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Supply Chain Logistics

1rem

The company’s Mourenx plant in Southwest France aims to become an API network hub, with first supplies expected by next year. 

Axplora Invests $52.5 Million into GLP-1 Manufacturing Facility

The facilities are expected to offer pharma shipment support by addressing time and temperature-specific requirements. 

UPS Welcomes Three New Cross-Dock Plants

A report offers a comprehensive benchmarking and assessment of pharmaceutical manufacturer engagement with specialty pharmacies.

Transforming Specialty Pharmacy Engagement

The 7,000 square-foot GMP facility will provide formulation development support, along with analytical testing services. 

Upperton Pharma Solutions Finalizes Construction of Sterile Manufacturing Plant

The license agreement will feature an upcoming Phase III trial and—depending on results—the development, manufacturing, and commercialization of evenamide as a potential treatment option.

Newron, Myung In Pharm Form Partnership Centered Around Treating Schizophrenia in South Korea

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.

Tackling Gaps in Manufacturing, Funding, and Expertise

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

What are the key challenges currently preventing the United States from meeting the FDA’s 

 of 10 to 20 CGT approvals per year by 2025, and how can these be addressed?

So really, I think partially the complexity of development and manufacturing of these therapies— there's incredible complexity to understanding how to not only manufacture and scale according to different patient populations that need to be targeted, so navigating some of those challenges from the development and manufacturers perspective, but then also understanding what the regulatory hurdles may be. How do we effectively understand the outcomes that we're trying to study in the clinical trial setting that ultimately will help us achieve a regulatory filing approval and eventual launch?

Navigating some of those regulatory hurdles through communication with the agency is really key as well. I mentioned the clinical trial challenges—I think having that dialog between the manufacturers and the agencies, from pre-clinical development through clinical development, and ultimately gearing toward that regulatory filing, makes a big difference in trying to expedite that pathway to market, and really understanding what the criteria are going to be, so that we can proactively try to mitigate those challenges and risks.

There's also COVID. COVID did a number on the entire sector. We really saw a decrease in financing and funding available. We know that these therapies are incredibly complex and require a high cost of investment to develop and ultimately achieve a commercial launch. Navigating funding hurdles as well has been a challenge, and I think really slowed some of the progress to an extent. And then finally, I think the workforce and expertise shortages come into play here. As a sector, the cell and gene sector is still relatively in its infancy stages, and so finding folks that have had an opportunity to work through the development and commercialization, both on the manufacturing side and from the regulatory agencies perspective as well, just to understand these therapies, and ultimately, how to develop and commercialize them. I think all of those things have really factored into why we haven't yet achieved the goal, but the exciting part is, I see a lot of progress being made in each of these areas that hopefully will start to see us catch up to that goal a little bit more quickly here in the near future.

In the second part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, explains the challenges associated with meeting the FDA’s 2025 CGT forecasted approval goal. 

The Future of Personalized Medicine

, 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.

How will the development of technology, especially personalized medicine, help in further strengthening the pharma supply chain? Is it scalable?

 For the pharma logistics industry—including the biotech supply chain—I am personally involved in about four projects. They are global projects to try to build this. In terms of some of the developments that I see in terms of manufacturing close to the patient, if you will see them, Nico, you will think that we’re in science fiction movie. We're going from a huge plant with 800 people working on some type of therapeutical drugs, to machines that are the size of a printer, which actually looks like magic. You put stuff in, and stuff comes out, and it looks like magic.

There’s a big investment right now on this type of manufacturing at very small scale. And of course, there are some questions. Is it scalable? Can we do this eventually? I think that if we have a lot of small machines, it is scalable. If we have a few small machines, it's not, but I think that we are working quite fast. I think in the next 20 years, it will be a completely different world.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Alex Guillen, global pharma and life sciences director at Tive, shares how the development of technology will help bolster the pharma logistics industry. 

Strengthening Production Efforts Domestically 

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.

Analyzing Branded and Generic Pharmaceuticals

managing director, global operations & supply chain practice at UST, discussed how the East and Gulf Coast port strikes highlighted the contrasting dynamics between branded and generic pharmaceuticals. Branded drugs, which offer higher profit margins, are produced at limited manufacturing sites, creating potential vulnerabilities. In contrast, generics have multiple supply sources but operate with tighter margins, leading to less robust business controls and raising concerns about safety. This disparity underscores the complex challenges faced by both sectors in the pharmaceutical industry. Colehower also spoke on the valuable in pharma supply chain transparency and visibility.

A transcript of Colehower’s conversation with

How did the East and Gulf Coast port strikes bring to light the differences between branded and generic pharmaceuticals?

I think it’s a fascinating space because of the differences, and when I say the differences, there are a couple things that I'm talking about. One is just the difference between brand and generic pharmaceuticals. It's feast or famine. The brands have lots of margin that they can throw at the problem, but at the same time, they're so proprietary, it's restricted, so you may only have one manufacturing operation that's producing that brand. That's a point of failure that has to be managed.

On the other hand, there’re the generics, where you may have lots of sources of supply, but they don't have the margin. Because they don't have the margin, they don't have some of the same business controls that in other cases might be a luxury, so you then start worrying about things like safety.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, describes how events such as the East and Gulf Coast port strikes have brought to light the differences between branded and generic pharmaceuticals. 

Editor Nicholas Saraceno, Bill Roth, SVP, Managing Partner, Blue Fin Group, speaks on key takeaways from his "Fight for the Dollar" keynote speech. 

Access Insights 2023: Bill Roth Provides an Overview of his Keynote Speech, Fight for the Dollar

: The keynote was a culmination of a story that I've been working on all year long. We've always heard about the flow of the dollar. I'm getting quite tired of that one graphic that represents how brands flow. There's nine other flows. What became obvious to us over the last year and a half was this concept of the fight for the dollar. No one is really laying back and allowing the channels to basically use the manufacturers. Between 340B, the removal of the AmCap, and the addition of the IRA, price increases as we know it have been abolished. If you do it moving forward, you're going to wind up regretting the actions. The way that I open it up, I ask this question: If you put a dollar bill equidistant in a four way intersection and you put a payer pharmacy/distributor equal to that and a gun goes off, who gets to the dollar bill first and why? Traditionally, the answer has been not the manufacturer. The fight for who gets that money has created awkwardness and I think the ability to talk about that in front of a group like this is great because we're putting a problem on the table that we all need to solve. 

SVP and Managing Director for Blue Fin Group offers a synopsis of the conference opener. 

Latest Conference Coverage

 editor Nicholas Saraceno, Andrew Brownlee, director, Berkeley Research Group, discusses how manufacturers calculate 340B pricing. 

Access Insights 2023: Andrew Brownlee Discusses How Manufacturers Calculate 340B Prices

: It is subject to a formula that all manufacturers have to provide. For branded pharmaceuticals, it is a ceiling price, which means that it's the maximum price that a manufacturer can charge for a 340B priced product. That ceiling price is subject to a discount of the unit rebate amount (URA). The URA is the greater of 23.1%, or the best price, which is essentially the greatest discount that the manufacturer offers on the branded product. Each 340B discount is also subject to an inflationary penalty, so if the list price of the product grows faster than core inflation, then there would be an additional discount added to the URA. 

Berkeley Research Group executive speaks about the role of manufacturers in 340B pricing. 

Manufacturing & Packaging

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