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1rem

 interview, Rob Sobie, chief product officer of Intelliguard, a provider of hospital medication management and data intelligence solutions, discusses:

The key challenges that hospitals are currently facing

Why he believes that the drug supply chain is failing

Successes surrounding the implementation of RFID technology

A high-level overview of the Drug Supply Chain Security Act, along with his thoughts on the latest exemptions that were recently announced by the FDA

Rob Sobie outlines the importance of supply chain transparency for the benefit of patients.  

The Impact of RFID: Enhancing Medication Management

 interview, Steve Silvestro, president of OptimizeRx, a digital communications platform, details:

The benefits to integrating direct-to-consumer (DTC) and healthcare provider (HCP) marketing strategies with technology, especially for patients and providers

The application of artificial intelligence (AI) toward the pharma marketing stage of commercialization

Ways that pharma marketers can navigate the rapidly changing landscape of state-level consumer privacy legislation

Recommendations for pharma brands as they start to think about 2025 planning

Steve Silvestro explains the value of artificial intelligence in launch plans, benefits to integrating DTC and HCP marketing strategies, and more. 

Incorporating AI into Commercialization Plans

Exploring the importance of contract development and manufacturing organizations in advancing the latest technology for effective delivery of temperature-sensitive medicines.

The Role of CDMOs in the Pharma Cold Chain Machine

How can stakeholders prepare for changing therapy requirements?  

LogiPharma Europe 2025: Reevaluating One’s CGT Value Chain

A keynote presentation describes how supply chain visibility should rely on digital capabilities. 

LogiPharma Europe 2025: Being a Part of an AI-Powered E2E Supply Chain

Taking stock of today's gains and tomorrow's potential for generative artificial intelligence in reshaping the industry.

Beyond the Hype: GenAI’s Real Impact on Life Sciences Manufacturing

The parties aim to create an end-to-end digital thread that links research data all the way through to life sciences manufacturing.

Siemens Inks $5.1 Billion Deal for Dotmatics

Innovation in Core Therapeutic Areas

PC: Over the next decade or so, what can we expect from Novartis from an innovation/tech perspective? What future plans are in the works?

I shared the key focus areas we have in terms of therapeutic areas. Our four core therapeutic areas are oncology, cardiovascular and metabolic diseases, neuroscience, and immunology. These are the areas where our R&D and imaging teams are relentlessly focused.

We are leveraging four key technology platforms: small molecules, biologics, cell and gene therapy, xRNA, and radioligand therapy. All of these platforms are active, ready to be deployed, and supported by a robust pipeline coming through operations.

It remains to be seen which specific molecule will ultimately succeed, but given the depth of our pipeline, we anticipate several potential breakthroughs. From an operations standpoint, we must ensure we’re ready to deliver these innovations to patients as soon as they become available—and that’s something we’re deeply passionate about.

Beyond the five current platforms, we also have a sixth platform on the horizon, driven by our strong innovation engine in R&D.

At LogiPharma, Steffen Lang outlined Novartis’ vision as a focused medicines company, emphasizing its ongoing transformation across operations to support the delivery of individualized, next-generation therapies. With many of today’s treatments tailored to smaller patient populations, Novartis is reimagining how it forecasts, manufactures, and delivers medicines to meet evolving patient needs.

A central theme of the discussion was the elevation of operations as a strategic function. No longer viewed as a purely tactical task, operations now serve as a key enabler of innovation—particularly as technological advancements drive significant changes across the value chain. To support this, Novartis prioritizes investment in the right talent, skills, and environment, enabling its teams to adopt and apply cutting-edge technologies in meaningful ways.

Technology was highlighted as a critical driver of transformation. At Novartis, digital tools are not implemented for their novelty, but for their measurable impact on key outcomes—such as GMP compliance, patient safety, environmental sustainability, supply reliability, and cost efficiency. From planning and forecasting to manufacturing and distribution, technology is embedded end-to-end to ensure patients receive their therapies on time, every time.

Looking ahead, Novartis remains focused on four core therapeutic areas: oncology, cardiovascular and metabolic diseases, neuroscience, and immunology. The company’s pipeline is supported by five key technology platforms—small molecules, biologics, cell and gene therapies, xRNA, and radioligand therapies—with the expectation of a sixth platform emerging in the near future. Operations teams are preparing now to scale delivery once these products are ready.

