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Pharma must align data, personalization, and cross-functional orchestration to deliver human-centered experiences that connect with patients, HCPs, and caregivers alike.

Omnichannel, Evolved: Redefining the Model for Modern Pharma Marketing

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

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

Combating Counterfeit Medicines Requires AI Integration and Industry Collaboration

, Mark Lee, MarqVision’s founder and CEO, highlights the rapid growth and increasing sophistication of the counterfeit pharmaceutical market, driven in large part by bad actors leveraging artificial intelligence (AI). Counterfeiters are now using AI to replicate authentic pharmaceutical packaging with high accuracy, build convincing fake websites, and manipulate search algorithms—including SEO—to lure vulnerable patients. Generative AI tools make it easier than ever to clone legitimate sites, trick search engines, and present fraudulent products as genuine.

Lee emphasizes that counterfeit pharmaceuticals pose a far greater threat than other counterfeit goods, such as luxury handbags, because fake drugs directly endanger patient health and bypass stringent safety regulations. Consuming these unregulated substances can lead to severe health consequences, making counterfeit medications both a public health crisis and a criminal enterprise.

According to Lee, these bad actors are evolving at an alarming pace—so quickly that even advanced anti-counterfeiting teams struggle to keep up. At MarqVision, the company reportedly employs top-tier engineers, including former Google software engineers, to develop AI tools capable of identifying and shutting down these threats. However, the speed and adaptability of counterfeiters make the challenge ongoing and complex.

Lee explains that it’s now possible to completely copy an official pharmaceutical company’s website, such as Pfizer.com, within seconds using code-replication tools. These fake sites often use slightly altered domain names—like “Pfizer.in” or “Pfizermedications.com”—and are nearly indistinguishable from the originals. As a result, the proliferation of such sites is growing, amplifying the risks to patients who may unknowingly purchase and consume counterfeit drugs.

Ultimately, Lee underscores that the combination of advanced AI tools and the high stakes of counterfeit pharmaceuticals is creating a rapidly evolving threat landscape—one that demands equally sophisticated and fast-moving countermeasures to protect consumers and maintain the integrity of the drug supply chain.

He also comments on the specific vulnerabilities in the global pharmaceutical supply chain that are most commonly exploited by counterfeiters; the key advantages of using AI-powered systems to detect and intercept counterfeit drugs compared to traditional anti-counterfeit methods;the role healthcare companies and regulators play in combating counterfeit medicines; and much more.

What should healthcare companies and regulators be doing to help combat counterfeit medicines, and where are the biggest gaps in enforcement or coordination today?

I think the government agencies and pharmaceutical companies should adopt at least some type of basic AI models that are capable of real-time, cross-platform enforcement that can learn and adapt as fast as these counterfeiters evolve. Now, beyond that, I think there are really two areas where pharmaceutical companies and these agencies can work on, which is also kind of beyond what we do today.

Number one, I think there's got to be a greater integration between AI and this physical authentication method. A lot of things that we do happens online. We look for fake counterfeiters online, we cluster them, we take them down, which is great, but these pharmaceutical companies actually have spent a lot of dollars in physical authentication. There's a lot of information about the packaging, and there's a way to authenticate these individual packages, or apps being installed, barcodes. I think there's got to be some connection between these, like online AI- driven authentication and the physical, real-world authentication methods. Right now, these are completely separate realms, and I think the government agencies or the pharmaceutical companies that are using both sides of the product can really drive that initiative.

I think by doing that, we can uncover a lot of these supply chain-organized crimes and things like that, in a more effective way. I think that would be very helpful to fight these problems, not only at the company level, but across the industry level. I think similarly, the second thing that needs to happen is there's got to be some kind of collaborative intelligence between companies, where pharma companies share anonymized threat data to build stronger collective defenses. Right now, what I see is that pharmaceutical companies have spent millions—if not more—on these product safety, product authentication programs, but there's very little sharing of information.

Everybody treats their own data as if it’s their own thing. If you find a counterfeit seller that’s selling a lot of Pfizer drugs, most likely, that seller is going to sell a similar category of products for other pharmaceutical brands, but those types of data are not being shared due to many reasons.

One of the reasons is that there’s also this concern about data privacy, so people don't want to share information about these sellers, even if they're criminal sellers. There's got to be some kind of regulatory framework to basically allow this kind of data sharing for suspected criminals, and there's got to be an investment in anonymization of these threat data, so that pharmaceutical companies can share data between one another, and that's going to be a very effective way to combat this organized crime.

In the fourth part of his Pharma Commerce video interview, Mark Lee, MarqVision’s founder and CEO, discusses how healthcare companies and regulators can strengthen defenses against counterfeit drugs by integrating AI with physical authentication methods and enabling secure, anonymized data sharing across the pharm sector.

Balancing Compliance and Supply Chain Continuity

, 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.

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.

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