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1rem

 interview, Claire Riches, vice president of clinical solutions at Citeline, dives into:

Specific inefficiencies in the current drug approval system that are the biggest obstacles to faster approvals

How the FDA can integrate data sources such as real-world data (RWD) to streamline approvals, while maintaining rigorous safety standards

Advancements in data collection and validation that make RWD a viable tool for drug approvals

The role payers and insurers should play in this shift toward a more data-driven, flexible approval framework, and how this could impact patient access to innovative treatments

The likelihood of bipartisan support for reforms that modernize drug approvals with shifting political priorities under HHS Secretary Robert F. Kennedy Jr.

Claire Riches highlights inefficiencies in the current drug approval process, while outlining the role of payers and insurers in shifting toward data-driven approval framework. 

Fast-Tracking the Future

 interview, Renier Brentjens, MD, PhD, deputy director and chair of medicine at the Roswell Park Comprehensive Cancer Center, discusses:

How he has seen the field evolve since its inception, and what excites him most about its future

How the Roswell Park expansion helps improve patient access to CAR T-cell therapy

The key safety concerns associated with CAR T-cell therapy, along with how Roswell Park aims to mitigate potential risks

How Roswell Park is working to make CAR T-cell therapy more widely available

The steps needed to be taken at the regulatory and healthcare policy levels in order to support the broader adoption of CAR T-cell therapy

Renier Brentjens, MD, PhD outlines the evolution of the space, while offering ways to boost patient access to these treatments. 

Embarking on the CAR-T Journey

 interview, Donald Prentiss, founder and CEO of Qualthera, explains:

The role that compounding pharmacies play in the pharmaceutical supply chain

How compounding pharmacies helped bridge the gap for patients in need of their medication (especially during the tirzepatide shortage), while dispelling the notion that commercialized and compounded drugs are competing with one another.

What he believes needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place

The inspiration behind Qualthera, along with its objectives

Donald Prentiss discusses the value of these pharmacies, especially during shortages.

A Closer Look Into the Role of Compounding Pharmacies 

The history behind the Drug Supply Chain Security Act (DSCSA)

The latest DSCSA exemptions and what that means for trading partners

How this piece of legislation and AI are able to intertwine

Nicholas Saraceno offers an overview of the legislation and how it impacts the pharma supply chain.

Nov. 27 is Here: What Does That Mean for DSCSA?

 interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into:

The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech

An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars

How he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later

Whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA

Podcast is available directly on SoundCloud.

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

A seminar shares key observations and learnings from the first round of direct price negotiations.

Asembia 2025: Understanding the Inflation Reduction Act

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market. 

Asembia 2025: A General Landscape of the Pharmaceutical Industry

A session dives into the trends surrounding specialty drugs and therapies, along with providing an overview of the drug development landscape. 

Asembia 2025: The Specialty Pharma Pipeline

The interchangeability designation for Yuflyma, a biosimilar to Humira, may help to improve patient access and reduce costs. 

FDA Grants Interchangeability Designation to Celltrion’s Humira Biosimilar Yuflyma 

Respective industry and government agendas could significantly reshape the US prescription drug market.

US Drug Price Negotiations and Transparency

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. 

Analyzing Tariffs’ Effect on the Biopharmaceutical Supply Chain

How have the recent US tariffs on Canadian goods impacted Theratechnologies' operations, particularly in terms of cost and supply chain management for your HIV therapies in the US market?

We will be affected by that, because the different ingredients that actually get into the making of EGRIFTA SV comes from the US, and comes to Canada for additional progress in the manufacturing. Then, it crosses the border again back to the US. Any company is going to have to do a very tight assessment of supply chain—which we have done—and currently, the active ingredient comes from the US, crosses the border in Canada, and will be taxed on the value of that active ingredient.

Then, there's part of the manufacturing process that is being done in Canada. When it will cross the border to the US, it will be taxed again on the value of that part of the manufacturing process, and the final assembly is done in the US.

