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The company’s branded form of nadofaragene firadenovec-vncg will also be produced at a hub in Parsippany, NJ. 

FDA Approves Additional Manufacturing Plant for Ferring’s Adstiladrin

The deal for the San Diego hub provides the CDMO with its first-ever North American manufacturing location for prefilled syringes and cartridges.

PCI to Purchase Full Stake in Ajinomoto Althea

The new firm—with 13 manufacturing facilities spanning France, Sweden, and Spain—will support the pharma supply chain through to commercialization. 

Meribel Pharma Solutions Joins the CDMO Marketplace

Vendors are growing, and product and service offerings are expanding.

The Hot Market for Cold Chain Services

When delays and disruptions threaten not only product integrity but patient
well-being, thorough risk assessment and mitigation are essential.

Reducing Risk in the Pharmaceutical Cold Chain

Will Moving Drug Production to the United States Help or Hurt Patients?

 CEO of Theratechnologies, explains how Theratechnologies' operations have been impacted by recent US tariffs on Canadian goods, especially concerning the manufacturing and supply chain for its HIV therapy, EGRIFTA SV. The active ingredients used in EGRIFTA SV come from the US, travel to Canada for additional processing, and then return to the US for final assembly. As a result, the company faces tariffs on both the raw materials and parts of the manufacturing process that cross the US-Canada border. While the tariffs will increase costs, the company benefits slightly since the tariffs are applied to raw materials and intermediate steps, rather than the fully finished product, which would have resulted in a higher cost increase.

Theratechnologies is currently assessing the full impact of these tariffs on its supply chain, including effects on insurers, governments, and patients. Despite these challenges, the company remains committed to ensuring timely delivery of its therapies to patients, managing the increased costs as best as possible.

Levesgque also comments on the forecasted obstacles regarding the availability of specialty medicines for US patients; making the decision to reshore manufacturing processes; and much more.

Note: The FDA approved the company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection on March 25. The new formulation will be commercialized under the tradename EGRIFTA WR and is expected to EGRIFTA SV.

What obstacles do you foresee regarding the availability of specialty medicines for US patients—as a result of supply chain challenges—and how can biopharma companies address these issues?

If you're manufacturing, you're really upstream, and you are looking for your first, contract development and manufacturing organization (CDMO). In light of this situation, now, you're going to try to get a CDMO that operates in the US, but if you're currently manufacturing elsewhere, this transition cannot happen on a dime. We're talking about years, we're not talking about months. There won't be any short-term solutions, and unfortunately, tariffs will apply and will will probably have an impact on the value of medicines. There's no other way.

Is the solution 100% to actually use a CDMO in the US? It could be, but again, I'm intrigued by the effect that it's going to have on pricing, and I think it will be a negative for us patients.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, explains what the mindset be for companies who are just starting the reshoring process.

How Pharma Leaders Can Secure Supply Chains 

, Brad Stewart, BDO’s national life sciences co-leader, describes the challenges that tariffs may pose to reshoring manufacturing services in the life sciences industry. He highlights the complexity of supply chains in this sector, which are large, long, highly-regulated, and slow to change. Given that future administrations may alter tariff policies, reshoring decisions need to account for the potential reversal of these changes. While it can be more expensive, prioritizing U.S.-based manufacturing capacity can help de-risk supply chains, particularly as tariffs and uncertainty continue to affect global operations.

Stewart emphasizes that the life sciences industry’s supply chain is not limited to finished products but also includes raw materials and components sourced from different countries. Drug substance production often occurs in one country, with fill-finish processes in another. The unpredictable nature of tariffs on goods at various stages of production further complicates the situation, especially when combined with issues like transfer pricing and taxes. These complexities require companies to develop strategies to better manage these risks.

To address these challenges, Stewart suggests that life sciences companies focus on minimizing risks by moving more of their manufacturing capacity back to the U.S. While this may come at a higher cost, it offers the benefit of stability in the face of changing tariffs and taxes. Stewart notes that building new manufacturing capacity in the U.S. is expensive but advisable for companies planning long-term investments, as it allows them to better manage risks and focus on their core mission of producing life-saving products.

