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One packaging aspect—the tape—is often overlooked, but is a valuable component of the shipping process. 

Why Pharmaceutical Products Need Sustainable Packaging

I remember the gut punch 15 years ago when we opened the letter from Florida’s top payer. The words were stark: a 50% reduction in reimbursement rates were announced for the following year. Our small, independent home infusion pharmacy had a heavy patient census of these covered lives, and this news not only threatened our financial stability, but our very existence. As the initial shock wore off, reality set in. The cold, hard truth in business is rather simple: Revenue - Expenses = Net Income. For a buy-and-bill pharmacy, slashed reimbursements meant our revenue (and ultimately, bottom line) was about to take a devastating hit.

The first instinct was to appeal the payer cuts, but that went nowhere. Next, we considered increasing our patient base to offset the loss in revenue, but we quickly realized that such strategies merely added to the cost of business without the guarantee of revenue pull-through. Infusion pharmacies can’t simply scale up without a significant influx of physician referrals, just as hospitals can’t magically add beds without major buildouts or M&A. With limited options to guarantee revenue growth, the only viable path left was to focus on controlling expenses.

Fast forward to today, and the landscape for pharmacies remains as challenging as ever. Next year’s reimbursement forecasts predict more turbulence with drivers like: Direct and indirect remuneration (DIR) fees changing, price controls imposed by the Centers for Medicare & Medicaid Services (CMS), and new policies around site neutrality—all lowering pharmacy reimbursement forecasts. Whether you’re running an independent pharmacy or managing one within a health system, these changes threaten to diminish the progress made through recent improvements in revenue cycle management.

Meanwhile, attention on cost containment has strayed over the last three years. According to a focus group of pharmacists, primarily from integrated delivery networks (IDNs), the concerted efforts to take on the new identity as a revenue center has absorbed so much energy it’s almost as if pharmacy has lost sight of its cost center hat. With reimbursements expecting to slide, many pharmacies lament that little can be done to achieve the financial wins that their revenue cycle management programs have provided over the past few years.

In the sense that complaining is going to turn the hearts of payer decisions, yes, it’s probably a futile effort to express further dissent.

Yet, there are other moves to make. Savvy procurement professionals are looking to financially counterbalance this expected impact to the pharmacy’s profit and loss by seizing on drug manufacturers’ inclination to shift more of their volumes to direct channels, where the freedom to negotiate is opening doors for newfound cost savings. Most progressive pharmacy teams have rev cycle already tuned up as tight as possible, and they’re facing the reality that there isn’t anything further to be done with the front portion of the equation. Now they’re shifting focus to realize drug acquisition cost savings to offset the downgrade in revenue forecasts. With labor costs a distant second, drug spend is commonly pharmacy’s largest expense.

It’s remarkable how we now divide so much of life into pre- and post-COVID eras. The pandemic humbled us in ways we couldn’t have predicted. Before, the idea of buying directly from pharmaceutical manufacturers felt overwhelming, with manual price negotiations, tedious contracting stretching into months, and multiple vendor registrations bogging down operations.

Then, the pandemic hit. Drug shortages forced pharmacies to rethink everything, driving them to lean on direct manufacturer relationships out of necessity. In the process, many discovered that purchasing directly from drug companies not only helped procurement teams navigate shortages but also unearthed significant cost savings.

For large institutions with a drug spend in the hundreds of millions, direct purchasing opportunities may seem insignificant. Take a hospital pharmacy with a $500 million drug budget—saving $50,000 by switching one national drug code (NDC) represents only 0.01% in annual savings when looking top-down. But when that same hospital faces year-over-year reimbursement cuts, every dollar saved becomes a counterweight to lost revenue. A more ground-up approach to savings is gaining traction, as pharmacies realize that cutting drug acquisition costs can soften the blow of reduced reimbursements.

Let’s say your payer mix suggests a $5 million reduction in reimbursement for 2025. By creating an initiative to save $5 million for the institution through direct purchasing—just 1% of the overall drug budget—you could theoretically neutralize the impact on net income without jeopardizing rebate structures or cost-minus agreements. Surplus savings could cover annual salaries of pharmacy staff, fund new initiatives like central fill models, or even justify budget requests for continuing education (CE) travel.

