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1rem

 interview, Vibhu Tewary, project director, IQVIA Institute for Human Data Science, discusses:

Highlights of the company’s report surrounding the “Long-term Market Sustainability for Infused Biosimilars in the US: Foundational Analytics on Emerging Risks to Sustainability”

The process that constructing and piecing together a report of this magnitude entails, along with where the idea itself came from

The ongoing challenges surrounding ASP-based reimbursement

A closed-door, multi-stakeholder virtual roundtable (based on his original report) that was previously held

Vibhu Tewary offers insight on this market segment, including a behind-the-scenes of what goes into designing a report. 

The Path Forward for Infused Biosimilars in the US

 interview, Mark Bouck, chairman and CEO of PharmAlliance, a pharmaceutical and life sciences services platform, dives into:

How PharmAlliance’s acquisition of Complete Health Economics Outcomes Research Solutions (CHEORS) helps expand global reach

The platform’s biggest goal to when it comes to CHEORS and market access services

How CHEORS helps navigate cost-effectiveness and market access hurdles

Acquisitions in the space that are currently in the works

Mark Bouck discusses PharmAlliance’s latest acquisitions, while reiterating its goals surrounding health economics and outcomes research.

Navigating Market Access Hurdles

 interview, Brandon Newman, Xevant’s CEO and founder, explores:

The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system

The role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved

How Xevant helps improve drug cost transparency efforts

Strategies for affordability Newman would offer the pharma industry that can be implemented immediately

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency. 

A Further Examination of Pharmacy Benefit Managers

This serialization system represents a business imperative that yields significant competitive advantages.

Serialization 2.0: Why It’s Time to Upgrade, and What’s at Stake

The rebrand creates a platform that is expected enhance the way life sciences companies bring their therapies to market.

Mercalis and PharmaCord Officially Merge, Form Valeris

The telehealth site will welcome its own small-dose, compounded version of semaglutide, which mimics the function of a GLP-1.

Noom to Sell Microdoses of Wegovy

The partnership is centered around cutting cold chain costs and emissions with smart packaging and carbon-neutral same-day delivery.

Invensify, Go2 Delivery Collaborate on Temperature-Controlled Courier Service

Andrew Witty resigns due to personal reasons, as Stephen Hemsley, chairman and former chief executive, will assume the position.

UnitedHealth Group CEO Departs

A Balancing Act

Deloitte’s life sciences R&D strategy leader

 describes how his company’s 15th annual Deloitte report on the return on investment (ROI) in pharmaceutical R&D reveals a continued upward trend, with a projected ROI of 5.9% for 2024. This marks a notable reversal from the consistent decline seen throughout much of the 2010s. During that period, ROI dropped largely due to a more challenging commercial environment, which reduced the projected value of drug pipelines. This was influenced by both business dynamics and a shift toward developing treatments for more specific, nuanced patient populations, often with smaller market sizes.

However, the past two years have shown a positive turnaround, with year-over-year increases in projected ROI. Two key drivers are behind this recent momentum. First, the overall projected value of late-stage drug pipelines has grown, especially when adjusted for risk, signaling stronger confidence in the commercial viability and clinical success of these therapies.

Second, a small number of exceptionally high-value drug programs have had an outsized impact. Among these, treatments in the GLP-1/obesity space stand out, significantly boosting the total value of the late-stage pipeline. These high-potential programs are reshaping expectations and driving much of the improvement in projected R&D returns.

The renewed optimism in pharma R&D ROI is largely attributed to an increase in risk-adjusted value across the pipeline and the emergence of breakthrough therapies in lucrative areas such as obesity treatment, highlighting a shift toward more valuable and promising innovation.

Dondarski also comments on the strategies companies can adopt to manage or mitigate escalating drug development costs; current best practices for balancing long-term pipeline sustainability with short-term financial returns; how GLP-1’s success influence future investment strategies in high unmet-need areas; how AI and automation realistically reduce clinical development timelines; and much more.