Stewart also comments on the internal constraints that nearly a quarter of life sciences CFOs are reporting as their biggest manufacturing obstacle; how artificial intelligence can help support pharma leaders in managing their supply chains; and much more.

In what ways might tariffs disrupt pharma supply chains, and how can leaders evaluate and prepare for the resulting challenges?

I wish there was an easy answer to that. I think the most honest answer is, nobody knows yet, and it's very challenging, because these—even in the last month or two—have changed in terms of when they were going to happen and what was going to happen. The challenge is the uncertainty, and that's really the most challenging thing in any business, uncertainty about what's going to happen. You can plan. Maybe you'll plan badly, or maybe you'll plan well if you know what's going to happen, but when you're uncertain of what's going to happen, it makes it much tougher.

With the fact that things are so uncertain, here's what people can do. One is that we expect and believe there will be tariffs on some things. Some of those seem to be pretty obvious, most things from China. Let's just ignore pharmaceuticals specifically right now. There are tons of raw materials that we use in the life sciences industry. Even if you're manufacturing in the United States, you still need to purchase equipment supplies. If you're using tubing, reusable, or single-use bags for bioreactors, filters, gloves, a huge number of things that are just routine, everyday purchases for people, whether they're for research and development or manufacturing, they’re coming from China and other countries. Those seem pretty certain that there are tariffs that are going to be implemented and potentially increasing.

I think in those cases, just like any other business, people want to look at their supply chains, they want to try and understand the basics you'd want to anytime. Do I have a reliable supply chain? Do I have a supplier who can provide products to me when I need them with a reasonable timeframe? Do I have the right cost suppliers? So maybe even with a 10% tariff or a 20% tariff, my supplier in China still is a lower cost than buying it domestically or buying it from someone in Europe.

Then three, I think it's good business practice, regardless, to have alternate supply chains. You should have backup suppliers for most of your products. Maybe they're more expensive, maybe you don't need to go to them, but that's just a really good business practice to have backup suppliers, particularly if it's an item which has to be qualified. You might even go through the qualification process to make sure that you can substitute in those suppliers as business conditions change.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, outlines the ways that tariffs disrupt pharma supply chains, along with how leaders can evaluate and prepare for the resulting challenges.

The Impact of Automation on Costs and Variability

, Jason C. Foster, CEO of Ori Biotech, describes how the current state of cell and gene therapies (CGTs) shows promising potential, particularly in curing cancer and rare diseases. These therapies are safe and effective, with evidence demonstrating their curative capability. However, their widespread adoption is hindered by challenges in manufacturing at large scales and at affordable costs, limiting patient access. While three CGT products have advanced from last-line to second-line therapies, the number of patients receiving treatment has remained relatively unchanged, signaling that access, not prescription willingness, is the primary issue.

Only about 10,000 patients were treated with CGTs in 2024, out of a much larger global pool of patients who could benefit, with access in the United States at just 20%, and far lower in other regions. The real obstacle is the inability to produce these living, often personalized therapies at the scale needed for broader distribution. Many existing production processes rely on outdated technology that cannot meet the demand or provide the level of access needed.

This situation creates a vicious cycle: limited access leads to doubts about the commercial viability of these therapies, affecting investment in future innovations. CGTs cost billions to develop, and investors and companies require financial returns to continue funding new therapies. If the therapies cannot reach the market or gain sufficient coverage, the commercial future of CGTs is uncertain, risking investment in this area and potentially diverting capital to other treatment modalities. Overcoming these manufacturing and access barriers is crucial for unlocking the full potential of CGTs and improving patient outcomes globally.

Foster also comments on the manufacturing bottlenecks; regulatory hurdles; role of automation; and economic and healthcare system challenges pertaining to CGTs.

How do you see automation playing a key role in improving efficiency, reducing costs, and ultimately, expanding patient access?

A broad church of automation has quite a lot of differences within it. Some people think the robots are coming to save us. Unfortunately, the robots are not coming to save us. Having a robot arm move one thing from one place to the next adds minimal value in the whole scheme of things. Ultimately, when it comes to automation, people always tend to use a car analogy, the Toyota manufacturing line idea or concept, which is not far off.

