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Things to know about the increasingly popular--and competitive--orphan drug space

Common misconceptions about the orphan drug designation

The third and final day of Trade & Channel Strategies in Philadelphia continued its slate of thought-provoking content with a morning session on “Balancing the GTN Bubble with Market Access Priorities.”

 Moderated by Jake McDowell, VP of market access, Partner Therapeutics, he was joined by Mike Rowland, senior director of pricing contracts and analytics, Acadia Pharmaceuticals, and Tom Evegan, principal, strategy & management consulting, RSM US.

The goal of the panel was to analyze the gross-to-net (GTN) bubble across multiple product mixes, including but not limited to brand, biosimilars, and generics; support the needs of the stakeholders by deliberating distribution networks and market access while determining ways for company profitability; and explore pricing's role when it comes to access. The GTN bubble is a term coined by Adam Fein, PhD, of the Drug Channels Institute, that has since become widely used to describe the growing gap between gross and net sales for drug manufacturers.

, Bill Roth succinctly refers to the GTN bubble as “the widening gap between the gross revenue (the total sales at list price) and the net revenue (the amount received by the manufacturer after discounts, rebates, fees, and other adjustments). This gap has been expanding significantly in recent years due to changes in regulations surrounding pricing in the industry; expansion of government programs; expansion of the use of programs such as 340B; and increased demands for rebates from pharmacy benefit managers (PBMs) and insurers.”

Keeping this in mind, the panel began with a dive into the some of the new factors that are impacting the gross-to-net specifically within the marketplace, growing that bubble.

“I think the easy one to always focus on from a larger chunk of growth-to-net is always managed care. I think any organization—large or small—is more than likely to have those conversations,” explained Rowland. “Regarding the distribution piece of it too, there's a sharper focus on that as well. I think of PHS specifically, along with contract pharmacy policy, as being really big and interesting one, as well as the rebate models that have recently been proposed. I think as PHS continues to grow as part of most manufacturers’ books, the ability to try to temper that a little bit is where you're seeing a lot of focus. I know most of the larger manufacturers are the ones that are going after that now, but with some of the recent legislative wins on the manufacturer side—as well as the one that's coming up with HHS—I think you might start to see a lot of the smaller and mid ones start to follow.

Evegan was in agreement, and noted the impact the 340B will continue to have in the immediate future.

“340B is going to be something that everyone in this room and back at your companies are going to be dealing with for quite some time,” he explained. “I think that the legislative aspects right now are still being debated in court. You probably have seen some cases that are out there: J&J filed, then withdrew, and then came back with their rebate model. A couple of other manufacturers have followed suit. I think the rebate model in 340B is going to change. There was interesting news that was brought up yesterday about the removal of pharmacies from that vertical integration model—it’s going to be interesting to see where that winds up, because I think that's going to impact quite a bit of 340B business moving forward.

“The key crux of the issue is that the government has not defined what a patient is for that program, so that's actually being held up legislatively, and that's important because any patient can actually show up to an outpatient facility, receive the drug, and then the institution receives the discount; for rebate, the manufacturers pay back versus the actual patient receiving any benefit. We’re seeing spillover in Medicare as well. … I did do some polling with some of our clients. We've actually seen 12 Medicare Part B states now coming online that are invoicing drug manufacturers in Medicaid. It's just something to think about as we talk about all these channels: what are the different nuances that we're seeing? One thing that gets a little bit overlooked—and relates or is tangential to the gross-to-net waterfall—is that there's also state transparency compliance. When you launch a new drug, we have to ensure there's compliance.”

Other points that were covered during the session included: the distribution models that are popping up as a result of these aforementioned factors; the product archetype and how that changes perspective as one looks at distribution and managing that accordingly; how the Inflation Reduction Act impacts GTN; and the impact that pricing is now having on gross-to-net, along with restrictions.

Editor's note: This article was updated on December 19, 2024 to reflect that the "gross-to-net bubble" is a term originally defined by Adam Fein of the Drug Channels Institute. 