In our case, there will be tariffs affecting the cost of manufacturing. Fortunately, it will be done on the value of what's crossing the border. Since this is raw material the first time and only another step in the production the second time, the value is not as high as the finished product, because if the finished product is $100 and you have tariffs of 25%, that tells you how much of an increase it will be.

In our case, there will be an increase. We'll try to manage that the best possible way. We're not done with assessing the impact of that for insurers, for governments, and for patients, but we are committed to making sure that our drugs will get to patients on time, every time, as they should.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, outlines how US tariffs on Canadian goods have impacted the company’s operations, particularly in terms of cost and supply chain management in the US market.

Preparing for DSCSA Deadlines 

, 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 the DSCSA implementation deadlines for pharma supply chain stakeholders fast approaching, what steps should be taken to ensure compliance? Are there any technological or operational adjustments that can help?

DSCSA is a mission-critical priority for every member of HDA. We've had work groups that have had daily and weekly meetings around the HDA table, and HDA has been working deliberately with the FDA on the traceability issues for probably two decades.

At the end of the day, DSCSA fundamentally means that we want to ensure the safe and effective implementation for our customers and for the products that they buy from us. Obviously, the most critical deadline is May 27, when pharmaceutical manufacturers and the repackagers need to meet the criteria in terms of the data at the package level, or have their waivers or exemptions in place, so it's important. It's an important indicator of readiness, not only for the manufacturers, but also for distributors and dispensers, and then for the distributors, for all of us, by Aug. 27, 2025, we've got to be able to receive and trace product from the manufacturers and provide data to our dispensers. We've got to receive and provide EPCIS data at the product unit level. This requires review of processes, such as the practices for returns—which is complicated—product quarantines, testing, and communication.

At the end of the day, I think the message here for all constituents is this has to be a priority, and it involves the technology you've deployed, it involves your systems. I think for all of us, it's really just a shift in the way we work. Our intent, our aim here at Morrison & Dixon, and I think with the rest of HDA, is to make sure that DSCSA is fully integrated into what we do. It's just not optional. And again, I'd like to hope that everybody involved with implementation feels the exact same way.

In the third 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, comments on the steps needed to achieve Drug Supply Chain Security Act compliance.

The Complexity of Healthcare Price Transparency

Turquoise Health’s SVP of market solutions

 describes how the recent executive order on healthcare price transparency aims to make pricing in the healthcare industry more accessible and understandable for patients. This initiative is a continuation of efforts by both the Trump and Biden administrations, with the goal of improving transparency around hospital and payer reimbursement rates. The central idea is to require all hospitals and insurance companies to publicly disclose their contractual reimbursement rates, meaning patients will have clearer insights into what insurers pay hospitals for services.

Historically, these prices were not transparent, making it difficult for patients to understand the actual costs of healthcare. While earlier laws introduced in 2019 improved pricing transparency, there have been enforcement challenges. The new executive order seeks to address these issues by ensuring hospitals and payers comply with transparency requirements. A key update in the order is the inclusion of prescription drug prices, which had previously been excluded from transparency rules.

The broader impact of this order is to make healthcare pricing as transparent and predictable as other consumer services, like booking a flight or a haircut. Although the system is not fully realized yet, this executive order lays the foundation for a future where patients can easily access upfront pricing before seeking healthcare services. This transparency is expected to simplify the decision-making process for patients, ultimately fostering a more informed and competitive healthcare environment.

O’Dell also comments on the biggest challenges healthcare organizations currently face in terms of price transparency; where the healthcare industry currently stand in terms of compliance with price transparency regulations; specific strategies Turquoise Health provides in order to help healthcare providers navigate and meet the new price transparency requirements; and much more.

What are the biggest challenges healthcare organizations currently face in terms of price transparency?

The biggest challenges I think healthcare organizations and payers face is just that the data that's required to be published is absolutely massive. The company I work for, Turquoise Health, is a price transparency company. We ingest a petabyte of data every single month, which is a massive amount of data to bring in. That means we're going out to 11,000 different sources and grabbing it from all the payers and all the hospitals, and trying to bring all that data in and standardize it. I think just the size is a very difficult part.