Knowing that investing in early-stage innovation is paramount, what are the current best practices for balancing long-term pipeline sustainability with short-term financial returns?

It's one of my favorite topics quite honestly, and it's a real pain point for a lot of different companies—it’s the cyclical nature. It comes back to the word we used earlier, which is discipline. I think the key to anyone's success is having a diversified pipeline. The word diversified can be interpreted in a lot of different ways.

It's not to say spreading yourself in over a million different areas is better, but rather, it's just important to have—from a capital allocation standpoint—whether it's thresholds or minimum, you just need to ensure that there's some degree of investment and innovation that's being focused on both those topics, early stage and late stage. The reality is, when there's cost constraints, there tends to be a disproportionate emphasis on where to look.

To me, there isn't a perfect answer. The key to success, I would argue, is number one, ensuring that you're continuing to focus on those different areas to some degree or some minimum threshold. And then number two, ensuring that as an executive leadership team, there's the recognition that we're solving for multiple things. Over indexing one way or the other just shifts where you feel that pain, or kicks the proverbial can down the road. It's largely about discipline, and solving for what's going to deliver the most enterprise value and patient value, as opposed to specific financial metrics.

In the final part of his Pharma Commerce video interview, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, describes best practices for balancing long-term pipeline sustainability with short-term financial returns.

The GLP-1 Effect

How do you see GLP-1 therapies’ success influencing future investment strategies in high unmet need areas, and which other disease areas do you believe have the greatest potential to replicate the commercial and clinical success seen with those therapies?

It's a good question, and it's a difficult question, because I'd argue it's a broader trend, at least since we've been writing the report. It’s the proverbial low-hanging fruit, as far as drug targets having been met. I think there's been such a strong emphasis across companies on really trying to drive their focus to unmet medical need, and that's why we've seen such a growth in oncology over the years. I think that doesn't necessarily indicate that there aren't other areas on medical need.

I think what makes the GLP-1 phenomenon so unique is that it's a throwback to the intersection of unmet medical need and large patient populations, The “so what” of this is difficult to summarize because the reality is, there's so much uncertainty with respect to what you're going to see anytime you go from the lab to the clinic. It certainly has reinvigorated—I would say— some of the therapeutic focus in those areas, and much like we've seen in other disease areas, I think we'll continue to see benefits in the sense that there'll be more therapies that come online that may have differentiated impacts to either smaller patient cohorts or subsets of just the broader obesity category.

I think it just showcases that there's still a lot of unmet medical need and a lot of different therapeutic categories. It's exciting to me that we're seeing the broader industry continuously focus on all those different areas, as opposed to just refining its concentration into certain areas.

In the fourth part of his Pharma Commerce video interview, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, explains how GLP-1 therapies’ success can influence future investment strategies in high unmet need areas.

How to Manage Rising Drug Development Costs

Despite the rising ROI, the cost of developing a drug has climbed to $2.23 billion. What strategies can companies adopt to manage or mitigate these escalating costs?

I think about it in two parts. The first is, what's actually driving the cost and the cost increase over time? I would say, generally speaking, that there's probably three factors that are really responsible for that. First and foremost is always attrition. Failure is always an issue. The later stage the failure, the more of an impact that it has specifically, because the figure you mentioned is more or less a normalized amount for what companies are spending to get an approval.

The second is R&D inflation. Certainly, if you follow the news, inflation has been a factor over the last couple of years. I think that within the world of R&D and R&D services, costs have risen even more so. Third, and finally, I think it oftentimes is the competitive dynamics, specifically in the clinical world. With so much of the industry focusing on similar areas, you don't normally use the word “competition” for patients, but the reality is, there're so many studies that end up taking longer to recruit, and that drives costs off. If I think about that, every company has probably a different area that they focus on if they're trying to address the cost part of the equation.

