Legal & Regulatory

Traceability

Trade & Brand Protection

Brand & Product Security

Business and Finance

Containers & Shippers

Devices

Software

Cold Chain

Commercial Channels

Artificial Intelligence

Digitalization

Real World Data

Data & Technology

Manufacturing & Packaging

Supply Chain

Logistics & Transportation

Commercialization

Pricing

Trade & Channel

Market Access

Opinion

Adherence

HUB Services

Patient Assistance Programs

Patient Support

News

Pharma Pulse

Academy

Publications

Partner Perspectives

Webcasts

Resources

Conferences

Conference Coverage

Conference Listing

Events

Videos

Peer Exchange

Podcasts

Editorial Podcasts

Subscribe

Pharmaceutical Commerce connects biopharma executives to insights on business processes, technologies, and strategies for taking approved drugs to market.

About Us

Advertise

Editorial

Contact Us

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Pharmaceutical Commerce - Biopharma Business News, Market Insights

Instagram

Facebook

LinkedIn

Threads

Soundcloud

Spotlight

Digital Editions

Security

Asembia AXS25 Summit 

Topics

Data and Technology

Legal and Regulatory

Supply Chain Logistics

1rem

Authors

In an era of increasing regulatory complexity, life sciences organizations are modernizing GxP compliance through digital tools like eQMS, cloud platforms, and automated validation, while expert validation services remain essential for aligning these technologies with real-world workflows and inspection readiness.

Modernizing GxP Compliance in Life Sciences: The Role of Digital Tools and Validation Expertise

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.

Balancing Compliance and Supply Chain Continuity

As the DSCSA enforcement date approaches (Aug. 27 for wholesale distributors), what strategies should organizations prioritize to ensure compliance while minimizing disruptions for manufacturers and providers?

Our strategy and mindset has been that this isn't going to happen overnight, and we all know that—God bless, you've been working on this for 10 years, and we've gone through the gamut of what technology are we going to use? We need some underlying capabilities, data like GLNs. How do you how do we identify a location standardized? How do we use GS1 global standards to do the standardization of packaging? Once we kind of started to get through, okay, what are the key building blocks we need? From a technology point of view, how do we identify sites of care? How do we identify the product, and then how do we start to track it and move it through the network?

Our strategy has always been we take federal particularly, and state regulations, very seriously. We pride ourselves at Cencora on we follow all state and regulatory laws. We also like to highlight where there might be risks, so working across the industry has been key for us too, working with the regulatory agencies at FDA, at the state boards of pharmacy, at EPA, DEA, a lot of the entities that tend to regulate—to let them know where there may be gaps or opportunities for them to lean in to help the industry comply.

As we get into Aug. 27, we're really looking at, how do we keep the supply chain moving? How do we also comply with the law at the same time and make those two strategic pillars not conflict? We're really using the tools that are in the toolkit of DSCSA, and one of them is the waivers and exceptions. We have been very transparent with our manufacturer partners, with the FDA, and sharing where we have data gaps. We've worked with the manufacturers for 10 years to say, serialize the product. Now let's talk about the data and the data accuracy.

First it was just getting a serialized data file—an EPCIS record—from the manufacturer. Then it became, are the records accurate? Let's start to match the physical product scans to the data. Then it became the timing of the data. Is the data coming? when is the product us coming to the warehouse? We have an ability to process it and move it in the supply chain. We're really looking at keeping the supply chain moving, using the waiver and exemptions as a way to say, we have some manufacturers that struggle with accuracy of data still. For those, can we get a waiver and exception, so we know it, and we're saying it to the market, but we're continuing to move the product. Then, how do we also educate the sites of care, all of the pharmacies, all of the hospitals, all of the clinics on this is what you need to do. How you do it is your choice from your regulatory support, but these are the three tasks that you need to do.

How do we work together t say, this is how you access the serialized data? This is how you now initiate a return, so we take our point in place in the education really seriously. Our whole goal is to keep the product moving, keep compliance top of mind, and front and forward. And if we can keep those two things going, I think for us, huge success.

I will also say this started kind as a burden and a regulatory thing. I think a lot of the market has said the US supply chain is the safest supply chain on the planet. We really looked at it as this is a way you transform the pharmaceutical supply chain. The connections we have with the manufacturer, we didn't have as connections 10 years ago. Healthcare system didn't use GS1 global standards, and now we are. This has really elevated, whether I think we want to admit it or not, it's elevated the connection between the trading partners. It's elevated a standard way to transact, and it's really made the supply chain more robust, more secure, and stronger. I'm not sure we thought that started when we started this. It's interesting to see the outcome of this.