Pre-COVID, manufacturer-direct commerce was riddled with friction, but today, advances in decision-support software and marketplace aggregators have made it easier by simplifying vendor setups, improving visibility into stock, streamlining price negotiations, and generating purchase orders in seconds. New technology also provides better optics into comprehensive savings analytics. More manufacturers are opening their portfolios directly to pharmacies to better manage channel fees, prevent product leakage into the grey market, identify prescription trends in real-time, and provide pharmacies with point-of-sale savings to enable cash pricing models whenever insurance coverage is either lacking or the out of pocket is too costly for patients.

Unlike pharmacy school, where 100% earns you an A+, procurement is a different game. While there are concerns about contracted volume obligations and maintaining rebates for better pricing, here’s the reality: if you’re 100% compliant to pre-committed vendor volumes, you exclude yourself from opportunities available on the open market that can make a difference to your budget. It’s not an overhaul of your entire purchasing strategy, but rather a closer focus on how to optimize the delta between committed and non-committed thresholds. Optimizing the 5-20% within your direct purchasing allowance can deliver enough juice in acquisition cost savings to compensate what’ll be missing from your reimbursement cup next year.

It’s easy to have a victim mentality, as I did 15 years ago, when external forces jeopardize your pharmacy’s ability to operate and serve patients. However, it’s the pharmacies who start thinking and surviving like a business who will be in the best position to adapt and thrive in this changing landscape.

Blake Powers is the CEO of Medigi, and a member of Pharmaceutical Commerce’s Editorial Advisory Board.

Tips for pharmacies with the reimbursement blues.

Dusting Off One’s Cost Center Hat

Pharmacies, most agree, are no longer simply just a place to pick up a filled prescription. Even before the COVID-19 pandemic, pharmacy services had begun to expand. The public health crisis, however, would thrust community pharmacies in the US into the spotlight, and they responded. Their offerings—and the reliance on them—exploded. 

Seemingly overnight, retail and community/independent pharmacies introduced virus testing clinics for COVID, then vaccination distributions at a large scale. Community pharmacies in particular have always been in the background, though, supporting doctors, patients, and communities. From prescription fulfillment, to test-and-treat services, to counseling, these entities play a vital role in the patient care ecosystem.

“The pharmacy itself has greatly changed—we're not just the destination you come to after you go to the doctor's office,” says Kathy Collier, DPh, regional vice president of operations, Express Rx Pharmacy. "We've had to shift in the pharmacy to be more of a destination healthcare place. We have had to pivot and become a place where we are part of that healthcare system.”

Pharmacists, of course, play a crucial role in public health. In addition to the COVID immunizations, community pharmacies administer vaccines for ongoing flu seasons, for global travelers, new parents, elderly citizens, and those immunocompromised—dealing with such afflictions as chicken pox to hepatitis A and B virus to yellow fever and respiratory syncytial virus.

Today’s pharmacist focuses on enhancing overall community health through an increasing educational role—offering directives on medication use, preventive care, healthy lifestyle advice, and aiding in chronic disease management for conditions such as diabetes and hypertension by offering personalized care and monitoring.

“In pharmacies at large, not everybody who walks in is sick. A lot of people are there because they're caregivers, so they need counsel just as much,” says Ian Stone, senior vice president of Mesmerize. “They need those five minutes with the pharmacist on how to administer the pill, the liquid, or whatever the drug is. Independent pharmacists do a really good job coaching.”

While many are experiencing unprecedented market and business challenges, such as the emergence of online pharmacies, industry director-to-consumer drug delivery models, and other alternative point-of care entrants, community pharmacies believe they still offer a unique and significant position in the mix. They don’t just serve local communities, they’re often part of them, too. Whether that’s, for example, sponsoring local sports team, building relationships, or being a go-to or trusted source for advice and support. While the dynamic may not be the same as in decades past, their presence and value still resonates in the community and with longtime customers.

“…We've got some pharmacies that have customers that come in every day, literally because they have nothing else to do,” says Laura Edmundson, PharmD, MBA, vice president of pharmacy at Brookshire Brothers, Inc., a Texas-based employee-owned grocery store. “They'll just come and they'll sit down and check their blood pressure on our blood pressure kiosk and say hello. That's part of their routine, visiting the pharmacies.”

