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 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering updates on international trade, a US manufacturing investment, and new federal rules shaping electronic health records.

The White House and European Union have agreed on a 

 that includes tariffs on pharmaceuticals and precursors. Per the deal, US imports from the EU will be subject to either the most-favored-nation rate or a 15% duty—whichever is higher. The move is expected to impact generics, APIs, and chemical inputs, with industry leaders warning of potential cost increases that could ripple through global supply chains.

In other news, Johnson & Johnson has announced a 

to expand its pharmaceutical manufacturing campus in North Carolina. The project will add significant capacity for biologics and sterile injectables while creating hundreds of new jobs. J&J says the expansion is part of its long-term strategy to strengthen US-based manufacturing and ensure supply resilience for critical therapies. The investment underscores the growing trend of reshoring pharmaceutical production in response to both policy and supply chain pressures.

Lastly, in health IT, the federal government has issued a 

 requiring electronic prescribing and prior authorization capabilities to be integrated into certified electronic health record systems. The goal is to reduce administrative burdens, improve prescribing accuracy, and streamline prior authorization processes for providers. By embedding these functions directly into EHR platforms, regulators hope to cut down on delays in patient access to medications and reduce friction between payers, prescribers, and pharmacies.

From shifting global trade rules to major domestic investment and regulatory updates in health IT, these stories highlight how policy, infrastructure, and technology continue to reshape the pharmaceutical landscape.

. For more insights on trends transforming pharmaceutical access and care delivery, visit 

Thanks for listening—until next time, stay well and stay informed.

This episode of Pharma Pulse covers the White House–EU agreement on pharmaceutical tariffs, Johnson & Johnson’s $2 billion expansion of its North Carolina manufacturing site, and a new federal rule requiring e-prescribing and prior authorization tools in certified EHR systems.

Pharma Pulse: Pharma Tariffs Take Shape, J&J Invests $2 Billion in US Manufacturing, and New EHR Rule Targets Prior Authorization

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at layoffs in gene therapy manufacturing, new technology trends in diabetes care, and research linking childhood COVID-19 to long-term cardiovascular risk.

Catalent has announced plans to lay off 

at its Baltimore gene therapy facility. The decision reflects ongoing restructuring efforts as the company seeks to streamline operations and reduce costs amid shifting demand in advanced therapies. While gene therapy remains a promising field, the layoffs highlight the financial and operational challenges facing CDMOs as they adapt to evolving pipelines and market dynamics.

 shows that the use of technology for glycemic control—including continuous glucose monitors and insulin pumps—has increased significantly among patients with type 1 diabetes. These tools have been linked to better blood sugar management and reduced complications, underscoring the growing role of digital health in chronic disease care. Wider adoption, however, still depends on equitable access and payer coverage, especially for younger patients and underserved communities.

Lastly, researchers have found that children who experienced severe COVID-19 infections may face a 

 of cardiovascular problems in adulthood. The study points to potential long-term effects on heart health, raising the importance of continued monitoring for this population. These findings add to the broader discussion on the lasting impacts of COVID-19 and the need for preventive strategies as these children age.

From workforce shifts in manufacturing to technology-enabled diabetes management and emerging long-term risks from childhood COVID-19, these stories illustrate the wide-ranging forces shaping the future of healthcare and pharma.

This episode of Pharma Pulse covers Catalent’s decision to cut 350 jobs at its Baltimore gene therapy site, new data showing rising adoption of digital tools for glycemic control in type 1 diabetes, and research linking severe childhood COVID-19 to heightened cardiovascular risk later in life.

Pharma Pulse: Catalent Layoffs, Diabetes Tech Adoption, and Long-Term Heart Risks from Childhood COVID-19

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering advances in agile drug manufacturing, a multi-billion-dollar RNA therapy collaboration, and how pharmacists are using telehealth to improve diabetes care in emergencies.

 with HHS and DARPA to push agile drug manufacturing technologies forward. The initiative prioritizes on-demand production of essential medicines, using 3D printing and advanced systems to quickly scale supply during crises. This model could help reduce shortages, strengthen national security, and provide a more resilient pharmaceutical supply chain.

