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The new deal imposes 15% tariffs on most EU exports, including pharmaceuticals.

United States, European Union Reach Trade Pact

Kevin Chinn, vice president and head of the cell & gene therapy service line at Cencora, outlines why early planning, stakeholder engagement, and innovative access strategies are key to long-term CGT success.

How CGT Developers Can Overcome Market Access, Regulatory, and Commercialization Hurdles

Agreement allows educational institutions to access cold chain packaging solutions without the typical request for proposal process, supporting research, lab operations, and healthcare training.

Cold Chain Technologies, E&I Cooperative Services Strike Deal to Provide Schools with Expedited Access to Cold Chain Solutions

These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

Smart Packaging in Pharma: Driving Adherence and Safety Through Digital Innovation

The Craigavon investment enhances Almac’s global clinical supply network with upgraded storage, distribution, and shipping capabilities to meet the growing demand for temperature-sensitive medicines.

Almac Expands Cold Chain Capabilities with Multi-Million-Dollar Investment

Using Data Loggers and Cold Chain Tech to Power Precision Pharma Delivery

, Heather Zenk, Cencora’s president of US supply chain, describes how today's distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want access to advanced therapies close to home, and distributors play a critical role in making that happen.

A major focus in this effort is maintaining product integrity, especially for cold chain items that must be stored between 2–8°C. Innovations in cold chain management now go beyond temperature tracking; they include predictive maintenance of infrastructure such as freezers and compressors. Distributors not only monitor product temperature but also evaluate the performance and potential failure risks of the equipment that manages the cold chain environment.

Zenk emphasizes the importance of marrying manufacturer data with real-time logistics. For example, if a care site accidentally stores a cold chain product outside the optimal range for a short period, data from the manufacturer can often confirm whether the product remains viable. This responsiveness supports safe patient care and reduces waste.

Another important innovation is the use of reusable cold chain totes, which service over 90% of the US market. These require robust freezing systems and operational oversight to ensure readiness and reliability. Zenk underscores that preventing failure, rather than simply reacting to it, is the next frontier in pharmaceutical distribution. By using data-driven insights and predictive engineering, the distribution process becomes more resilient, ensuring that patients can access vital therapies without delay or compromise.

She also comments on the advanced technologies that are proving most effective in enhancing real-time visibility and operational efficiency; strategies organizations should prioritize to ensure compliance while minimizing disruptions for manufacturers and providers as the DSCSA compliance date approaches; lessons learned from recent drug shortages and global disruptions; the practical steps that can be taken in transportation, packaging, and warehousing to meet sustainability goals without compromising reliability or cost-effectiveness; and much more.

What advanced technology or data-driven solutions are proving most effective in enhancing real-time visibility and operational efficiency?

You can use binary data loggers, which might be in a, I'm moving a large quantity, a large quantity from point A to point B. Maybe I'm moving something warehouse to warehouse, so you can have a binary tracker. We use tools like Sensitech. We use data feeds—loggers that are feeding a system so that we can look at from end to end. We also are really tracking with third parties when we're using next-day air freight.

When I'm putting a very sensitive, high-dollar specialty pharmaceutical for an oncolytic or for a retinologist into the airspace, tracking that packaging in near real time with our third party also really matters. We know when it's in the air, when it gets to a hub, when it gets sorted, when it gets on a truck, and that entity in instance, really, the value that Cencora brings, is we're doing all of that in a 12- to 14-hour period of time. From the moment that I'm putting it into a cold chain pack out inside a cold chain refrigerated asset to track that package, all the way through to the site of care getting it, is under an 18-hour window to 24-hour window.

We know our cold chain materials have been qualified, certified, and we're doing all of that high quality work to know that can stay from 2-8°C up to 48 hours, up to 36 hours. We have different conditioning packages that last for different durations so we can meet the need. If I'm going to Guam, for example, we have to go to Guam. There's patients in Guam that we service. We know we need a 48-hour pack out there, so making the right cold chain asset match the service that we need is some blocking and tackling you just have to be able to do in the pharmaceutical supply chain in today's world.

