Chronic Disease Priorities, Biomarker Breakthroughs, and CGT-RLT Synergies

Behind the Headlines, Episode 22

ICH Q12 and Post-Approval Changes

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Teva Pharmaceuticals manufacturing site. Locally, Teva produces oral solid medicines and packaging. | Image Credit: © jetcityimage - stock.adobe.com

 announced on May 27, 2025 that its investigational anti-interleukin-15 (IL-15) antibody, TEV-53408, has been granted Fast Track status by FDA (1). The treatment is intended for people with celiac disease who are on a gluten-free diet.

Such a diet—which must be kept strictly and lifelong—is currently the only treatment for celiac disease, a chronic, autoimmune disorder that is triggered by gluten and results in a range of mostly gastrointestinal symptoms (1). TEV-53408 is being evaluated at present in a Phase IIa trial in order to assess its safety and efficacy in adults with celiac disease.

Teva’s TEV-53408, an anti-IL-15 monoclonal antibody for celiac disease, has received FDA Fast Track status, supporting faster development and review.

The drug targets IL-15 to help prevent intestinal damage in patients with celiac disease who are already on a strict gluten-free diet.

This news follows Teva’s recent biosimilar launch with 

 and highlights industry momentum around autoimmune and rare disease therapies.

“FDA’s decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease,” said 

 MD, PhD, executive vice president, Global R&D and chief medical officer at Teva, in a company press release (1). “Teva is driven by a commitment to innovation and this latest achievement gets us one step closer to providing promising, innovative treatment options for patients with chronic autoimmune diseases like celiac disease.”

TEV-53408 is a monoclonal antibody intended to inhibit the activity of the cytokine IL-15, in order to prevent intestinal damage and other symptoms associated with celiac disease, which affects approximately 1% of the global population (1).

In April 2025, Teva Pharmaceuticals, the US-based affiliate of Teva Pharmaceutical Industries, made another significant announcement for the company, saying that it was 

 to launch eculizumab-aagh (under the brand name EPYSQLI), a biosimilar referencing eculizumab (brand name Soliris) (2). Eculizumab-aagh was approved by FDA in July 2024 to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as in November 2024 to treat generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive, all difficult-to-treat rare diseases. The biosimilar is being offered at a 30% discount of the Wholesale Acquisition Cost of the reference biologic (2,3).

 this one to a human anti-IL-7Rα antibody, bempikibart (ADX-914) made by Q32 Bio of Waltham, Mass., for the treatment of alopecia areata, a common, autoimmune skin disease characterized by hair loss, often in circular, coin-like patches, on the scalp as well as other areas of the face and body (4,5).

Fast Track status was designed by FDA to facilitate development and expedite review of certain drugs that are being formulated to treat serious conditions, addressing previously unmet medical needs (1).

Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA.

 Press Release. May 27, 2025.
2. Teva Pharmaceutical Industries. 

Teva and Samsung Bioepis Announce Biosimilar EPYSQLI (eculizumab-aagh) Injection Now Available in the United States.

 Press Release. April 7, 2025.
3. Mirasol, F. 

Teva and Samsung Bioepis Launch Biosimilar Eculizumab in US Market.

Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata.

 National Alopecia Areata Foundation | NAAF. 

Articles

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

GSK signage, logo, emblem on the facade, British multinational pharmaceutical and biotechnology company. WARSAW, POLAND - JUNE 3, 2023 | Image Credit: © OlekAdobe - stock.adobe.com

 announced on May 28, 2025, that a Phase III trial (PIVOT-PO)—evaluating the investigational oral treatment tebipenem HBr for complicated urinary tract infections (cUTIs), such as pyelonephritis—will be stopped early for efficacy based on the recommendation of an Independent Data Monitoring Committee (IDMC) (1). The IDMC review did not identify any new safety concerns beyond those identified in previous studies of tebipenem, with diarrhea and headache listed as the two most common adverse events.

The recommendation was based on a planned, interim data analysis of the nearly 1700 patients enrolled in the study (1). GSK said that the trial met the primary endpoint of non-inferiority of tebipenem HBr, compared with intravenous imipenem-cilastatin, in hospitalized adult patients with cUTIs including pyelonephritis.

