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Although companies are faced with constraints, regulations, and challenges in this space, the positives supersede the negatives.

Why Reliable Pharma Shipping Outweighs Cost

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. 

LogiPharma USA 2024: Enhancing Cold Chain Insights

One topic of major focus at this year’s LogiPharma USA is sustainability. Of course, some could make the argument that it has been a buzzword for quite some time now, as noted by various stakeholders’ pledges to achieve net zero emissions over the next couple of decades. However, what is just as important as one stating his or her intent to solve a problem is one’s effort in determining 

A panel discussion regarding "How Pharma Can Better Understand Its Carbon Footprint and Reach Sustainability Goals" convened yesterday, and was moderated by Joe Van Der Bosch, president of DeSpir Logistics. He was joined by Alaina Passavant, account manager, CDP Supply Chain; Kaushik Datta, a pharma supply chain expert, Chandan Trehan, digital supply chain & sustainability Lead with Bosch; Jeff Tucker, CEO, Tucker Company Worldwide, and Joe McCannon, director for sustainability at the Office of the Federal Chief Sustainability Officer, Council on Environmental Quality (CEG).

The presentation was powered by multiple objectives, including:

Becoming aware of various the types of data and data sharing that is happening across the ecosystem.

Defining carbon offsetting and how it can be of value to reach sustainability goals.

Demonstrating the results and benefits of sustainability efforts

From Passavant’s point of view, there is certainly plenty to be done in this regard, and with these efforts comes complexity.

“From my seat and who I work with, there are companies who want this environmental data, whether it be emissions, energy use, or water and commodity tracking from their suppliers. They're trying to understand what their supply chain is doing,” she explained. “They come to CDP, because we have a questionnaire that tracks this and asks suppliers and companies about this. They're finding that the most basic thing is that they don't know who to contact at their suppliers. They don't know who's responsible. They don't know if their supplier has a sustainability team or is aware of what even emissions are.

“ … I think one of the big opportunities that we're having, though, is that there is a significant growth in expectations of improving on all topics, whether that be sustainability for planet or sustainability for cost reductions, profit margins, etc., but just having that growth and the opportunity to come together as customers in a similar level of your supply chain to then ask your suppliers to do XYZ or to report on things [is valuable].”

In that manner, supply chain stakeholders can come together to agree upon common KPIs, which can drive action and improvement forward. After all, it’s impossible to improve something that immeasurable.

When it comes to how tech can help support industry’s efforts in achieving change, Trehan pointed out that it ought to stem from the use of both artificial intelligence and internet of things, as these can be beneficial toward the environment.

“When you use technologies like these, you are not just improving efficiency, but you are also reducing wastages in your supply chain, which have a direct impact on the sustainability aspect,” he explained. “When you bring in a technology like blockchain, you're creating a more democratized balance of information data sharing between your supply chain partners, which essentially brings down the resistance to a little bit to some extent when it comes information sharing; we know we work in a very regulated environment, and any information or any data which is not necessarily required for any regulatory filing is often received with a lot of resistance. People ask, why do you need this data?

“… One thing that I'll definitely say is when we embark on a journey of making investments in the supply chain, especially around technology, we have to approach it with a little bit of guarded optimism. There's no one technology that can solve the problem in its entirety. It's a team game, and everybody either wins or loses together. So that kind of guarded optimism is absolutely necessary.”

Van Der Bosch posed the question to McCannon, is what's being described as how industry is responding to this challenge any different when you look inside the government, and how do you think the government can help support the industry in these initiatives?

Being that he works for the federal government, McCannon noted that industry’s take on the situation is not that dissimilar from government’s perspective. However, being that the government functions as one massive organization, the challenge lies in orchestrating it to be more effective, more sustainable, and more resilient. As the largest purchaser of goods and services in the world, a lot of the day to day involves trying to navigate this complexity of orchestration and understanding how the CEQ can work with all of the agencies in the executive branch.

“I would say that the way we've approached, the way we've started is by trying to set very clear, expectations for what we hope to accomplish, and also to set an example for other governments and other organizations,” he said. “That started with something called Executive Order 14057, which came out in December of 2021, and this executive order said, in pursuit of a net zero emissions economy by 2050, the federal government is going to make some really serious commitments to decarbonizing its own operations.”

