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Supply Chain Logistics

1rem

 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

James D. Chambers, PhD, MPharm, MSc, professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, dives into why biosimilars contribute to a reduction in cost and increase in patient access, while highlighting challenges to adoption. 

The Biosimilars Landscape Through the Eyes of an Economist

FDA approves an expanded access program that would offer patients an alternative to Merck’s bladder cancer medication. 

ImmunityBio to Supply Recombinant BCG to Alleviate Tice BCG Shortage

A qualitative study examines how Medicaid telehealth reimbursement policies affect staffing and patient-centered care.

Impact of Telehealth Reimbursement Policies on Federally Qualified Health Centers

Digging a little deeper into the drug class phenomenon reveals some interesting takeaways on a smaller subgroup of users.

Beyond the GLP-1 Headlines 

The agreement is centered around improving cell culture efficiency and CGT quality. 

PHC, CCRM Partner up on Furthering Cell and Gene Therapy Development

The Role of Collaborative Supply Chains in Improving Patient Outcomes

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 do you believe supply chain collaboration is becoming increasingly critical in this day and age?

It's interesting because what we're seeing is that the adoption of cloud-enabled collaborative supply chains really helps the life sciences—specifically pharmaceutical organizations—enhance their real- time data sharing, which results in improving visibility and streamlining coordination among both their internal stakeholders, as well as their external suppliers, co-manufacturers, co-packers, and the very intricate supply chain that they rely on.

This collaboration leads to faster decision making and overall reduced operational costs, which of course, results in greater agility and being able to respond to market changes, update changes, or label changes, as well as potentially any disruptions that come along. What we're seeing in addition to that is that cloud-based systems support regulatory compliance and continue to enable advanced analytics, which results in being able to have more granular demand forecasting. Inventories can be optimized, and ultimately, this leads to improved patient outcomes and accelerating the time to market for new therapies.

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on why she believes supply chain collaboration is becoming increasingly critical today.

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.

How HCPs and Patients Influence the CGT Approval Process

, 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.

The involvement of HCPs and patient organizations is critical in understanding meaningful clinical outcomes. What role do these groups play in shaping the approval process, particularly for rare patient populations with significant unmet needs?

So I'll start from the provider perspective. I think, especially in rare disease, but really, this is applicable across cell and gene for different types of therapies than maybe what the agency may be used to seeing in terms of devices or traditional pharmaceuticals. That said, from a healthcare professional (HCP) perspective, allowing the opportunity to give their expert insights and clinical experience, not only to the agency, but to all the stakeholder communities, so that we know that we're developing therapies that ultimately are going to achieve some type of clinical significance, some type of clinical outcome that is meaningful from the provider's perspective, and of course, most importantly, from the patient's perspective.

To focus on where the HCP is coming from, being able to give their insight into how we can develop these therapies to achieve a meaningful clinical outcome, is really important. That helps us design trials and implement the trials operationally, more meaningfully as well, and then they can help really interpret and contextualize the data. Making this something that's clinically meaningful to the right audiences is really critical, and then the providers can also help advocate and educate the patients.

A lot of patients have a lot of questions about cell and gene therapies, and so being able to trust your provider and get more information through those medical channels is critically important for patients, not only thinking about participating in a trial, but ultimately enrolling in a clinical trial, or families, caregivers, parents, if it's a pediatric indication. Having that advocate and educational champion through the HCP lens is really important. And then, similarly, on the patient side of things, patients are the strongest voice in this entire community.

I think every manufacturer's goal is to develop a therapy that is going to help a patient, which involves listening to what matters to the patient. Do we have patient-centric clinical outcomes in our clinical trials? Are we developing this with the patient in mind that not only recruit patients into the clinical trials, but retains patients into the clinical trials if they have a better understanding up front of what that's going to take in terms of an investigational protocol? And then the patients can go be such a strong voice, both in terms of policy, but also in terms of the FDA’s review. If they have listening sessions or advisory committees where they want to hear directly from patient communities, engaging with the patient community and understanding from their perspective, really just opens the eyes of all of the different stakeholders involved, whose ultimate goal it is to help treat those patient populations more effectively.