There’s so much of an effort at all the different companies where we serve to try and think about how in two areas. One is, how can you just really double down on operational efficiency? Much of that is through data and AI, which is perhaps the least surprising thing ever. Then the second is continuing to ensure that what companies are focusing on within their pipeline, A) they feel like they have a differentiated way to kind of pursue either that molecule or that indication, given their knowledge of the disease area, and then B) ensuring that there's the appropriate degree of rigor and discipline when it comes time to making either go, no-go, or investment decisions to ensure that you’re really maximizing the utility of how you deploy your R&D capital.

In the second part of his Pharma Commerce video interview, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, outlines strategies that companies can adopt to help mitigate these increasing costs.

The Positive Momentum Behind Pharma Innovation

Deloitte’s annual ROI of R&D report—now in its 15

 year—highlights a continued rise in projected R&D ROI to 5.9% in 2024. What key factors do you believe are driving this positive momentum in pharmaceutical innovation?

We've written the report for 15 years now. If you were to look at the year-over-year changes in the IRR figure, for much of the 2010s, we saw a pretty consistent decline, and that was attributable to many factors.

I would say first and foremost was a tighter commercial environment, and so the projected value of what was in the pipeline was decreasing. Some of that's driven up by the commercial nature of the business, but then, some of it reflects the shift in terms of more nuanced patient populations. Over the last couple of years, we've seen the opposite happen. We've seen a year-over-year year increase last year, then again this year.

That's attributable to a few things, but I would call out two things specifically. Number one is what I was just articulating—it's the projected value of what's in the late-stage pipeline, and from a risk adjustment perspective, it's increased in both those last two years.

Then, the second is really what specifically is driving that, and I think we've seen this year in particular that a substantial amount of that increase is driven by a disproportionately small number of exceptionally high value programs, and so particularly in the GLP-1/obesity space, there's an outsized amount of value in that category that has driven up, primarily the increase year over year.

In the first part of his Pharma Commerce video interview, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, shares the key factors that he believes are propelling a continued rise in projected R&D ROI.  

Therapy Advancements Highlight Growing Cost and Access Concerns

, Fran Gregory, VP, emerging therapies, Cardinal Health, shared key insights into the evolving landscape of cell and gene therapies. Speaking about the current state of the market, the anticipated growth of the pipeline, and the critical steps needed to ensure long-term sustainability, Gregory highlighted both the transformative potential of these therapies and the systemic challenges that must be addressed. Her perspective offered a comprehensive look at where the field stands today—and where it's heading next.

PC: You were a part of the ‘Cell, Gene and Beyond: What’s Working and Where Do We Go Next’ panel. Can you provide a brief synopsis of what the session entailed?

Our presentation provided a foundational overview of cell and gene therapy, including the current state of the market and where we believe the field is headed. We offered a pipeline snapshot, spotlighted several key products, and discussed what’s going well in the space. From there, we identified areas that require additional attention to ensure continued progress.

We've made significant strides over the past eight years since the first cell and gene therapy launch. This session was really about exploring the next wave of advancements necessary to propel the industry forward.

PC: What stands out to you most about the current state of the cell and gene therapy pipeline, and where is the momentum building right now?

The most striking aspect is how rapidly the field is evolving. The pipeline is incredibly promising in terms of patient impact—we anticipate over 100,000 patients could be treated with cell and gene therapies by 2030. However, there's also a significant financial burden. We're projecting $75 to $80 billion in healthcare system costs by that same year, which is approaching quickly.

While it’s inspiring to consider the lives that could be transformed by these therapies, we must also address affordability. That means advancing innovative payment models, implementing robust outcomes tracking, and refining health economics frameworks.

As for the pipeline itself, it's currently heavily concentrated in oncology and hematology, with many approved and in-development therapies in those areas. But what’s especially exciting is the emerging diversification—we’re beginning to see growth in other therapeutic categories like neurology, ophthalmology, rheumatology, and immunology. This broadening suggests the pipeline will continue to expand its impact across a wider range of diseases in the near future.