Pharmacy deserts has become a popular term in 2024. These are geographic areas—a neighborhood, town, or county—where some or even all of the pharmacies have closed. So what happens when a community pharmacy has to close? In rural towns, the local pharmacy is often the closest healthcare provider for miles. At these locations, people can check their blood pressure, access healthy foods, get advice on over-the-counter (OTC) aids, or better understand their prescription drug interactions and side effects. For patients with unreliable access to transport, local pharmacy delivery and walkability matter most.

“We have a lot of rural locations at Express Rx (based in Little Rock, AR), so it is very important for us to be able to offer some of these services that maybe people in our communities can't get because they don't have a local doctor's office,” says Collier. “It's huge now that we can offer immunizations and some testing that they would have had to drive to another town to get or just not get it at all.”

Adequate access to healthcare is an ever-present challenge. Telehealth boomed during the pandemic —telemedicine use among physicians grew from 15.4% in 2019 to 86.5% in 2021, according to the National Center for Health Statistics.

 But not every patient has reliable internet or the computer literacy necessary for telehealth visits, however. It’s important that pharmacies are there when patients have questions.

“We're the most accessible healthcare provider,” says Edmundson. “You don't need an appointment to ask your pharmacist a question or to get counseling from them.”

As mentioned, nationwide, pharmacies are closing. Across the US, more than 7,000 pharmacies have shuttered since 2019, according to data from Lucas Berenbrok, PharmD, associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. He considers that estimate conservative. Of those pharmacies, 54% were independent drugstores, an AP analysis of Berenbrok’s data found.

 It’s not just the “little guys,” however. In June, CNN reported that Walgreens planned to close a “significant number” of its 8,000+ stores. CVS, reportedly, already closed 244 stores between 2018-2020, and had plans to close about 900 more starting in 2021.

“The biggest thing lagging behind now is that we don't have provider status. We can't bill, in many cases, for clinical services. We can put pills in a bottle, but we can't bill for every sort of point-of-care test,” says Michael Halliwell, director of pharmacy and whole health, Balls Food Stores, a longtime retail grocery chain serving Kansas City, KS

 “The hard part is that pharmacies have been crying about reimbursement for a long time, and it's gotten worse and worse. Over the last five years, there has been a dramatic reduction in what we get reimbursed.”

Halliwell adds that a big issue has been the increasing levels of direct and indirect remuneration (DIR) fees. “We're paying 2020-freeze clawbacks,” he notes. “We’ve been getting hit with DIR fees since January 1—twice the DIR fees, in fact, which literally levels so many independent pharmacies who don't have cash. It’s bad out there.”

The margins, therefore, have gotten smaller and smaller, with more tasks falling on pharmacists’ plates and fewer resources to go around. Every time someone shops online or elsewhere for cheaper prescription or OTC products, the pharmacy loses ground. With rising prices for prescription drugs in recent years and new complexities emerging in payer coverage, pharmacies, much like patients, have felt the squeeze.

There is some help from new advances in technology and automation. Inbound call centers, as well, assist in managing the volume of pharmacy calls and utilize central-fill pharmacies to fulfill recurring prescriptions. This allows pharmacists more room to operate at the top of their license, offering in-person consultations and counseling, testing, and immunizations.

“Community pharmacies are stressed at the moment. We've got a lot on our shoulders,” says Edmundson. “All those patients have to go somewhere, which just puts more workload on the pharmacies that are still here. There have to be workflow adjustments to make offering these types of services viable.”

Without a significant shift, the current trend of pharmacy closures will likely continue. To turn back the tide, experts believe policies need to change, and community pharmacies need stronger support and advocacy to bridge the healthcare gaps that are steadily widening.

Marina Crouse is a copywriter with MJH Life Sciences®, parent company of Pharmaceutical Commerce. She works closely with such MJH media brands as Mesmerize, which specializes in patient education at the point of care.

Michael Christel is Group Managing Editor of Pharmaceutical Commerce, Pharmaceutical Executive, and Applied Clinical Trials.

