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Direct-to-consumer and direct-to-patient models are major contributors. 

Why CX Is a Difference Maker for Pharma

Following Frazier Healthcare Partners' investment in Knipper Health, Willis Chandler has officially been appointed as Knipper’s president and CEO.

Accelerating treatment initiation through embedded technology

How exactly does Knipper aim to get patients started on treatment at a faster rate? The therapy initation partner utilizes embedded digital enrollment, real-time benefit investigation, and automated prior authorization right into provider workflow—these are also directly linked to various fulfillment options, such as specialty pharmacy, direct-to-patient (DTP) cash, free goods, samples, and third-party logistics (3PL) provider-administered programs.

The role of 3PL in Knipper’s value proposition

Last year, the company’s 3PL arm, Knipper 3PL, was featured in 

’s annual third-party logistics outlook,

 in which it explained the value of 3PLs over the decade, commenting that “the focus of the healthcare supply chain is to get therapies to patients who need them and conduct business in a way that is compliant and ethical while showing fiduciary responsibility that increases gross-to-net margins for the companies and investors who support them. 3PLs are an essential piece of this puzzle and provide cost-effective, compliant, efficient, and safe avenues to get products to the patients who need them. Over the next 10 years, manufacturers will continue to see that value and will continue to trust the right 3PLs for their specific program requirements.”

Patient-centric, gross-to-net optimized solutions

Essentially, all of the company’s services are centered around enhancing outcomes for both patients and biopharma partners by tailoring delivery to patient needs and maximizing gross-to-net efficiency.

Chandler’s pharmaceutical experience spans years in the pharma services space, powered by strategic leadership roles. His most recent position prior to Knipper was as executive in residence at Frazier, in which he was responsible for helping to powers investments and growth plans spanning the entire the pharmaceutical services ecosystem.

Prior to that, Chandler held various senior leadership roles, including as Cencora’s president of global pharma services, where he managed the wholesaler’s consulting, outsourced commercial operations, hub services, and distribution. Before his time at Cencora, Chandler co-founded Shields Health Solutions, a specialty pharmacy integrator serving health systems.

“Knipper is at the forefront of transforming therapy initiation through a data-enabled, patient-centric platform,” commented Nathan Every, general partner at Frazier. “We are excited to partner with Willis and the Knipper team to build on the company’s strong foundation and accelerate its growth. Willis’s experience across commercial pharma services makes him well-suited to lead Knipper through its next chapter.”

Chandler will replace Michael Laferrera, who was at the helm for 13 years as president, and five and a half years as the CEO. Laerrera will continue to be involved with the company as a member of the board of directors.

“I’m thrilled to join Knipper at a time when we are redefining how quickly and efficiently patients begin therapy,” said Chandler. “By embedding real-time medical and pharmacy automation at the point of care, aligning fulfillment to patient needs, and powering decisions with actionable data, I look forward to accelerating our mission to create a faster, more efficient path from order to therapy.”

Other members of the leadership team not only expressed approval of this move, but confidence in the direction that the company is headed in.

“Knipper is very well positioned to lead the next evolution in therapy access through a fully integrated, technology-driven platform,” expressed Frank Segrave, Knipper’s chairman of the board. “Willis brings the expertise and vision to scale this model for biopharma, and we look forward to his leadership in our next phase of growth.”

1. Willis Chandler to Lead Knipper Health as New President and Chief Executive Officer. Knipper Health. July 8, 2025. Accessed July 14, 2025. 

https://www.knipper.com/2025/07/08/willis-chandler-to-lead-knipper-health-as-new-president-and-chief-executive-officer/

2. Saraceno N. Willis Chandler to Lead Knipper Health as New President and Chief Executive Officer. 

. February 2, 2024. Accessed July 14, 2025. 

https://www.pharmaceuticalcommerce.com/view/peeking-behind-the-curtain-the-current-state-of-pharma-3pls-and-future-outlook

The industry veteran will lead the company’s next phase of growth, focusing on faster treatment initiation through integrated digital platforms and optimized fulfillment strategies.