Finally, Lang noted key areas for continued industry collaboration, including digital transformation, sustainability, and workforce training. As Novartis continues to pioneer new ways to bring breakthrough therapies to patients, the company remains committed to sharing insights and driving collective progress across the pharmaceutical ecosystem.

Steffen Lang, president, operations, executive committee member, Novartis, discusses what to expect from Novartis over the next decade in terms of technological innovations. 

Latest Conference Coverage

LogiPharma Europe 2025: Driving Innovation in Core Therapeutic Areas

A Change in Healthcare Education and Provider Awareness

, Colin Banas, MD, DrFirst’s chief medical officer, describes have many Americans face significant challenges in accessing GLP-1 drugs due to their high cost. Despite the growing popularity and usage of these medications, which were originally developed for diabetes treatment, the price remains largely unchanged. Even with insurance coverage, patients often encounter co-pays or out-of-pocket expenses upwards of $500 to $600, making the medications unaffordable for many. Research indicates that once out-of-pocket costs exceed $100, medication adherence drops dramatically, further limiting access.

Additionally, insurance companies frequently require patients to try other medications first, a process known as step therapy, which can delay access to GLP-1 drugs. The drugs' weight loss benefits have garnered attention, but insurance companies still primarily cover them for diabetes treatment, leaving individuals seeking them for weight loss without coverage options. Moreover, as ongoing research uncovers more potential benefits of GLP-1 drugs—such as their positive effects on cardiovascular disease, Alzheimer's, and chronic kidney disease—insurance policies have not yet adapted to these expanded uses. As a result, many Americans who could benefit from these drugs for conditions beyond diabetes find that coverage is not available.

Banas also comments on patients turning to direct-to consumer (DTC) platforms following insurance denials; rumors of DTC advertising being banned; and much more.

What are your thoughts on the rumors that RFK Jr. could potentially ban DTC advertising?

As a provider it might be mixed, but there's actually an interesting consequence of DTC ads, and it is conversation and it is education, meaning, as a provider, I am also exposed to what my patients are being exposed to. I see the advertisement at the Super Bowl, or the flyer in the magazine or the web page. A lot of these therapies, a lot of these drug classes, are brand new and accelerating so quickly that it is actually very hard to keep up.

In a roundabout way, if I see that, and if I'm bombarded with it as a provider, I actually take that as a cue to, ‘oh, I need to educate myself,’ not necessarily on that drug in particular, but on that therapy class. The reason is, ‘wow, there's something new that's out there. I should be on top of it,’ and, ‘oh, I think I'm going to get questions about this.’ I do think that's an interesting side effect of DTC.

The other thing I'll say about RFK—there are a lot of things on pause right now. There's a lot of trepidation, especially in the health IT world. What is going to happen with existing road maps, around interoperability, around some of the CMS initiatives that providers are participating in? I will say it does seem to be a tech-forward administration, and so I do think there's going to be advances—maybe even accelerations—in artificial intelligence, hopefully in interoperability, and the digitization of the medical record. Because a lot of these things can't be accomplished without data, and you can't get the data unless you're collecting it, aggregating it, and using it in an appropriate way.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Colin Banas, MD, DrFirst’s chief medical officer, shares his thoughts on the rumors that RFK Jr. could potentially ban DTC advertising.

Reasons Behind the Rising Popularity of DTC Online Prescription Services

As also noted by the iPrescribe survey, what are the primary reasons why 52% of respondents choose DTC online prescription platforms?

At first, I was like, ‘wow, that's crazy.’ And then I was like, ‘oh no, that actually makes sense.’ There are a couple things that come to mind. I'm still an actively practicing physician, although not nearly as comfortable in the outpatient space as I am on the inpatient space. I was a hospitalist, but a lot of patients may not want to bring these things up with their doctors. For whatever reason, a lot of patients may feel—like I spoke about earlier—that they're not going to qualify for that particular therapy, or that they've been down this path with their doctor before, and the doctor is just simply not going to prescribe it. ‘I've tried this before. My doctor is a stickler for this sort of thing.’ 