Essentially, what you're doing is you're replacing human beings that are highly skilled, very expensive, and that they're not enough of, with machines. And the machines are very good at doing the same thing over and over again in the same way every time, and not introducing variability, which human beings are not very good at. No matter how expert we are, we tend to introduce variability because we're human. What the new generation of automation technologies like Ori’s, which is called the IRO, essentially automates that bottleneck, that core bottleneck we were talking about, which is seven to 10 days of a standard CAR-T manufacturing process. It allows us to do the same thing every time. To sterilely move fluids from one step the next inside the system, the cells stay in optimal cell growth conditions, so you can shorten processes. The way we are able to increase throughput and decrease variability while decreasing cost is decreasing labor. The first cut is that we take about 60% of the people needed out of the process, which is great, because those people are highly skilled and can be doing lots of other high-value things, besides micro pipetting under the hood or tube welding. Those things are not value added.

Let’s get the automation technology to do that, and then the remaining 40% of labor is de-skilled. You have a high school graduate, technician-level person, versus a PhD immunologist, of whom there aren't enough of, so that labor equation shifts dramatically. A lot of the cost savings that I just quoted you—that 50% cost reduction—comes from labor.

The other big bucket where the costs come from, equally, are driven by automation, which is, we're much more efficient at using those very expensive reagents that go into the process. They’re the ingredients, if you will. If CAR-T was like baking a cake, you've got media which feeds the cells. You've got activation reagents, which are very expensive. You've got growth factors, cytokines, which are very expensive, you’ve got viral vector, which is very expensive. Can we use those inputs much more efficiently, so that we can use less of them as an example and therefore drop the costs and still get that same safe and effective product out? We've demonstrated with our automation technology that we're able to use—just as an example—about 116

 of the amount of media. So we use one liter, versus some processes which use 16 liters. Like a perfusion bioreactor, where it's just kind of washing through the system, we can use about 25% of the viral vector. We've demonstrated you can get the same number of CAR-positive cells, so CAR-T cells out of the process, using a viral vector MOI of 0.25 as you would use today in a process, using an MOI of one, so essentially 75% less viral vector. And that in and of itself is a massive cost savings. The ability to drive costs out of the system, have repeatable, reliable, scalable processes that we do the same thing every time, no matter where we are in the world, and how many manufacturing facilities we're working in, is part of the key that automation unlocks, and that's one of the ways in which we envision a future where tens of thousands and then hundreds of thousands of patients get treated every year.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, comments on how he envisions automation in the CAR-T manufacturing space playing a role in improving efficiency, reducing costs, and ultimately, expanding patient access.

Breaking Down Regulatory Challenges in Cell Therapy Production

How are regulatory hurdles impacting the advancement of CGTs, and what changes would you like to see along that front in order to accelerate patient access?

I think on the regulatory side, the regulator has been incredibly supportive of advanced therapies and rethinking the way to conduct business as usual. They've offered to combine Phase I, II, or Phase III together, so that we can get faster through the clinical trial process. As an example, thinking about the ethical concerns around double-blind, placebo-controlled trials in late-stage cancer patients—it’s probably not ethical to put some of them on placebo, so they've been quite forward-looking and forward-thinking.

Recently, the US FDA has put forward something called the Advanced Manufacturing Technology designation, which will allow platforms like Ori’s to essentially put a master file, a dossier, in with the agency. They'll review it, and they'll be aware of the system, which will help speed up the application for companies that are using it, ultimately trying to get those products to patients more quickly. I think the regulator has been very supportive of the industry, and Peter Marks and his team at CBER (Center for Biologics Evaluation and Research) have done a great job in my opinion.

