding a different indication for it, delivering it by a different route or in a different dosage form. And that, of course creates some interesting challenges. If you are going to take an existing API and use it in a different way, and you're not the original brand, once again, you're back to the supply chain.

You have to source the API, and you have to secure your supply chain, but then the other thing you have to do is come up with a way to different dosage delivery forms. I mean, if the typical delivery form is an oral solid dose or it's an injection, now companies are looking at things like orally disintegrating tablets, for example, or the use of suppositories. In both cases, though, that means, because they're not standard dosage delivery forms, you have to find a partner who has experience in formulating oral disintegrating tablets or formulating suppositories. Once you've figured out how to formulate it, then you have to manufacture it.

The manufacturing of an oral disintegrating tablet is similar, but different in very distinct ways, from manufacturing a tablet. And of course, with a suppository, you need a very specific and unique set of equipment to manufacture suppositories as well. So finding partners who can help you do that is a bit of a challenge, but we're seeing the rise in explosion of the 505(b)(2) market is incredible. And what that does for our clients is it buys them some time as well. They can maintain their margins, they can maintain some of their revenues, and it buys them time to bring their new molecular entities or new APIs to market to develop those.

Videos

Mike Stenberg, LGM Pharma, notes rising FDA audits in China/India and supply chain risks forcing deeper vetting and stock.

Strategies for Building Pharmaceutical Supply Chain Resilience in a Shifting Market

 recently spoke with Mike Stenberg, Vice President – Business Development, LGM Pharma, to get his perspective on trends that shaped pharmaceutical development and manufacturing in 2025 and where things are headed in 2026. In this part 1 of our three-part interview, Stenberg, who brings over 30 years of experience to the CDMO sector, shares his insights on the shifting pharmaceutical landscape. Stenberg identifies two major trends defining the industry in 2025: a significant return to FDA inspections and a pervasive pessimism regarding supply chain resilience.

Stenberg highlights a notable shift in regulatory oversight. While overall FDA inspections remain approximately one-third lower than pre-pandemic levels from 2019, inspections in China and India have returned to or even exceeded those levels. Interestingly, he notes, the continued global reduction is primarily due to fewer inspections occurring within the United States.

A significant portion of the discussion focuses on supply chain uncertainty. Stenberg explains that industry-wide anxiety regarding growth and pricing pressures has created a "self-fulfilling prophecy” in which companies are reacting with caution and reduced investment, naturally leading to the slower growth they fear. To combat these risks, the industry is moving beyond just vetting primary suppliers. Companies are now auditing their entire supply chain, including the providers of key starting materials used in APIs.

To ensure stability, many are adopting strategies such as second and third sourcing and maintaining safety stock. However, Stenberg warns that safety stock ties up essential cash, further limiting a company's ability to invest. Additionally, while there is a growing demand for geographic diversification to move supply chains away from India and China, sourcing APIs from the US or Europe remains difficult and expensive due to limited supply.

Managing a modern pharmaceutical supply chain is like building a house during a storm; it is no longer enough to ensure the primary contractor is reliable; you must now inspect every nail and board from the sub-suppliers to ensure the entire structure remains standing.


I have been in the CDMO industry for the last 30 plus years. I've worked for a variety of different CDMOs in the industry, worked with some discovery CDMOs, as well as finished product CDMOs. I’ve worked now for LGM for the last three years, and that's been a very exciting ride.

So a couple of major trends. We see so many things going on in 2025. It's been a rather exciting year, if you want to use that word. But we've definitely seen an increase in FDA inspections. You know, when we look back at what the inspection kind of landscape looked like pre-COVID, back in 2019, and we compare that—we're still waiting for results in 2025, but just our own lived experiences—we're seeing a growth or a return to normal in the number of FDA inspections. You would expect that. What's, significant or what's interesting about that is, overall, FDA inspections are still down about a third compared to 2019, but when we look at inspections in countries like China or India, the number of inspections in 2024 are at, or possibly even above what they were in 2019.

So, we still have that third reduction, and where's that reduction coming from? By far the most FDA inspections are occurring in the United States. So the reduction or the still decreased amount of inspections that are occurring are related to the United States. But it's interesting that when we look at China and India, they're at pre-COVID levels, and I expect in [2026] they'll be even higher than pre-COVID levels. So, we see that trend going on in a big way. In our industry we work a lot with India and China, so we're very cognizant of that.

The other thing we see going on is just a pervasive concern about the supply chain and uncertainty surrounding the supply chain. That has led to what we see, what we hear, what we feel is a pessimism around the ability for the industry to grow. It's interesting because in a way, you know, when you're pessimistic about your growth potential and you're worried about the supply chain then in an ever-increasing pressure on decreasing prices, your natural reaction to the industry is to slow down, be more cautious, invest less.

That becomes a self-fulfilling prophecy in that when you do those things, of course you grow slower. So you're concerned about slow growth and the actions you take slow your growth. We're seeing that pessimism and that concern about the supply chain cuts across the entire pharmaceutical industry, and we've noticed it in our business as well.

The supply chain's doing a lot of different things to try and deal with those kinds of things. The number one thing is people are really trying to secure their supply chain. So we see really this increased emphasis on vetting your entire supply chain. It's been pretty common that you would certainly vet your primary supplier.