There’s a little bit of, I don't want to say gaming the system, but finding your sweet spot for your providers, and sometimes, whether it's comfort, whether it's the ability to access your primary care doctor, which I mentioned before can take months sometimes. The third thing—until recently, and the survey actually bears this out, but if you had asked me these questions two years ago, I would have almost guaranteed you that primary care doctors, internists, family doctors, were not writing for GLP-1s. I can almost guarantee it because it was this new diabetic medication that was on the scene, and I'm telling you that as an internist myself, there's a certain ‘we're comfortable with insulin, we're comfortable with metformin and glipizide,’ and maybe some of the other SGL2 inhibitors. I'm sorry I'm using all this jargon, but some of these other medications.

Once you hit a certain threshold, you're like, ‘I need an endocrinologist. I need a specialist. This is out of my comfort zone.’ And as the data started coming in, folks had to get more and more comfortable with it. You actually see internists prescribing this at a higher rate, year-over-year. You even see OBGYNs writing for these particular drugs, because a lot of times, women are using their OBGYNs as their primary care doctors, but two years ago, that wasn't the case.

You can imagine there's this sort of—as the industry catches up, or as folks get more and more comfortable with this—maybe patients don't realize that their doctor is indeed comfortable with this medication, and so they go looking for alternative. Again, not overly surprised. They certainly make it easy. It is easy to do these things on these DTC platforms, intentionally so.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Colin Banas, MD, DrFirst’s chief medical officer, uncovers the main reasons why 52% of respondents choose DTC online prescription platforms.

The Growing Role of DTC Healthcare

An iPrescribe survey found that many patients turn to DTC platforms following insurance denials. How can these platforms address these challenges more effectively in order to better serve patients?

It's an interesting survey that you brought up, and there really were two big revelations that came out of it. I'm not sure that anybody would be surprised by them. Like you said, about a third of the time, it was related to cost as a reason to go DTC, whether it was insurance doesn't cover it, or out of pocket is simply too much when I go to my local retail pharmacy. The other one was convenience, which we can set aside and talk about in a second, but DTC is filling a need. I would consider it an access need.

It's providing a convenient way for access and options. In the old days, I had one option, I'm going to go to my doctor, and I'm going to wait to get on the waiting list. Maybe in six months, I'll finally get in to see them, and in my 15 minutes, I might be able to rattle off all of my chronic diseases and concerns, and maybe weight loss will bubble up to the top. Hopefully, if my doctor knows about this particular therapy, is comfortable with this therapy, and is educated, maybe I might qualify. You can imagine, as we've become so used to instant access in other areas of our lives—think about retail, think about banking, think about aviation—all these things are available at the touch of our app on a phone or a mobile device.

It becomes accessibility, it becomes option. And then there’s competition. In the United States, competition among all of these various accessibility options potentially leads to alternatives, whether it's alternative therapies, alternative costs, things like that. I am not surprised in the slightest that DTC has become a bigger and bigger portion of the way Americans seek healthcare. In fact, some of the pharmaceutical manufacturers actually are offering their own DTC now. I think of LillyDirect as one of the pioneers in that space.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Colin Banas, MD, DrFirst’s chief medical officer, explains the rise in patients turning to DTC platforms following insurance denials.

Futureproofing Pharma Supply Chains 

, Brad Stewart, BDO’s national life sciences co-leader, describes the challenges that tariffs may pose to reshoring manufacturing services in the life sciences industry. He highlights the complexity of supply chains in this sector, which are large, long, highly-regulated, and slow to change. Given that future administrations may alter tariff policies, reshoring decisions need to account for the potential reversal of these changes. While it can be more expensive, prioritizing U.S.-based manufacturing capacity can help de-risk supply chains, particularly as tariffs and uncertainty continue to affect global operations.

Stewart emphasizes that the life sciences industry’s supply chain is not limited to finished products but also includes raw materials and components sourced from different countries. Drug substance production often occurs in one country, with fill-finish processes in another. The unpredictable nature of tariffs on goods at various stages of production further complicates the situation, especially when combined with issues like transfer pricing and taxes. These complexities require companies to develop strategies to better manage these risks.

To address these challenges, Stewart suggests that life sciences companies focus on minimizing risks by moving more of their manufacturing capacity back to the U.S. While this may come at a higher cost, it offers the benefit of stability in the face of changing tariffs and taxes. Stewart notes that building new manufacturing capacity in the U.S. is expensive but advisable for companies planning long-term investments, as it allows them to better manage risks and focus on their core mission of producing life-saving products.

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.

How can artificial intelligence help support pharma leaders with managing their supply chains and addressing potential material shortages?