There's a couple things still left to do I would argue, globally and also within the US market. One is this idea of comparability is still kind of a question mark. Not to get too technical, but let's say we put a product in (Product A) and we say, this is how we're going to make it. We're going to make it using these tools and this process, and that's generally what your dossier says. It says it's effective and safe for patients to do it this way. If you want to change something about that process, the perceived bar is very high, so if I'm using a 15-year-old technology but better technology comes out, my ability to switch from one to the other is very difficult, and it's seemingly very high-risk, and the bar is quite high, because we have to show the process is comparable. If we improve it too much, it becomes a different process, and you have to go back and start over—do your critical trial over again—which logically doesn't make any sense, but it's the way the regulatory construct works. This ability to take advantage of new technologies is very difficult, and so we're stuck with these old, decades-old processes with decades-old tools that aren't performing. They aren't delivering enough doses for patients, they aren't delivering cost-effective therapies to the market. I think that transition process, the definition and the understanding of how to transition to a newer process that is better in various ways, and how to smooth that, is a way that the regulator could certainly help us solve that market access problem and scaling up these production processes. That’s one way.

Another way, I would suggest—and this has been debated for years and years—is obviously therapy developers go through essentially the same process to get a drug approved in the US, and then they have to do the same thing in Europe, and then maybe they have to do the same thing in the UK, and then maybe they do the same thing in Australia. But effectively, they're using the same processes. They're looking at the same criteria. Is it safe? Is it effective? What does the clinical data look like? What a gigantic waste of resources and time. You have patients that are literally dying on the waiting list, but having each regulatory authority set slightly different rules—but also with the same end in mind—it just doesn't seem like a good use of all of our time and all of our skills and efforts. Some sort of a mutual recognition, which has been discussed for many years, I think would be quite helpful.

And then the last I would offer up is that circular supply chain we discussed—where your cells might get on an airplane and fly halfway across the world—that kind of logistical complexity will never scale. If you have to transport cells via airplane here, there, and everywhere, it's always going to be expensive, it's always going to be complicated. It's never really going to be super cost-effective, where you could have this as a first- or second-line therapy. We've talked a lot in the industry about distributed manufacturing, so instead of having a centralized facility where all the cells come in from all over the world, you might move those facilities out in kind of a hub-and-spoke model, closer to the patient, closer to the hospital, minimizing logistics time, minimizing complexity, so that we cut vein to vein times for patients. These are very sick people at the end of the day, and they need their therapies quickly. This idea of distributed manufacturing has taken hold in the hearts and minds of the industry, but the how to get it done, what it really looks like, and the how do we sort of think about this from a regulatory perspective hasn't really been clarified.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, discusses how regulatory hurdles are impacting the advancement of CGTs, along with the changes he would like to see along that front in order to accelerate patient access.

Navigating Internal Constraints and Uncertainty 

What are the internal constraints that nearly a quarter of life sciences CFOs are reporting as their biggest manufacturing obstacle, and what other hurdles are they encountering?

So at BDO, we just completed our CFO survey, and part of that was looking specifically at life sciences CFOs. As you said, 24% of them said internal manufacturing constraints were a huge problem that they face. There’re a lot of different challenges hidden there. We think of big companies, like Pfizer, that have huge global footprints of manufacturing, but the reality is, most companies are smaller, don't have internal manufacturing, and may work with a CDMO partner, or scaling to that.

They're still in discovery phase and moving towards clinical phase. Some of those just don't have the capability or capacity for internal manufacturing and wonder how to do that. It’s sort of a confluence of events that make it an incredibly challenging time. The Biosecure Act, which was proposed last year, puts strain on potential Chinese partners to produce biologics for people, and currently, the talk about tariffs and other things have made it very challenging, because people just don't understand what's likely to happen in the future, and so it's very difficult for people to plan and figure out what they're going to do right now.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, outlines the internal constraints that CFOs are reporting as their biggest manufacturing obstacle, along with other hurdles they are encountering.

Overcoming Bottlenecks in Personalized Medicine Manufacturing

What are the primary factors causing manufacturing bottlenecks in this space, and how can the industry overcome them in order to scale up production?

There're really three problems that need to be solved simultaneously, Unfortunately, it's not just one. Throughput is one, so how many doses can we just physically manufacture? There are costs, because obviously high cost of goods often drives high prices to the end payer. The third is quality.