When we look at APIs, for example, you're always looking into the quality history and trying to detect any potentials for future problems, but that's not enough anymore. Now we are vetting, and people want you to vet, their suppliers, so whatever pressures your primary supplier’s facing in their particular geography is exacerbated by who their suppliers are too.

So in the area of APIs, who's supplying the key starting materials and what are the risks associated with them? The other thing that we see going on in trying to secure supply chains is second sourcing, of course. Now third sourcing. We see people starting to lay in safety stock, which makes a lot of sense.

The safety stock means you carry more inventory, which inventory is equal to cash, so it reduces your ability to grow and invest. It has a whole range of attendant problems associated with that. People are trying to geographically diversify. We are commonly asked, routinely asked, to find and source APIs, but not in India or not in China; really difficult to do. It's possible, you can get some APIs from Europe and you can even get some from the US, but there aren't a plentiful supply of APIs from those sources, and they tend to be more expensive as well.

Frits Stulp, Implement Consulting, says AI and global collaboration are key to addressing patent cliffs and accelerating regulation.

Global Collaboration and Technological Acceleration to Evolve Drug Innovation

 recently spoke with Frits Stulp, Partner Life Sciences, Implement Consulting Group, to get his perspective on trends that shaped pharmaceutical development and manufacturing in 2025 and where things are headed in 2026. In this part 2 of our two-part interview, Stulp highlights that "geopolitics influence" the current pharmaceutical landscape, noting that "ever since COVID, there has been a lot of concern on the supply chain" and an unprecedented "focus on shortage management." He observes that the industry is struggling with the "challenges of patent cliffs" and the reality that "it is difficult to find new blockbusters." As a result, he expects that "M&A activity... will continue" and potentially grow because "considering how difficult it is to find new blockbusters... that level of interest will stay there or even get bigger."

Addressing the "decline of clinical research taking place in Europe," Stulp argues that balancing local and global efforts is vital because "looking across all these different continents is what gives the power to develop the right medicines and to monitor our medicines." He identifies "the application of new technology, like AI" as the primary solution for "addressing patent cliffs and concerns." A key area of interest is the "concept of working together with the regulator in a secure space," specifically through pilots like the PRISM project.

These environments allow for the use of "AI agent-like functions" to "accelerate the regulatory process." Stulp notes that this requires a "cultural change" for scientific authors, shifting from trading comments on documents to a system in which participants "actually work in the same document and we have a common thread that's taking place there." He notes that many current initiatives involve "live products, live variations of those products, and with real regulators." While this evolution may be "scary, maybe even a bit risky for some people," Stulp maintains it is necessary to show "that this can work" because the industry needs to "accelerate."

I think it's a very relevant topic at this time, and I'm afraid that even the geopolitics influence this. There has, of course, ever since COVID, been a lot of concern on the supply chain. And I've never seen as much focus on shortage management as we do today both in Europe and other regions.

At the same time, we see, of course, that this industry has been faced with challenges of patent cliffs. It is difficult to find new blockbusters. And I think we even see how geopolitically some regions are advancing faster or differently. There's a lot going on in the US. There's of course a lot going on in China.

And being a European, I actually see the decline of, for example, clinical research taking place in Europe. So there is both from a governmental point of view, but also from local industry or at least local representation of industry, there's a lot of focus on “How do we balance it out?” Because actually looking across all these different continents is what gives the power to develop the right medicines and to monitor our medicines.

And I think that's something we should really be looking at. I do expect that the application of new technology, like AI, like we said is going to be a key way of addressing patent cliffs and concerns. I think there is a lot of M&A activity and I think that will continue because of course, as economies change opportunities may arise, and considering how difficult it is to find new blockbusters, I think that level of interest will stay there or even get bigger.

And then of course the challenge is “How do I integrate that into my existing company? How do I keep the data, how do I streamline my processes?” And that's actually where I think it gets interesting for me again. “How can we make all of that work?”

Like I mentioned, the concept of working together with the regulator in a secure space, and the pilots that are taking place in that field, many of them coming from the PRISM project in the US but also some of the companies undertaking efforts in that already is extremely interesting in my view.

Working together in a highly secure environment also allows you to start using some of the new tools that are out there. And I think a great example is how can you use AI agent-like functions in an environment that's secure for your data, often very sensitive data, so that you can actually accelerate the regulatory process that you're in?

That accelerated regulatory process is something we also have to get used to because you can already see that the way of working is the way that we have been used to for a long time, and now all of a sudden when we don't share documents with comments to each other, but we actually work in the same document and we have a common thread that's taking place there, that does change the ball game a lot and that does make it exciting as well. And I think that's also asking for a cultural change. For some authors in the scientific field, that may be challenging. But I think that is what I'm really looking forward to, and it will require more pilots. And I'm also happy to say that many of the pilots that I've seen in this space, you can barely call them pilots because they are with live products, live variations of those products, and with real regulators.

And the outcomes are, therefore, also real world to be used. And I think that's exciting, sometimes a bit scary, maybe even a bit risky for some people, but that is the way to show that this can work and we do need to accelerate.