In the third 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 European Union intends to impose a 30% tariff on US imports valued at $117 billion if a trade deal is not reached, and if President Trump ends up enacting that same rate on the EU at the beginning of next month, per 

 Items include cars manufactured in the United States, bourbon whiskey, and Boeing aircraft.

The EU plans tariffs on various US products into one bundle.

EU considers anti-coercion measures and retaliatory action

Although it hasn’t been activated as of this time, the idea of invoking the EU’s anti-coercion instrument (ACI) has been circulating, which would come into play during a no-deal scenario. According to Crowell & Moring LLP,

 “the ACI provides a legal framework for a centralized and structured EU response to third country “coercion” through diplomatic means and, failing that, through any counter measures deemed necessary. The ACI states that one of its objectives is to ensure its responses are always in strict adherence to internal and international legality.”

US pushes reciprocal tariffs amid global trade shifts

In essence, if a deal isn’t reached, the EU could consider launching various retaliatory actions—via the limitation of US investments and taxes on US tech companies. A majority from EU member states would be needed, however.

The United States has requested a “near-universal” tariff on EU goods higher than 10%, with exemptions pertaining to various medical devices, aviation, some medical devices, manufacturing equipment, some spirits, and generic medications.

This comes as the US finalized an agreement with Japan requiring American importers to pay a 15% reciprocal levy on Japanese exports to the United States, including autos and their parts.

Pharma prepares for tariff-driven reshoring

Meanwhile, the pharmaceutical industry continues to prepare for levies by the beginning of next month, which could coincide with the planned reciprocal tariffs rates that were previously set.

Trump has described it as being a “low tariff” that would slowly increase over the course of approximately a year, with a tariff reaching up to 200% still being a possibility. Import taxes are vital, says the US president, to not only help guide the reshoring of manufacturing efforts back to the United States, but also contribute to financially supporting the “Big, Beautiful Bill” that he had signed on the Fourth of July. The bill builds on the 2017 Tax Cuts and Jobs Act, making most tax reductions permanent while raising funding for border security, defense, and energy production.

Many companies have already been in the process of reshoring manufacturing to the United States to avoid the impending tariffs, including AstraZeneca, who plans to invest $50 billion by 2030 in US-based drug manufacturing and R&D, marking its largest single manufacturing investment globally.

 The announcement is headlined by a new state-of-the-art facility in Virginia that will produce active pharmaceutical ingredients (APIs) for weight management and metabolic treatments, leveraging AI, automation, and data analytics.

“Today’s announcement underpins our belief in America’s innovation in biopharmaceuticals and our commitment to the millions of patients who need our medicines in America and globally,” said AstraZeneca CEO Pascal Soriot at the time that the news broke. “It will also support our ambition to reach $80 billion in revenue by 2030. I look forward to partnering with Governor Youngkin and his team to work on our largest single manufacturing investment ever. It reflects the Commonwealth of Virginia’s desire to create highly-skilled jobs in science and technology, and will strengthen the country’s domestic supply chain for medicines.”

1. Delfs A, Nardelli A, Valero J. EU Readies €100 Billion No-Deal Plan to Match US 30% Tariff. 

. July 23, 2025. Accessed July 23, 2025. 

https://www.bloomberg.com/news/articles/2025-07-23/eu-readies-100-billion-no-deal-plan-to-match-us-30-tariff

2. The Anti-Coercion Instrument: What Is It and How Europe Might Use It Over the Next Four Years. Crowell & Moring LLP. Accessed July 23, 2025. 

https://www.crowell.com/en/insights/client-alerts/the-anti-coercion-instrument-what-is-it-and-how-europe-might-use-it-over-the-next-four-years

3. Dlouhy JA, Wingrove J, Nohara Y. Trump Strikes Deal With Ally Japan Setting Tariff Rate at 15%. 

. July 22, 2025. Accessed July 23, 2025. 

https://www.bloomberg.com/news/articles/2025-07-22/trump-says-japan-deal-reached-with-tariff-rate-set-at-15

4. Saraceno N. Trump Says Pharma Industry Should Expect Tariffs by Aug. 1. 

. July 17, 2025. Accessed July 23, 2025. 

https://www.pharmaceuticalcommerce.com/view/trump-pharma-industry-tariffs-by-aug-1