The session began with an overview of the cell and gene therapy (CGT) landscape—where the industry stands today and what the future may hold. The discussion included a pipeline review, highlighted key products, and identified both current successes and future areas of focus. Since the first CGT approval eight years ago, there has been significant progress. The conversation emphasized the need to continue advancing the field to ensure its momentum is sustained.

The CGT pipeline is rapidly evolving and holds tremendous promise, with projections estimating over 100,000 patients may benefit by 2030. However, this comes with a projected $75–80 billion cost to the healthcare system, prompting the need for sustainable payment models. Currently, around half of the pipeline targets oncology and hematology, but the field is expanding to include neurology, ophthalmology, rheumatology, and immunology, signaling broader therapeutic impact.

Patient outcomes from CGTs are transformative, yet there’s a growing need for long-term data to quantify their durability and cost-effectiveness. The discussion underscored the importance of robust health economic modeling and outcomes tracking to demonstrate value and guide reimbursement strategies. Insights from groups like ICER already point to the value of CGTs, but more evidence is required to solidify these claims.

Innovative payment models are crucial for long-term sustainability. The most promising models include outcomes-based contracts, where reimbursement aligns with patient response, and annuity payments, which spread costs over time. Models based on performance guarantees are less popular due to their all-or-nothing structure.

Looking ahead, the boldest move the industry can make is to collaboratively develop systems that ensure patient access while addressing affordability. Achieving this balance will require cooperation across stakeholders—payers, manufacturers, providers, and intermediaries—to ensure CGTs deliver on their full potential.

Fran Gregory, VP, emerging therapies, Cardinal Health, discusses the evolving cell and gene therapy landscape, highlighting pipeline growth, cost challenges, and emerging therapeutic areas beyond oncology and hematology.

Latest Conference Coverage

Asembia 2025: Therapy Advancements Highlight Growing Cost and Access Concerns

Why Distractions Are Detrimental to Business

 CEO of Theratechnologies, explains how Theratechnologies' operations have been impacted by recent US tariffs on Canadian goods, especially concerning the manufacturing and supply chain for its HIV therapy, EGRIFTA SV. The active ingredients used in EGRIFTA SV come from the US, travel to Canada for additional processing, and then return to the US for final assembly. As a result, the company faces tariffs on both the raw materials and parts of the manufacturing process that cross the US-Canada border. While the tariffs will increase costs, the company benefits slightly since the tariffs are applied to raw materials and intermediate steps, rather than the fully finished product, which would have resulted in a higher cost increase.

Theratechnologies is currently assessing the full impact of these tariffs on its supply chain, including effects on insurers, governments, and patients. Despite these challenges, the company remains committed to ensuring timely delivery of its therapies to patients, managing the increased costs as best as possible.

Levesgque also comments on the forecasted obstacles regarding the availability of specialty medicines for US patients; making the decision to reshore manufacturing processes; and much more.

Note: The FDA approved the company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection on March 25. The new formulation will be commercialized under the tradename EGRIFTA WR and is expected to EGRIFTA SV.

Why are distractions detrimental to business?

This creates distraction. Distraction is never good in business, especially if you drive innovation and you're focusing on bringing solutions to patients. I think the situation is uneasy, because, first of all, we're not totally sure that we have the facts to actually juggle with this issue the best possible way and find a solution.

My last thought is, there's always a payer for medicine. Sometimes it's the patient, sometimes it's the government. If governments are basically taxing medicines, that means that governments that are reimbursing medicines will pay a higher price. That is bound to be an issue. The US government has an Inflation Reduction Act in place so that we cannot increase the prices of medicines for the medicines they are imbursed. They want to control cost.