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenna Dale, director of client relations at Cencora, describes why these pharma supply chain stakeholders are vital in understanding meaningful clinical outcomes. 

Focusing on the Patient

, Donald Prentiss, founder and CEO of Qualthera, describes how compounding pharmacies play a critical role in addressing unique and unmet medication needs that cannot be met by commercially available drugs. Their role in the pharmaceutical supply chain varies depending on the type of compounding facility: 503A or 503B.

A 503B facility, also known as an outsourcing facility, primarily supplies office-use medications to healthcare providers, who then administer them to patients. These facilities must adhere to current Good Manufacturing Practice (cGMP) standards, as they are FDA-registered and subject to inspections. In contrast, a 503A facility focuses on compounding medications based on individual prescriptions, typically in smaller, patient-specific batches. This allows for customization, such as removing allergens or adjusting dosage forms to better suit a patient's needs.

Both types of compounding pharmacies are particularly useful in cases of drug shortages or when commercially available drugs are insufficient. For example, if a patient requires a medication that is in short supply, a compounding pharmacy can step in to provide a tailored solution. This flexibility makes compounding pharmacies essential for meeting the unique needs of patients, whether by modifying an existing medication or creating entirely new formulations to address specific medical conditions.

Ultimately, the primary function of compounding pharmacies is to bridge gaps in the pharmaceutical market by providing personalized, alternative treatments that meet the diverse needs of patients.

Prentiss also comments on the tirzepatide shortage, the notion that commercialized and compounded drugs are competing with one another, what needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place, and much more.

Could you describe the importance of the patient within the pharma supply chain?

We're here to serve the patient. They are our primary stakeholder. Whether there's physicians involved, nurse practitioners, vendors, 503A’s, 503B’s. I just encourage everyone to remember that and bring it back home. At the end of the line, there's going to be your family member, my family member, who will be affected by these medications, and we definitely do not want to have a repeat of what happened with the New England Compounding Center, which is widely known in industry. That is actually what gave birth to section 503B, which created outsourcing facilities just over 10 years ago. We don't want more tragedy like that. Let's just keep it focused on the patient, keep it focused on quality, and I think we'll end up just fine.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, describes the importance of the patient within the pharma supply chain.

A Qualthera Deep Dive 

What was the inspiration behind Qualthera, and what are its objectives?

Our tagline is “quality therapy for life.” It has a double meaning. Life meaning lifespan from newborn to hospice, as well as situational—whatever life throws at you in between. Again, that key focus on quality [is essential]. As the name suggests, we compounded quality and therapy to come up with a name, Qualthera. Looking at the pharmacy landscape, you see the CVS, Walgreens on every single corner, and really focused on the retail, one-size-fits-all drugs, and then you look at the compounding space a little bit more fragmented. You have the mom and pops, or the independents across the country really serving their local areas. In my personal opinion, the personal touch, the community integration, the level of accountability associated with the independent compounding pharmacy world is just really appealing. I think that's what a lot of people appreciate and love, and that's why they stick to those types of pharmacies if they can get their drugs there.

As I looked around, I said, there's really nothing at scale. Meaning, a compounding pharmacy, same brand across every country. You're going to have networks. I think there's one or two large compounding networks out there, but a lot of them have the same, original name. They're not consistently branded. You have to look at the locations on the site and things like that, and there's not another network that has a store in every single state and territory, and that's my goal. I want to have Qualthera compounding pharmacies across the country, in every state, which gives you a lot of benefits.