1. Evegan T, McDowell J, Rowland M. Balancing the GTN Bubble with Market Access Priorities. December 12, 2024. Trade & Channel Strategies, Philadelphia. 

https://informaconnect.com/trade-channel/

2. Roth B. Going Inside the Gross-to-Net Bubble and Its Nuances. 

https://www.pharmaceuticalcommerce.com/view/going-inside-the-gross-to-net-bubble-and-its-nuances

A panel examines the gross-to-net bubble across various product mixes, how pricing impacts market access, and more.  

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Trade & Channel Strategies 2024: A GTN Bubble Balancing Act

The Gap in DSCSA Readiness 

, Joe Lipari, direct of product management for Systech, dives into how the Drug Supply Chain Security Act (DSCSA), signed into law by President Obama in 2013, has actually been in development for nearly two decades, with earlier state-level efforts like California’s e-Pedigree push. Initially, the full implementation deadline was set for Nov. 27, 2023, marking the completion of serialization and traceability across the pharmaceutical supply chain. However, due to industry readiness issues, the FDA introduced a “stabilization period” to allow for testing and system adjustments. The stabilization period, meant to iron out bugs, turned into a series of delays, and the implementation date has been pushed back multiple times.

In October 2023, the FDA announced another delay, introducing a phased approach to DSCSA compliance. Manufacturers now have until May 2025 to meet requirements, wholesale distributors until August 2025, and mid-to-large dispensers until November 2025. Small dispensers, defined as those with 25 or fewer employees (including pharmacists and pharmacy technicians), have an extended deadline of November 2026. This phased approach allows different parts of the supply chain to comply gradually, but the full implementation will not be realized until at least 2026.

The FDA’s latest exemption allows eligible trading partners that have either completed or documented efforts to complete data exchange connections to be given some leeway in enforcement. This continues the trend of delays and phased compliance, highlighting ongoing challenges in fully implementing the DSCSA across the industry.

Lipari also explains the penalty for non-compliance, the likelihood that these deadlines put forth by the FDA will be met, and more.A transcript of Lipari’s conversation with

What do you believe the likelihood is that these deadlines put forth by the FDA will be met?

The funny thing is, we were having this conversation back in August and September. The HDA [Healthcare Distribution Allinace] does their Traceability Seminar in DC every year. You have the FDA there and a lot of different legal entities there, and that question continues to be asked of, what are you guys going to do? The answer was, no, there will not be any more delays. And a month later, we have the announcement. History has sort of shown us that any dates within the DSCSA implementation framework are subject to change.

If I was a betting man. I’d have to look at the track record of this implementation and say that I'm not sure if any of the dates will hold. But I mean, from my experience with Systech, we are more on the manufacturing side. A majority of our serialization customers are Big Pharma, mid-, mid-tier pharma. With our traceability platform, we have manufacturers, we have distributors, we have repackagers, CMOs. There is whole breadth of trade partners, but the manufacturers, for the most part, are ready. They've been serializing product for quite some time. They have systems in place to do verification. They have systems in place to handle tracing requests. They have systems in place to electronically share data. You hear from the wholesale distributor—from a KPI perspective—the wholesale distributors ramping up their enablement across their DCs.

In the beginning, you heard numbers and by the end of the stabilization period, definitely those numbers all went in the right direction, as far as how much was enabled, and then furthest downstream, you get to the dispensers. That's really where I think the main problem with readiness lies, and it's a tough space.

In the US, there's something to the tune of 90,000 different dispense locations. That ranges from the CVS and Costcos of the world—which are massive corporations—all the way to your mom and pops, those little pharmacies. I have one in my town, and they're independently owned, a single location, but that doesn't mean they're not exempt from DSCSA. They are the same prescription serialized drugs that are flowing through those facilities, just like CVS. It’s a tough space because of how many different types and the wide range of business types that exist in that space. There was a clear message that the dispense side was not going to be ready. If this thing did get pushed through, [there may have been] calls for patient safety, and what happens with quarantine product if you can't meet the letters of the law? I get that side of it, but there's a piece of me that feels we've been talking about this since 2013, and so how much further can we kick this can down the road?