“We’re proud of today’s positive result for patients diagnosed with cUTI, includingpyelonephritis, where oral treatments are much needed,” 

 chief executive officer of Spero Therapeutics, said in a GSK press release (1). “We look forward to working with GSK on next steps for tebipenem HBr, and would like to thank the patients, investigators, and other clinical staff who have participated in PIVOT-PO trial to reach this advanced stage.”

In the United States, an estimated 2.9 million cases of cUTIs are treated annually (1). The current standard-of-care includes intravenous carbapenem antibiotic treatment; if approved, tebipenem HBr would be the first oral carbapenem antibiotic available in the US.

“Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock,” 

 GSK chief scientific officer, said in the release (1). “Currently many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections, contributing to over $6 billion per year in US healthcare costs. These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home.”

Developments on several other fronts at GSK were presented 

 at the American Thoracic Society International Congress, held in San Francisco from May 16–21, 2025 (2). This group of presentations, GSK said in a preview of the event, largely focused on optimal patient care that facilitates prevention and treatment of diseases such as asthma and chronic obstructive pulmonary disease.

GSK said it plans to work with US regulatory authorities to include the data from the PIVOT-PO trial, up to when it was stopped on the IDMC’s recommendation, later in 2025 (1). Full results are planned to be submitted for presentation at an upcoming scientific congress, and for publication in a peer-reviewed journal, but GSK did not specify in the press release which events or publications were being targeted.

PIVOT-PO Phase III Study for tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee.

GSK Continues to Advance the Future of Respiratory Medicine and Patient Care with New Data at ATS.

Both companies viewed the early end to the PIVOT-PO trial as a positive development, with GSK saying it would work with US regulatory authorities to move the treatment forward in 2025.

GSK, Spero Therapeutics Oral UTI Treatment Trial Stopped Early for Efficacy

A lab technician in protective gear operates a tablet displaying a green checkmark in a high-tech pharmaceutical laboratory. | Image Credit: © greenbutterfly - stock.adobe.com

® Group interfaced with nearly a dozen companies at the annual INTERPHEX conference in New York City on April 1 and 2, 2025, and while one of the overarching topics may have been the tariff policies of United States President Donald Trump’s administration—in which there were new developments during the event—many of the interviewees over those two days were eager to share their businesses’ latest innovations in manufacturing and how those might fit into the industry at large.

Most people interviewed did have at least one eye on what the Trump administration’s decisions might mean in terms of outsourcing, as best expressed by David Loula, global product director at ITT Engineered Valves.

“If you are procuring components [from] or some of your supply chain is based, for example, in China, you’ve seen a recent increase in tariffs on components coming out of China that has a direct impact on our costs, and it’s something that we have to decide as to whether we’re going to pass those costs along to our customer base, or we’re going to eat those costs ourselves,” Loula said. “You don’t always know if the steel components that you’re buying have metals that were sourced in one of the target countries. So that one’s a little trickier to figure out, but we’re working closely with our supply chain to identify which of those items might have direct impact on our cost position.”

Beyond those concerns, however, three main manufacturing themes emerged: safety, sustainability, and the rise of artificial intelligence (AI) and automation.

Joe Bobacher, regional sales manager for OPW Engineered Systems in Hamilton, Ohio, spoke to PharmTech Group about preventing spills in the manufacturing process, which all companies would like to ideally avoid in order to not lose product, but also to prevent anything corrosive from leaking into the environment.

“As safety evolves throughout manufacturing process facilities where you have fluid transfer, spill prevention is very important,” Bobacher said (2). “So, we find that companies are looking to reduce the amount of spills at a site because a lot of facilities and processes have that fluid transfer and the products that we supply.”

One category that has increased in popularity in recent years is single-use equipment, technologies, or entire systems, a trend noted by Todd Andrews, global director of Applications and Business Development for the Biopharma business at CPC.

When it comes to safety, Andrews said single use used to be a “wild wild West” where everyone wanted a customized solution. This was a complex problem, he said, and stressed the supply chain because manufacturers were often stuck making different assemblies for the different demands of their various customers. But these suppliers have since adapted.

“What we’re seeing now is a lot of forward-thinking end users trying to break up—we call it ‘break up the octopus’,” Andrews said. “Instead of this giant tubing assembly, how do you break it up into the common subassemblies? And you almost can treat it like a Lego, where you may have a ‘T’ or a cross and you can basically customize at the point of use, instead of customizing with the OEM [original equipment manufacturer]. And if you’re an OEM supplying this, this adds a lot more efficiency, because now, instead of making lower volumes of multiple part numbers, you can make higher volumes of lower part numbers.”