Perhaps even more important than that is the word that I just said, which is “standards.” In order for it to be useful, everyone's got to do it in the exact same way. It's kind of like, everyone's got to drive on the same railroad track size if you want the trains to be able to integrate and go across state lines. Same is true for these data flows. We're getting there, but we're not quite there yet, meaning that hospitals’ contracts are highly variable, so the way one hospital might contract for a service is very different, compared how the next one does. When they publish the data, now you have to find a way to make it apples to apples so that a consumer can compare. That is the absolute hardest part of price transparency—they can show you the price, but you as a consumer might not know what to make of that unless someone standardizes it.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris O’Dell, Turquoise Health’s SVP of market solutions, discusses the biggest challenges healthcare organizations currently face in terms of price transparency.

Breaking Down the New Executive Order on Healthcare Price Transparency

Can you explain the key provisions of the recently released executive order on healthcare price transparency and how it will impact the healthcare industry?

These executive orders are about price transparency, and this is not a new concept for the Trump administration or for the Biden administration for that matter. This happens to be one of the few bipartisan things perhaps that's out there. In essence, what they want to do is make all hospitals and all payers make all of their contractual reimbursement rates public. Those are complicated terms if you're not in the industry, but it basically just means, what is your insurer, as a patient, pay to the hospital for the service that you received? As wild as this sounds, until these price transparency laws were out, none of that ever existed.

That was all a guessing game, and no one had any visibility into it. Over the course of the last four years, since the first version of these laws came out in 2019, we've seen a lot better prices, and we've seen a lot better data on these—what does the payer pay to the hospital?

Why are we talking today? Why does this new executive order even need to happen? It's because first they feel that the laws have not been enforced enough. They're saying, these are good laws, but we need to really make sure that hospitals and payers are doing this, and we're going to enforce it if they're not doing it. The second thing that comes through is drug prices. Hospitals and insurance companies had to make all their rates available, but somehow, the pharmacy benefit drugs, or prescription drugs—as they reference in this executive order—squeaked away and didn't have to comply with the regulations.

They're coming back and saying, we're going to enforce and we're going to make sure that drug prices are visible. What does this mean for the whole healthcare industry? I actually agree with what I think the government believes here, which is that it makes it easier for a patient to understand what they're going to pay for healthcare services before they go in. They use this term of “guaranteed upfront prices,” and that's their government speak for saying it's as easy to go get healthcare services and know what you're going to pay as it is to book a flight or go get a haircut or whatever example you want to use—that's what they're going for. We are not there yet, but these are the building blocks and foundation that they're using to get there.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chris O’Dell, Turquoise Health’s SVP of market solutions, outlines the key provisions of the recently released executive order on healthcare price transparency.

Pharma’s Response to the Biosecure Act

, 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.

What is the Biosecure Act, and in what ways are pharma companies preparing for it, especially from a compliance standpoint?

 The Biosecure Act came about last year, and Congress thought that certain Chinese companies had too much access to the to the US market, or created a threat to US companies because they had access to information about American citizens, a variety of different things. In the Biosecure Act, Congress posed several different things. One was that if a company received funding from the US government, they were barred from doing business with specific Chinese companies. In the Biosecure Act, Congress named five companies to start with. They additionally set up a process where future companies could be added to that list, and the bill never passed. It passed the House, didn't pass the Senate, and then we've changed Congresses and administrations, so we don't know what'll happen.

Although, I was on a call last week, and at least one of the people felt that it'll come back up again at some point this year, but essentially, what it did is it created turmoil in people's supply chains. The five companies that were named are some of the largest partners of life sciences companies around the world, and all of a sudden, potentially not being able to have your product manufactured by them is very challenging. For companies that already were partnered with those companies, I think most of them took a wait-and-see approach, because if you're making a biologic, you may have a year or 18 months of tech transfer, and all the cost—that's after finding a new partner to manufacture a product—to move the product, and manufacturing to a new supplier.