In biotech deal news, Skyhawk Therapeutics and Merck KGaA have struck a 

to develop RNA-targeting small molecules for neurological diseases. The agreement provides Skyhawk with upfront payments and milestones, while Merck gains access to Skyhawk’s splicing platform. With neurology remaining a high-need therapeutic area, this collaboration reflects growing investment in RNA-based approaches beyond oncology.

 shows that pharmacist-led telehealth programs could play a critical role in supporting patients with diabetes, particularly during public health emergencies. By providing medication management, education, and regular monitoring remotely, pharmacists can help reduce gaps in care when in-person visits aren’t possible. Experts say integrating pharmacists more fully into telehealth models could improve outcomes and reduce strain on healthcare systems.

From agile manufacturing and RNA innovation to new models of pharmacy-led care, these stories highlight how technology, partnerships, and expanded provider roles are reshaping pharma and healthcare delivery.

You can catch Pharma Pulse directly on 

This episode of Pharma Pulse explores a Battelle–Aprecia partnership with HHS and DARPA to accelerate on-demand drug manufacturing, a multi-billion-dollar Merck KGaA–Skyhawk collaboration to advance RNA therapies in neurology, and how pharmacist-led telehealth is improving diabetes care during emergencies.

Pharma Pulse: Agile Drug Manufacturing Advances, Merck–Skyhawk RNA Deal, and Telehealth Expands Pharmacists’ Role

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering three major developments—from new US policy on drug manufacturing to a high-profile pricing change for a leading obesity drug, and new research on vaccine safety.

 directing the creation of a domestic stockpile of active pharmaceutical ingredients, or APIs. The goal is to reduce reliance on foreign sources, strengthen the pharmaceutical supply chain, and ensure readiness for public health emergencies. This policy could have significant implications for manufacturers, potentially accelerating domestic production investments while reshaping global sourcing strategies.

 the UK list price of its GLP-1 drug Mounjaro by 170%. The company attributes the move to aligning prices with the therapy’s value and global market conditions, but the hike has sparked debate over affordability and access—especially as GLP-1 demand surges worldwide. Critics warn that higher prices could limit uptake within the UK’s National Health Service, while proponents say it may reflect the drug’s potential in addressing obesity and diabetes at scale.

 has found no link between aluminum-containing childhood vaccines and adverse health outcomes. Researchers reviewed decades of data and concluded that aluminum adjuvants, used to boost immune response, are safe and do not contribute to chronic illness. The findings are expected to reinforce public health messaging and counter misinformation, particularly as vaccine hesitancy remains a challenge in some communities.

From US manufacturing policy to international drug pricing and reaffirmed vaccine safety, these stories show how regulation, market dynamics, and public health science are intersecting to shape the pharma landscape.

This episode of Pharma Pulse discusses a new executive order to build a domestic API stockpile, Eli Lilly’s 170% price increase for Mounjaro in the UK, and long-term research confirming the safety of aluminum in childhood vaccines.

Pharma Pulse: US API Stockpile Plan, Mounjaro Price Hike in UK, and New Data on Vaccine Safety

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation.I’m your host, and today we’re covering three key developments—from major manufacturing investments to a shake-up in pharmacy customer satisfaction rankings, and shifting insurance coverage for GLP-1 drugs.

to expand active pharmaceutical ingredient manufacturing in the United States. The move aims to strengthen domestic supply chain resilience and reduce reliance on overseas sourcing—an increasingly critical priority for both industry and policymakers. This expansion is expected to boost AbbVie’s capacity to produce high-demand active pharmaceutical ingredients for its branded and pipeline products, while supporting US-based jobs in advanced pharmaceutical manufacturing.

 on pharmacy customer satisfaction reveals that mail-order services and supermarket pharmacies are now outpacing traditional chain pharmacies in patient experience. Consumers cite convenience, better pricing, and shorter wait times as top drivers of satisfaction. This trend could influence prescription fulfillment patterns, with more patients turning to alternative pharmacy channels—particularly as health systems and retailers explore new distribution models.