 That's the question for the last two years is: how does AI really change what we're doing here? Specifically, in the supply chain, i'ts one of those areas where people are starting to use AI, which is helpful, and as I said earlier in a question, you really want to make sure that you understand your supply chain. You have backup suppliers, but you're also managing your inventories, and sometimes, when things are uncertain, you hold larger inventories just to minimize your risks, and I think that's really where people have the opportunity to use AI right now—trying to understand where weaknesses are in their supply chain, where critical parts are that they don't necessarily think about.

Let's just say there's tubing or certain bags you use, or a buffer you use all the time, and on the surface, it seems to not be a problem, because you always have it in stock. There're no complaints, but what you don't realize is you have a six-month lead time for that buffer because it's something that you have custom made, or it's shipped from somewhere else. You just have a really great person in your supply chain group who always knows to order it nine months ahead of time, and keeps a close eye on inventory to make sure you have it because they've been there long enough to understand it's a constraint in your supply chain.

I think that's really a huge opportunity. We sometimes have humans who understand what they're doing so well that it seems obvious. It seems like everything's working well, but what you don't realize is if that person leaves or retires or something else, that suddenly breaks down. I think that's a chance with AI to look for those non-obvious weaknesses in your supply chain. It's certainly an opportunity too for financial people to try and model what would happen. What’s my cost of goods going to end up being if next month, there's a 20% tariff from all my raw materials coming from this country, or a 50% tariff, whatever it may happen to end up being from all my raw materials there.

They can then start thinking through those different potential scenarios and saying, well, maybe the least risky thing for me to do is to import it for my company that the tariffs are 20% now, but supply is adequate. I know I can get it whenever I need it, I have a good relationship with that supplier, and it may not be worth saving a little bit of money with someone that I'm uncertain that I'm going to get supply from.

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, addresses how AI can help support pharma leaders with managing their supply chains and addressing potential material shortages.

Overcoming Health Data Blockages in Polypharmacy

, Tom Dorsett, CEO, RazorMetrics, describes how polypharmacy refers to the use of five or more medications by an individual, and it is becoming an increasingly prominent issue in the United States. Polypharmacy has been recognized for years but is growing more significant, especially within Medicaid, Medicare, and large commercial sectors, including self-funded employers.

One of the key drivers of this rise is the growing number of chronic conditions, which affect a large portion of the adult population. Around 40% of adults in the US have four or more chronic diseases, contributing to the increase in polypharmacy. Furthermore, among the working adult population between 40 and 79 years old, 24% are impacted by polypharmacy, a trend that continues to grow. This issue highlights the complexity and challenges of managing multiple health conditions and medications in an aging population, leading to potential risks related to drug interactions and overall healthcare management.

Dorsett also explains why he believes this concept is such an overlooked driver of unnecessary spending and adverse health outcomes, strategies that should be taken to overcome health information exchange blockages, and much more.

What strategies should be taken in order to overcome the health information exchange blockages that are associated with polypharmacy and its cascade of side effects?

 What the US healthcare system lacks at this point is ample health information exchange. We did a really good job back with the HITECH [Health Information Technology for Economic and Clinical Health] Act back in 2008, where $22 billion was put out there for the mass adoption of electronic health records. By and large, the whole system is electronic at this point, but those systems still experience data blocking. The 21

 Century Cures Act has gone a long way in trying to remove those blocks between health organizations—they don't necessarily like to share that information because it makes it a lot easier for the patient to go over to another health system if their data is readily available.

The other issue is that EHR vendors themselves don't necessarily like to play ball in that regard. What this creates is a situation where you've got these EHRs not talking to each other. If I go see my cardiologist at one system and am prescribed a statin for my high cholesterol, and for whatever reason, maybe I get referred because I'm on a health plan where you have to have a referral, I get referred over to another system. I might go in, and if I'm not really highly aware of the particulars of the medication, and I don't mention that I'm already on it, they're not going to have any visibility to that at this other institution, and they may prescribe me another statin. This happens all the time.

My co-founder, Dr. Siva Mohan, is a semi-practicing Interventional Cardiologist at Emory, and he sees this almost every day. He practices at Emory, and then patients go over to Piedmont and get prescribed another statin. You have that duplication, which can be very dangerous, and it's due to the fact that they aren't communicating. It’s not their fault—it's just that the systems aren't built to do that in most cases. That's one of the areas where we're able to help, because we see a holistic view through the claims of all the medications, but the duplication issue is a big problem too with polypharmacy.