In the second part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

How Predictive Maintenance and Localized Distribution Are Shaping Pharma’s Future

, Heather Zenk, Cencora’s president of supply US supply chain, describes how today's distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want access to advanced therapies close to home, and distributors play a critical role in making that happen.

As pharma products become more complex, how is the distribution strategy evolving to ensure timely, safe, and compliant delivery? Alongside that, what innovations in cold chain technology are setting the standard for ensuring product integrity across these complex distribution networks?

We're sitting between the manufacturers and the sites of care, and we really see ourselves as the connector. I'm connecting access from a manufacturer's new and innovative therapy to a site of care, and that site of care could be an independent pharmacy in a small rural town, all the way to a large academic medical center in a huge urban area, to a physician- based office. We really look at all sites of care, because realistically, all healthcare is local.

You don't go outside of your community to receive care. You like to see your physician at the grocery store. You like to see your pharmacist around town. It provides comfort, it provides the realness of human connection. We really take it seriously that we're connecting new therapeutic ways to the sites of care. And with that, it's how do we make sure their product is viable? With a lot of the sustainability and new products that are coming to market, we need to keep in 2-8°C, which, for the common person, is refrigerated. We also want to make sure that we have a way to track that. The manufacturer would know when they develop it, what the exclusion is, so if it gets to 9°C, how long can it be at 9°C, and still viable if it gets to 1°C?

But realistically, if you keep it in 2-8°C, the expiry date that's on the package would be the therapeutic window that a site of care could deliver it. A lot of what we're doing is trying to connect—as we tend to do every day—the data with the time. If by chance, a site of care would call to say, “oh shoot, I got that cold chain product. It's sitting on my shelf. I didn't notice it. It's probably been about two hours, is it still okay if I give that to my neighbor, my friend, my patient?” Most of the time, we have data from the manufacturer that can say that's viable. It can be out of this window. Then two, we're taking seriously inside our four walls. It’s monitoring the temperature, yes, but it's also monitoring the equipment that manages the temperature. Think of it as, and this is non-sexy stuff for supply chain, but compressors, think of it as HVAC units. Think of it as the entities that are running our freezers that have the basic material that goes into our reusable totes that we use every single day. We have reusable totes that are driving 90-plus-percent of the US market. How do we freeze those? If a freezer’s equipment is going to fail, it's us understanding this compressor is now at 70%, and we should have someone either fix it, look at it, stop it, or understand the risk that we have.

Monitoring temperature is table stakes. You have to be able to do that. It's now how do I anticipate if a piece of equipment is going to fail? Does that piece of equipment need a preventative maintenance check by a maintenance team member? Setting those types of things up as much as we can to eliminate equipment failing or anticipate when it might and take those signals. I don't think I would have thought about doing that as a as a pharmacist, but we all think about our home life. Your refrigerator fails at the worst possible time. How do we stop that? What types of engineering things can we look at to eliminate that? And that's really where we're going—from a tactical positioning—so we don't have large failures. And two, I think it's also connecting manufacturers’ data from how they develop a product, how they get it to finish dosage, where do they take it?

In the first part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

The Evolution of the CGT Launch and Distribution Model

, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been largely resolved, with organizations now demonstrating clear strategies, scalable capacity, and well-vetted supply chains. Regulatory hurdles have also been substantially addressed, and most companies are effectively engaging primary launch sites, especially major academic medical centers, ensuring they are trained and ready for product deployment.

However, several persistent challenges remain. Reimbursement, particularly in Europe, continues to be a major hurdle—even for mature companies with marketed therapies. Another notable issue is physician education, especially outside of large teaching hospitals. Many community-based physicians lack a deep understanding of cell and gene therapies, creating a barrier to broader adoption.

Sawicki also pointed to community care engagementas an area needing attention. While major centers are prepared, regional and community sites are lagging in terms of readiness and support. According to available market data, current therapies are reaching only about 20% of the addressable patient population in the United States and Europe, with even lower uptake globally.