Pharmaceutical Technology®/Pharmaceutical Technology® Europe/BioPharm International

When referring to this article, please cite it as Lavery, P. Companies Reveal Their Next Moves in Manufacturing. 

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.

Companies Reveal Their Next Moves in Manufacturing

 is senior vice-president and general manager (IDMO Business), Cellares.

3d rendering of Human cell or Embryonic stem cell microscope background. | Image Credit: © Anusorn - stock.adobe.com

Despite the tremendous therapeutic prom­ise of cell and gene therapies (CGTs) for pa­tients globally, the space is at a crossroads. Long-standing issues around patient acces­sibility have contributed to investor pullback, biotech companies shuttering, and even a few life-saving therapies being pulled from markets.

The industry needs to do better to support all pa­tients in need. The biggest obstacle to accessibility has been pharma’s need to effectively reinvent manufacturing for living drugs made from human cells. It has not been possible to develop large-batch man­ufacturing as is done for most other therapeutic mo­dalities, meaning commercial-scale manufacturing has until now been unrealistic. Finally, the industry is beginning to incorporate Industry 4.0 concepts that have worked well for other types of manufac­turing, including automation.

Industry 4.0 is more than just the types of tech­nology that are deployed. Rather, these approaches underscore integration across the end-to-end patient journey. Many biopharmaceutical companies are still thinking about a black box (or several) to swap in for specific manufacturing processes, but that won’t enable the kind of scale most therapies will need to meet total patient demand. Still others are relying on contract development and manufacturing organiza­tions (CDMOs) to enable scale through next-generation end-to-end platforms, which can still be capacity constrained by upstream and downstream processes.

A new model is the integrated development and manufacturing organization (IDMO). As the name implies, this includes fully integrated smart manu­facturing facilities for true end-to-end scale. It relies on flexible manufacturing capabilities without re­quiring changes to hardware, meaning process modifications are entirely managed through software. As a result, technology transfer between smart facilities in any geography is streamlined through the lever­age of platform standards. Combined, these aspects will make it easier to scale cell therapies globally and meet total patient demand.

The tenets of the IDMO concept can be viewed from the top down: manufacturing facilities must be stan­dardized and interconnected, technology within each smart factory must ensure end-to-end integra­tion, and the platform technologies themselves must be robust enough to serve multiple functions.

Execution starts from the bottom up. From its be­ginnings, the biggest choke point in the cell therapy space has been manufacturing, which makes that the first place to start.

Today, commercial cell therapies have progressed toward becoming front-line treatments for certain hematological malignancies, meaning tens of thou­sands of additional patients may soon be eligible for these therapies. However, that number of batches haven’t even been manufactured yet in aggregate. It likely will not be long before cell therapies are also ap­proved in other indications, including autoimmune diseases. Even with heavy investment from pharma companies and the CDMO sector in new facilities and streamlined processes, traditional manufacturing is years away from meeting total patient demand.

Manufacturing at scale requires reducing the footprint, eliminating manual processes, increas­ing throughput, and lowering cost of goods. The most robust approach to address these issues is the deployment of fully closed and automated end-to-end manufacturing platforms. These platforms do not require traditional cleanroom spaces because manual process steps are eliminated through robotic orches­tration of streamlined and fully integrated manufac­turing processes.

“End-to-end” can be misleading. If a therapeutic de­veloper or CDMO has just purchased multiple units with the intent to scale, they will need to develop all new up­stream and downstream systems to match the system’s throughput. Even the best manufacturing system, in isolation, might just mask a bottleneck, rather than fix it.

The IDMO smart factory approach incorporates multiple ancillary technologies to enable the fullvalue proposition of end-to-end automated manu­facturing. That includes designed-for-purpose in­frastructure and facilities, requiring a high degree of engineering expertise.

John Tomtishen is senior vice-president and general manager (IDMO Business), Cellares.

When referring to this article, please cite it as Tomtishen, J. Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck. 