Knipper Health Taps Willis Chandler as New President and CEO

How DSCSA Is Transforming Supply Chain Data Exchange

 roundtable discussion, Nicholas Saraceno, editor of 

 and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, and the growing importance of data management in achieving these goals.

The pharmaceutical supply chain is a multi-stage system encompassing: research & development; manufacturing; distribution: pharmacies and healthcare providers; and patients.

This system plays a vital role in supporting both individual and public health. It ensures patient safety by maintaining drug quality, authenticity, and regulatory compliance. Additionally, it supports public health by providing consistent access to essential medications and vaccines. During times of crisis—such as pandemics, natural disasters, or supply disruptions—the supply chain becomes even more critical for delivering life-saving therapies and maintaining stability. Efficient supply chain logistics also contribute to cost control

helping reduce healthcare spending and improve the affordability of medications.

Ultimately, a resilient, transparent, and well-managed pharmaceutical supply chain is foundational to maintaining global healthcare systems. It ensures that patients receive the medications they need when they need them, and that providers and manufacturers can work collaboratively to meet evolving challenges in healthcare delivery.

The panel consisted of Dave Malenfant, an expert that specializes in optimizing the supply chain through innovative solutions for people, processes, and technology; Opeyemi Odusami, a seasoned professional with over 12+ years of experience and 10+ years at Sanofi; and Bob Celeste, Founder, Center for Supply Chain Studies, and Executive Director, Open Credentialing Initiative (OCI).

Each expert brought distinctive perspectives on the value of the pharmaceutical supply chain, including techniques for resilience.

Malenfant highlighted offers a holistic, circular model defined by seven stages: plan, source, make, deliver, sell, sustain, and return. This perspective emphasizes the importance of viewing the supply chain as an interconnected system, where resiliency depends on maintaining strong links across all stages. Each segment can have its own strategy, but the key is ensuring smooth, uninterrupted flow of both materials and data from end to end. Disruptions—such as current hospital drug shortages—often reflect failures at earlier stages, like sourcing or manufacturing. For instance, many shortages stem from the inability to obtain active pharmaceutical ingredients (APIs), which then ripple down the chain. He encouraged the audience to think of resiliency not just as a concept, but as an ongoing process of identifying weak links and implementing strategies to strengthen them, thereby ensuring the continuity and stability of the entire supply network.

Odusami added that supply chain resiliency involves not only responding to crises but also anticipating and preventing them. In addition to maintaining a synchronized supply chain—from purchasing and manufacturing to logistics and distribution—companies must build adaptability into their systems. This means being prepared for disruptions while also using data and planning to predict future issues. A resilient supply chain ensures continuity in drug delivery to patients, even during crises. Aligning all parts of the supply chain is key to maintaining consistent access to medications and protecting public health in the face of unexpected challenges or shortages.

As for Celeste, he noted that as more regions like the United States and Europe adopt product serialization, data and product misalignment has become a growing challenge in the pharmaceutical supply chain. In the US, such mismatches often result in products being placed in quarantine, with limited time and space to resolve the issue before the product is returned or removed. A key aspect of supply chain resiliency is the ability to efficiently manage these exceptions to avoid disruptions. Since serialization errors can escalate quickly, developing systems to handle data alignment and resolve issues promptly is critical to keeping products moving through the supply chain.

The panel also dove into risk mitigation; the handling of drug shortages, and crisis management; ensuring product quality across global manufacturing sites; dealing with counterfeit products; the Drug Supply Chain Security Act (DSCSA); the importance of a developing a deep talent pipeline; sustainable practices; and much more.

In the fourth part of this roundtable discussion, a panel of subject matter experts dive into data exchange challenges relating to the Drug Supply Chain Security Act.

Peer Exchange: How DSCSA Is Transforming Supply Chain Data Exchange (Episode 4)

Why Medical Education Must Catch Up 

, Sean O’Hearen, founder and principal consultant at 1st Line Partners, discusses the critical issue of substandard and falsified (SF) medicines and the lack of awareness among healthcare professionals (HCPs). Despite SF drugs posing a growing global health risk, only 2% of HCPs are trained to detect them, and over 80% don’t consider them a serious threat. The Johns Hopkins Bloomberg School of Public Health has recently started focusing on this issue, holding its second symposium on the topic with support from Pfizer. Their work is encouraging, signaling that academic institutions are beginning to address these systemic educational gaps.