Finally, standardization of processes, particularly across clinical sites and within supply chain systems, remains an issue. Inconsistent procedures and infrastructure gaps at these levels hinder the ability of sites to fully support these complex therapies. Addressing these shortcomings will be critical to expanding access and realizing the full potential of cell and gene therapy worldwide.

Sawicki also comments on how supply chain expectations have shifted amid tighter funding, FDA leadership changes and evolving CMC standards; the critical role of cryopreservation, real-time logistics data and AI-enabled fulfillment in protecting product integrity and patient outcomes; what pharma leaders can borrow from CGT’s operational playbook to improve resilience across therapeutic areas; and much more.

How do you envision the CGT launch and distribution model evolving over the next three to five years, especially as global demand and regulatory complexities increase?

I think most folks, as they're looking to launch, they're learning from the past, as it relates to mistakes that were made. They are looking at standardization upfront. They're looking at cost efficiencies up front. They're looking at trying to harmonize against what is already out there in the field, so that a clinical site doesn't need to bring on a ninth or 10

 different software platform to be able to support their given therapy class.

Scale is another critical consideration. Now that there's a lot of manufacturing infrastructure out there, both from the sponsor as well as the CDMO markets, from a supply chain standpoint, the infrastructure around the temperature-controlled storage, and distribution has greatly improved. Obviously, the volume of equipment for storage and distribution has greatly improved, and the infrastructure around facilities to be able to support all these markets has greatly improved, so what it does is it lowers the barrier to launch. It lowers the barrier from a risk standpoint, because you already have the pioneers in the market that have done it, and it facilitates smoother launches, and then allows them to focus on driving absorption into that addressable market.

I think that's one of the things that you're going to see is a huge focus, because they’ve got all those large academic centers down, and they really understand it. That's really kind of a turnkey element. It's really focused on how do we reach those other 80%, so you're going to see those distribution models really changing to support that community care engagement over time. That means you're going to have novel models where the sites can engage and put infrastructure in at a fraction of the cost that they would have had to traditionally to be able to support cell and gene. You're going to see, a lot better educational paradigms for the physicians to be able to better understand the value of cell and gene in space. You'll see the maturation of the reimbursement models to be able to better support this, as the ROI becomes better understood.

Regulatory wise, there's a pathway. There’s a clear understanding of the regulatory pathway to drive these across most of the primary geographies. I think all of these things make it easier. If you look back from 2017 to 2023, we were averaging one or two approvals a year. We're now up to that five to six approvals a year range. I think that'll maintain over the next couple of years, and I think by 2030, you're probably looking at 10 to 12 a year, so that really changes the game as it relates to acceptance and awareness. That much investment going into this space will also drive cost optimization, and that's the next big element, to drive that cost element down where you're not spending, hundreds of thousands, or millions of dollars on a treatment, but that cost model will come down to probably tens of thousands to hundreds of thousands, which will increase acceptance and availability across the globe.

In the final part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, predicts how he anticipates the model growing over the next three to five years, especially as global demand and regulatory complexities increase.

Leading by Example

What lessons can pharma leaders in traditional therapeutic areas learn from CGT’s highly specialized operational strategies, particularly in terms of supply chain resilience and adaptability?

Well, I think you have to take a step back and look at the broader pharmaceutical market. If you look at the trend in the active therapeutics that are in development, the vast majority of them have shifted into a temperature-controlled format, so biologics have had a huge expansion. You’ve got things like buy specifics, you've got all sorts of new modalities that are coming out, but almost all of them have a temperature-control requirement associated with them. With cell and gene, there's really extreme rigor around the temperature management and product management in the field because it's patient-specific material that's irreplaceable.

A lot of those learnings that have been gained over the last 10 years or so in the cell and gene space—as it relates to risk management, temperature-controlled considerations, qualification and validation of thermal packaging—all of those things are paying benefits back to the broader space today, in particular with reducing scrap rates, reducing risk, and also, the value of decentralized depots, so to speak. Instead of having one large depot that distributes all product out, they're going to more regional formats, which will help them, I think, over time, in expansion of those therapeutic classes into lesser developed areas/emerging markets. I think all of those things will pay benefits over time to the broader market.