1. Telemedicine Use Among Physicians by Physician Specialty: United States, 2021. National Center for Health Statistics. February 2024. 

https://www.cdc.gov/nchs/products/databriefs/db493.htm

2. As Pharmacies Shutter, Some Western States, Black and Latino Communities are Left Behind. AP. June 3, 2024. 

https://apnews.com/article/pharmacy-closure-drugstore-cvs-walgreens-rite-aid-91967f18c0c059415b98fcf67ad0f84e

3. Meyersohn, N. Why Walgreens, CVS, and Rite Aid are Closing Thousands of Drug Stores Across America. CNN. June 28, 2024. 

https://www.cnn.com/2024/06/28/business/walgreens-cvs-closing/index.html

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

Community Pharmacies in Crisis: Navigating the Challenges and Closures

Emerging biotech companies launching niche therapies (e.g., CAR-T, radiotherapies) operate without a commercial blueprint. Each disease state is unique. Each account has its own mix of stakeholders. Companies can’t rely on syndicated data to help them uncover all essential account-level insights. As a result, these innovative companies are all pioneers at launch, creating their own custom commercial models. Further, these companies need to rely heavily on their field teams to gather granular intelligence about accounts that cannot be sourced from syndicated data.

It’s therefore imperative that these companies—which are often lean and budget-constrained—create fruitful partnerships between home office commercial teams and the field force. The most successful of these partnerships will be marked by seamless information exchange and robust insight collection. Success starts with appreciating the uniqueness of niche therapy commercialization.

The unique complexities of niche therapy commercialization

Unlike traditional pharmaceutical products that cater to a large patient base, niche therapies (in therapeutic areas such as oncology and hematology) target small patient populations and are therefore relevant to only a limited set of physicians. Further, the complexity of administering the therapies and the intensive training required limits the number of treatment facilities. In CAR-T, for example, treatment involves T-cell extraction, reinfusion, and close patient monitoring.

Companies must gather granular account-level information to accurately understand opportunity. For instance, the number of apheresis chairs a facility has or how many ICU beds it reserves are key metrics that help a company with a CAR-T therapy understand opportunity.

There’s a moral imperative here, as well. Patients suffering from rare diseases deserve access to efficacious treatment. Therefore, a company’s effort to optimize its commercial model and onboard more treatment centers is also an effort to improve patient access and outcomes. To succeed in this complex mission, a company must look across its commercial infrastructure, starting with technology.

Build a dynamic commercial technology infrastructure

The technology at the center of niche therapy commercialization is the customer relationship management platform. For niche therapy commercialization, companies need powerful, user-friendly and flexible commercial technology that enables them to build rich account profiles. These profiles should incorporate the various pieces of data and information (some quantitative, some qualitative) that capture key operational details and reveal true opportunity within accounts. It should also help the company map stakeholders accurately, which will help the sales team hone its efforts. Further, this technology should:

Empower the sales team in the field by equipping them with customized views summarizing target accounts and relevant insights.

Facilitate a smooth two-way information exchange between the home office commercial team and the field sales force. Commercial leaders should be able to deliver information that helps reps in the field. Reps should be able to easily do everything from entering a call to adding contextual information about an account.

Accommodate change as the company brings its therapy to market, expands its account targets, and adjusts to shifts in the dynamic niche therapy space.

Housing account plans in flexible, accessible, and user-friendly commercial technology can empower the sales force and add nimbleness to a company’s commercial operations.

Enable effective field intelligence gathering with sound process

A rare disease company can’t turn to syndicated data sources for certain insights into its target accounts. Uncovering opportunities within accounts requires specialized knowledge. A company gathers this knowledge to a significant extent through its sales force. Reps gather valuable insights about account capacity and capabilities, stakeholder mix, and more.

Commercial leaders must therefore equip reps with the robust and flexible technology tools we discussed in the last section, as well as clear instructions for how and when to share information via those tools. Asking for too much information from the sales force could limit information sharing, as reps struggle to comply with the commercial team’s time-consuming requests. On the flipside, sparse requests for information from the field limit valuable insight sharing. Commercial leaders should home in on the most essential pieces of information that will enable the company to develop rich account profiles and advance the commercial effort.