Well, governments in Canada and elsewhere have the same type of approach, so that is really opening up a potential can of worms that could create a lot of grief. How it will settle, I don't know, but I think that the people that are putting in place these changes now have not assessed that properly, and it will have repercussions. As I said before, I think the pharma industry will be nimble again, will stay focused, and will try to identify solutions. There are potential solutions, but as I said, most of them cannot be implemented on a dime. It's a significant disruption in the way we operate, especially for two countries that are so intertwined in all they do, as Canada and the US are.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, describes the uneasiness behind regulatory complications. 

Turning Sustainability Pledges Into Progress

PC: How can stakeholders ensure that sustainability takes precedence, even over other important business drivers?

There are three key takeaways from the panel—and from observing how the sustainability movement has evolved.

First, it's important to share practical proof points. In the early stages, we saw a lot of pledges, but now it’s time to translate those pledges into action and outcomes. I describe this as the shift from “pledge to promise.” Demonstrating how sustainability efforts lead to positive business results is critical.

Second, be patient. We often expect immediate results, like flipping a light switch. But sustainability is a long-term objective, and it requires perspective and perseverance.

Third, embed sustainability into everyday business processes. Rather than treating it as a one-off transformation project, integrate it into your operating model. Success is more likely when it becomes part of your standard way of working.

: The panel discussion on sustainability emphasized shifting the focus from compliance to making sustainability a business imperative. The panelists shared their experiences where sustainability initiatives have driven operational efficiencies, influenced supplier partnerships, and enabled early access to supplier innovation. The key takeaway was viewing sustainability as an investment in both the planet and the future of the business, rather than just a cost-driven concern. This shift in perspective has made sustainability an integral part of operations, to the point where acting unsustainably no longer makes sense.

To get more companies on board, the panel suggested three key strategies: first, providing proof points to show the business benefits of sustainability, transitioning from pledges to tangible results; second, being patient and understanding that sustainability is a long-term goal that requires persistence; and third, embedding sustainability into everyday business processes rather than treating it as a large-scale transformation project.

Looking ahead, the next five to ten years are expected to be marked by unprecedented collaboration between competitors, recognizing that sustainability is a collective challenge. The integration of AI with sustainability efforts is also seen as a major opportunity to innovate and accelerate progress toward net-zero goals.

Gilead, specifically, has made notable strides in sustainability, focusing on product, water, waste, and carbon goals. Their commitment to reducing Scope 1 emissions by 46% ahead of schedule demonstrates the importance of integrating sustainability into business processes.

Finally, AI’s role in sustainability is a key area of interest, particularly in how it can be standardized for the common good, contributing to goals like reducing consumption and waste.

Joydeep Ganguly, SVP, corporate operations, interim CIO, Gilead Sciences, shares how stakeholders can drive meaningful, lasting impact by turning pledges into proof points, exercising patience, and embedding sustainability into core business operations.

LogiPharma Europe 2025: Three Ways to Turn Sustainability Pledges Into Progress

The Impact of Pharma Tariffs on Drug Shortages

, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors

 outlines his vision for the future of the organization and the key priorities he hopes to drive during his tenure. He expresses a strong sense of privilege and responsibility in succeeding Kirk Kaminsky and looks forward to collaborating closely with Debbie Weitzman of Cardinal Health to strengthen connections across the pharmaceutical supply chain.

Hatcher emphasizes the often-overlooked value that distributors bring to the healthcare ecosystem. Representing more than 1,200 manufacturers and serving around 330,000 pharmacies and care providers, he describes distributors as being part of an "irreplaceable network" that plays a vital, behind-the-scenes role in ensuring the availability of medications and healthcare products across the country.

He outlines three main priorities for his leadership. First, he aims to enhance engagement within the distribution community—bringing together pharmacies, manufacturers, and distributors around their shared mission. Second, he highlights the critical importance of implementing the Drug Supply Chain Security Act (DSCSA) across the supply chain. With an extension recently granted, Hatcher underscores the need to meet the updated deadlines to maintain the reliability and integrity of the distribution network.

