. He can be reached at nsaraceno@mjhlifesciences.com.

Nicholas Saraceno, Editor

LogiPharma USA 2025: Challenges Currently Impacting the Temperature-Controlled Space

In a recent panel discussion on supply chain security, Krenar Komoni, founder and CEO of Tive, emphasized the growing importance of collaboration among vendors, logistics providers, and technology companies to combat evolving threats in the industry. The conversation highlighted two main types of theft impacting the supply chain: direct theft, where goods are physically stolen from trailers or containers, and strategic theft, a more sophisticated form involving social engineering tactics where fake carriers impersonate legitimate ones to intercept shipments.

To address these risks, panelists discussed a multi-layered security approach. Tools like carrier vetting software, GPS trackers, seals, and even armed escorts were identified as part of a tiered defense system. Komoni stressed that no single solution can fully secure a supply chain; rather, companies must integrate multiple protective measures into their operations to build resilience.

A major highlight of the discussion was the shift in the pharmaceutical industry from passive monitoring to real-time tracking, accelerated by new technologies like the Solo Pro device. This transition enhances visibility and responsiveness in managing high-value or sensitive shipments.The panel also explored how closer partnerships between logistics providers, shippers, and tech firms are strengthening the supply chain. This “triangle” of collaboration allows for better implementation and use of advanced technologies, increasing trust and efficiency across the board.

Looking ahead, Komoni noted that AI and automation will play a larger role in supply chain security, helping to predict threats and streamline operations in a rapidly evolving environment. The session concluded with a clear takeaway: securing the supply chain requires continuous adaptation, strong relationships, and layered, technology-driven solutions.

A transcript of Komoni’s conversation with 

What challenges are currently impacting the temperature-controlled space?

 So the temperature control space and all the various companies, especially in the pharmaceutical side, they're going through a transition phase, which I call it, going from passive to real time. And it's taking its time. And I wish we were there sooner, but there's a lot of reasons why we're not there yet. Technology providers haven't moved as fast we're finally just for instance, with dive, we released a solo pro device, which is a pharma specific real time tracker that meets all the 21 CFR Part 11 requirements. It's GXP compliant. And to be able to move everything from passive to real time, it's gonna take a little bit longer time. Call it another 12 months, maybe 24 to 36 months max. But this is one of the challenges right now, is this transition, and what comes with this transition as everything becomes more real time. Now, various workflow automations that need to be in place suddenly can actually work. And with AI and these workflow automations, customers are going to be able to get benefit from the real time data and see their costs go down, their quality go up, and customer experience improve.

Videos

Krenar Komoni, founder and CEO of Tive, highlights the transition in pharma from passive to real-time temperature control, noting delays in technology adoption but emphasizing how AI and automation will soon drive cost savings, improved quality, and stronger customer experience.

 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 diving into Mark Cuban’s bold disruption of the prescription drug market, AstraZeneca’s latest investment in US manufacturing, and Bristol Myers Squibb’s multibillion-dollar move into RNA-based medicines.

Entrepreneur Mark Cuban’s Cost Plus Drugs is shaking up the healthcare landscape by showing that 

 for affordable prescriptions. The company’s direct-to-consumer model sells generic drugs at transparent prices, offering patients savings that often surpass traditional insurance copays. Industry experts say this model is forcing payers and PBMs to re-examine drug pricing structures, while providing uninsured and underinsured patients with an accessible, simplified alternative.

AstraZeneca is expanding its Virginia facility financial commitment

, raising its total investment to $4.5 billion as part of its broader strategy to strengthen US-based production. The expansion will support the company’s biologics and antibody-drug conjugate pipeline—key areas of growth in oncology and immunology—while boosting domestic supply chain resilience amid global manufacturing shifts.

Lastly, in biopharma M&A, Bristol Myers Squibb announced a 

$1.5 billion acquisition of Orbital Therapeutics

, a company specializing in RNA-based medicines. The deal underscores BMS’s commitment to expanding its early-stage research portfolio in genetic and immune-mediated diseases, as the company aims to diversify its revenue base ahead of key patent expirations later this decade.

From cost transparency and domestic manufacturing to next-generation RNA innovation, these developments reflect a fast-evolving landscape for pharma strategy and patient access.

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

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

Podcasts

This episode of Pharma Pulse covers how Mark Cuban’s direct-to-consumer pharmacy is challenging traditional drug pricing models, AstraZeneca’s $4.5 billion investment to expand its Virginia manufacturing site, and Bristol Myers Squibb’s $1.5 billion acquisition of Orbital Therapeutics to advance RNA-based medicines.

Pharma Pulse: Mark Cuban Disrupts Drug Pricing, AstraZeneca Expands US Manufacturing, and BMS Bets Big on RNA Therapeutics

AI’s Next Step in Pharma Quality: From Detection to Closed-Loop Prevention

According to Shawn Opatka, VP and GM Honeywell Life Sciences, nearly all organizations—about 99%—are engaging with artificial intelligence in some capacity, though the degree and focus of implementation vary widely. Many companies are piloting AI tools within quality, regulatory, and traceability operations to address persistent challenges such as labor shortages, skills gaps, and the overwhelming volume of data inherent to modern pharmaceutical operations.