Prepare for a future of increased complexity

The niche therapy space is dynamic. For one, competition is increasing. As more therapies come to market, treatment sites will become increasingly crowded. Companies will battle over a smaller pool of opportunities, at least in the short term.

In the long term, companies are seeking to expand the number of treatment sites, equipping facilities beyond specialized tertiary care centers with the training and resources needed to administer niche therapies. The expansion of treatment will benefit patients. It will also further stretch biotech companies’ commercial teams as they expand their efforts to identify and engage with new stakeholders. In a hospital, for example, these stakeholders could span the entire organization—from the emergency room and intensive care unit to specific departments like neurology.

Companies that prioritize granular intelligence gathering in the field and enable it with flexible commercial technology (instead of trying to force new requirements into rigid tools), will be best equipped to navigate this complex and evolving space.

Develop two-way partnerships with the field

Commercial leaders at emerging biotech companies should view niche therapy commercialization as an account management exercise. Account management requires granular understanding of customers (in this context, treatment sites and the stakeholders within them). To gain that granular understanding, companies need to create a healthy two-way partnership between home office and the field sales force.

To enable this two-way partnership, companies must think bigger. View commercial technology as more than a place to log call activity. View sales force and home office engagement as something integral to daily operations (instead of something that happens during periodic status meetings). And understand the trajectory of the niche therapy space. It’s one marked by dynamic innovation, and, as a result, more competition and growth in the number of treatment sites. It's a space that promises to transform patient lives in the years to come. To ensure a company’s therapies breakthrough and reach patients in need, it must foster partnership with the field, putting robust and flexible commercial technology and sound process at the heart of the effort.

Jennifer Maurer is executive director of commercial and CAR-T operations at Legend Biotech, while Laura Riccio is an associate partner at Beghou Consulting.

How emerging biotech companies can create fruitful partnerships between home office commercial teams and the field force to enable this intelligence gathering, while driving commercial success.

Operating Without a Commercial Blueprint: Empowering the Field for Niche Therapy Launches

Three Themes Powering Logipharma USA

Over the past 20-plus years, LogiPharma USA has been a conference known for uniting various biotech, pharma, and medtech supply chain executives in one place in order to help spark creativity and innovation.

The event’s agenda—spread out over the course of three days—was designed with the intention of covering a plethora of different subject areas, otherwise known as themes. After speaking with Ryan Portela, the show’s program director, he further confirmed the multiple themes that headlined this year’s event, which is apparent via the sessions that were held. Being in attendance for the sessions, the 

 team gathered noteworthy moments that accurately captured LogiPharma USA’s essence, ranging from end-to-end supply chain visibility to thoughts on bolstering the temperature monitoring and data sharing process.

Given the magnitude of LogiPharma USA for the pharma logistics industry, what were some of the biggest themes that came out of the conference?

Latest Conference Coverage

Three Themes Powering LogiPharma USA

Co-hosted by IntegriChain, Blue Fin Group, and Federal Compliance Solutions, the goal of the Access Insights Conference is to share the latest trends, strategies, insights, and tactics for data-driven access and commercialization. Bill Roth, general manager and managing partner of IntegriChain’s consulting business, which includes Blue Fin Group, set the tone early in his keynote surrounding “Financial Headwinds and Tailwinds to Commercialization.”

Offer a “Who Moved My Prescription?” conclusion

Share what popping the gross-to-net (GTN) bubble signifies

Describe how this will change market access and channels

Note the ways to navigate specific archetypes and portfolios

Provide a summary and recommend next steps

Roth started off the presentation off with plenty of honesty.

“The information I'm going present to you guys this afternoon is not rosy. We’re not in a good spot as an industry,” he said. “There are lot businesses that are in pain right now. I was really focused on this concept of pain and the concept of community, and I think that's why I'm really appreciative that Josh Halpern, our CEO, makes this happen every year—this is only about thought leadership. We're not here to sell anything. We're not here to pitch anything. This is not about money for us. This is about our industry needing help, and I think if we recognize where we have pain and we come together as a community, we'll be able to solve the problems that are in front of us.”