Many people were sort of like, well, let's keep a close eye on this and make a decision if something happens. For companies that were looking for new partners, from what we've seen talking to our BDO clients, there was a big drop off in people that were partnering with those Chinese companies. It was just a lot of potential risk to them. Many of these are companies that have one product, it's their first time manufacturing, and the thought of potentially mid-clinical trial or something else, having to go and find a new partner and transfer it to someone else, was just too much risk for them. I think a lot of those companies have chosen partners other than those named, even in many cases, choosing non-Chinese partners, just because of the potential risk. That's definitely created a lot of stress and turmoil in the supply chain, people moving to US CDMOS, European CDMOs, Korean, all over the world, and so again, it's like I said before, uncertainty isn't helpful. We're already in life sciences, an incredibly high-risk business. By definition, it's a high-risk business. And then to introduce these other uncertainties, makes it exponentially more challenging.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life sciences co-leader, details the Biosecure Act, including the ways pharma companies are preparing for it, especially from a compliance standpoint.

Breaking Down Regulatory Challenges in Cell Therapy Production

, 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 are regulatory hurdles impacting the advancement of CGTs, and what changes would you like to see along that front in order to accelerate patient access?

I think on the regulatory side, the regulator has been incredibly supportive of advanced therapies and rethinking the way to conduct business as usual. They've offered to combine Phase I, II, or Phase III together, so that we can get faster through the clinical trial process. As an example, thinking about the ethical concerns around double-blind, placebo-controlled trials in late-stage cancer patients—it’s probably not ethical to put some of them on placebo, so they've been quite forward-looking and forward-thinking.

Recently, the US FDA has put forward something called the Advanced Manufacturing Technology designation, which will allow platforms like Ori’s to essentially put a master file, a dossier, in with the agency. They'll review it, and they'll be aware of the system, which will help speed up the application for companies that are using it, ultimately trying to get those products to patients more quickly. I think the regulator has been very supportive of the industry, and Peter Marks and his team at CBER (Center for Biologics Evaluation and Research) have done a great job in my opinion.

There's a couple things still left to do I would argue, globally and also within the US market. One is this idea of comparability is still kind of a question mark. Not to get too technical, but let's say we put a product in (Product A) and we say, this is how we're going to make it. We're going to make it using these tools and this process, and that's generally what your dossier says. It says it's effective and safe for patients to do it this way. If you want to change something about that process, the perceived bar is very high, so if I'm using a 15-year-old technology but better technology comes out, my ability to switch from one to the other is very difficult, and it's seemingly very high-risk, and the bar is quite high, because we have to show the process is comparable. If we improve it too much, it becomes a different process, and you have to go back and start over—do your critical trial over again—which logically doesn't make any sense, but it's the way the regulatory construct works. This ability to take advantage of new technologies is very difficult, and so we're stuck with these old, decades-old processes with decades-old tools that aren't performing. They aren't delivering enough doses for patients, they aren't delivering cost-effective therapies to the market. I think that transition process, the definition and the understanding of how to transition to a newer process that is better in various ways, and how to smooth that, is a way that the regulator could certainly help us solve that market access problem and scaling up these production processes. That’s one way.

Another way, I would suggest—and this has been debated for years and years—is obviously therapy developers go through essentially the same process to get a drug approved in the US, and then they have to do the same thing in Europe, and then maybe they have to do the same thing in the UK, and then maybe they do the same thing in Australia. But effectively, they're using the same processes. They're looking at the same criteria. Is it safe? Is it effective? What does the clinical data look like? What a gigantic waste of resources and time. You have patients that are literally dying on the waiting list, but having each regulatory authority set slightly different rules—but also with the same end in mind—it just doesn't seem like a good use of all of our time and all of our skills and efforts. Some sort of a mutual recognition, which has been discussed for many years, I think would be quite helpful.