Lastly, as demand for GLP-1 drugs for diabetes and obesity continues to surge, insurance companies are 

. Some payers are introducing stricter criteria—or even dropping coverage—due to escalating costs and long-term budget concerns. This shift raises questions about patient access and affordability, especially as GLP-1s remain among the most expensive chronic-use therapies on the market. Experts warn that without broader cost-containment strategies, many patients may be forced to discontinue treatment, potentially undermining clinical outcomes.

From bolstering US manufacturing capacity to responding to changing consumer preferences and navigating the economics of GLP-1 coverage, these stories highlight the evolving forces shaping pharma and healthcare delivery.

This episode of Pharma Pulse explores AbbVie’s $195 million investment to expand US API production, new survey results showing mail-order and supermarket pharmacies outpacing traditional chains in customer satisfaction, and rising affordability pressures as insurers restrict GLP-1 coverage.

Pharma Pulse: AbbVie Boosts Domestic API Manufacturing, Supermarkets Lead in Pharmacy Satisfaction, and GLP-1 Coverage Tightens

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at three stories shaping the intersection of pharmaceutical business, healthcare delivery, and patient safety.

 to acquire Solaris Health, a large urology-focused physician practice management company, for $1.9 billion. The move is aimed at expanding Cardinal’s specialty physician services footprint, particularly in the fast-growing urology and men’s health segments. Analysts see this acquisition as a way to deepen Cardinal’s presence in physician practice networks while enhancing specialty drug distribution opportunities—a strategic play in a market where integrated care and specialty therapeutics continue to grow.

 in centralized pharmacy service centers to strengthen supply chains, improve efficiency, and enhance patient care. These hubs allow health systems to consolidate compounding, packaging, and distribution for multiple facilities—freeing up hospital pharmacists to focus on direct patient care. Centralization also improves inventory management and helps mitigate the impact of drug shortages. As healthcare systems face ongoing staffing and cost pressures, this model is gaining traction as both a cost-control and quality-improvement strategy.

has found a potential link between GLP-1 receptor agonists—widely used for diabetes and weight loss—and an increased risk of optic nerve disorders. Researchers caution that while the association does not prove causation, it raises important safety considerations given the growing use of these drugs. Physicians are being urged to monitor patients for early signs of vision problems, especially as prescriptions for GLP-1s surge in both endocrinology and obesity care settings.

From strategic acquisitions to innovative hospital pharmacy models and emerging drug safety concerns, these stories reflect the complex landscape pharma and healthcare leaders are navigating.

This episode of Pharma Pulse dives into Cardinal Health’s acquisition of Solaris Health to strengthen specialty services, how hospital networks are investing in centralized pharmacy hubs to improve efficiency and supply chain resilience, and new research linking GLP-1 drugs to potential optic nerve disorders.

Pharma Pulse: Cardinal Health Expands with Solaris Acquisition, Hospitals Centralize Pharmacy Hubs, and GLP-1 Safety Signals Emerge

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering leadership changes at the FDA, new research on COVID-19 risks for childhood cancer survivors, and strategies pharma companies are using to stay competitive as healthcare costs climb.

 of the FDA’s Center for Biologics Evaluation and Research—just weeks after resigning from the post in late July. Prasad, who was appointed in May, stepped down following public criticism from political commentator Laura Loomer, who targeted his past support for Democratic politicians and his role in the temporary halt of Sarepta’s Elevidys shipments.

Multiple media reports indicate his return came at the request of FDA Commissioner Marty Makary, with the White House reviewing the remarks that had sparked controversy. An HHS spokesperson stated that the administration would not allow “fake news media” to distract from the agency’s work.

reveals that adults who survived childhood cancer face a significantly higher risk of severe COVID-19 outcomes. These individuals were more likely to require hospitalization, intensive care, or mechanical ventilation compared to peers without a cancer history. Researchers point to long-term health effects from cancer treatment—such as organ damage and immune suppression—as potential contributors. The findings underscore the need for tailored preventive strategies, including vaccination prioritization and ongoing monitoring, for this vulnerable population.

Finally, with global healthcare costs on the rise, pharma companies are exploring ways to remain competitive while delivering value. Strategies include optimizing supply chains, investing in digital health solutions, and shifting toward value-based pricing models that link reimbursement to real-world patient outcomes. Analysts, including 

, note that companies able to combine operational efficiency with innovation will be better positioned to weather pricing pressures and meet growing demand for affordable, high-quality care.