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

CPHI Americas 2025 Interview - Christy Eatmon

As part of its coverage of CPHI Americas 2025, which was held in Philadelphia from May 20–22, 2025, 

® interviewed Christy Eatmon, global subject matter expert for Sterile Drug Products at Thermo Fisher Scientific, about the company’s presence at the event, and some of its latest ventures including the Accelerator Drug Development services that Thermo Fisher rolled out in the fall of 2024.

Also included in the discussion was Thermo Fisher’s contract development and manufacturing organization (CDMO) perspective on world events in 2025 and how they relate to the pharmaceutical industry, particularly higher global tariffs and the emergence of more widely used and available smart technologies such as automation and artificial intelligence (AI).

“I think in the past, CDMOs functioned as ‘just the hands,’ just a manufacturing house. Now we really want to partner with our customers,” Eatmon says in the interview. “We want to be the trusted partner, the team that’s bringing innovation to the market. We have added some aspects of AI to our processes. One of those to know, especially on the drug product side, is that we’ve integrated AI-assisted inspection. This is for large-scale commercial programs right now, but basically, we have a module where we’ve been able to decrease rejects, improving our yields, and then also using very expedited, very fast automated visual inspection—as every serial product, every unit, needs to be inspected, either by person, manually, or automated by a system of cameras.”

Click the video above to watch the full interview.

, where she and other representatives of CDMOs across the industry discuss the changing nature of outsourcing models.

Videos

Christy Eatmon of Thermo Fisher Scientific reviewed her company’s experience at CPHI Americas 2025 and discussed recent industry trends that are driving strategic partnerships.

CPHI Americas 2025: The Evolving Role of the CDMO

Israel Ortíz is vice president and general manager at Accruent.

Digital Transformation Strategies: Modernizing Business Processes, digital transformation strategies with an image of a digital roadmap for organizational change See Less | Image credit: ©Johannes – stock.adobe.com

Pharmaceutical manufacturers, such as Pfizer, Johnson & Johnson, and Novartis, are driving digital transformation to enhance production efficiency and maintain compliance—an essential factor in ensuring product quality, patient safety, and commercial success. However, navigating the evolving pharmaceutical regulatory landscape presents significant challenges, requiring substantial investments in both human and technological resources.

Digital Transformation in Pharmaceutical Manufacturing.

Striking a balance between compliance and innovation can introduce security concerns and operational complexities, particularly as manufacturers become increasingly data driven. As pharmaceutical manufacturers collect and analyze large volumes of sensitive data, such as production metrics and quality control records, ensuring the security and integrity of this information becomes critical. Part of this challenge is also the ability to track readily available, accurate data for presentation to regulatory boards. To address these hurdles, approved work procedures, visible audit trails, and environmental monitoring help prevent quality issues and product loss.

Robust computerized maintenance management systems (CMMS) software provides a centralized system for compliance, asset protection, and operational data. By leveraging such technology, pharmaceutical manufacturers can enhance efficiency, reduce costs, improve quality control, ensure accurate documentation, and strengthen cybersecurity and data integrity.

Navigating a complex regulatory landscape is one of the biggest challenges that pharmaceutical manufacturers face. Regulatory compliance not only safeguards patients and consumers, it also plays a pivotal role in maintaining trust within the industry. However, the constantly evolving nature of global regulations requires organizations to be both vigilant and adaptable, often necessitating substantial investments in human and technological resources.

Pharmaceutical manufacturers must adhere to strict guidelines set by regulatory bodies and codes, such as FDA, the European Medicines Agency (EMA), the US Code of Federal Regulations (CFR), and other international authorities. These regulations are designed to ensure drug safety, efficacy, and quality while maintaining transparency in production and distribution.

Key regulatory frameworks govern electronic records and signatures, requiring pharmaceutical companies to implement strict access controls, audit trails, and validation processes to ensure data integrity. They also provide guidance on computerized systems used in pharmaceutical manufacturing, emphasizing risk management, system validation, and data security. Enforced globally, good manufacturing practices (GMPs) ensure that pharmaceuticals are consistently produced and controlled according to quality standards. Compliance requires meticulous documentation, validated production processes, and stringent hygiene protocols. As regulations continue to evolve, manufacturers must proactively adopt digital tools to streamline compliance efforts. Failure to meet these regulatory requirements can result in costly penalties, production halts, and reputational damage.