5. Saraceno N. AstraZeneca Commits $50 Billion to US Manufacturing and R&D Efforts by 2030. 

https://www.pharmaceuticalcommerce.com/view/astrazeneca-commits-50-billion-us-manufacturing-research-development-2030

The European Union plans to impose a 30% tariff on $117 billion worth of US imports if a trade deal is not reached, mirroring potential US tariffs on EU goods. The EU is considering using its anti-coercion instrument to respond to US actions. The US seeks reciprocal tariffs on EU goods, excluding certain sectors. The pharmaceutical industry is preparing for potential tariffs, with companies like AstraZeneca reshoring manufacturing to the US. AstraZeneca plans a $50 billion investment in US drug manufacturing and R&D, emphasizing innovation and domestic supply chain strengthening.

Meanwhile, President Trump continues to push reciprocal levies and reshoring efforts, while pharma prepares for escalating costs.

EU Threatens 30% Tariffs on $117 Billion of US Goods Amid Trade Standoff

, President Trump reached a formal trade agreement with the European Union in which a maximum 15% levy will be imposed on “most” EU exports, including autos and their parts; semiconductors; and pharmaceuticals.

The EU will also be investing $600 billion in the US and purchasing $750 billion worth of US energy exports through the year 2028.

Deal averts 30% tariff threat while triggering pharma sector concerns

This development comes as an Aug. 1 deadline to reach a deal loomed, and after the EU planned on imposing a 30% tariff on US imports valued at $117 billion if a trade deal was not reached (after Trump had threatened a 30% levy of his own).

Though it didn’t end of being activated, the idea of invoking the EU’s anti-coercion instrument (ACI) had been floated around, which could have possibly been enacted during a no-deal scenario. As noted by Crowell & Moring LLP,

 “the ACI provides a legal framework for a centralized and structured EU response to third country “coercion” through diplomatic means and, failing that, through any counter measures deemed necessary. The ACI states that one of its objectives is to ensure its responses are always in strict adherence to internal and international legality.”

Pharma industry faces $13–$19 billion in potential costs

However, with branded drugs being included in the tariff, analysts are now projecting that this deal could ultimately cost the pharma sector between $13 billion and $19 billion. Not only does medication represent the largest European export to the US, the EU is also responsible for nearly 60% of pharma imports entering the US.

This comes during a time when coincidentally, 60% of life sciences and healthcare leaders are anticipating that the current or forthcoming tariffs and pricing policies will have “some impact” on their businesses.

Tariff structure could escalate, encouraging US drug manufacturing

Trump had originally noted that a “low tariff” would slowly increase over the course of approximately a year; there had also been talks up a tariff reaching up to 200%, which could still be on the table, given that the idea hasn’t necessarily been dismissed.

The tariff is meant to encourage pharma manufacturers to reshore their production back to the United States, which has been in the works for many players, including AstraZeneca, who plans to invest $50 billion by 2030 in US-based drug manufacturing and R&D, marking its largest single manufacturing investment globally.

 The announcement is headlined by a new state-of-the-art facility in Virginia that will produce active pharmaceutical ingredients (APIs) for weight management and metabolic treatments, leveraging AI, automation, and data analytics.

Forecasting and inventory strategies emerge as risk mitigation tools

It remains to be seen whether some of the aforementioned costs will be offset by efforts to stockpile medications, but experts in the space think that this could be a safe approach for the time being, and analytical capabilities moving forward will be paramount.

“Right now, I'd want to try and stockpile as much inventory as I could in the US, just to take that tariff uncertainty out of it,” explained Brad Stewart, BDO’s national life sciences co-leader. “The product’s already on shore, and I can then sort of deal with what happens, or at least have a little bit more time to do that … One challenge we have is we may not have all the information today to make the decisions that we need to, but we certainly have the tools available to build the model and forecast, so that if someone says tomorrow, the tariff from this country or that country is going to be 22.1%, you can put that into the model and understand what impacts it's going to have on your business, and at least have the information necessary to make those decisions.”