In the fourth part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains the lessons pharma leaders in traditional therapeutic areas can learn from CGT’s highly specialized operational strategies, particularly in terms of supply chain resilience and adaptability.

Supply Chain Planning in the Current CGT Climate

How have recent shifts in FDA leadership, funding constraints, and evolving CMC standards impacted supply chain planning for CGT products?

It's really a wait and see. A lot of folks are just taking it slowly to understand any impact. The previous administration was very supportive of cell and gene. The current administration has expressed support, but we obviously have to see that play out, and so I think a lot of folks in the industry are kind of in a wait and see modality right now around that.

From a financing standpoint, there was over $15 billion raised last year in 2024 for cell and gene, which was 30% growth over 2023, which is very positive. There's a potential of 10 EU and 17 US filings, and five to six new therapy approvals this year, representing a record number of approvals last year. That piece continues to be extremely aggressive, and as more of these therapies get into the market, the awareness improves, the visibility improves, the infrastructure improves, the standardization improves, which really ties back into the supply chain planning, and standards—all of those elements, really.

As this becomes more mainstream, there's a lot more impetus to address those issues, and we see a lot of that right now, lots of folks are earnestly looking at standardization, in particular, around supply chain, regulatory, and patient management, which should all have very positive impacts over time.

In the second part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains how recent shifts in FDA leadership, funding constraints, and evolving CMC standards have each played a role in this process.

Preparing for CGT Launches

What are commercialization teams doing well—and where are they falling short—when it comes to preparing for global cell and gene therapy launches?

If you're looking from a clinical to commercial standpoint, if you look at the first launches the channel, they had a lot of challenges early on. They had a manufacturing readiness issue, which has largely been addressed. Most companies, as they go to launch today, have a defined strategy. They have the capacity to be able to support the commercial launch. They've vetted out their supply chain sufficiently, they understand the challenges associated with the supply chain around cell and gene distribution. They also have largely addressed most of the regulatory challenges associated with the cell and gene space, and they typically do a good job in engaging the primary sites—the larger teaching hospitals—and getting them online, trained, and ready to support that commercial launch activity.

The areas that they still are challenged in is reimbursement. Reimbursement is always an issue. In particular, ex-US reimbursement in Europe. Even mature companies with commercial products are still struggling with reimbursement challenges associated with it. There is also physician education outside of the larger teaching hospitals. If you go beyond that, it’s that small subset of physicians that are very comfortable and understand the benefits of cell and gene, and below that, there's an education issue: a large number of physicians that are oncologists and others, especially outside of those large teaching hospitals, just don't have a fundamental understanding of cell and gene, and there's still a challenge.

Community care engagement is still a challenge as well, pushing out into those more regional sites. If you look at the data in the market, they're currently only hitting about 20% of addressable patient population in the US and Europe, with the rest the world much lower than that, and standardization is still an issue in particular. The support mechanism and the supply chain mechanisms—and standardization— is a challenge for them, in particular for the clinical sites to be able to support these products. I would say those are probably the biggest elements today.

In the first part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses both the successes and challenges in commercializing cell and gene therapies.

How Regulatory Mandates Influence Technology

, Kirsten Newquist, Identiv’s CEO, defines “smart pharma packaging” as the integration of technology into pharmaceutical packaging to enhance product identification, tracking, and patient engagement. She explains that packaging primarily involves embedding technologies such as RFID radio-frequency identification (RFID) or Bluetooth low energy (BLE) into pharmaceutical containers. These technologies assign a unique digital ID to each package, enabling serialization, which is critical for tracking and traceability across the global supply chain.