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, predicts the probability that these DSCSA compliance deadlines put forth by the FDA will be met.

For pharmaceutical companies, reaching the post-approval phase of a drug's life cycle is a significant achievement. This journey begins with research and development, progressing through clinical trials, and undergoing evaluation and authorization before entering the post-approval stage. However, the journey of a drug does not end there.

In this last phase, companies may consider broader drug use, new therapeutic indications, or wider target populations, along with the commercialization into new countries. As marketed products reach larger populations, developers expand and redefine their knowledge of the drug's safety profile. Manufacturing processes must also be enhanced to ensure continuous, timely access to state-of-the-art medicines globally.

Effective post-approval lifecycle management is critical for commercial success, yet when operating across multiple countries and markets, life sciences organizations often run into post-approval regulatory challenges. Post-approval management activities include registration renewals, labeling updates, administrative variations, chemistry, manufacturing and control updates, marketing authorization transfers and withdrawals. Regulatory professionals face a variety of obstacles during this stage, including:

A lack of harmonization between regions and health authorities that leads to varying regulatory requirements or classification systems

Specific, local requirements that require tailored strategies for each market

Unpredictable approval timelines that can vary significantly across countries, regions, and health authorities

Varied implementation periods for regulatory changes or updates

Divergent decisions from health authorities that may result in different outcomes for similar submissions

Given these challenges, a robust post-approval lifecycle management is essential for success. There are three key steps for designing a solid regulatory strategy: planning, communicating, and delivering.

The first step is to create a detailed and adaptable plan—a critical foundation for a post-approval regulatory strategy. Strategic planning entails collaboration with relevant stakeholders across the organization that may be impacted. Engage early in key discussions with all team members around their priorities to help identify the necessary considerations and components of the plan. Additionally, it is critical to prepare for a range of scenarios and assess various viewpoints.

Establish a strong communication strategy to effectively disseminate details across an organization. When there are changes, ensure that both the changes and communication about them are transparent and easily accessible. Providing supporting evidence for decisions is key in case issues arise. Regularly follow up with stakeholders to keep them informed of progress and to gather any recommendations for adjustments.

Clearly define critical roles and responsibilities for each team member. Leverage key performance indicators and escalation pathways while providing status updates to track progress across the board. Create a culture that encourages team members to learn from mistakes and ensure every regulatory action adds value for patients.

In today’s digital age, utilizing cutting-edge technologies such as artificial intelligence and data analytics can significantly enhance post-approval lifecycle management activities. These tools ensure that teams stay up to date in the rapidly shifting, ever-evolving regulatory environment and face challenges directly by monitoring regulation shifts and forecasting potential market challenges. Regulatory experts can provide guidance and much needed support throughout the process as well.

Navigating the post-approval phase of a drug's lifecycle is a complex and lasting endeavor that requires careful planning, clear communication, and successful delivery. Organizations must be willing to collaborate across multiple teams to address potential hurdles and rely on regulatory expertise to rapidly adapt to regulatory demands. By building a comprehensive regulatory strategy, leveraging regulatory intelligence, and engaging region-specific experts, pharmaceutical organizations can successfully accomplish some of the most critical work in a drug’s journey.

Marcela Miño is the global head of lifecycle management for marketed products at IQVIA. She leads a high-performing regulatory team that supports all regions. Based in Buenos Aires, Argentina, Marcela holds a pharmacy degree and an MBA in general management. She has over 18 years of regulatory experience at IQVIA and 10 years in the pharmaceutical industry.

It’s essential for commercial success, but presents its share of obstacles.

Beyond the Finish Line: Why Post-Approval Regulatory Strategy Matters

Many might agree that cancer—and the care associated with it—often involves major time commitments on patients and their caretakers.

` In fact, within the oncology community, these types of commitments are being coined as the “time toxicity” of cancer care.

Patients with advanced solid tumors are believed to spend 20-30% of their days with healthcare contact, with the potential for it to be counterweighed by this aforementioned time toxicity.

 As of now, there is limited research on the concept, such as the sources, who it impacts, and impacting results.