O’Hearen notes he’s not an expert in medical or pharmacy education but emphasizes that the BESAFE report—referenced in the interview—offers actionable recommendations. These include integrating SF medicine awareness into undergraduate curricula for healthcare students, establishing dedicated modules in medical schools, and expanding continuing education for practicing professionals. In his experience, frontline education, especially at infusion centers administering life-saving treatments like oncology drugs, plays a critical role in identifying and preventing counterfeit drug use. Nurses and healthcare workers trained to detect signs of falsification are a vital line of defense.

Efforts are underway globally, with the World Health Organization and the International Pharmaceutical Federation leading collaborative projects with African universities in countries like Nigeria, Uganda, and Tanzania. These efforts aim to establish standardized, research-backed curricula to address the growing threat of SF medicines, especially in regions more vulnerable to drug fraud.

While progress is being made, O’Hearen believes the issue is still in its early stages of recognition and response. With more academic and clinical institutions like Johns Hopkins stepping up, the hope is to eventually embed SF medicine detection and awareness into formalized education systems worldwide—closing critical gaps in the healthcare supply chain and improving patient safety.

He also comments on how the private sector should support and scale these efforts to ensure that HCPs globally receive standardized training; the communication strategies stakeholders should adopt to alert without alarming, ensuring patients stay confident in genuine pharmaceuticals, while also remaining vigilant against counterfeit threats; and much more.

Your article highlights that only 2% of HCPs are trained to identify substandard and falsified (SF) medicines, and over 80% don’t view SF drugs as a serious issue. What systemic gaps in medical and pharmacy education need to be addressed, and how can academic and clinical institutions accelerate awareness training?

Clearly, as the Johns Hopkins research indicates, it's a significant issue. The first thing I would say is that I think the industry is very pleased that the school with the resources of Johns Hopkins and their public health team recognize excellence, and the public health arena are getting behind this issue, and it's only been a couple of years. The report that I was referring to in the article was their second symposium, so they're just recently getting behind it, with sponsorship from Pfizer. Great to see that push.

One thing I should say is that I'm not an expert on medical and pharmacy education, number one. You can access that report through the BESAFE references, but that report you'll give some very specific recommendations, as far as what can be done to address the education gap that that they're seeing.

They're talking about all levels of education. It’s starting with undergrad curricula for healthcare professionals, pharmacists, folks who are interested in medical degrees. Of course, medical school having dedicated curricula around that, and continuing education related to that. I think there's also a component that pharmaceutical manufacturers and industry associations are doing today, and that is providing education to healthcare professionals, either in cases where they're reacting to an incident and a known issue, and then that education of those frontline workers becomes part of the solution.

I've been involved in many cases where we're trying to solve, and that's a significant part of the solution is educating those healthcare practitioners. Just as an example that's been at infusion centers: one of the trends we’re seeing is life-saving type of treatments—like oncology treatments—in certain parts of the world where counterfeits are turning up. It's enabling those nurses, who are working with the products and patients to help them understand how to identify counterfeit medicine.

The issue that the report highlights is that there are few standardized curricula. There's the International Pharmaceutical Federation, which, I think, at least based on what I've seen—I haven't done extensive research on this—but that's kind of the first of its type of a really, thoroughly researched and an organized effort. Notably, that was sponsored and put together by with the help of the World Health Organization and International Pharmaceutical Federation. The universities involved were in Africa. There were five countries in Africa, Nigeria, Uganda, Tanzania, and some others, so obviously, they're trying. The World Health Organization in particular is trying to focus on those parts of the world where this issue is even more significant than it is in other parts of the world. In terms of the big picture, I think we're in early stages on addressing the issue. Johns Hopkins isn't the only university that's getting behind this issue, but as more and more universities recognize it, I think that the goal would be to try to get this education into standardized curriculum.