Lastly, he stresses the importance of storytelling—articulating the value and sophistication of the distribution sector to external audiences. He notes that while distributors are often discussed in various contexts, it's essential to clearly communicate their indispensable role in maintaining a secure and efficient healthcare supply chain.

Overall, Hatcher's vision centers on strengthening collaboration, ensuring compliance, and raising awareness of the distribution sector’s critical contributions.

Hatcher also comments on his day-to-day workflow at Morris & Dickson, including how it supports the efficiency and reliability of the company’s operations; steps that should be taken to ensure DSCSA compliance; types of implications that the potential 25% tariffs on pharmaceuticals can cause; and much more.

With potential 25% tariffs on pharmaceuticals looming, what type of implications can they cause, as far as manufacturers reshoring their production services are concerned?

We’re paying a lot of attention to what the current administration is looking at, in terms of policies that affect healthcare. In particular, the tariffs is one that we are keeping a close eye on. We want to support what the president is trying to do, for obvious reasons, but we also want to make sure that there are no unintended consequences associated with any kind of tariffs. What we've done, Nico, is we've respectfully urged a little bit of caution around this for really obvious reasons. Onshoring product from a manufacturer standpoint is not something that's done very quickly and easily, and so what we fear and what we worry about is any immediate impact. What we’ve also asked for is waivers for pharmaceuticals, and we’ve supported that position.

I think PhRMA has done the same, but our fear is that it contributes further to the already troubling drug shortages that we're all confronted with, dealing with, and are trying to mitigate for our customers. We're very supportive of trying to ensure as much manufacturing as possible, but it's going to take years to get those facilities underway, those facilities ready to go. The other issue is API (active pharmaceutical ingredient). The vast majority of API is not domestically sourced, and so that also has an impact. If that API isn't sourced in the US, it'll likely be subject to tariffs as well.

We really need to make sure that we're enlightening everyone about the complexity associated with the pharmaceutical supply chain. We want to avoid disruption. We want to avoid further shortages, and we want to make sure that we're supportive of our trade partners along the way. I think everyone's looking at this with an eye of caution. From our vantage point, economically, distributors—as I mentioned at the onset—play a vital role in the movement of products. We're not replaceable. We're not easily replaceable, but at the same time, we also have a very low margin profile for this business—less than 1%—and so the other concern that we have collectively is that the economic impact on tariffs, potentially on distributors and on our customers, could be very burdening and difficult.

This is something we're going to continue to watch very closely. We've engaged with the administration. We're going to be spending time in April on Capitol Hill, and our hope is that we can really have a constructive dialog about some of the caution points associated with the tariffs.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors, outlines the implications that potential 25% tariffs on pharmaceuticals could have, as far as manufacturers reshoring their production services are concerned.

How Pharma Leaders Can Secure 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.

In what ways might tariffs disrupt pharma supply chains, and how can leaders evaluate and prepare for the resulting challenges?

I wish there was an easy answer to that. I think the most honest answer is, nobody knows yet, and it's very challenging, because these—even in the last month or two—have changed in terms of when they were going to happen and what was going to happen. The challenge is the uncertainty, and that's really the most challenging thing in any business, uncertainty about what's going to happen. You can plan. Maybe you'll plan badly, or maybe you'll plan well if you know what's going to happen, but when you're uncertain of what's going to happen, it makes it much tougher.

With the fact that things are so uncertain, here's what people can do. One is that we expect and believe there will be tariffs on some things. Some of those seem to be pretty obvious, most things from China. Let's just ignore pharmaceuticals specifically right now. There are tons of raw materials that we use in the life sciences industry. Even if you're manufacturing in the United States, you still need to purchase equipment supplies. If you're using tubing, reusable, or single-use bags for bioreactors, filters, gloves, a huge number of things that are just routine, everyday purchases for people, whether they're for research and development or manufacturing, they’re coming from China and other countries. Those seem pretty certain that there are tariffs that are going to be implemented and potentially increasing.