I think if that can get ironed out at some point, it's been a huge challenge, and maybe they're able to fix it through some sort of government-run utility. I think that's probably what it'll take. They tried to do it by doling out a bunch of money at the same time they were doing the EHR subsidies for physicians and institutions, but by and large, any sort of organization that was trying to exchange information could go purchase their own application or network to do this, and even those wouldn't talk to each other. It largely failed, sadly, and it's really gone a long way towards creating this issue.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Tom Dorsett, CEO, RazorMetrics, shares the strategies that should be taken to overcome health information exchange blockages.

Enhancing Pharma Supply Chain Transparency and Trust

, Laura Johnson, senior director of sales, life sciences, Loftware, discusses how supply chain collaboration is becoming increasingly important, particularly in the life sciences and pharmaceutical sectors. According to Johnson, the adoption of cloud-enabled collaborative supply chains is crucial for improving real-time data sharing. This enhances visibility and coordination among internal stakeholders, external suppliers, co-manufacturers, and co-packers, who all play a role in the complex supply chain process.

This collaboration leads to faster decision-making and reduces operational costs, resulting in greater agility. Pharmaceutical organizations are better able to respond to market changes, regulatory updates, label changes, and potential disruptions. In addition, cloud-based systems facilitate regulatory compliance and advanced analytics, enabling more accurate demand forecasting. These systems also optimize inventory management, which directly contributes to improving patient outcomes and accelerating the time to market for new therapies.

Ultimately, cloud-based collaborative supply chains help streamline operations, reduce costs, and improve the overall efficiency of the pharmaceutical industry, benefiting both companies and patients.

companies are exploring new ways to ensure that their products and shipments are protected, why the demand for supply chain transparency is continuing to gain momentum, and much more.

Why is the demand for supply chain transparency continuing to gain momentum, and what role are track-and-trace initiatives playing in that effort?

I've been in the industry for a while, so I was around doing and providing solutions to support, track and trace way back in the beginning. You mentioned RFID was certainly a hot topic, and it continues to be. I think that companies are continuing to embrace track and trace. There's a better understanding that the technology has certainly improved immensely over the past 10 to 15 years, so I think it's easier for them to adopt and get the support, and the funding and things that might be needed to deploy these types of systems.

In general, the adoption of track and trace in life sciences certainly enhances the supply chain transparency. It provides that real-time monitoring of products across the network, from production all the way to patient delivery. I think that's really what the intent of it was back when we started focusing on it, deploying sterilized product, as well as the tagging in different ways, whether it's RFID or two-dimensional barcodes, which are a little bit harder to counterfeit than a standard linear barcode. Getting back to track and trace, it certainly improves regulatory compliance as well, and if needed, it can lead to the ability for brand owners or manufacturers to be able to act very swiftly or quickly, should a recall or something else be needed.

In my opinion, by leveraging technology, organizations can improve data accuracy. They reduce inefficiencies often seen when a brand owner is working with a co-packer or another trading partner, and having track and trace across the entire network certainly helps to build trust with these different stakeholders and eventually the consumer.

In the third part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, discusses why the demand for supply chain transparency is continuing to gain momentum, while also explaining the role that track-and-trace initiatives are playing in that effort.

AI's Role in Shaping the Future of Pharmaceutical Development

chair of the FDA Regulatory practice at Lowenstein Sandler, discusses the potential impact of upcoming tariffs on pharmaceutical supply chains, focusing on Canada, Mexico, and China. He believes that tariffs on Mexico and Canada would have minimal effects on supply chains, as the pharmaceutical industry sources relatively little from these countries. The real concern lies with China, which is a major supplier of active pharmaceutical ingredients (APIs) and finished drug products. A significant portion of recent pharmaceutical deals has involved licensing Chinese drugs, which could be affected by tariffs if they disrupt supply chains.

If the relationship between the United States and China worsens, tariffs could have a more substantial impact. Specifically, they might increase the cost of generic drugs, since China is a crucial supplier for these products. Despite this, Shehan notes that many generic drugs are already extremely cheap, with some prescriptions costing just a few cents. Even if prices doubled, it may not drastically affect consumers. Specialty generic drugs, however, could see more noticeable price increases.