As a result, a qualitative analysis published in 

 sought to identify the facets of cancer care that may be considered most taxing and those impacted most by the time burdens, while measuring the associated consequences.

The study investigators recruited participants from the University of Minnesota’s M Health Fairview clinic, which is considered a National Cancer Institute-designed cancer center. In order to have a demographically diverse group when it came to age, gender, socioeconomic status, and cancer site, they utilized what are considered “purposive and criterion sampling methods.” In total, three groups were recruited:

 These consisted of English-speaking adults with advanced gastrointestinal cancer who were receiving systemic treatment.

 There were patient-identified informal (unpaid) partners, who could qualify for the study even if the patient did not.

 These were advanced practice clinicians (physician assistants and nurse practitioners), physicians, nurses, social workers, and schedulers.

Qualitative interviews were conducted from Feb. 1 to Oct. 31, 2023, while the data were analyzed from February 2023 to February 2024. There was a total of 47 participants interviewed, with 16 of those being patients [8 aged ≤60 years; 12 women (75.0%)], 15 care partners [12 aged ≤60 years; 9 women (60.0%)], and 16 clinicians [11 women (68.7%)]); 15 care partners [12 aged ≤60 years; 9 women (60.0%)], and 16 clinicians [11 women (68.7%)]).

There was also a total of 31 subthemes gathered, which were divided into five themes.

Theme 1 monitored the time burdens related to health care outside the home (such as parking, travel, and waiting time); theme 2 consisted of invisible tasks hanlded at home (eg, handling insurance and medical bills, receiving formal home-based care); theme 3 was centered around how care partners were impacted alongside patients (burdens involving the greater network of family, friends, and community); theme 4 reported on the consequences of time burdens (demoralization or short visits that shifted to all-day events), and theme 5 represented the positive time spent in clinical interactions and hope for change.

Overall, said the study authors, “the results of this study will guide the oncology community to map, measure, and address future time burdens,” but it’s also important to note—as a limitation—these findings may not be an accurate representation of beliefs of the entire community of people who have either lived with or have professional experience of cancer.

1. Banerjee R﻿, George M﻿, Gupta A﻿. Maximizing home time for persons with cancer. 

2. Gupta A﻿, Eisenhauer EA﻿, Booth CM﻿. The time toxicity of cancer treatment. 

3. Gupta A, Johnson WV, Henderson NL, et al. Patient, Caregiver, and Clinician Perspectives on the Time Burdens of Cancer Care. 

A qualitative analysis consisting of patients, care partners, and oncology clinicians measures the sources of time burdens, along with how these impact various individuals.

Measuring Time Burdens Around Cancer Care

Adragos Pharma, a contract development and manufacturing organization (CDMO) based in Germany, has purchased Baccinex, a Swiss-based provider of aseptic fill-finish manufacturing.

 The deal—whose terms remain undisclosed—is expected to boost the CDMO's sterile manufacturing offerings, while also representing growth on a global scale.

Baccinex’s experience in the sterile fill-finish space dates back over 20 years, specifically pertaining to processes surrounding liquid and lyophilized vials. The company’s plant is both FDA-certified and EU-GMP certified, offering clinical trial supply, along with small-to-medium scale commercial production.

“Joining Adragos Pharma marks a new chapter for Baccinex. Our shared commitment to quality, innovation, and customer-centric solutions creates an exciting synergy that will enable us to deliver even greater value to our clients worldwide,” said Dr. Ursula Bausch, founder and CEO of Baccinex.

Adrago also appreciates the opportunity to grow its preence in the pharma manufacturing sector.

“The acquisition of Baccinex represents a significant milestone for Adragos,” noted Dr. Andreas Raabe, the company’s founder and CEO. “Baccinex’s proven expertise in sterile liquids and lyophilization, combined with its operational excellence, enhances our ability to provide integrated solutions from development through to commercial supply. This addition strengthens our position as a global partner of choice for high-quality pharmaceutical manufacturing.”

In other Adrago news, earlier this month, the CDMO unveiled its ampoule filling line at its Livron facility in France.

 The new line represents a step toward not only enhancing production capacity, but in boosting quality and compliance.