In an era of digital transformation, data integrity has become a critical component of regulatory compliance. Regulatory bodies mandate that pharmaceutical manufacturers maintain complete, accurate, and tamper-proof records throughout the product lifecycle. This diligence ensures transparency and accountability in the production process, helping to prevent the loss of millions in products, as well as errors, contamination, or fraudulent activity.

Ultimately, while compliance challenges can be demanding, they also present opportunities for pharmaceutical manufacturers to modernize operations, enhance efficiency, and build greater trust with regulatory authorities. Compliance also presents opportunities—adhering to regulatory standards can drive operational efficiency, reduce costs, enhance quality control, and strengthen cybersecurity measures.

When referring to this article, please cite it as Ortiz, I. Digital Transformation in Pharmaceutical Manufacturing.

 Pharmaceutical Technology®/Pharmaceutical Technology® Europe/BioPharm International

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.


Digital Transformation in Pharmaceutical Manufacturing

An antiviral used to treat hepatitis B and C | Image Credit © luchschenF

 (pharma&) has received a regulatory variation from the UK’s 

Medicines and Healthcare products Regulatory Agency

 (MHRA), authorizing its wholly owned subsidiary, 

 GmbH, as an approved manufacturing site for the API in Pegasys (peginterferon alfa-2a), according to a May 28, 2025 news release from the company (1). This regulatory update marks a significant milestone in stabilizing the long-term supply chain of Pegasys in the United Kingdom and enables the company to begin product replenishment across the region.

Following the MHRA decision, pharma& expects that eligible patients in the UK will begin to see improved access to Pegasys in the coming weeks.

“We are delighted that the MHRA has granted approval for the production of Pegasys API at Loba biotech GmbH. This marks a critical step forward, building on the recent EMA [European Medicines Agency] approval, securing the path forward for Pegasys replenishment across the United Kingdom,” said E

, founder and managing director of pharma& (1).

·MHRA approval of Loba Biotech enables in-house Pegasys API production, reinforcing pharma&'s control over its biologics manufacturing process.

·UK Pegasys supply chain gains long-term stability as pharma& scales bio-manufacturing capacity at its Loba Biotech facility.

·pharma&’s investment in Pegasys API production reflects growing industry focus on supply chain resilience for essential biologic therapies.

Strategic Manufacturing Investment Supports Global Pegasys Continuity

The decision to invest in internal API manufacturing capabilities followed pharma&'s acquisition of Pegasys from F. Hoffmann-La Roche AG in 2021 (2). Roche had announced in 2019 that it would cease global commercialization of the product (1). Since then, pharma& has prioritized uninterrupted patient access to Pegasys, with a particular focus on markets affected by supply shortfalls.

Following the acquisition, pharma& observed a surge in demand for Pegasys, leading the company to invest in bio-manufacturing infrastructure at Loba biotech GmbH. The regulatory approval for this site underscores the company's commitment to securing reliable access to critical therapies.

“Since acquiring Pegasys, pharma& has remained dedicated to maintaining continuous access to this medicine for eligible patients,” Zagler added (1). “The MHRA’s approval, along with our investment in Loba biotech, represents pharma&’s ongoing commitment to preserving the availability of essential medicines and foster their development worldwide to leave no patient behind.”

While supply restoration in the UK and Europe is advancing, pharma& also continues to work closely with regulatory bodies in other regions, including the United States, to support expanded access for eligible patients.

Pegasys mechanism of action and indications

Pegasys is a pegylated type I interferon (IFN), primarily interferon alfa-2a, according to the release (1). Type I interferons—including IFN-α, IFN-β, IFN-ε, IFN-κ, and IFN-ω—are a class of alpha-helical cytokines central to innate and adaptive immune responses, with evolutionary origins tracing back approximately 500 million years. These proteins exert antiviral effects by binding to the interferon-α receptor (IFNAR), composed of IFNAR1 and IFNAR2 subunits.

Pegylation of interferon alfa-2a involves the covalent attachment of a branched polyethylene glycol (PEG) molecule, resulting in the formulation known as Pegasys (1). The 40-kilodalton PEG moiety enhances pharmacokinetics by acting as a protective barrier and extending systemic exposure.

In the UK, Pegasys has been authorized for the treatment of chronic hepatitis B (CHB) in adults and children aged three years and older, as well as chronic hepatitis C (CHC) in adults and children aged five years and older (1). CHC treatment in pediatric patients is approved in combination with ribavirin.

