Strengthening Production Efforts Domestically

In a video interview with Pharma Commerce, 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.

A transcript of his conversation with PC can be found below.

PC: According to the API Innovation Center, an estimated 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?

Guillen: 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.