I think number one for me personally, as an operator on both the 503A and the 503B side, you reduce a lot of regulatory pressure. Right now, there's a race in the compounding world to say, who has the biggest pharmacy? I landed a 45,000 square-foot facility here, and 50,000 here. For me, although you get that economies of scale there, you can ship across all 50 states. If you get an issue in Florida and Texas finds out about it, Texas is going to want their pound of flesh too, right? If you get a fine there, you're going to get a fine there, and that goes into a database, and all the other states find out about it, and they want to get their pound of flesh too.

There's a lot of regulatory pressure. You put a lot on these pharmacists that have to maintain all these licenses in different states for you to ship there. [Regarding] environmental risk—if you saw what happened to Baxter, a hurricane happens, or some facility gets damaged, you're down. I want to diversify that risk. I want to have all these pharmacies across each state, also have the ability to serve the contiguous states as well, to have that redundancy. But we're not going to load these stores down with 50 licenses and just carry that kind of risk, but you still get the economies of scale and the group purchasing power, because you're all under common ownership. You can transfer prescriptions because you're on the same software. We have some pretty unique models behind the scenes that will help us scale faster, and we're really excited about that.

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, discusses the origins of the compounding pharmacy, including what it seeks to accomplish.  

Clearing Up the Competition Myth 

The tirzepatide shortage officially ended October of last year. Up to that point, what role did compounding pharmacies play in bridging that gap for patients in need of their medication? Could you dispel the notion that commercialized and compounded drugs are competing with one another?

I think these are two great questions. To start off with the with the shortage piece—like I said, when there's limited or no supply, the FDA has what's called a drug shortage list. I encourage your viewers and listeners to look at that list to get an example of what's on there. Whether it be tirzepatide or semaglutide, you can go to that database and see whether or not that particular drug is on shortage. If it is on shortage, then compounders have the ability to make a one-to-one copy of that.

What happened in this case is that these blockbuster drugs, [they’ve got] all these wonderful indications, and everything's going really well. Obviously, that ate up all the supply, and so that opened the door—by way of the shortage list—for compounders to again step in and fill that gap. That's what you've seen them do. As you mentioned, back in October is when the FDA indicated that it was now off of shortage. There was some litigation out there from the Outsourcing Facilities Association and others that argue that it was not actually off of shortage in the market, because a lot of pharmacies were getting feedback that patients were still having trouble getting that, since they couldn't get it from their wholesalers to give it to their patients. You saw some back and forth there.

Since that time—I believe sometime in December—the FDA came back and said, “okay, we're going to provide 60 days for compounding pharmacies to essentially continue to service patients as the supply kind of ramps back up from the drug manufacturer. For outsourcing facilities, I think it's 90 days to do that. When you think about shortages, such as from the perspective of an outsourcing facility, I'm making the large batches. Again, they follow cGMP, so they have to put their stuff through studies. These are called stability studies. They have to prove the long-term, the potency, the sterility profile, and impurities across the shelf life of that BUD [beyond use data] that they're putting on the label. That can cost hundreds of thousands of dollars.

If I'm only allowed to make something when it's on shortage, I have to be fairly certain that it's going to be on shortage a good while, so I can recoup my cost, while also making some money, because they are a business, they have to make good business decisions. That's a little bit of the rub between compounding pharmacies and the FDA and drug manufacturers—compounding pharmacies can step in to fill these gaps, only when on shortage, but guess what? This is off shortage now. You stop making it, and now you're stuck, holding back with your cost.

I saw it firsthand during COVID. When a lot of supply chain disruption happened, there were shortages of all kinds of critical drugs, using hospitals, for example. There was actually a really neat situation where there was collaboration with the FDA and with industry stakeholders to help create a website, a list of all these 503Bs that could make all these medications to help bridge that gap. It was a perfect situation to show what compounding was all about. Even with hand sanitizer—FDA came out with a formula, with a set BUD. So it says, “hey, if you make this compounders, then you can sell hand sanitizer,” because we were short.