This statement became even more apparent when he presented a graphic that illustrated the stock performances of “Big Nine” publicly traded access and channel companies over the last decade, which would include that of: Cigna, CVS Health, McKesson, United Healthcare, Walgreens, Cencora, Humana, Rite Aid, and Cardinal Health. From the retail pharmacies that are facing the challenge of branded product abandonment to wholesalers struggling to figure specialty out, the struggles are there.

As previously alluded to, due to pharmacy pressures, brands have become increasingly unimportant to the pharmacy economic picture, Roth explained. According to Blue Fin Group proprietary research, the top 100 brands only represent 6.4% of the total unit volume, with the remaining belonging to generics. Being that low-volume branded are afterthoughts for the retailer, perhaps it’s logical that retailers wouldn’t prioritize those.

So what’s been the aftermath? Retail pharmacy has fragmented and splintered into brick-and-mortar, e-commerce/cash/telehealth/DTP, and digital integrated tech hub service solutions, given the changes in product mix, reimbursement, and the rise of cash pharmacy.

By offering a longitudinal look at a reform, his timeline showed that in 1947, healthcare operated as a cash business. “If retail fails, are we moving to a cash pay model? You don't have a cash pay model really up and running, but give Mark Cuban credit. What he did was shine a light on a problem in our industry. I'm on three generic products. I haven't used insurance for my products in five years. I've been paying cash the whole time through. So Amazon's figured it out, Cost Plus Drugs has figured it out.”

However, with retail set to lose 25-33% of their brick-and-mortar stores, ecommerce is now average wholesaler price (AWP) less 23-25%, which could ultimately mean that the market will return to mail order or cash pay, while drug shortages could potentially drive compounding.

Many manufacturers have been shocked by government policy and GTN—the government attempted to assert its influence via CMS through Medicaid, pertaining to coverage and limitations of pricing and price increases through the unit rebate amount (URA) and consumer price index for all urban consumers (CPI-U). Also, the Inflation Reduction Act (IRA) is a “double down” on Medicaid policy by applying it to Medicare, which affects commercial.

Previously, Roth noted that GTN relied on modeling the effect of decisions that were made in business silos, but nowadays, the approach is to have a forecast that spans across various aspects of industry, including statutory discounts, discounts to payers, pharmacies, group purchasing organizations (GPOs), and distributors, while describing how this changes over time.

When it comes to general medicine and specialty lite, of the 34 non-specialty drug launches last year, only one have had been verified to have met its forecast, suggesting that manufacturers are realizing that the wholesale to retail model is no longer effective for brand launches. Meanwhile, if one examines cell and gene therapies, these manufacturers are looking to get payer coverage, but instead are relying on Letters of Agreement for authorization.

Although these only represent a sliver of his points, Roth wanted to leave the audience with the following takeaways:

Be aware of the therapeutic area, product archetype, and benefit design

Educate management teams early on regarding changes in the market

Design multi-generational plans beyond brand managers’ short-term decisions, which are often only 12-18 months out

Marketing efforts, market access, trade, field, and patient affordability should be aligned with GP and finance

Proficiency with both GTN and reimbursement forecasting is key

Never assume that channels will be there to support

1. Financial Headwinds and Tailwinds to Commercialization. October 14, 2024. Access Insights Conference, Washington, DC.

The conference’s opening keynote sets the scene for 2025 and the years to come. 

Access Insights 2024: Commercialization’s Financial Headwinds and Tailwinds

The cold chain logistics process—and pharmaceutical logistics in general—often leaves stakeholders with questions surrounding improving both the data visibility and data sharing processes.

Moderated by Tony Fonk, president and CEO of SpotSee, a discussion on “From Clinical to Commercial: Improving Cold Chain Insights Across the Value Chain,” featured insight from Jeff Lander, director of global logistics engineering, Moderna; Alok Bhatt, senior director, global biologics operations, Bristol Myers Squibb (BMS), and Paul DellaVilla, director of digital solutions and services, Cold Chain Technologies. The gentlemen wanted to determine ways to build processes into company policies that can enable better visibility, discuss ways to monitor aforementioned data, and describe the value of partnerships in these efforts.