1. Trump Says US has Reached Trade Deal with European Union as Aug. 1 Deadline Loomed. 

. July 28, 2025. Accessed July 29, 2025. 

https://www.cbsnews.com/news/trump-european-union-trade-deal-reached-scotland/

2. Saraceno N. EU Threatens 30% Tariffs on $117 Billion of US Goods Amid Trade Standoff. 

. July 23, 2025. Accessed July 29, 2025. 

https://www.pharmaceuticalcommerce.com/view/eu-threatens-30-percent-tariffs-us-goods-amid-trade-standoff

3. Satija B. EU-US Trade Deal Could Add up to $19 billion in Pharma Industry Costs, Analysts Say. 

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-us-trade-deal-could-add-up-19-billion-pharma-industry-costs-analysts-say-2025-07-28/

4. Saraceno N. How Life Sciences Firms Are Evolving to Navigate Trade, Tariff, and Pricing Turbulence. 

. July 25, 2025. Accessed July 29, 2025. 

https://www.pharmaceuticalcommerce.com/view/life-sciences-firms-evolving-trade-tariff-pricing-turbulence

5. Saraceno N. How Pharma Executives Can Prepare for Tariff Uncertainty. 

https://www.pharmaceuticalcommerce.com/view/how-pharma-executives-prepare-tariff-uncertainty

President Trump and the European Union have reached a trade agreement imposing a 15% levy on most EU exports, including pharmaceuticals. The EU will invest $600 billion in the US and purchase $750 billion in US energy exports by 2028. The deal averts a potential 30% tariff threat but raises concerns in the pharmaceutical sector, which could face $13–$19 billion in costs. The tariff aims to encourage US drug manufacturing, with companies like AstraZeneca planning significant investments. Forecasting and inventory strategies are suggested to mitigate risks associated with tariff uncertainties.

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

United States, European Union Reach Trade Pact

How Pharma Executives Can Prepare for Tariff Uncertainty

, Brad Stewart, BDO’s national life sciences co-leader, describes how a proposed 200% tariff on pharmaceutical imports could have significant short- and long-term impacts on US drug manufacturing and distribution, with immediate concerns focused on the stability of the generic drug market. According to Stewart, generic drugs make up the majority of medications used in the United States, but they are highly vulnerable to shortages because many become sole-source products after their initial launch. Within a few years of going generic, multiple manufacturers often consolidate into a single supplier due to limited demand and low margins. This leaves the supply chain fragile, as any disruption—such as shortages of active pharmaceutical ingredients (APIs), manufacturing conflicts, or facility issues—can quickly lead to supply gaps. The pandemic underscored these vulnerabilities.

In the short term, Stewart warns that a 200% tariff would exacerbate these challenges by increasing the costs of imported generics, which are critical for maintaining affordable drug access. This could limit availability and raise costs for patients, providers, and insurers, leading to potential shortages and higher out-of-pocket expenses.

Longer term, tariffs of this magnitude would likely drive a rise in overall drug prices in the United States. Companies would have little choice but to pass on increased costs to consumers, insurers, and healthcare systems. While patients might not feel the impact immediately due to insurers absorbing costs, premiums, and healthcare charges would eventually rise.

Stewart emphasizes that reshoring pharmaceutical manufacturing is not a quick fix. Building new manufacturing facilities or scaling domestic production requires a long lead time—typically three to five years—and involves complex regulatory and logistical challenges. As a result, while tariffs may encourage companies to explore onshoring, significant capacity expansion is unlikely to occur in the near term.

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.

What operational or strategic steps should pharma executives be taking now to mitigate risks while awaiting clarity on tariff implementation?

I think to just simplify the things I would do if I were a US or even a non-US life sciences company looking to figure out how I managed my drug supply, and being able to get it to do business in the United States, is right now, I'd want to try and stockpile as much inventory as I could in the US, just to take that tariff uncertainty out of it. The product’s already on shore, and I can then sort of deal with what happens, or at least have a little bit more time to do that.

Two, looking at alternative vendors. Since I don't yet know what all the tariffs are going to be on what products from what countries, and where I'm making product, really looking if there are opportunities to change those suppliers that will have a positive impact on the price of the drugs, or my cost to manufacture them.

Certainly, as we discussed, I think modeling and really looking at it. Do I really understand my supply chain from a global perspective, and if I change one part of it, what impact does it have on all the other parts of it? I think that's what many of the executives are doing. The industry now is starting to think very strategically. One challenge we have is we may not have all the information today to make the decisions that we need to, but we certainly have the tools available to build the model and forecast so that if someone says tomorrow, the tariff from this country or that country is going to be 22.1%, you can put that into the model and understand what impacts it's going to have on your business, and at least have the information necessary to make those decisions.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, covers the operational or strategic steps that pharma executives ought to be taking now in order to mitigate risks while awaiting clarity on tariff implementation.

Akshay Kapadia

Articles

Latest Updated Articles