He also points out that if trade tensions extend to regions like the EU, India, or Japan, the situation could change. A broader trade conflict could influence drug prices, especially for certain medications. Overall, while tariffs on China may increase drug prices in the short term, the full impact will depend on the nature of global trade relations and the extent of supply disruptions.

Shehan also comments on how he believes the new administration will influence FDA approval processes for commercial products, other specific regulatory updates that drug developers should be closely monitoring in the current landscape, and much more.

How do you anticipate the evolving regulatory environment impacting the future of pharmaceutical development, especially in the context of emerging technologies like AI?

To me, AI is an extension of technology that already exists out there, an improvement. But, like in some other applications, I don't think it's as big a change, because people have been using advanced computing techniques in this area for quite a while. It'll be interesting if we're able to shorten development times. I think that can be very promising area.

Perhaps you're able to use AI to better define the patient populations that drugs should be tested in and approved for, so you end up in a world where you have more customized drugs, and perhaps those have a shorter development pathway and an approval process. That's pretty exciting. I go to conferences, and you hear a lot of talk about the possibilities. Now, we just need to kind of conceptualize them.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jim Shehan, chair of the FDA regulatory practice at Lowenstein Sandler, explains how he anticipates the evolving regulatory environment impacting the future of pharmaceutical development, especially in the context of emerging technologies like AI.

The Value of Workforce Development and Advanced Data Tools

, Jenna Dale, direct of client relations at Cencora, shares how pharmaceutical manufacturers are able to handle supply chain disruptions. She explains that while these issues may arise due to political or environmental factors, they aren't new challenges for the industry. Manufacturers have faced similar hurdles before and are accustomed to managing risks that affect production. The key to overcoming these challenges, according to Dale, is having a robust continuity plan in place. Such plans help ensure that manufacturing remains uninterrupted, even when external factors like tariffs create obstacles. By identifying potential risks and preparing for them, manufacturers can continue the development and commercialization of therapies despite external pressures.

Dale also comments on key challenges preventing the United States from meeting the FDA’s forecast of 10 to 20 cell and gene therapy (CGT) approvals per year by 2025, the need for continued investment by the FDA in reviewers and staff to support clinical reviews, and much more.

You mentioned the need for continued investment by the FDA in staff to support clinical reviews. What are some specific areas where this investment could have the greatest impact in accelerating approval timelines?

nvestment by the FDA mirrors what we try to see in terms of investment needed on the manufacturing side of things, specifically in terms of the training and development of the workforce. Coming back to that again, these therapies are very novel and complex, and we need a partner, as a manufacturing organization and as a regulatory agency. This consists of really partnering to understand, and training, developing, and investing in the workforce so that ultimately, we can become more proficient, not only in the development but through the reviewers’ lens as well, and expanding the review team.

The FDA has made publicly available statements in terms of their commitment to increasing the workforce. The more that they can expand their teams, the more throughput there's going to be, the more opportunity for collaboration between the manufacturers and the agency. Having that increased volume, coordination, and communication between both parties, I think can only help to expedite the pathway to market. I also think that the development of advanced data analysis tools can be really helpful here.

Looking at very complex clinical data, advancing the technology that can help these reviewers get through data analysis, and really understand the clinical trial data more efficiently and effectively, can help expedite some of the review as well. Continued investment in the regulatory pathways and just development of potentially expedited pathways, or just alternative ways more to engage with the manufacturers more [are also important]. We know that the RMAT (

regenerative medicine advanced therapy) designation 

has been a huge factor for a lot of companies to pursue that and open up additional engagement with the FDA, so I think a continued investment in those areas can really go a long way.

In the third part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, dives into specific areas where FDA investment could have the greatest impact in accelerating approval timelines.

Analyzing Supply Chain Complexities 

, Alex Guillen, global pharma and life sciences director at Tive, highlights a significant concern: the rapid advancement of technology and its potential misuse by organized crime. While technology itself is not inherently dangerous, the pharma industry's slow adoption of emerging tech, such as IoT devices, sensors, and cloud-based integration, has made it vulnerable. Guillen points out that other industries have embraced these technologies much faster, enhancing their security and efficiency, while the pharma sector has lagged behind.