In the first part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, lays out the systemic gaps in medical and pharmacy education that need to be addressed, along with how academic and clinical institutions can accelerate awareness training in identifying substandard and falsified medicines.

The pharmaceutical industry stands at the threshold of a long-overdue transformation in how serialization is approached, implemented, and managed. For more than a decade, serialization has largely been driven by compliance, delivering solutions that meet regulatory requirements but offer limited value beyond the legal minimum. Today, however, the world of pharmaceutical serialization is poised for a strategic leap forward.

We call it Serialization 2.0, and it’s more than just a technical evolution. It’s a business imperative that yields significant competitive advantages.

The missed opportunity of the last decade

For a moment, let’s imagine a serialization environment fully aligned with the principles of Pharma 4.0, with built-in quality checks, real-time OEE monitoring, AI-assisted maintenance, and seamless data visibility across packaging sites and enterprise systems. Imagine validated configurations deployed in minutes instead of months.

That vision is not only possible—it’s necessary. Most serialization systems in place today are based on proprietary technologies. They are outdated, on unsupported operating system versions, and difficult to scale. While these systems still meet compliance obligations, they come at an increasingly steep operational and financial cost. Maintenance is complex. Upgrades are disruptive. Innovation is simply not occurring.

Serialization 2.0 addresses this directly, offering open, interoperable, and future-ready architectures. These systems are designed for long-term efficiency, enabling companies to respond faster to client demands, reducing total cost of ownership, and laying the groundwork for AI, predictive analytics, and smart packaging technologies. Serialization 2.0 will allow faster adoption of future compliance requirements as the regulatory landscape changes.

The question is no longer if modernization is needed, but rather, how soon can you begin?

The numbers alone are compelling. An estimated 70,000 packaging lines have been serialized worldwide over the last decade; as of today, many are running on aging infrastructure, outdated software, and hardware at the end of its lifecycle. A significant number of operating systems are no longer supported. Servers are near capacity, and the associated databases can’t keep pace with new demands. And while global standards, (such as GS1 or OPC-UA) have made incremental progress, true interoperability remains elusive.

In many regions, including the United States, gaps in data communication standards and integration frameworks leave companies vulnerable to escalating costs and diminished agility. Vendors, meanwhile, continue to deliver proprietary solutions at every level—from cameras and line software to full-site platforms. This locks clients into ecosystems that are expensive to maintain, slow to evolve, and can’t be supported by modern IT management tools.

To break this cycle, the move to Serialization 2.0 starts with three decisive steps:

Eliminate proprietary hardware, particularly vision systems that restrict upgrade paths.

Standardize line controls by removing line automation from the serialization computer and leveraging proven automation tools.

Deploy open site-level software that is capable of integrating with any line solution and enterprise platform.

A closer look at the serialization architecture from L1 (line devices) through L3 (site systems) reveals critical areas for reform.

Line-level technologies have seen dramatic advances. Smart cameras, printers, and barcode readers now feature embedded intelligence and robust standard interfaces. The introduction of AI-driven monitoring, smart inks, and texture-based verification tools presents new opportunities for error reduction and quality assurance. Predictive maintenance, driven by real-time data, can dramatically reduce unplanned downtime.

Today, the majority of serialization implementations are still constrained by proprietary vision systems and nonstandard communication protocols. Moving forward, hardware investments should prioritize open, future-proofed systems with standardized interfaces to accommodate emerging technologies.

Most vendors continue to rely on computers to manage both automation and serialization tasks. This design is an artifact of their roots in vision systems, not a reflection of best practices in automation.

In reality, programmable logic controllers (PLCs) are purpose-built for line control. They’re more reliable, cost-effective, and easier to scale. Transitioning automation to PLCs—while keeping computers focused on computation-heavy serialization logic—unlocks major benefits.

In one multi-site deployment of over 30 lines, this architecture saved more than $5 million and cut downtime to less than two weeks per line. The message is clear: future-ready serialization starts with using the right tool for the job.