From leadership shifts at the FDA to new public health research and evolving market strategies, these stories highlight how science, policy, and economics intersect to shape the pharmaceutical landscape.

This episode of Pharma Pulse covers Vinay Prasad’s return to lead the FDA’s biologics center after a brief resignation, new research on severe COVID-19 risks for childhood cancer survivors, and the strategies pharma companies are adopting to stay competitive amid escalating healthcare costs.

Pharma Pulse: Vinay Prasad Reinstated as FDA CBER Head, New COVID-19 Risk Data, and the Industry’s Response to Rising Costs

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today, we’re covering three developments shaping the pharmaceutical landscape—from regulatory innovation to high-stakes IP settlements and potential policy shifts out of Washington.

, aimed at improving drug manufacturing resilience in the US The initiative allows manufacturers to undergo an early, proactive quality systems review—before production even begins.

This approach is designed to reduce inspection delays, strengthen supply chain reliability, and ensure timely patient access to essential medicines. It’s a shift from reactive inspections to preventive oversight, which could be critical for minimizing shortages and maintaining consistent drug quality.

In the business arena, GSK has secured a 

 in an mRNA patent dispute involving CureVac, Pfizer, and BioNTech. The agreement nets GSK $370 million upfront and lowers the royalties it will pay on future mRNA vaccines developed with CureVac.

The resolution clears the path for both companies to advance their pipelines without the drag of ongoing litigation. Analysts see it as a positive for GSK’s mRNA ambitions, potentially improving profitability on upcoming vaccine launches, and as a sign that mRNA IP disputes may increasingly be resolved through negotiated settlements. Meanwhile, CureVac is also expected to receive $370 million at acquisition closing and $50 million from GSK for monetizing a portion of US product royalties that are due under its existing license agreement that was announced in July 2024.

Looking to policy, President Donald Trump is set to meet with pharmaceutical industry executives to discuss strategies for 

 and R&D investment. While details of the proposals have not yet been released, the meeting reflects a renewed focus on bolstering US pharma competitiveness, from supply chain security to innovation incentives.

Industry watchers will be paying close attention to whether the discussions lead to concrete policy measures—such as tax incentives, regulatory streamlining, or public-private partnerships—that could influence investment flows and production capacity in the years ahead.

From the FDA’s proactive quality program to a high-profile mRNA settlement and potential policy shifts aimed at strengthening US pharma, these developments underscore how regulation, business strategy, and government engagement are converging to shape the industry’s future.

This episode of Pharma Pulse explores the FDA’s new proactive quality review initiative for drug manufacturing, GSK’s $370 million mRNA patent settlement with CureVac, and upcoming discussions between industry leaders and policymakers on strengthening US pharmaceutical innovation and supply chains.

Pharma Pulse: FDA Launches Pre-Check Program, GSK Secures mRNA Settlement, and Pharma Leaders Eye US Investment Boost

 podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I'm your host, and in today’s episode, we’re looking at how grocery-based pharmacies are transforming into vital community health hubs—right in the aisles where you shop.

, Martha Kirkpatrick notes that as major pharmacy retailers pull back on brick-and-mortar locations, a new model is gaining traction: the in-store pharmacy that does far more than dispense medications. In fact, as the pharmacy desert crisis worsens across rural and underserved communities, these embedded healthcare touchpoints are evolving to deliver clinical services, nutrition counseling, and even real-time patient education.

Pharmacists are stepping up as frontline providers—offering point-of-care testing, immunizations, and chronic disease management, especially in areas where primary care access is limited. According to recent studies, over 40% of U.S. counties now qualify as pharmacy deserts. In this new care landscape, pharmacists aren’t just filling prescriptions—they’re filling critical care gaps.

And it doesn’t stop there. The grocery setting opens the door for what experts are calling “food-as-medicine.” Patients are receiving guidance on how nutrition ties into conditions like diabetes or hypertension—sometimes just steps from the produce aisle. This is more than a trend; it’s a shift toward whole-body, preventive care in everyday settings.

To support this transformation, pharmacies are also turning to digital tools to boost health literacy and combat misinformation. Companies like Mesmerize are providing tailored video education directly through in-store screens. These displays help patients ask smarter questions, make informed choices, and stay engaged with their health—all in real time.