Full safety information and the Summary of Product Characteristics for Pegasys are accessible through the 

pharma& Receives MHRA Approval for Pegasys Manufacturing Site Variation, Adding Loba biotech for API Production and Ensuring a Reliable, Long-term Supply in the UK

Medicines & Healthcare products Regulatory Agency. 

MHRA approves Loba Biotech to manufacture Pegasys API, enabling pharma& to strengthen UK supply and ensure continued access for eligible patients.

pharma& Secures MHRA Approval for Pegasys API Production at Loba Biotech

A doctor in a white lab coat shaking hand showing symbol of medicine innovation, treatment, discovery and healthcare analysis. | Image Credit: © chadchai - stock.adobe.com

 felt by many subject matter experts and key opinion leaders in the bio/pharmaceutical industry as the tariff policies of United States President Donald Trump's administration became a dominant topic of discussion at INTERPHEX 2025, held from April 1–3, 2025 in New York City.

These changes figure to shape what partnerships, and which types of partnerships, companies seek in R&D, manufacturing, commercialization, and other areas of the drug product lifecycle over the next several years.

What follows is a recap of some of those company representatives’ opinions, speculations, and in some cases, even preemptive plans to tackle a landscape that may not yet have definitively changed, but may be constantly shifting sooner rather than later.

Widespread uncertainty over evolving US tariff policies is delaying capital projects and supply chain decisions across the pharmaceutical sector.

Tariff impacts vary widely—US-based firms see supply-side disruptions, while foreign companies fear reduced access to US partnerships and markets.

Policy-driven incentives may accelerate domestic pharmaceutical manufacturing and automation, but progress hinges on clearer long-term guidance.

William Wainwright, business development manager at Iwata Label USA, a division of Japan-based IL Group, 

 many in the industry are feeling—a sense of not quite knowing what might come next.

“It's obviously a very dynamic situation, and it's changing quite daily, sometimes by the hour,” Wainwright said (1). “Definitely, if the tariffs do stick long-term, the business will have to adjust to that. But I think a lot of players in the industry are waiting to see if and how long the tariffs are going to stick around. Because, as we've seen ... they're there, they're not there, the percent is changing. Obviously, all that goes into the calculus.”

Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, 

 a slowdown of sorts in the progress of new projects.

“The biggest impact is the uncertainty, because we are in a capital investment world,” Murphy said (2). “Many companies, it would appear at the moment, are taking a wait-and-see attitude. Many projects are starting to become delayed, maybe pushed back, until it's understood what the environment is.”

A dichotomy emerged in these interviews, between the outlook of those companies based in the US and those that are not. Chris Gooding, general manager at CRL Solutions of Red Wing, Minn., said he 

did not anticipate his business would be significantly impacted

 in the near term, but did say that it does not operate entirely in a vacuum.

“The way that our products are made, as a government contractor, we source everything locally in the US, so for any of our US customers, obviously there's no impact,” Gooding said (3). “As we export and things change, there could be an impact there ... Like everybody else, I'm trying to see how this unfolds, but as of today, everything that we do is sourced through the US suppliers.”

 co-founder and CEO of RheaVita, which is headquartered in Ghent, Belgium. But de Beer’s concern was 

“This is all pretty new for us, as a European company,” de Beer said (4). “It creates some uncertainty for pharmaceutical manufacturing innovation. Some substantial savings are done toward the regulatory authorities, [and the] pharmaceutical industry, they need the regulatory authorities to support their innovation. So hopefully, these savings toward the regulatory bodies are not, let's say, limiting or making innovations slower. And of course, we also strongly hope that these tariffs will not scare American companies to invest in European technologies, which are also very beneficial for American companies.”

 head of Sales for Automation NTH, and David Loula, global product director for ITT Engineered Valves, noted their respective companies’ positions as US-based businesses that rely, or may rely, on foreign equipment, and the relationships they must foster to procure what they need.

“The biggest impact right now is on our ability to price components and lead time for things,” Sarvey said (5). “We do final assembly, and everything is designed and built, here in the States for Automation NTH; we're based in [the] Nashville, Tenn. area. But a lot of the components that we get, whether it be raw materials, aluminum, steel, or even electronic components like sensors or cord sets or even cameras or robots, are coming from overseas. So we have to make sure that we've got language in our proposals to say that although this might be the price right now, and this is the lead time right now, in 30 days that might change. It's been hard to hold on to that price and lead time for a longer period of time. It hasn't affected our design or what we use yet. So right now, it's just a little bit of uncertainty of, how quickly can we come to a solution with one of our customers or clients, and can they make a decision on it? And a lot of times on large capex [capital expenditure] purchases, it's a longer decision period, so the price is just in flux.”