For years, site-level (L3) serialization software has served as a fallback if the enterprise (L4) solution goes offline. Unfortunately, vendors use these systems to enforce product lock-in, restricting the ability to integrate with alternate line-level solutions.

It’s time to demand more. Open, interoperable site systems enable seamless communication across all layers—from equipment and line control to enterprise reporting. They also reduce support costs, simplify scaling, and increase transparency across facilities.

Clients evaluating L3 solutions should prioritize modular platforms that support open data exchange and are vendor-agnostic by design. Procurement teams must demand interoperability commitments in contracts to avoid being locked into obsolete platforms.

In our opinion, companies that embrace Serialization 2.0 will:

Lower operational costs through simplified maintenance and standardized hardware.

Increase agility in meeting client and regulatory demands

Boost scalability and resilience by leveraging open architectures.

Position themselves for new tech adoption as Pharma 4.0 accelerates.

Just as importantly, Serialization 2.0 enables better decision-making across the enterprise by unlocking data trapped in proprietary systems. With enhanced visibility and interoperability, companies can drive continuous improvement, optimize performance, and respond proactively to shifting regulations or supply chain demands.

Serialization 2.0 isn’t just an upgrade—it’s a strategic investment in future readiness. Those who delay risk being left behind in a marketplace that increasingly rewards adaptability, transparency, and operational excellence.

Pharmaceutical leaders must take a hard look at their current serialization infrastructure and ask a simple but urgent question: Are we building for compliance—or for competitiveness?

With open systems, smarter controls, and interoperable architectures, Serialization 2.0 offers a clear path forward. It’s time to seize the opportunity.

John F. Jordon, P.E., is chief customer officer, while Pavel Dimitrov is director of product management, both with advanco.

This serialization system represents a business imperative that yields significant competitive advantages.

Serialization 2.0: Why It’s Time to Upgrade, and What’s at Stake

Hikma Pharmaceuticals USA today will be financially committing $1 billion by the year 2030 to further grow its US manufacturing and R&D capabilities.

 With an investment of this magnitude, the company expresses its interest in harnessing its domestic services to develop, produce, and deliver various medications that may be needed by the US healthcare system to ultimately meet patient needs.

Expanding domestic drug production to meet US healthcare demands

The company has been operational in the United States since 1991, and has spent upwards of $4 billion over the past 15 years to bolster its US-based R&D and manufacturing services. These enhancements allow for a yearly domestic capacity of manufacturing more than 12 billion finished doses of essential meds. Meanwhile, its parent company, Hikma Pharmaceuticals plc, is based in London.

"… Hikma has grown to become a top three US supplier of sterile injectable medicines by volume with more than 180 injectable products in our portfolio and a growing pipeline,” commented Dr. Bill Larkins, president, Hikma Injectables. “This new phase of US investment will enhance and expand our sterile injectables production capabilities and enable us to continue providing our broad portfolio of essential medicines to US patients."

Strengthening US R&D footprint across key states

This project exemplifies Hikma’s interest in raising the volume of meds it creates and produces across its various R&D and manufacturing sites in Columbus and Cleveland, OH, along with Cherry Hill and Dayton, NJ. 

"We are proud to continue our ongoing investments in US manufacturing and R&D to better serve the needs of American patients," said Dr. Hafrun Fridriksdottir, president, Hikma Rx. "Hikma and our 2,300 dedicated US people are committed to supporting healthier communities nationwide by providing Americans with a steady and reliable supply of domestically produced quality medicines."

US Rep. Buddy Carter (GA-01), who attended Hikma’s groundbreaking event at its Columbus plant, added that, "As a pharmacist and chairman of the American-Made Medicines Caucus, I understand the crucial role Hikma and other generic manufacturers play in delivering affordable and accessible medicines to Americans. It's important that we onshore the production of these critical drugs. I will continue working with Hikma to strengthen our national security and public health by making life-saving generic medications here, in America, and applaud them for their announcement today.”