AI is playing a growing role too, helping validate health content and power visuals that are both accurate and accessible. Messaging can even be locally targeted—for example, raising awareness when a regional pharmacy adds point-of-care testing services.

Importantly, this model is cost-free to the pharmacy. Support includes everything from screen installation to IT coordination, funded by health-conscious sponsors who recognize the value of reaching engaged audiences in healthcare settings. It’s a win-win—patients get better access and education, and pharmacies become true community health anchors.

So what’s next? As care continues to decentralize, grocery-based pharmacies are perfectly positioned to lead. They're merging clinical services, everyday convenience, and trusted health education—all while supporting underserved communities.

This episode of Pharma Pulse examines how in-store pharmacies are evolving beyond prescriptions to deliver clinical services, nutrition support, and real-time education, bridging care gaps in pharmacy deserts across the United States.

Pharma Pulse: Redefining the Pharmacy Aisle

How recent executive orders—both under the Biden and Trump administrations—have reshaped the drug pricing landscape, and the legal challenges or uncertainties they present for pharmaceutical companies

What life sciences companies should be doing now to proactively prepare for further executive action on drug pricing and market access

The key differences in how executive policies versus legislative actions affect the pharma industry’s pricing and commercialization strategies

The legal and strategic risks executive policy shifts pose to investors and biopharma leaders who may be planning product launches or portfolio expansion over the next few years

Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

How Recent Executive Orders Impact the Drug Pricing Landscape

An FDA Form 483 cited unaddressed contamination, pest infestations, and equipment failures at manufacturer’s Bloomington, IN facility, which was acquired in the Catalent buyout. 

Novo Nordisk’s Indiana Plant Flagged by FDA for Contamination and Safety Lapses

Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain. 

White House and EU Finalize Trade Deal With 15% Cap on Pharma Tariffs

The company will be heavily investing over the next decade to build a new biopharmaceutical facility in Holly Springs, NC, creating 120 jobs and reinforcing its $55 billion pledge to strengthen US manufacturing, R&D, and innovation.

Johnson & Johnson Commits $2 Billion to North Carolina Manufacturing Expansion

The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.

Catalent to Lay Off 350 Workers at Baltimore Gene Therapy Plant 

Peer Exchange: Building the Next Generation Supply Chain Talent Pipeline (Episode 9)

 roundtable discussion, Nicholas Saraceno, editor of 

 and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, and the growing importance of data management in achieving these goals.

The pharmaceutical supply chain is a multi-stage system encompassing: research & development; manufacturing; distribution: pharmacies and healthcare providers; and patients.

This system plays a vital role in supporting both individual and public health. It ensures patient safety by maintaining drug quality, authenticity, and regulatory compliance. Additionally, it supports public health by providing consistent access to essential medications and vaccines. During times of crisis—such as pandemics, natural disasters, or supply disruptions—the supply chain becomes even more critical for delivering life-saving therapies and maintaining stability. Efficient supply chain logistics also contribute to cost control,

helping reduce healthcare spending and improve the affordability of medications.

Ultimately, a resilient, transparent, and well-managed pharmaceutical supply chain is foundational to maintaining global healthcare systems. It ensures that patients receive the medications they need when they need them, and that providers and manufacturers can work collaboratively to meet evolving challenges in healthcare delivery.

The panel consisted of Dave Malenfant, an expert that specializes in optimizing the supply chain through innovative solutions for people, processes, and technology; Opeyemi Odusami, a seasoned professional with over 12+ years of experience and 10+ years at Sanofi; and Bob Celeste, Founder, Center for Supply Chain Studies, and Executive Director, Open Credentialing Initiative (OCI).

Each expert brought distinctive perspectives on the value of the pharmaceutical supply chain, including techniques for resilience.

