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Supply Chain Logistics

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Articles

Unified corporate image emphasizes supply chain services

Inmar Rebrands Reverse-Logistics and Related Business Units

HDMA’s educational arm has new chair, vice chair

Center for Healthcare Supply Chain Research Renews Its Board

Delta Air backs away from prohibiting battery-powered temperature sensors in temperature-controlled pharma shipping

Overlapping, Imprecise Regulations Cause a Hiccup In Temperature-Sensitive Pharma Shipping

Big Brown will take over existing Merck distribution centers, absorbing them into its international healthcare logistics unit; Merck is also selling a lab to PPD

UPS strikes pioneering supply-chain deal with Merck

Financial and business changes are driving an evolution in channel management strategies

Marching up the channel management curve

As the number of specific services associated with sample distribution has grown, so has the number of service providers a manufacturer might use. It’s time to think about consolidating these services

Rethinking Sample Distribution

interview, Tracy Lopez, North America’s head of customer service and 3PL operations for Dr. Reddy’s Laboratories, explains:

How the third-party logistics (3PL) process typically operates

Key factors manufacturers should take into account when choosing a 3PL, along with the range of services a reliable 3PL should offer

The important lessons learned since the onset of the COVID-19 pandemic that have contributed to improving operational efficiencies

Trends within the pharmaceutical industry that 3PLs should be preparing for

The role of 3PLs in shaping the pharmaceutical industry over the next decade

Tracy Lopez uncovers the fundamentals pertaining to third-party logistics providers.

Selecting the Right 3PL

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

The key challenges that hospitals are currently facing

Why he believes that the drug supply chain is failing

Successes surrounding the implementation of RFID technology

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

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

The Impact of RFID: Enhancing Medication Management

 interview, Chris Williams, International Managing Director of Alloga Europe and ICS, discusses:

What’s needed to support advanced therapy medicinal products from a temperature standpoint

The current state of third-party logistics (3PLs) in Europe and what areas need to improve

How expectations of pharma companies have changed in terms of what they expect a 3PL partner to provide

How Alloga’s new facilities in Spain and the Netherlands fit within the company’s strategy

What he believes 3PLs can do to support supply chains more efficiently

Chris Williams expands on the services that a third-party logistics (3PL) partner should offer, while sharing ways to alleviate standard supply chain issues.

The Capabilities of a 3PL Provider

 interview, Peter Ax, founder and CEO of UpScriptHealth, a direct-to-consumer telehealth company, describes:

Why he believes ongoing and active drug shortages are the highest they’ve been since ASHP began tracking this in 2001

The current landscape of shortages in general

How drug shortages directly affect patients

What is needed to alleviate these issues surrounding the supply chain

Peter Ax provides insight as to industry’s lack of supply, along with how to mitigate these issues. 

Addressing the Drug Shortage Crisis

 interview, Chip Davis, president and CEO of the Healthcare Distribution Alliance (HDA), a national organization that represents primary pharmaceutical distributors, discusses:

The benefits of the Distribution Management Conference, and the value it provides for the industry

, including a look at how the challenges presented to distributors now differ, and how they are being addressed

Progress that has been made toward full connectivity since the FDA announced a “stabilization period” to finalize implementation of the DSCSA before November 2024, along with some of the most significant issues for trading partners

Some of the root causes of drug shortages, and how distributors are work to mitigate them

Key initiatives and plans that the HDA is focused on for the second half of 2024, and how these will shape the future of the pharmaceutical supply chain.

Chip Davis recaps the organization’s Distribution Management Conference and addresses distributors’ preparedness for DSCSA implementation. 

Overcoming Supply Chain Challenges

 interview, Allen Jacques, a life sciences industry thought leader at Kinaxis, dives into:

What he sees as limitations of current government efforts when it comes to boosting domestic production of essential medicines, and why they aren’t sufficient

The challenges that generic drug manufacturers are facing today

Why more resilient and transparent supply chains are necessary in the pharmaceutical industry, and how these can help mitigate shortage issues

Allen Jacques explains the history behind medications’ lack of supply, while offering ways to help alleviate their impact. 