And then the last I would offer up is that circular supply chain we discussed—where your cells might get on an airplane and fly halfway across the world—that kind of logistical complexity will never scale. If you have to transport cells via airplane here, there, and everywhere, it's always going to be expensive, it's always going to be complicated. It's never really going to be super cost-effective, where you could have this as a first- or second-line therapy. We've talked a lot in the industry about distributed manufacturing, so instead of having a centralized facility where all the cells come in from all over the world, you might move those facilities out in kind of a hub-and-spoke model, closer to the patient, closer to the hospital, minimizing logistics time, minimizing complexity, so that we cut vein to vein times for patients. These are very sick people at the end of the day, and they need their therapies quickly. This idea of distributed manufacturing has taken hold in the hearts and minds of the industry, but the how to get it done, what it really looks like, and the how do we sort of think about this from a regulatory perspective hasn't really been clarified.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, discusses how regulatory hurdles are impacting the advancement of CGTs, along with the changes he would like to see along that front in order to accelerate patient access.

The Connection Between Pharma Innovation and Health Policy Development

, Geoffrey Joyce, PhD, director of health policy at the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California (USC, describes how the 10% tax on Chinese goods and a potential 25% tariff on pharmaceuticals could have notable effects on the price, quality, and safety of generic drugs. He explains that while branded and generic drug markets operate differently, the cost of generics is typically much lower, with intense competition driving prices down. A 10% tariff on generics might not significantly impact costs because most of the price is tied to distribution, not manufacturing. However, the COVID-19 pandemic highlighted the risks of relying on countries like China and India for essential generics, which has led to a push to bring production back to the U.S.

A 25% tariff would likely make domestic production more attractive, but generics are low-margin products, so this may result in higher consumer prices. Joyce suggests that tariffs could disrupt supply chains but not lead to significant changes in US production in the short term. Additionally, the low-profit nature of the business could encourage foreign manufacturers to cut corners, potentially reducing drug quality. California's failed attempt to create its own generic drug industry illustrates the challenges in stimulating domestic production for these low-margin drugs.

While tariffs might encourage some domestic production, it could come at the cost of higher prices and possibly lower drug quality. The overall impact on the drug supply chain remains uncertain, with concerns about reliability and safety, especially if foreign manufacturers face increased production costs.

Joyce also describes what makes the generic drug market susceptible to supply chain disruptions; how the tariffs can affect price or competition within the branded drug space; health policy developments that coming down the pike that the pharma supply chain should prepare for; and much more.

Are there any health policy developments coming down the pike that the pharma supply chain should prepare for or be aware of?

Well, when you talk to pharm execs, their big concerns are the IRA and tamping down prices on branded products. The reductions have not been that great so far, but I think it's a Pandora's box, where now you're opening up price negotiations for branded drugs. Then, the other issue that they're all worried about is 340B and changing that system, which has been a problem. That's what at least from the pharm execs I've talked to in the last couple of months, those are their two primary concerns. They’re for-profit companies, so they have to think about, where am I going to make my investments? Am I going to get a return on investment?

We worry about if we focus too much on launch prices and the price of drugs in early stage, it's going to have a detrimental effect on innovation. We don't worry about that in the generic space. Those are homogenous products, and we don't have to worry about a downside. Anything that sort of facilitates that market and makes it more competitive, the better. I would argue—and I have argued in the past— you could set price floors on a lot of generic products and maybe induce domestic production.

Yes, it would be more expensive than getting those drugs from India and China, but I think people might be willing to pay an extra $2, $4, or $5 for what they perceive as a safer, higher quality generic product, given prices on generics generally speaking, are low. But again, basically pharma outsourced all this stuff because labor and materials were cheap overseas. It made total sense. And I think COVID and other shortages have made us realize that there's a risk and a downside to that.

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Geoffrey Joyce, PhD, director of health policy at the Leonard D. Schaeffer Center for Health Policy & Economics at USC, comments on health policy developments that the pharma supply chain should be aware of.

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.

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.

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