This digital ID allows stakeholders—from manufacturers to pharmacists and patients—to verify a drug’s authenticity at every step of its journey. This significantly reduces the risk of counterfeit drugs entering the system, as products can be authenticated upon delivery or administration. Newquist emphasizes that this kind of smart packaging not only strengthens supply chain security but also fosters better patient engagement, offering real-time data that can support dosage verification and proper usage.

Additionally, she notes a secondary dimension of smart packaging: smart drug delivery systems. These include technologically enhanced devices like auto-injectors, smart pillboxes, or connected syringes, which offer further layers of verification and ensure patients receive the correct medication and dosage. While this may go beyond traditional packaging, it aligns with the broader goals of improving safety, compliance, and confidence in the pharmaceutical supply chain.

Overall, smart pharma packaging plays a crucial role in combating drug counterfeiting by improving transparency and traceability from production to patient use. By embedding intelligence into packaging and delivery systems, the pharmaceutical industry is better equipped to protect product integrity and ensure patient safety in an increasingly complex global supply chain.

Newquist also comments on the role embedded product intelligence plays in maintaining cold chain integrity, and why is this so critical for pharmaceutical safety and efficacy; how regulatory mandates, such as the Drug Supply Chain Security Act (DSCSA), influence the adoption of smarter packaging technologies across the industry; some of the biggest challenges pharmaceutical companies face in implementing this infrastructure, and much more.

How are regulatory mandates, such as the DSCSA, influencing the adoption of smarter packaging technologies across the industry?

These regulatory mandates, they can be game changers in terms of people adopting this type of technology, because these are difficult systems to implement and they require upfront investment. They require a lot of partners working together—there's a lot of complexity to make these work. When they're regulated, that puts some real fire behind actually having to implement these things.

Specifically, RFID technology is definitely one way that these regulations can be adhered to and can be moved forward. We've definitely seen more interesting questions and people wondering how this can really benefit DSCSA implementation. Serialization is required at the package unit level. RFID can automate some of this, and really help to scale up some of these ways of compliance. It can also provide some additional benefits as well as just compliance with the regulation. They can also help in terms of traceability, inventory management, providing real-time analytics. We definitely have seen that these regulations create a lot of interest and a lot of people are exploring how to implement these solutions so that they can be in compliance.

In the third part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, shares the ways in which regulations, including DSCSA, are impacting the adoption of smarter packaging technologies across the industry.

Embedded Product Intelligence’s Role in Maintaining Cold Chain Integrity

What role does embedded product intelligence play in maintaining cold chain integrity, and why is this so critical for pharmaceutical safety and efficacy?

In addition to a digital ID, you can also embed sensors into the smart packaging, so you can embed temperature sensors, humidity sensors, pressure sensors, and obviously, probably the most critical for cold chain management is temperature sensors.

What this really enables you to do—especially if you're using active-sensing technology in combination with RFID—is really be able to track in real time the temperature of these very expensive, organic pharmaceuticals that are really driving the industry growth today. I think it's absolutely a critical part of what smart packaging can do, and as you said, the rise of personalized medicine, the rise of all these organic compounds that are being developed by the pharmaceutical industry, they absolutely do require very careful monitoring throughout the supply chain.

I think this technology that enables not only the digital identification—but can also include sensors to monitor temperature—can be a real game changer, by ensuring that these drugs are being taken through the supply chain at the appropriate temperature. By getting this information in real time, if they see that it's not being maintained at the proper refrigeration level, there’s actually things that they can do to ensure it gets back into refrigeration to really maintain the compliance that they need for the right temperatures. We think that's a really important part of the smart packaging trends.

In the second part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, describes why this technology is essential for pharmaceutical safety and efficacy.

Strengthening Production Efforts Domestically 

, Alex Guillen, global pharma and life sciences director at Tive, highlights a significant concern: the rapid advancement of technology and its potential misuse by organized crime. While technology itself is not inherently dangerous, the pharma industry's slow adoption of emerging tech, such as IoT devices, sensors, and cloud-based integration, has made it vulnerable. Guillen points out that other industries have embraced these technologies much faster, enhancing their security and efficiency, while the pharma sector has lagged behind.