We need to make sure that we're addressing throughput, costs, and quality all at the same time. If you only address one, let's say we can make lots of products, but they still are half a million to $5 million a patient, it’s still going to be difficult to get access. Maybe we can address costs, but if we can only make 10s of products or hundreds of products, we're not going to treat more patients. It's this kind of ability to address all three of those things that’s just truly required. So ultimately, the bottlenecks in the process consists of a couple unique factors. Obviously, we discussed that this is a circular supply chain. It's a personalized medicine that starts with a patient and ends back with that same patient. That's totally unique, because there's nothing we've ever had to face before. When you're stamping out tablets putting them in bottles, and sending them to pharmacies, that's a very kind of well-established and understood supply chain. Similarly, with biologics, we figured that out, but those are generic, not with a capital G, but a little G. They can apply to any patient. That same medicine goes to all the patients, and it's universally applicable. In this case, if you make a product for you, it's no good for me, and that has its own implications, because we have to make sure and get back to that exact patient and there's a lot of steps along the way.

The true bottlenecks today are several-fold, so that circular supply chain is challenging. It's not insurmountable, but it's challenging when you have to harvest the patient cells in one country, freeze them, transport them to an airport, fly them halfway across the world, process them for three, four, or five weeks, freeze them, and fly them back. That kind of logistics increases the complexity and cost, but as we look to the throughput question, how we just get more doses through the system, it's really the part of the process that is the bottleneck. When you're making a CAR-T therapy as an example for you, we would take your patient, your immune cells. We'd freeze them. We'd send them to a manufacturing facility somewhere. We would thaw them. We would choose the cells we want. We'd select them, and then we would wash and concentrate. All of those steps in the upfront that we're preparing the cells, getting them ready, that takes about six hours or so.

The next steps include the activating of the cells to get them ready to grow, the genetic reprogramming. You'll be very familiar with the challenges around viral vector manufacturing and how we actually create a CAR-T cell, in this case, out of a T-cell, which has to do with it, the DNA, the transfer from the viral vector, and then the expansion steps. Upfront took about six hours. That bit takes about 240 hours, so 10 days or so. And if you look at the bottleneck, something that takes 240 hours, clearly is always going to be the bottleneck, if you've got six-hour processes running. So what we need to do—and what the IRO platform that Ori has launched recently intends to do—is address that core bottleneck, those steps that are the longest, the most labor-intensive, and the most expensive. If we address that bottleneck well, which we think we are able to certainly help—and I'll tell you why I think that, and how that works exactly—addressing that bottleneck alone can move us 10x higher throughput. So we get the same footprint, the same clean room, and we can make 10 times the number of doses, while at the same time cutting cost of goods by 50%.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, comments on the primary factors causing manufacturing bottlenecks in the space, along with how the industry can overcome them in order to scale up production.

Unlocking the Potential of Cell and Gene Therapies 

you provide your perspective on the current state of CGTs, along with their potential for transforming medicine?

I think we've demonstrated beyond a doubt, the curative potential. These are safe products, these are effective products, and they offer the opportunity to cure cancer and rare diseases, and that's not really in dispute. I think everyone sort of agrees that that's the case. What's really holding the industry back today—and ultimately impacting access for patients—is that these products just can't be made in large enough quantities and at a cost that can make them widely available. Clinically, we have three products I believe that have moved from last-line therapy, where they started, to second-line therapy, so they moved up several rows or several lines of therapy, showing that they're clinically effective after those earlier patients. But still, the number of patients getting access has basically stayed the same, and that shows us that the constraint isn't actually necessarily prescribing or the willingness of physicians to use the products.

It's more about, how do we make the products available? To your point, in almost all the products that are available only in the US or in some small parts of Europe, all together, there are eight or nine approved cell therapies. I'm going to focus most of my comments on cell therapy—gene’s a little bit different—but both the comments apply to both. Across all of the approved cell therapies, we treated about 10,000 patients last year in 2024 and that is great for those 10,000 patients and their families, but unfortunately, that leaves hundreds of thousands of patients that didn't get treated. The numbers, the statistics you often see include that about 20% of patients in the US are able to get access to these therapies, which isn't a great number; one in five. Ultimately, most of these patients are very sick, and this is their last hope.