Moderna has been making an augmented customer experience its ultimate priority, with the help of direct-to-pharmacy or direct to patient care-type efforts.

“This year, we put a focus on an enhanced customer experience, to be able to not have something show up that needed to be intercepted, that wasn't in temperature range. We were really striving for call it for lack of better words, an Amazon Prime experience for our end user base,” Lander explained. “So that was real-time tracking visibility, and also the ability to intercept the shipment. It also included if we saw our temperature trending in the wrong direction, if we saw some sort of interruption in the network via UPS or FedEx in terms of a missed flight, to be able to provide the visibility, while also having accurate information in terms of temperature, letting it arrive a day or two longer, and knowing confidently that the product is still viable.”

From a brand management perspective, having high customer service levels are imperative—BMS strives to be at 98-99% for most products. Considering the company’s portfolio, many of its customers or wholesalers or hospitals, would function on three months worth of inventory in some cases. In these situations, last mile is still valuable, but to a different extent. However, adding the cold chain variable makes it more a supply chain integrity concern.

“We cannot be playing with our quality—it's important,” noted Bhatt. “Every time we do not deliver the product and don't have the last-mile visibility, that impacts our customer service level, that affects our impact to the patient itself.”

Cold Chain Technologies’ definition varies in the sense that it is literally the final step—the company is interested in the direct-to-patient type of shipment, which requires a different approach when it comes to packaging, and monitoring services, especially when thinking about specialty pharmacy.

“We work a lot with the wholesalers or the direct pharmaceutical manufacturer, where they're going out to their patient, and they still really have that ownership and control of supply,” said DellaVilla. “You typically see them being a little more conservative—with a little bit more protection—whereas you go to the last mile, which is like a specialty pharmacy application, and this really handled more by the URAC standards than you would say, a traditional FDA standard. You're typically looking to be little more cost conscious because you're shipping a smaller volume, so that might be individual dosing, or one-month supply of pharmaceutical products, so the cost impact and the type of shipping will vary in those places.”

Fonk posed the question on everyone’s mind: What are the realities of achieving accuracy, interoperability, and sharing the information?

“It really depends on the type of supply chain,” commented Lander. “It's different for final-mile distribution than it is for a cell and gene therapy drug; it very much depends on the stability of the drug and the final outcome you're trying to achieve. For us, it's really trying to figure out what that right, protection, trackability to price point really is.”

For Bhatt, this concept of traceability begins at the drug substance level.

“When you think about cost of goods, 80% of the cost of the product is in drug substance, which is API [active pharmaceutical ingredient] right, even before it goes to a vial or a syringe,” he explained, “so at the end of the day, the cost of the product is really something that we want to save for now, depending on what the definition of the holy grail is or not. We want to make sure that we are not over emphasizing on traceability, where we don't have to a lot of time.

“As we move forward, there are cost pressures. We talk about IRA, we talk about ESG goals. That’s a moving target for us, where we are getting pressure as a company, as an industry, to bring our costs down. But then there is the 20% that now we have started to focus on as well, where we want to make sure how much is too much—just because we have something should we leverage that? Does it make sense, what's the strategy, or what's the risk strategy toward it?”

When it comes to being able to maintain the integrity of the product, DellaVilla believes that success in the area should start with some sort of control that is able to monitor supply chain variability.

“Control is a big part of how the pharmaceutical industry has looked at maintaining integrity of product, and control could be qualified packaging,” he said. “It could be a chemical indicator, it could be a temperature monitor. It could be a real-time tracker. And because there's that much variability in the supply chain and how we were showing control, I think as we get into the details of the Drug Supply Chain Security Act—and starting to understand how that's going to play and need to be monitored—I think what you're going to need to see is different tools evolve for tracking, not just the serialization, but also those excursions you're going to need to get to a place in which you differentiate. It's about how you start to compare those varied methods of control. That's really going to get to the crux of how we approach it.”

Fonk T, Lander J, Bhatt A, DellaVilla P. From Clinical to Commercial: Improving Cold Chain Insights Across the Value Chain. September 24, 2024. LogiPharma USA 2024. Boston.

A panel offers its perspective on bolstering the temperature monitoring and data sharing process. 

Bradley Dunlap

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