This technological lag creates a critical vulnerability for pharmaceutical companies, especially in supply chain management, where the risk of cyberattacks and system breaches is growing. The fast pace of technological development, coupled with the industry's lack of preparedness to defend against these threats, makes pharma particularly susceptible to malicious activities, including hacking and data manipulation. Guillen emphasizes that the industry's relatively slow uptake of advanced technologies like IoT and cloud computing has left them exposed to potential risks, especially from organized criminal groups leveraging these tools for nefarious purposes.

Ultimately, Guillen suggests that the key challenge for the pharma industry moving forward will be to rapidly enhance its technological capabilities and adopt a more proactive approach to security. By doing so, pharma companies can better protect themselves against the evolving landscape of threats, ensuring that their supply chains remain secure and resilient in the face of these emerging risks.

Guillen also comments on a 2024 report surrounding pharma supply chain security and visibility, what needs to be done in the United States to increase manufacturing output, and much more.

According to the API Innovation Center, an 

 additional 30 billion doses of essential medicines could be produced in the United States without incurring the expense of building a new manufacturing plant. What needs to be done in the US to increase output? Could it follow a blueprint set forth by Europe and other nations?

If you look historically in the last 15 years, the US been a little bit behind compared to Europe in biologic manufacturing. This is changing. It’s going quite fast—I'm sure we have those capabilities. In order for that to happen, I think there are some steps that government and manufacturers, will have to put in place in order to make sure that we, the government, stays at that level, or at least catches up with the rest of the world. In the biologic manufacturing. Thinking about that, for Supply Chain processes, a lot of the manufacturing and distribution in the United States is domestic, so biologics, are made in the US and distributed in the US, like 60&, 70%. Only 30% are being exported abroad. That means the supply chain is already adapted for the country.

If we're going to produce 30 billion doses, we're not going to stop importing doses from anywhere else, so there's going to be the need to export as well. Otherwise, it wouldn't make financial sense. Thinking about that, let's say I'm comparing to Europe, just as a point of comparison. No better, no worse. I think there is a higher complexity in the supply chain in Europe because of customs, language, labeling, regulatory—there is a complexity, especially with a lot of Europe's products being sent into the APAC region. There is a lot of knowledge over there in terms of supply chain, which is complex, and it's more difficult in Europe. I think the United States will have to step up in that area, saying, okay, it's not just about the domestic market. We also need to export to Canada, Mexico, Latin America, in order for it to make sense. Hopefully, the health in United States will get better and better, and you will not have to actually use it so much, domestically. I think one of them is to kind of step up into the supply chain, so that they are able to manage those processes, as well as other supply chains that are being done.

The other area that I will look at is when we're talking about manufacturing the doses—that's one thing—but the sourcing of that manufacturing, the sources of the APIs, of the reagents, of the chemicals, they come from somewhere. Those supply chains that have been done today—they ended up, for the majority, in some plants somewhere in the world where we are doing the manufacturing, If you want to step up that level, that supply chain will also have to be strengthened because about 60% to 70% of the APIs and reagents come from China and India, and they are coming into Europe. Right now, we have to come do the manufacturing in the US, though that means generating new supply chains working in that robustness, and making that happen. I think that in the US, as long as the manufacturers and the government put together this strengthening of the supply chain, I think there is a great opportunity to do this locally.

The other thing that really resonates right away to me is if you take personalized medicine, such as cell and gene therapy, all those new medicines that are coming are closer from manufacturing to the patient because we're not talking about mass production of chemicals. We are doing personalized medicine. We take cells from the body, send it to a lab, and back to a patient.