If only one in five can get access, clearly those other four out of five are having the worst outcome, which isn't what any of us want. In the rest of the world, it's far fewer than that. The global average is about less than 5% of patients get treated. That’s the current state of affairs. I think the challenge that we face is we're trying to apply lessons from small molecules and biologics to a totally new modality. These are living medicines. They're often personalized for that individual patient. This brings with it a whole host of unique challenges, and the platforms that were developed for regenerative medicine or other types of manufacturing just aren't good enough.

They haven't been able to solve the problem. In a lot of our processes found in currently available products, we're using 10-year-old or 15-year-old technology, which has proven it can't scale and proven it can't actually create the kind of access that we would want for patients. That's the big issue facing patient access today. Because of these challenges, there's kind of this, I don't know what the negative of a positive cycle is. It's the opposite of that, which is unfortunately because these products haven't been able to reach patients in large numbers, there's a question about their commercial viability.

You know very well that it costs $1 billion or $2 billion to develop a cell therapy or a gene therapy. There's a couple billion dollars potentially at risk, so the investors that put that capital up and the companies that spend 10 or more years developing it need to be able to make that money back and make a profit to invest then in the next wave of therapies. Unfortunately, the commercial viability of these products is in question. Can they actually reach the market? Can they actually get market access and get coverage? Will they get prescribed for patients, because if the answer is no to those questions, those early-stage venture capitalists might look elsewhere, in other modalities, for other types of therapies that could be developed, because ultimately, it's a business and it needs to deliver an ROI.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, offers his perspective on the state of CGTs, along with their potential for transforming medicine.

The Case for Reshoring Manufacturing to the United States

How will the tariffs impact the reshoring of manufacturing services?

In four years, we'll have another administration, and maybe this goes the entire opposite direction. These are very challenging things, because our supply chains in the life sciences industry are large, long, highly-regulated, and take long periods of time to change, so changing something that you might change back in a couple of years is difficult.

I think there are some obvious things though. If you have capacity in the US now, does it make sense to prioritize that? Absolutely. That's just like we said in the earlier question, a way to de-risk your supply chain. If you're working with a CDMO or you have internal manufacturing capacity that you can utilize—and maybe it's slightly more expensive—it's probably worth that small additional cost to de-risk it and not have to deal with that uncertainty. It depends on what you're doing. Also, I think one of the things that people don't think about is that it's not just the finished products we worry about. We get raw materials from other countries. We purchase products that we need in the manufacturing process, whether it's for testing or actual manufacturing. One thing people don't think about is our supply chain to actually manufacture these drugs is global. It's not at all uncommon for drug substance to be made in one country and then fill-finish to occur in another country. That's why the uncertainty is frustrating. Because then you're like, okay, where are these tariffs going to be put on? When I'm shipping DS to another country for a fill-finish, or when that fill-finish product comes back, or at every point in that value chain? Then, you layer that on top of transfer pricing and taxes—not tariffs, but the actual taxes that that people are paying on these products. Those are very complex issues that I think companies are going to have to start to work through to try and understand how to best manage that.

What strategies can pharma leaders use in order to start shoring up their supply chains?

The easiest point for most life sciences companies now may be just to minimize risks like that. If I can move some of that capacity back in the United States, look to do more of the work here so that I'm not worried about what the taxes or tariffs or anything else may be going forward, those are just things that allow me to focus on my core business of making products to help save people's lives. I think the other thing—particularly about whether people will start to build new capacity in the United States, which Lily is doing—is that it’s a much more expensive thing to do, but I certainly think it makes sense if anyone's planning on building new capacity to very seriously consider doing that in the United States.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, discusses how the tariffs impact the reshoring of manufacturing services, alongside the strategies that pharma leaders can use in order to start shoring up their supply chains.

The Role of Electronic Labeling in Sustainable Practices

, Laura Johnson, senior director of sales, life sciences, Loftware, discusses how supply chain collaboration is becoming increasingly important, particularly in the life sciences and pharmaceutical sectors. According to Johnson, the adoption of cloud-enabled collaborative supply chains is crucial for improving real-time data sharing. This enhances visibility and coordination among internal stakeholders, external suppliers, co-manufacturers, and co-packers, who all play a role in the complex supply chain process.