Opatka emphasized that while AI experimentation is widespread, the industry remains in the early stages of full-scale deployment. Companies are still testing how best to integrate AI into regulated environments, where oversight and validation requirements remain stringent. This experimentation phase, he suggested, reflects a broader willingness within pharma to embrace innovation while maintaining compliance with evolving standards for data integrity and product oversight.

Ultimately, the sector’s cautious but active engagement with AI represents a balancing act: driving efficiency and insight through automation and predictive tools while ensuring transparency and control remain uncompromised. As regulators sharpen expectations around digital accountability, AI’s role in improving data traceability, quality assurance, and operational resilience will only grow more central to the pharma enterprise of the future.

He also dives into the biggest risks companies face if they attempt to scale AI solutions without a strong quality and compliance framework in place; the role of AI evolving within pharmaceutical quality systems; the definition of successful AI adoption in pharma; and much more.

How do you see the role of AI evolving within pharmaceutical quality systems, from reactive issue management toward more proactive assurance and risk prevention?

 From a reactive and proactive standpoint, we've actually been doing a bit of that for a while now, and have some adoption with our customers. What we would really like to see and focus on, and starting to see some traction is, closing the loop in the process.

You could take a simple, proactive or reactive example where you present a user with some data and allow them to make a choice based on some data that AI has. It's hey, here's what we think happened, and let them make that decision and finally decide, okay, this is the reason why that happened, but using AI to actually assist the operator, but then close the loop on the process to go back and then provide that data in a way that provides more insight and knowledge in a closed loop. That's really where we're focused on, and I think the use cases that are really exciting.

In the third part of his Pharma Commerce video interview, Shawn Opatka, VP and GM, Honeywell Life Sciences, explains that as pharma quality systems evolve, AI is shifting from reactive problem-solving to proactive, closed-loop risk prevention, enhancing operator insight, decision-making, and continuous process improvement.

LogiPharma USA 2025: The Value of Visibility, Technology, and Trust

In a keynote fireside panel on “The Future of Supply Chain in the Era of Advanced and Specialty Therapies,” industry leaders underscored the growing importance of collaboration across the entire healthcare ecosystem. The discussion, highlighted by insights from McAsey alongside other panelists, explored how new demands in the supply chain are reshaping the delivery of advanced therapies to patients.

The most critical theme was collaboration across all nodes of the supply chain. Unlike traditional models, where stakeholders often operated independently, today’s environment requires a highly integrated approach spanning manufacturers, distributors, providers, and ultimately, patients. This collaborative framework ensures that therapies not only move efficiently through the system but also maintain integrity and accessibility at every step.

Technology emerged as a central enabler of this collaboration. Advanced tools are helping companies improve visibility, track therapies in real time, and strengthen communication across the supply chain. By integrating digital platforms, stakeholders can reduce risks, address disruptions quickly, and provide a stronger assurance of patient outcomes.

Another key theme was the intentional use of physical assets. As therapies become increasingly specialized, supply chains must adapt with precise logistics tailored to these high-value, sensitive products. From controlled storage environments to optimized transportation networks, precision in handling is now a necessity rather than an option.

Finally, partnerships beyond the core manufacturer-distributor-provider triad are proving indispensable. Logistics providers, transit partners, and visibility technology vendors all play a vital role in ensuring therapies are delivered safely and reliably.

Taken together, the panel illustrated that in the era of advanced and specialty therapies, no single entity can deliver care alone. The future of patient-centered supply chains lies in shared responsibility, cross-sector collaboration, and leveraging both technology and physical infrastructure to achieve better outcomes.

McAsey also comments on how advanced therapies are challenging traditional supply chain models; the value of end-to-end visibility, real-time data, and collaboration in reducing disruption and ensuring continuity of care; trends she’s noticed at this year’s LogiPharma USA; and much more.

Could you describe the value of end-to-end visibility, real-time data, and collaboration in reducing disruption and ensuring continuity of care? Also, what trends have you noticed at this year’s LogiPharma USA?

As you think about end-to-end supply chain visibility and the reducing disruptions, I think it's about timing. If a provider understands that something might be late through visibility, through a text alert, through an alert on an ordering portal, they can then better prepare the patient. At the end of the day, it's the patient experience that's really important in the patient cure, or mitigation of whatever they might be dealing with.

That visibility from shipping point to provider or to pharmacy is critically important, but it's the same further upstream of a distributor understanding when a product is going to hit the dock, so that we can prioritize receipt if it's a product that's in short supply or there's an emergency order for, so those components of visibility and timing are really important.

And then product efficacy—if we're shipping refrigerated products and the monitors that are inside those boxes and containers, at least we know throughout the journey of that product whether an excursion has occurred, and therefore then a drug doesn’t get administered to a patient that isn't of the utmost quality.

Also, what trends have you noticed at this year’s LogiPharma USA?

There's a ton of digital, ton of technology, ton of AI ,and a ton of cold chain solutions. I'm kind of looking at all three of them. The questions that these have kind of led to is how to create more efficiency, more visibility, and more efficacy of the drugs that are moving through the pipeline, and how, as a distributor, are we best positioned in making the investments with the right partners to ensure that that happens.

Ammie McAsey, SVP of Supply Chain Operations, McKesson, explains the critical role of real-time visibility, digital tools, and cold chain innovation in ensuring product quality, reducing disruptions, and strengthening patient care.

Nicholas Saraceno, Editor

Articles