I think those are very specific instances where compounders responded, but there were still questions of, if we jump in and make these medications, how long and what kind of tail can we expect when they come off as shortage to again, recoup our costs? There were was a lot of back-and-forth discussion on that, in order to help protect everyone's interests.

Looking at your second question when it comes to competition, the straightforward answer is that they’re not competitors. They serve two different needs—two different levels of the supply chain—but you're certainly right. That is the perception out there, and unfortunately, it's propagated by both sides. In any industry, you're going to have good actors and bad actors. Some see, on the compounding side, the opportunity to make a lot of money during this remarkable point in time, and not necessarily respect the boundaries around compounding. Again, unique unmet needs or shortage. I think it's just really a call to action or collaboration with compounders, with the FDA, with drug manufacturers, I think this is a unique point in time that we could really do a lot of good for the key stakeholder, the patient.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, describes compounding pharmacies’ efforts in tackling the tirzepatide shortage, and dispels the notion that commercialized and compounded drugs are competing with one another.

Clearing Up the Competition Myth

The Role of Compounding Pharmacies in Meeting Patient Needs

Generally speaking, what role do compounding pharmacies play in the pharmaceutical supply chain?

I think the primary role for compounding pharmacies is to fulfill unique unmet needs when it comes to the medication needs of patients across the country. How those needs are met are dependent on the dosage form. Who is administering the medication will then decide whether or not it's coming from what's called a 503B, an outsourcing facility, or a 503A, which is a your traditional compounding pharmacy. Typically, on the 503B side, you're going to have them primarily focused on supplying office-use medications to doctors, who then administer to patients in the office. You're going to have some of them that do have the ability to dispense pursuant to prescription.

But the tricky part there is, on the 503 B side, they have to follow what's called current Good Manufacturing Practice, or cGMP, because they are registered with the FDA, and succumb to those inspections. On the 503A side, you're going to have them focused on the just for Nico, or just for Don; your prescription only. They're not making these large batches of medication, and that's going to be a certain adjustment, just like on the B side, to what's commercially available. Whether Nico is allergic to something in a medication, we can make it without that excipient. For example, we can put in a different dosage form that's more amenable to his specific needs, unique unmet needs, either through the 503B or through the 503A, and then also what's called just in general shortages, which we'll get into a little bit later, when there's just limited or no supply of these commercially available drugs. That's where both of these types of compounding facilities can step in and help fill that gap, which is very important.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, comments on the role that compounding pharmacies play in the pharmaceutical supply chain from a macro perspective.

Behind the Scenes of Being a Clinical Trial Participant

, Jon Kostas,executive director of the APP

 discusses how the main goals and priorities of the APP are to serve as a trusted industry voice in the realm of psychedelics, aiming to provide clarity in an area that is often confusing due to the wide range of information and varying compounds. The organization seeks to advance psychedelic treatments through the FDA approval process, making these therapies accessible, affordable, and covered by insurance. In addition to expanding access, the APP emphasizes patient safety, ensuring that individuals receive the correct dosage and undergo appropriate mental and physical screenings before treatment. The focus is also on establishing best practices and safety standards for psychedelic use, ensuring that only eligible and qualified patients pursue these treatments.

Kostas also explains why he believes there was a need for this type of resource, what went into the making the launch happen, and the current state of psychedelic research, while sharing a personal story surrounding his participation in a randomized clinical trial involving psilocybin.

A transcript of Kostas’ conversation with

Could you describe the double-blind, randomized clinical trial involving psilocybin that you participated in?

Start to finish, it was about 54 weeks, and then I believe we took like a five or so month break in between. How it worked was, I went in for a screening. I had about a month or two of preparation to get me ready on what I might experience during these psilocybin sessions, because they give you a high dose of psilocybin (if you get the psilocybin and you don't get the placebo). That's why we're really emphasizing the safety here, because there is hope. This saved my life, but I did this with medical doctors. I did this with PhDs. I did this in a hospital setting, so if anything bad were to happen, they'd know how to get me through it.