Given the present rise in smart technologies, artificial intelligence, and the like, Sarvey said he is observing an effort to 

“Long-term, we have seen a few companies that are our customers that are reaching out to look at automated manufacturing stateside, where they had been producing the parts overseas,” he said (5).

Loula was already looking specifically at some of the most prominent countries the Trump administration had prioritized setting its sights on, China, Canada, and Mexico, in trying to assess 

how US manufacturers would act going forward.

“There's a lot of puts and takes that are taking place ... If you are procuring components or some of your supply chain is based, for example, today in China, you've seen a recent increase in tariffs on components coming out of China that has a direct impact on our costs, and it's something that we have to decide as to whether we're going to pass those costs along to our customer base or we're going to eat those costs ourselves,” he said (6). “The tariffs that are being applied to Canada and to Mexico and some of the other countries where other metals are being imported has almost more of an indirect implication on cost, because you don't always know if the steel components that you're buying have metals that were sourced in one of the target countries. So that one's a little trickier to figure out, but we're working closely with our supply chain to identify which of those items might have direct impact on our cost position.”

 from higher tariffs imposed by the US, said 

 co-founder and CEO of the biotechnology company Sunflower Therapeutics.

“I think if we think about the impact that it potentially can have on, for example, the biologics industry here, it provides not only an opportunity, but a strong incentive to onshore manufacturing, and potentially to actually do it in a way that, combined with automation, can create kind of the facility of the future,” Love said (7). “That's more of a distributed manufacturing concept, or a micro facility like we're seeing revolutionize the electric vehicle space or new textiles or food production. I think it's time that we think about how this could be a driver for us to do something similar for protein and biologics production.”

Murphy agreed that the policies could indeed lead to a business boom, but worried that progress was being halted as companies formulate responses and action plans that fit their unique needs.

“If the practices are successful in onshoring more manufacturing, then it could eventually be a net gain for our business and additional facilities being constructed,” Murphy said (2). “But at the moment, it just seems that many projects are being held while people are trying to determine what their spending model will look like.”

Similarly, although de Beer had expressed some doubt about the pace of innovation continuing at a robust clip, he said the changing tides don’t mean companies should stop developing themselves and their offerings entirely, or seeking out new and useful partners.

“Today, I would say there is some uncertainty,” de Beer said (4). “But on the other hand, I think we as innovative companies should also try and think on how to deal with that. And I think we should stay positive.”

Sarvey, meanwhile, attempted to put the US government’s intentions for the pharmaceutical industry in perspective.

“The end goal, I'd have to imagine, is to bring that manufacturing back,” Sarvey said (5). “It is a journey. It's a many-year journey. But we are seeing a few signs of opportunities where a company that was manufacturing elsewhere is interested in what a concept for an automation line would look like stateside. So, that's kind of the two ends of the spectrum.”

As alterations in US policies continue, so will pharmaceutical partnerships. However, the full impact of these changes may not be seen by the end of the current Trump term, and could have the potential to outlast it by years or more.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes.

, April 1, 2025.
2. Lavery, P. and Mirasol, F. 

INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing.

, April 2, 2025.
3. Lavery, P. and Haigney, S. 

INTERPHEX 2025: Beta Bags and Sterile Manufacturing.

, April 3, 2025.
4. Lavery, P. and Haigney, S. 

INTERPHEX 2025: Continuous and Controlled Freeze-Drying.

, April 2, 2025.
5. Lavery, P. and Haigney, S. 

INTERPHEX 2025: AI and Automation in Pharma.

, April 2, 2025.
6. Lavery, P. and Mirasol, F. 

INTERPHEX 2025: Innovations in Advanced Sensing Technologies that Answer the Need for Reliable Valve Function.

, April 3, 2025.
7. Lavery, P. and Haigney, S. 

INTERPHEX 2025: Automation for Protein Manufacturing.