As a result of the new line, ampoule production capacity will not rise to over 160 million ampoules annually, and fill volumes will range from 1 ml to 20 ml.

“We are always attentive to our customers’ needs to better serve their patients. We recognized not only a regulatory demand in Annex 1 but also an urgent need for greater capacity, particularly for larger-volume ampoules,” commented Marco Gorgas, Adrago’s CCO. “That’s why we installed this fourth line, allowing us to offer a capacity of over 160 million ampoules, including options up to 20 ml, tailored to serve our clients’ evolving requirements.”

1. Adragos Pharma Acquires Baccinex – A Leading Swiss Sterile Fill-Finish Expert. 

. November 25, 2024. Accessed November 29, 2024. 

https://adragos-pharma.com/adragos-pharma-acquires-baccinex-a-leading-swiss-sterile-fill-finish-expert/

2. Project Future: We launched our new production line in our Livron facility! 

. November 7, 2024. Accessed November 27, 2024. 

https://adragos-pharma.com/project-future-we-launched-our-new-production-line-in-our-livron-facility/

The transaction reaffirms the CDMO’s interest in growth on a global scale. 

Adragos Pharma Acquires Baccinex, Growing Sterile Manufacturing Services  

Skills Needed to Thrive in the Evolving Industry Landscape

, Gaurav Gupta, managing director and head of R&D at Kotter, discusses the regulatory pressures and rising R&D costs impacting the pharmaceutical industry as it looks toward 2025. Gupta highlighted that many regulatory challenges, such as drug pricing pressures from the Inflation Reduction Act, will persist in the coming years. Additionally, he pointed out the growing integration of real-world evidence into clinical trials and the need for regulators to keep pace with emerging technologies like AI. Gupta believes that these trends will continue to shape the industry without major new disruptions expected in the short term.

He also comments on the steps pharmaceutical leaders should take to better prepare their teams and organizations for supply chain disruptions; specific technical and "soft" skills that will be critical for pharmaceutical leaders and frontline employees to thrive in the evolving industry landscape, and how this can help when it comes to proactivity in handling talent shortages.

A transcript of Gupta’s conversation with

What specific technical and "soft" skills will be critical in order for pharma leaders and frontline employees to thrive in the evolving industry landscape of 2025, and how can these help when it comes to being proactive in handling talent shortages?

We can take two portions to that. I think on the technical side of it, a lot of it [revolves] the skills that you've always needed, but what's probably different now is really more of a focus on how to utilize technology effectively. And that's not just AI, although AI is obviously a big portion of that. Skills around how to use that more effectively [is important], which involves doing that from two perspectives: how do you develop those skills in existing talent, but then how do you recruit for that?

That's not only good from a business standpoint of being able to find those skillsets, but also, frankly, it helps you tap into a broader talent pool. With all of the conversation around technology and AI right now, I think a lot of people are actually looking for jobs where that is a component and requirement. I think that it does help on that front.

The other part, and probably where we have a lot more research around this, is what we were talking about earlier, the skill sets around adaptability. What is increasingly clear is that uncertainty in the environment is not going down, but rather the uncertainty in the environment is only going to go up. What that means is whether it's leaders or folks on the frontline, the skill sets that are going to make us successful is the ability to be flexible, the ability to be agile, the ability to pivot.

What does that mean from a skills perspective? Well, a lot of it is traditional leadership skills, being able to actually paint a picture of where you want to go, but then being able to question when assumptions have changed, being able to question when what we thought was true may not be true anymore. It's skills like change skills, both for yourself as an individual, so how can I myself be more willing to be able to change, and then also, how can I get my team to appreciate when change is necessary? I think that skills around change, adaptability, flexibility, are on the softer side, and then on the on the technical side, it’s really around, how you utilize technology more effectively in whatever aspect of your job where it makes the most sense.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, comments on the specific technical and soft skills that are critical in order for pharma leaders and frontline employees to excel in an ever-changing industry landscape, while explaining why these skills are beneficial when it comes to being proactive in handling talent shortages.

Jeff Antos, Weinberg Group

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