He also revealed breaking news regarding a program that will be released in the coming weeks.

“ … I think this is the first time that's being shared that we are launching in the middle of October, something called the Supplier Accelerator, which will be a web-based program, starting with webinars, where we'll basically be walking through the really vast federal resources that are available to help organizations—and certainly including pharmaceutical organizations, which are some of our biggest suppliers—to take advantage of the resources that were introduced by several Biden-Harris administration programs, including the Inflation Reduction Act. And this has billions of dollars in it in the form of incentives, tax credits, grants, which can be used for onsite microgrids, building efficiency projects, electrification of fleets, and introduction of vehicle charging infrastructure.”

VDB J, Passavant A, Datta K, Trehan C, McCannon J. How Pharma Can Better Understand Its Carbon Footprint and Reach Sustainability Goals. September 24, 2024. LogiPharma USA 2024. Boston.

A panel offers insight surrounding the industry’s carbon footprint, including ways to begin initiating positive change. 

LogiPharma USA 2024: How Pharma Can Reach Its Sustainability Goals

What Are Pharmacy Deserts? 

 Jenni Zilka, SVP, community & specialty pharmacy and president, Good Neighbor Pharmacy, noted that pharmacy deserts are communities without access to pharmacies, hindering residents' ability to fill prescriptions and access healthcare services. These areas are often also healthcare deserts. Definitions vary by location: urban areas lack pharmacies within a mile, suburban areas within two miles, and rural areas within ten miles. Approximately 35 million people live in pharmacy deserts, making this issue pressing. Factors contributing to their rise include reimbursement pressures, decreased foot traffic post-COVID, and the inability of pharmacies to bill for services beyond prescription filling. Independent pharmacies, often serving underserved communities with a majority of government-paid patients, are particularly affected. Zilka also alluded to legislation that is helping to improve patient access.

A transcript of Zilka’s conversation with 

What exactly are pharmacy deserts, and why have they become so prominent?

If you think about a pharmacy desert, it's kind of exactly how it sounds. It's communities where there is no pharmacy, where people cannot fill their prescriptions, but as you know, in many of these pharmacy deserts, they may also be healthcare deserts, where the pharmacy is already playing the role of providing necessary services to maintain good health all around, well beyond just dispensing prescriptions. The definition—which is kind of an industry standard of what a pharmacy desert is—is really where there's no pharmacy, meaning there's no care for the local residents and patients of that area. And it's a little different, depending on if you're urban, suburban or rural, but essentially, it's a one-mile radius. If you're in the city, if people live more than a mile away from the nearest pharmacy; if you're in the suburbs, it's two miles. If you go to more rural settings, then it's 10 miles. Our data shows us that there's an estimated 35 million people live in a pharmacy desert, meaning they don't have access to a pharmacist or perhaps healthcare in general. So that's what a pharmacy desert is.

You asked why we are talking about pharmacy deserts, and why they are more prevalent than perhaps they have been in the past. Candidly, it's just because pharmacies are of all sizes and shapes. Of course, we're here today representing independent pharmacies, but regardless of whether it's an independent or a chain pharmacy, they are really at risk of going out of business. You're probably reading about it in the news these days, but essentially, there're a few key factors that are driving that.

The first is reimbursement pressure. They are continually being reimbursed less for prescription drugs on a day-to-day basis. And then I think as importantly, when you think about COVID, it drove a lot of traffic into the pharmacies. Since COVID is behind us, the need isn't as great. They're not getting as much food foot traffic either, coming into the pharmacy as they were during COVID. It's a combination of reimbursement pressure along less foot traffic. but I think as importantly, not having a vehicle to bill for some of the services that they that they provide, goes well beyond filling prescriptions. What's interesting about independent specifically is that the makeup of their patient base is typically over 50% government paid, meaning state Medicaid or Part D. These are already underserved communities. These are where there's a strong need for a healthcare provider, and that's where they typically where they typically reside.

In this video interview with Pharma Commerce Editor Nicholas Saraceno, Jenni Zilka, SVP, community & specialty pharmacy and president, Good Neighbor Pharmacy, clarifies the meaning behind pharmacy deserts, along with reasons for their increase in prominence. 

Steve Beda

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