A growing trend: Global pharma investment in US manufacturing

Hikma joins a plethora of companies in the biopharma/pharmaceutical sector who have elected to build a more resilient US supply chain by committing to reshore production, which also avoids having to paying the looming 25% tariffs on pharma imports that are anticipated to be enacted by President Trump. Last month, 

 reported that UCB—whose global HQ is in Brussels, Belgium—decided to invest $5 billion into a new, state-of-the-art biologics manufacturing plant in a US location to be named a later time.

 It not only creates around 300 permanent, highly skilled jobs in the biologics manufacturing space, but an additional 500 during the construction process.

“At UCB, we are guided by a clear purpose—to create value for patients now and into the future,” said Jean-Christophe Tellier, UCB’s CEO. “This investment reflects our growing impact in the US and our ambition to bring our forthcoming pipeline to patients around the world. By expanding our biologics manufacturing footprint, we’re not only reinforcing our global supply chain—we’re also contributing to the vitality of biomedical innovation, high-skilled jobs, and long-term economic impact in the US.”

Across the rest of the industry, a multitude of companies—such as Regeneron, Roche, Merck, and Thermo Fisher—have also been making financial commitments toward growing their US manufacturing of their own. This includes a combined $53 billion by Regeneron and Roche to improve their manufacturing and R&D infrastructure, $1 billion by Merck, and $2 billion by Thermo Fisher.

Piramal Pharma Limited also revealed that would investing $90 million toward growing two of the company’s plants located in the United States: Lexington, KY, and Riverview, MI.

1. Hikma Pharmaceuticals USA announces $1 Billion of new US investment to further expand its domestic manufacturing and development of essential generic medicines. PR Newswire. June 28, 2025. Accessed July 3, 2025. 

https://www.prnewswire.com/news-releases/hikma-pharmaceuticals-usa-announces-1-billion-of-new-us-investment-to-further-expand-its-domestic-manufacturing-and-development-of-essential-generic-medicines-302493824.html

2. Saraceno N. UCB to Invest $5 Billion into US Production Plant. 

. June 16, 2025. Accessed July 3, 2025. 

https://www.pharmaceuticalcommerce.com/view/ucb-invest-5-billion-us-production-plant

3. Saraceno N. Piramal Pharma to Invest $90 Million in US Site Expansions. 

https://www.pharmaceuticalcommerce.com/view/piramal-pharma-to-invest-90-million-us-site-expansions

The company joins a wave of global pharma companies reshoring operations to strengthen the US supply chain and meet patient needs through domestic innovation and capacity.

Hikma Commits $1 Billion to Boost US Drug Manufacturing and R&D Services by 2030

Historically, new drugs were approved for a single therapeutic use. However, industry trends have shifted, with pharmaceutical companies increasingly identifying and developing additional indications for existing medicines. This approach is supported by regulatory agencies such as the FDA and EMA, which recognize the value of leveraging established safety profiles for new uses.

As a result, the number of expanded indications for drugs has nearly doubled in the past decade. Platform drugs—those whose core technology can be adapted for multiple indications—are especially attractive. Once a drug’s safety is established for its first indication, regulatory risks for additional approvals are reduced, making this a cost-effective way to bring new therapies to market.

Branding strategies: Single versus multiple brands

Choosing between a single brand or multiple brands for a drug with several indications is a complex and high-stakes decision. The optimal approach depends on several factors. The regulatory environment plays a key role; the FDA is generally cautious about multiple brand names for the same molecule, primarily due to concerns about medication errors and overdosing. Multiple brands may be permitted if there is stigma associated with one indication, significant dosage differences, or low comorbidity between indications.

The EMA is more flexible, allowing different trademarks for new marketing authorizations if justified by public health or co-marketing needs, though applicants must justify the need for multiple brands and demonstrate how patient safety will be maintained.

Therapeutic area differences also influence branding decisions. If indications are closely related—such as within the same therapeutic class—a single brand is often preferred. Conversely, if indications are unrelated or have significant differences in patient populations, dosing, or disease severity, multiple brands may be more appropriate. Patient safety and social stigma are additional considerations; dual branding can help avoid confusion and reduce the risk of overdose, especially when dosing or patient populations differ significantly. It can also help mitigate social stigma associated with specific indications, such as erectile dysfunction.