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

Geopolitical Shifts Change Nature of Pharma Partnerships

 announced via a news release dated May 21, 2025, that it has signed an agreement to acquire 

., a clinical-stage biotechnology company specializing in therapies for neurodegenerative diseases (1). The acquisition aligns with Sanofi’s strategic emphasis on neurology and is intended to enhance its capabilities in early-stage drug development within this therapeutic area.

Vigil’s lead candidate, VG-3927, is an oral small molecule that acts as a TREM2 agonist. This compound is being prepared for a Phase II clinical trial in Alzheimer’s disease, according to the release (1). TREM2 activation is hypothesized to enhance the neuroprotective functions of microglia by promoting their migration to sites of neural injury, increasing their phagocytic activity, and supporting cell survival and proliferation. These functions are considered critical in mitigating chronic inflammation and debris accumulation in neurodegenerative conditions.

·Sanofi acquires clinical-stage biotech Vigil Neuroscience to expand its neurology drug pipeline focused on neurodegenerative disease therapies.

·VG-3927, Vigil's lead candidate, is a TREM2 agonist targeting microglial function; Sanofi plans to advance it into Phase II trials for Alzheimer’s.

·The deal reflects Sanofi’s strategic use of early investments to secure biotech assets and accelerate central nervous system drug development and manufacturing.

“This acquisition is fully supporting Sanofi’s strategic focus on neurology and on advancing science and leveraging our expertise in immunology to solve areas of critical unmet need,” said 

, head of research and development at Sanofi (1). TREM2 represents a compelling target at the intersection of immune dysregulation and neurodegeneration, particularly in people living with Alzheimer’s because they face devastating cognitive decline with limited treatment options. Vigil’s expertise is complementary to our capabilities in neurology and reinforces our dedication to developing innovative medicines to improve people’s lives. Vigil’s team are a welcome addition, and we look forward to working with them and the patient community.”

The news release notes that Vigil’s research is focused on the role of microglia in central nervous system disorders (1). In neurodegenerative diseases, microglial dysfunction contributes to progressive neuronal damage. Current Alzheimer’s treatments offer limited efficacy and stringent eligibility, underscoring the need for novel therapeutic approaches.

Sanofi’s acquisition follows a strategic $40 million investment made in June 2024, which included the exclusive right of first negotiation for VG-3927 (2). The decision to proceed with the full acquisition reflects Sanofi’s broader strategy of early equity investments to secure potential assets in critical areas of unmet medical need (1).

“We are incredibly proud of the extraordinary and diverse team at Vigil and the progress we have made in developing innovative TREM2-based therapeutics. We look forward to joining forces with Sanofi's team to leverage Sanofi’s resources, broad platform and far-reaching network to fully unlock and accelerate the development of VG-3927 for the potential treatment of Alzheimer’s disease—a devastating disease with significant unmet need,” said 

, president and chief executive officer of Vigil.

, Vigil’s second investigational molecule. The deal is expected to close in the third quarter of 2025 and will not impact Sanofi’s financial guidance for the year.

Sanofi to Acquire Vigil Neuroscience, Inc., Adding a New Investigational Medicine to Treat Alzheimer’s Disease to the Neurology Pipeline

Vigil Neuroscience Announces $40 Million Strategic Investment from Sanofi

Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.

Sanofi to Acquire Vigil Neuroscience to Expand Neurodegenerative Disease Pipeline

Inside Experic: Revolutionizing CDMO & Clinical Packaging Services

Experic is a contract development and manufacturing organization (CDMO) that delivers integrated pharmaceutical solutions across the drug development lifecycle. With specialized expertise in complex formulations, including precision low-dose capsule filling and inhalation therapies, Experic supports clients from early development through global distribution. Its advanced facility and experienced team enable rapid project execution through customized manufacturing, packaging, and clinical supply services. By unifying these capabilities under one roof, Experic streamlines timelines, ensures product integrity, and accelerates time to market for both emerging biotech and large pharmaceutical companies.

Experic’s integrated CDMO capabilities and how they support end-to-end pharmaceutical development and distribution.

The unique technologies and expertise that well positions Experic in complex drug formulation and clinical packaging.

Dave Wood, CEO at Experic, discusses how decades of expertise with advanced technologies helps pharmaceutical and biotech partners bring products to market faster.

Featured Content

Behind the Headlines, Episode 22

ICH Q12 and Post-Approval Changes

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know