This technological lag creates a critical vulnerability for pharmaceutical companies, especially in supply chain management, where the risk of cyberattacks and system breaches is growing. The fast pace of technological development, coupled with the industry's lack of preparedness to defend against these threats, makes pharma particularly susceptible to malicious activities, including hacking and data manipulation. Guillen emphasizes that the industry's relatively slow uptake of advanced technologies like IoT and cloud computing has left them exposed to potential risks, especially from organized criminal groups leveraging these tools for nefarious purposes.

Ultimately, Guillen suggests that the key challenge for the pharma industry moving forward will be to rapidly enhance its technological capabilities and adopt a more proactive approach to security. By doing so, pharma companies can better protect themselves against the evolving landscape of threats, ensuring that their supply chains remain secure and resilient in the face of these emerging risks.

Guillen also comments on a 2024 report surrounding pharma supply chain security and visibility, what needs to be done in the United States to increase manufacturing output, and much more.

 recently released a 2024 report surrounding pharma supply chain security and visibility. Could you elaborate on some of the highlights of that report?

 I went through the report and for some of the responses that we had, I knew more or less that would be the trend, but for some of them I was quite surprised, actually. When we talk about, for example, one of the biggest threats that companies are seeing today is product tampering and repackaging as one of the major ones. I was trying to see, why product tempering and repackaging? If we acknowledge that the supply chain of pharma is one of the more robust today, I wouldn't expect the biggest concern being product tampering—something happening in the product—because it is an industry which, by definition, is extremely regulated and very secure. Looking back into what could the reason of these concerns could be, for example, on this point itself, it is getting more and more complex. Supply chain complexity that we have today is probably 10 times more complex than we had only 15 years ago. That complexity itself—whether it's components, APIs being manufactured in certain parts of the world, transported across the ocean, while having manufacturing spread in different parts of the world, and then having patients in another part of the world—makes this whole supply chain very complex and very difficult to manage. 

That supply chain has been getting more and more complex through time. Due to this complexity, I can imagine that it becomes more and more difficult to protect product itself because the industry relies more and more on third-party operators. If you take an example of freight forwarders; before, if they could do 70% of it, now, they probably can do 20%, 30% of it, and they have to rely on third-party to do the rest. They cannot be everywhere, so they go to all the other companies. That makes it more difficult for freight-forwarders themselves to actually manage the proper products in the best, proper way. The same applies to the repackaging side.

When I see repackaging, I'm also thinking, if 20 years ago, we had a lot of pharmaceuticals, now, the high value is in biologicals. Biologicals are more complex under packaging, under temperature conditions, and therefore, it becomes more difficult for companies to actually handle those. We saw it through COVID. When it came to the minus 70 degrees Celsius product, the product has to be transported at this temperature. It is industry knowledge right now almost half of that got lost or wasted because of not having the infrastructure to manage it. I think that as temperatures go lower, in terms of new medicine and new therapies, it's going to be a bigger challenge to be able to manage that supply chain, whether it is a handling of the product or whether it is the repackaging of the material.

I think that was one of the first ones that it is driving. The second one is regarding temperature control. We can see that the industry is supposed to be extremely robust in terms of temperature management. Why, all of a sudden, is it so concerned as the biggest risk? I can only associate it with a huge amount of new therapies that are coming on board. If you take, last year in 2023, there were about a handful of cell and gene therapies approved by the FDA, and we see the amount that are going to be approved in 2026 is in the tens of thousands of therapies. This is a huge step up, so I think that as it gets more complex with ultra-cold temperatures, the companies need to progress in infrastructure. That doesn't happen so quickly. I think those areas are quite the biggest, recognized threats from the people we interviewed. 

The last thing that I was surprised about is the concern about theft itself. I went in to dig into some of the information on some of that we know. Actually, the pharmaceutical industry does not have such a huge number of thefts compared to other industries like luxury. Nevertheless, this could represent a fear of the future. This case is not today, but it could happen, and why it could happen is a complexity that I think some customers are just having a hard time to grasp. So those are the three areas: two of them are quite clear—trying to figure out the reason—one of them I was surprised, but it could be just a fear for the future. I will need more analyzing to find out. Maybe at LogiPharma, we get more information on if this fear is really out there, but those are definitely the three areas that I was quite impressed with.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Alex Guillen, global pharma and life sciences director at Tive, describes the highlights of a recent pharma supply chain security and visibility report that his company released.

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