I think in those cases, just like any other business, people want to look at their supply chains, they want to try and understand the basics you'd want to anytime. Do I have a reliable supply chain? Do I have a supplier who can provide products to me when I need them with a reasonable timeframe? Do I have the right cost suppliers? So maybe even with a 10% tariff or a 20% tariff, my supplier in China still is a lower cost than buying it domestically or buying it from someone in Europe.

Then three, I think it's good business practice, regardless, to have alternate supply chains. You should have backup suppliers for most of your products. Maybe they're more expensive, maybe you don't need to go to them, but that's just a really good business practice to have backup suppliers, particularly if it's an item which has to be qualified. You might even go through the qualification process to make sure that you can substitute in those suppliers as business conditions change.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, outlines the ways that tariffs disrupt pharma supply chains, along with how leaders can evaluate and prepare for the resulting challenges.

The Impact of Automation on Costs and Variability

, Jason C. Foster, CEO of Ori Biotech, describes how the current state of cell and gene therapies (CGTs) shows promising potential, particularly in curing cancer and rare diseases. These therapies are safe and effective, with evidence demonstrating their curative capability. However, their widespread adoption is hindered by challenges in manufacturing at large scales and at affordable costs, limiting patient access. While three CGT products have advanced from last-line to second-line therapies, the number of patients receiving treatment has remained relatively unchanged, signaling that access, not prescription willingness, is the primary issue.

Only about 10,000 patients were treated with CGTs in 2024, out of a much larger global pool of patients who could benefit, with access in the United States at just 20%, and far lower in other regions. The real obstacle is the inability to produce these living, often personalized therapies at the scale needed for broader distribution. Many existing production processes rely on outdated technology that cannot meet the demand or provide the level of access needed.

This situation creates a vicious cycle: limited access leads to doubts about the commercial viability of these therapies, affecting investment in future innovations. CGTs cost billions to develop, and investors and companies require financial returns to continue funding new therapies. If the therapies cannot reach the market or gain sufficient coverage, the commercial future of CGTs is uncertain, risking investment in this area and potentially diverting capital to other treatment modalities. Overcoming these manufacturing and access barriers is crucial for unlocking the full potential of CGTs and improving patient outcomes globally.

Foster also comments on the manufacturing bottlenecks; regulatory hurdles; role of automation; and economic and healthcare system challenges pertaining to CGTs.

How do you see automation playing a key role in improving efficiency, reducing costs, and ultimately, expanding patient access?

A broad church of automation has quite a lot of differences within it. Some people think the robots are coming to save us. Unfortunately, the robots are not coming to save us. Having a robot arm move one thing from one place to the next adds minimal value in the whole scheme of things. Ultimately, when it comes to automation, people always tend to use a car analogy, the Toyota manufacturing line idea or concept, which is not far off.

Essentially, what you're doing is you're replacing human beings that are highly skilled, very expensive, and that they're not enough of, with machines. And the machines are very good at doing the same thing over and over again in the same way every time, and not introducing variability, which human beings are not very good at. No matter how expert we are, we tend to introduce variability because we're human. What the new generation of automation technologies like Ori’s, which is called the IRO, essentially automates that bottleneck, that core bottleneck we were talking about, which is seven to 10 days of a standard CAR-T manufacturing process. It allows us to do the same thing every time. To sterilely move fluids from one step the next inside the system, the cells stay in optimal cell growth conditions, so you can shorten processes. The way we are able to increase throughput and decrease variability while decreasing cost is decreasing labor. The first cut is that we take about 60% of the people needed out of the process, which is great, because those people are highly skilled and can be doing lots of other high-value things, besides micro pipetting under the hood or tube welding. Those things are not value added.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, comments on how he envisions automation in the CAR-T manufacturing space playing a role in improving efficiency, reducing costs, and ultimately, expanding patient access.

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