Malenfant highlighted offers a holistic, circular model defined by seven stages: plan, source, make, deliver, sell, sustain, and return. This perspective emphasizes the importance of viewing the supply chain as an interconnected system, where resiliency depends on maintaining strong links across all stages. Each segment can have its own strategy, but the key is ensuring smooth, uninterrupted flow of both materials and data from end to end. Disruptions—such as current hospital drug shortages—often reflect failures at earlier stages, like sourcing or manufacturing. For instance, many shortages stem from the inability to obtain active pharmaceutical ingredients (APIs), which then ripple down the chain. He encouraged the audience to think of resiliency not just as a concept, but as an ongoing process of identifying weak links and implementing strategies to strengthen them, thereby ensuring the continuity and stability of the entire supply network.

Odusami added that supply chain resiliency involves not only responding to crises but also anticipating and preventing them. In addition to maintaining a synchronized supply chain—from purchasing and manufacturing to logistics and distribution—companies must build adaptability into their systems. This means being prepared for disruptions while also using data and planning to predict future issues. A resilient supply chain ensures continuity in drug delivery to patients, even during crises. Aligning all parts of the supply chain is key to maintaining consistent access to medications and protecting public health in the face of unexpected challenges or shortages.

As for Celeste, he noted that as more regions like the United States and Europe adopt product serialization, data and product misalignment has become a growing challenge in the pharmaceutical supply chain. In the US, such mismatches often result in products being placed in quarantine, with limited time and space to resolve the issue before the product is returned or removed. A key aspect of supply chain resiliency is the ability to efficiently manage these exceptions to avoid disruptions. Since serialization errors can escalate quickly, developing systems to handle data alignment and resolve issues promptly is critical to keeping products moving through the supply chain.

The panel also dove into risk mitigation; the handling of drug shortages, and crisis management; ensuring product quality across global manufacturing sites; dealing with counterfeit products; the Drug Supply Chain Security Act (DSCSA); the importance of a developing a deep talent pipeline; sustainable practices; and much more.

In the ninth part of this roundtable discussion, industry experts discuss how the pharma supply chain is evolving into an integrated business planning function, highlighting the need for diverse skill sets, digital dexterity, and AI-enabled capabilities to prepare Gen Z and future leaders for patient-centric problem solving.

Peer Exchange: Building the Next-Generation Supply Chain Talent Pipeline (Episode 9)

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.

What Supply Chain Leaders Need to Know About COVID Vaccine Policy Uncertainty

, Ron Lanton, partner at Lanton Law, discussed the high-stakes implications of a new lawsuit filed by leading medical organizations to restore access to COVID-19 vaccines for children and pregnant people. Lanton explained how the case reflects deeper tensions between scientific standards, federal authority, and political influence, while also outlining what pharmaceutical supply chain leaders should watch for in terms of compliance, risk, and operational impact.

PC: Given the recent lawsuit filed by major medical organizations to restore access to COVID-19 vaccines for children and pregnant people, how might this legal action influence federal authority over vaccine distribution, and what should pharmaceutical supply chain leaders be watching for in terms of compliance risk and operational impact?

The lawsuit seems aimed at challenging federal policies on COVID-19 vaccines, but it faces significant hurdles. The plaintiffs argue that Robert F. Kennedy Jr.’s actions lacked both a legal and scientific basis. There is strong research supporting vaccine effectiveness, and it’s not clear what scientific rationale underpins some of HHS’s decisions.

That said, the lawsuit may have limited impact because of its timing and the nature of Kennedy’s involvement. His actions relate more to guidance than outright bans. He’s not formally refusing or blocking access to vaccines—it’s more of an informal way of restricting access. For example, the agency’s current immunization schedule states that children ages six months to 17 years who are not immunocompromised 

 receive a COVID-19 vaccine, but it frames this as a shared decision between clinicians and parents. That framing raises questions about how federal agencies are being held accountable to long-standing scientific standards, especially as those standards become increasingly politicized.

For supply chain leaders, the key is to monitor not just this lawsuit but broader policy developments within HHS and CMS. Agencies are adjusting vaccine guidance in real time, and many of these changes aren’t publicly debated or transparent. The rollback of the Richardson waiver, for example, means the public no longer sees draft rules, proposed changes, or comments before implementation. That reduces oversight and makes it harder to anticipate regulatory shifts.

Ron Lanton, Partner, Lanton Law, warns that shifting federal policies and ongoing lawsuits could create compliance challenges and operational risks that pharmaceutical supply chain leaders must closely monitor.

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