Classic examples illustrate the application of these strategies. For instance, Cialis (tadalafil) is marketed for erectile dysfunction, while Adcirca (also tadalafil) is used for pulmonary arterial hypertension. The rationale for dual branding includes unrelated therapeutic areas, different patient populations, stigma associated with erectile dysfunction, and significant dosage differences. Similarly, Viagra (sildenafil) is indicated for erectile dysfunction, while Revatio (also sildenafil) is used for pulmonary arterial hypertension. The same reasoning applies to different dosing and patient populations, leading to the use of two distinct brands to differentiate indications and manage stigma.

In contrast, Enbrel (etanercept) is used for both rheumatology and dermatology autoimmune diseases. Because these indications are closely related, a single brand is maintained across uses, leveraging the established reputation and safety data.

Recent examples further highlight these considerations. Humira (adalimumab) is prescribed for multiple autoimmune indications, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. A single brand is used across all indications, reinforcing market leadership and the safety profile due to overlapping prescribers and consistent dosing. Keytruda (pembrolizumab) is another example of a single brand maintained across multiple oncology indications, including melanoma, non-small cell lung cancer, and head and neck cancer, due to its broad use across various cancer types and similar dosing and administration.

Ozempic (semaglutide) is indicated for type 2 diabetes, while Wegovy (also semaglutide) is used for chronic weight management. The use of two distinct brands helps differentiate between diabetes and weight management, addressing regulatory and safety concerns, even though patient populations may overlap. Prolia (denosumab) is used for osteoporosis, while Xgeva (also denosumab) is indicated for cancer-related bone complications. Dual branding reflects distinct clinical needs and dosing regimens.

Similarly, Zometa (zoledronic acid) is used for cancer-related bone complications, and Reclast (also zoledronic acid) is indicated for osteoporosis, with dual branding helping to avoid confusion and ensure appropriate use.

Strategic considerations and operational challenges

When adopting a single-brand approach, it is important to identify all potential indications early to choose a versatile trademark. Sales and marketing efforts must be coordinated across indications, especially if targeting primary care physicians. Developing a unified brand character and clear communication about the drug’s mechanism across indications is essential. Sales and medical teams should be trained to address questions about all indications.

For a multi-brand approach, it is essential to engage regulatory authorities early in the development process. Managing global trademark availability and protection can be complex and costly. Separate brand teams and plans may be necessary, but maintaining cross-functional collaboration is crucial.

Pricing and inventory must be monitored for each brand, particularly if doses overlap or differ. Clear implementation plans and resources should be provided for regional affiliates.

Understanding treatment patterns at the facility level is critical for optimizing resource allocation and identifying growth opportunities for multi-indication drugs. Sales figures alone may not reveal which indications are driving growth, highlighting the need for advanced analytics to inform strategy.

Overall, pharmaceutical companies must carefully weigh regulatory, commercial, and operational factors when deciding between single-brand and multiple-brand strategies for drugs with multiple indications. Classic examples such as Cialis/Adcirca and Viagra/Revatio demonstrate the importance of therapeutic area differences, patient populations, and stigma. Recent cases, including Humira, Keytruda, Ozempic/Wegovy, Prolia/Xgeva, and Zometa/Reclast, highlight the ongoing relevance of these considerations in today’s market. Early planning, clear communication, and data-driven insights are crucial for maximizing value and ensuring patient safety.

The views expressed in the article are those of the authors and not of the organizations they represent.

Partha Anbil is at the intersection of the life sciences industry and data & analytics, including GenAI/ML/NLP. He is a Senior Advisor to NextGen Invent Corporation, an AI, data analytics, and digital transformation company. He has over 25 years of experience in the industry.

Kamini Anbil is an experienced consultant in the life sciences industry. She spent six years with ZS Associates, a top boutique global management consulting and technology firm specializing in the Life Sciences sector.

As drug development increasingly targets multiple indications, pharma companies must make strategic branding decisions—balancing regulatory requirements, market dynamics, and patient safety—to choose between single-brand or multi-brand approaches.

Tomas Gorny

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