That kind of manufacturing is being done more locally. It doesn’t make sense to ship cell and gene therapies out of Europe and into the United States. It will make more sense to make it locally because the cold chain conditions are much tougher. The temperatures are much lower. The supply chain is more complex, and it would just make total sense to try to make it as close as possible to the patient. The nice thing about this, Nico, is that these processes and the supply chain for the cell and gene, and for all the new therapies, they are being worked on today—this is not a “don't” thing. This is something that we as an industry are working on right now, including how we're going to do it, to make this possible. If you take traditional pharma, those supply chains are already set. For new therapies, it’s something that we are building as we speak. We have meetings about it every month. How are we going to do this? If we don't build a supply chain to manage this, new therapies will not go into the market.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Alex Guillen, global pharma and life sciences director at Tive, explains what needs to be done in the United States in order to increase manufacturing output.

Analyzing Supply Chain Complexities 

 recently released a 2024 report surrounding pharma supply chain security and visibility. Could you elaborate on some of the highlights of that report?

 I went through the report and for some of the responses that we had, I knew more or less that would be the trend, but for some of them I was quite surprised, actually. When we talk about, for example, one of the biggest threats that companies are seeing today is product tampering and repackaging as one of the major ones. I was trying to see, why product tempering and repackaging? If we acknowledge that the supply chain of pharma is one of the more robust today, I wouldn't expect the biggest concern being product tampering—something happening in the product—because it is an industry which, by definition, is extremely regulated and very secure. Looking back into what could the reason of these concerns could be, for example, on this point itself, it is getting more and more complex. Supply chain complexity that we have today is probably 10 times more complex than we had only 15 years ago. That complexity itself—whether it's components, APIs being manufactured in certain parts of the world, transported across the ocean, while having manufacturing spread in different parts of the world, and then having patients in another part of the world—makes this whole supply chain very complex and very difficult to manage. 

That supply chain has been getting more and more complex through time. Due to this complexity, I can imagine that it becomes more and more difficult to protect product itself because the industry relies more and more on third-party operators. If you take an example of freight forwarders; before, if they could do 70% of it, now, they probably can do 20%, 30% of it, and they have to rely on third-party to do the rest. They cannot be everywhere, so they go to all the other companies. That makes it more difficult for freight-forwarders themselves to actually manage the proper products in the best, proper way. The same applies to the repackaging side.

When I see repackaging, I'm also thinking, if 20 years ago, we had a lot of pharmaceuticals, now, the high value is in biologicals. Biologicals are more complex under packaging, under temperature conditions, and therefore, it becomes more difficult for companies to actually handle those. We saw it through COVID. When it came to the minus 70 degrees Celsius product, the product has to be transported at this temperature. It is industry knowledge right now almost half of that got lost or wasted because of not having the infrastructure to manage it. I think that as temperatures go lower, in terms of new medicine and new therapies, it's going to be a bigger challenge to be able to manage that supply chain, whether it is a handling of the product or whether it is the repackaging of the material.

I think that was one of the first ones that it is driving. The second one is regarding temperature control. We can see that the industry is supposed to be extremely robust in terms of temperature management. Why, all of a sudden, is it so concerned as the biggest risk? I can only associate it with a huge amount of new therapies that are coming on board. If you take, last year in 2023, there were about a handful of cell and gene therapies approved by the FDA, and we see the amount that are going to be approved in 2026 is in the tens of thousands of therapies. This is a huge step up, so I think that as it gets more complex with ultra-cold temperatures, the companies need to progress in infrastructure. That doesn't happen so quickly. I think those areas are quite the biggest, recognized threats from the people we interviewed. 

The last thing that I was surprised about is the concern about theft itself. I went in to dig into some of the information on some of that we know. Actually, the pharmaceutical industry does not have such a huge number of thefts compared to other industries like luxury. Nevertheless, this could represent a fear of the future. This case is not today, but it could happen, and why it could happen is a complexity that I think some customers are just having a hard time to grasp. So those are the three areas: two of them are quite clear—trying to figure out the reason—one of them I was surprised, but it could be just a fear for the future. I will need more analyzing to find out. Maybe at LogiPharma, we get more information on if this fear is really out there, but those are definitely the three areas that I was quite impressed with.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Alex Guillen, global pharma and life sciences director at Tive, describes the highlights of a recent pharma supply chain security and visibility report that his company released.

Cold Chain

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