Mitigating Drug Shortages

 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

 interview, Rob Besse, Archbow Consulting’s VP of distribution services, shares:

A general overview of how the 3PL process works, using his 20-plus of pharma supply chain experience as added insight

The factors that manufacturers should consider when selecting a 3PL, along with the array of services that a quality 3PL should provide

Valuable lessons he believes 3PLs learned during the COVID-19 pandemic that have helped improve efficiencies

Trends affecting the pharma industry that 3PLs be on the lookout for the rest of the year

Podcast is available directly on SoundCloud.

Rob Besse offers a breakdown of the third-party logistics (3PL) process, including lessons that these providers have learned coming out of the pandemic.  

A First-Hand Account of 3PLs

A panel of experts examines how stakeholders can support strategies that improve patient outcomes, while also navigating various distribution models.

Asembia 2025: Rethinking the Drug Distribution Process

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

The company’s branded form of nadofaragene firadenovec-vncg will also be produced at a hub in Parsippany, NJ. 

FDA Approves Additional Manufacturing Plant for Ferring’s Adstiladrin

The program measures a company’s air cargo supply chain efforts when it comes to quality, safety, and compliance.

IATA CEIV Celebrates a Decade of Enhancing Air Cargo Efficiency 

The Carlsbad plant is expected to accelerate both the development and commercialization of cell therapies. 

Thermo Fisher Scientific Unveils Advanced Therapies Collaboration Center 

Will Moving Drug Production to the United States Help or Hurt Patients?

 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.

What obstacles do you foresee regarding the availability of specialty medicines for US patients—as a result of supply chain challenges—and how can biopharma companies address these issues?

If you're manufacturing, you're really upstream, and you are looking for your first, contract development and manufacturing organization (CDMO). In light of this situation, now, you're going to try to get a CDMO that operates in the US, but if you're currently manufacturing elsewhere, this transition cannot happen on a dime. We're talking about years, we're not talking about months. There won't be any short-term solutions, and unfortunately, tariffs will apply and will will probably have an impact on the value of medicines. There's no other way.

Is the solution 100% to actually use a CDMO in the US? It could be, but again, I'm intrigued by the effect that it's going to have on pricing, and I think it will be a negative for us patients.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, explains what the mindset be for companies who are just starting the reshoring process.

The Future of Specialty Medicine

First of all, the easiest solution is to produce everything in the US. It just so happens that EGRIFTA SV will transition to a new formulation that we believe will be approved by the end of this month, and that will be entirely manufactured in the US. It just so happened that in our case, at this juncture, we have a relatively short-term solution coming up whereby, we're not going to have this situation that I've described, where components are crossing the border several times.

This being said, I think that any company that would like to actually get such a strategy forward at this time would actually encounter many difficulties, because it takes time to actually select a CDMO, a manufacturing facility that is qualified that can do something for you. It takes a lot of time. Our economies—especially in Canada and the US—are intertwined, and our plants in Canada are FDA-approved. If you try to do this in a short period of time, fyou're going to have to face complexity, but second of all, you're not sure that you're going to be able to produce the same thing in the US at the same cost.

Often, the manufacturing facilities in Canada and elsewhere were set up because they could do quality work, but at a lower cost, so that's going to be really challenging. I think that this is why many companies, especially biotechs, may actually be vulnerable to this phase of uncertainty, because they don't have the same cash position as Big Pharma, and yet, they account for a lot, if not the vast majority, of innovation. This definitely creates a lot of challenges.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Paul Levesque, CEO of Theratechnologies, describes potential availability challenges brought on by supply chain obstacles.

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.

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.

Preparing for DSCSA Deadlines 

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 Quest to Deliver Reliability

Could you describe your day-to-day workflow at Morris & Dickson, and how it supports the efficiency and reliability of your operations?

In the second 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, describes his day-to-day workflow at Morris & Dickson, and how it supports the efficiency and reliability of the distributor’s operations.

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