A lot of people should have hope that are struggling right now, or their family members are struggling, but I'd encourage them to do this through the proper channels, and right now, that's through FDA clinical trials. We’re on the cusp of FDA approval, so hopefully they can do this through the healthcare system in the near future, but you need preparation, and you need to be mentally prepared and physically healthy to go through these experiences.

That was a big part of the clinical trial I was in: the team, the psychological support, a lot of preparation, a lot of integration after, and the sessions themselves. I was there for about a whole day, I mean, eight hours, and you're really feeling the effects of the drugs for a good, maybe 4,5,6 hours, and then they keep you there to make sure you're okay. How I did this was that I was technically like an outpatient, where I showed up for the day in the morning, did my procedure, and then I had someone pick me up from the hospital after, so I think that's probably how it'll look and be implemented into our current system.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), describes the randomized clinical trial involving psilocybin that he participated in.

Addressing Misconceptions Surrounding Psychedelics 

Kostas also explains why he believes there was a need for this type of resource, and what went into the making the launch happen, while sharing a personal story surrounding his participation in a randomized clinical trial involving psilocybin.

What went into making the APP a reality, and what were some of the challenges that you faced throughout the process?

The biggest challenge was a lot of the misinformation about psychedelics and the stigma. As a former study participant, I was in a clinical trial about 10 years ago. In 2015, I entered it as a treatment-resistant patient for alcohol use disorder. I had tried everything to stop drinking. Nothing worked. I was terrified of psychedelics, but I was so desperate that this was the only shot I had at getting any help, and this worked as soon as my first of three psilocybin sessions.

Psilocybin is one of the compounds in hallucinogenic mushrooms. I had a synthesized version of that. I've never ingested mushrooms, and I haven't done psychedelics outside of this clinical trial. I stopped drinking after my very first session, and I haven't touched alcohol. I haven't craved alcohol, and I haven't craved psychedelics at all after leaving the trial. This worked almost like an antibiotic for me, and there is a lot of misinformation out there, such as, can you treat one drug with an addiction to another drug?

Alcohol is technically a drug. They're also studying this for opiate use disorder, methamphetamine use disorder, cocaine use disorder, nicotine. The early results look very promising, and I'm hopeful that we'll have a lot more options for patients in the coming years, but a lot of the lawmakers thought that I was still taking psychedelics every day, like a prescription pill, or that I might have gone to the jungle to do this, but I had been doing this clinical trial in New York at NYU.

The biggest challenge has been the misinformation. We've been relying heavily on our scientific advisors that are from the universities and academic researchers that have been doing this research for, in some cases, decades. Then, there are these biotechs that are actually getting this through drug development to hopefully make this a prescription and make this a viable treatment, and give another option to patients. They have their whole set of obstacles as well through the Schedule I drugs, so there have been a few different obstacles, but that's why we felt that this was a great time to get everyone together, get all the leaders together, to really drive that voice and steer the conversation of how we get the federal government to support this research and support giving new options to patients out there.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), addresses the importance of stopping the spread of misinformation when it comes to psychedelics.

Building a Voice for Psychedelic Research

Why did you believe there was a need for this type of resource?

We've been at this for a couple of years now with initial discussions. We’ve had great relationships prior to this—starting with the members—so we've always had an open line of communication. Our work prior to this was a lot of educational work for the decision makers. What we would do is facilitate getting the best subject matter experts in front of the decision makers in Congress or in the executive branch, to lead with the data and the scientific evidence out there. This naturally happened. The timing couldn't have been better, with a new Congress coming in and a new Administration coming in, so despite what party was in power or will be in power in the future, it's good to have an association to be that guiding voice into responsible research and hopefully, medical applications of these compounds.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), explains why this resource is an asset, specifically for research in the psychedelic space.

Patient Support

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