This collaboration leads to faster decision-making and reduces operational costs, resulting in greater agility. Pharmaceutical organizations are better able to respond to market changes, regulatory updates, label changes, and potential disruptions. In addition, cloud-based systems facilitate regulatory compliance and advanced analytics, enabling more accurate demand forecasting. These systems also optimize inventory management, which directly contributes to improving patient outcomes and accelerating the time to market for new therapies.

Ultimately, cloud-based collaborative supply chains help streamline operations, reduce costs, and improve the overall efficiency of the pharmaceutical industry, benefiting both companies and patients.

companies are exploring new ways to ensure that their products and shipments are protected, why the demand for supply chain transparency is continuing to gain momentum, and much more.

Are there any other concepts powering the 

 that you’d like to point out, and how will they potentially change in 2026?

The only other thing I think is important to mention is the increasing importance of sustainability, and the fact that sustainability really is starting to reshape the regulatory side and operational landscape for a lot of different businesses across all industries. But there certainly is a lot of pressure for pharmaceutical—as well as medical device companies—to really look at how they're packaging products, and take a very deep look at things like plastics, the packaging itself, and the use of that packaging, meaning, how easy is it to open but yet still being safeguarded, anything having to do with the documentation around packaging and the products, and moving more towards electronic types of access for updated information, which all lead to better sustainability. There's less waste.

Within the topic of sustainability, lots of the large global organizations that we work with have to report to their local agencies that amount of waste every year, and in some countries, areas, and regions, they're taxed on it, so if they can continue to help reduce the amount of discarded materials or minimize the amount of plastics that are being used, it just further supports sustainability.

Back to the report, I think that there were 79% of respondents that said that these stricter regulations and compliance requirements are absolutely pushing their businesses to adopt more sustainable practices. To your question about next year, it's only going to continue, in my opinion. We're really going to need to take a deeper look at that, and information coming out of our solutions could help them with that reporting: how many labels were discarded, how many eIFUs (electronic instructions for use] or electronic materials were used, versus something that was on a printed stock or inserted into the packaging. I think companies are recognizing that the cost-saving potential of sustainable practices and specifically, electronic labeling or enterprise labeling, are going to play a key role in supporting these.

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on other concepts that are powering the company’s 2025 Supply Chain Trends Report, and how they could possibly change in 2026.

Building Confidence in CGT Innovation

, Jenna Dale, direct of client relations at Cencora, shares how pharmaceutical manufacturers are able to handle supply chain disruptions. She explains that while these issues may arise due to political or environmental factors, they aren't new challenges for the industry. Manufacturers have faced similar hurdles before and are accustomed to managing risks that affect production. The key to overcoming these challenges, according to Dale, is having a robust continuity plan in place. Such plans help ensure that manufacturing remains uninterrupted, even when external factors like tariffs create obstacles. By identifying potential risks and preparing for them, manufacturers can continue the development and commercialization of therapies despite external pressures.

Dale also comments on key challenges preventing the United States from meeting the FDA’s forecast of 10 to 20 cell and gene therapy (CGT) approvals per year by 2025, the need for continued investment by the FDA in reviewers and staff to support clinical reviews, and much more.

In your opinion, how important is the development of FDA guidance documents for manufacturers, and what areas of CGT development would benefit most from standardization?

Guidance from the FDA is really critical for these manufacturers. If we think about the cell and gene sector being in its relative infancy, compared to other sectors within the healthcare space, having that guidance from the regulatory agency can help provide clarity and predictability for the manufacturers navigating that early part of their product lifecycle, and can really help them facilitate compliance across the board in their programs.

I think that providing that level of comfort—as well as some guardrails—can help manufacturers feel more confident in the way that they're going about developing and establishing their company around a given asset or portfolio, and it really helps encourage innovation. When we provide some level of structure and framework for these companies, it oftentimes allows them to move more quickly, knowing that they're on the right path, especially for these cell and gene therapies that are complex and could potentially have variability, such as autologous therapies. Having that ability to mitigate risks as much as possible and standardize the processes can really go a long way, not only to ensure safe and effective products as much as possible, but to provide that pathway to success for these manufacturers.

In the fourth part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, explains the value of FDA guidance documents for manufacturers, along with the areas of CGT development that would benefit most from standardization.

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