Legal & Regulatory

Traceability

Trade & Brand Protection

Brand & Product Security

Business and Finance

Containers & Shippers

Devices

Software

Cold Chain

Commercial Channels

Artificial Intelligence

Digitalization

Real World Data

Data & Technology

Manufacturing & Packaging

Supply Chain

Logistics & Transportation

Commercialization

Pricing

Trade & Channel

Market Access

Opinion

Adherence

HUB Services

Patient Assistance Programs

Patient Support

News

Pharma Pulse

Academy

Publications

Partner Perspectives

Webcasts

Resources

Conferences

Conference Coverage

Conference Listing

Events

Videos

Peer Exchange

Podcasts

Editorial Podcasts

Subscribe

Pharmaceutical Commerce connects biopharma executives to insights on business processes, technologies, and strategies for taking approved drugs to market.

About Us

Advertise

Editorial

Contact Us

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Pharmaceutical Commerce - Biopharma Business News, Market Insights

Instagram

Facebook

LinkedIn

Threads

Soundcloud

Spotlight

Digital Editions

Security

Asembia AXS25 Summit 

Topics

Data and Technology

Legal and Regulatory

Supply Chain Logistics

1rem

Authors

Team-Up seeks to bring manufacturers and logistics providers together

A new approach to pharma supply-chain collaboration

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.

Multi-Indication Drug Branding in Today’s Pharmaceutical Industry

Patient Engagement Is Critical to Developing Breakthrough Treatments

PC: What risks do you foresee for companies developing first-in-class therapies if patient perspectives are no longer formally incorporated into regulatory discussions?

Eliminating patient perspectives from regulatory discussions would remove a key source of value—especially in the context of rare or recently characterized diseases. In many of these cases, there are no formal natural history studies to guide therapeutic development. Without that foundational data, we must rely heavily on the insights and feedback from patients and caregivers to truly understand the disease.

While biological and mechanistic rationales are essential to evaluating a novel therapy, they don’t capture the full picture. The patient experience plays a critical role—not just in shaping our understanding of the condition but also in fostering meaningful engagement with the patient community. Whether you're a regulator, developer, or payer, incorporating these perspectives helps you form a more informed view.

If this input is removed from the regulatory process, a vital component is lost. Companies and payers can still engage with patient groups to gain insight, but the absence of a formal mechanism at the regulatory level limits the consistency and impact of that engagement.

That said, it’s not an all-or-nothing scenario. The patient voice can still influence drug development through other channels, but losing the dedicated regulatory avenue would be a setback. Ultimately, the goal is to develop novel medicines for patients. Involving advocates who deeply understand the disease—and who raise awareness of the real-world challenges patients face—is essential. Removing that from the process would, in my view, be detrimental.

: The proposed policy change by the Department of Health and Human Services (HHS) that could reduce formal mechanisms for patient advocate input in regulatory discussions poses significant risks to drug development, especially for rare and serious diseases. Patient advocates are crucial in helping developers understand the lived experiences of patients and caregivers, especially in conditions with limited natural history data. Their insights inform decisions around clinical trial design, site and endpoint selection, and regulatory strategies. Organizations such as GRIN Therapeutics have prioritized patient advocacy from the outset, integrating advocates into their teams to ensure ongoing dialogue and collaboration throughout development.

Historically, public participation has been instrumental in shaping healthcare policy. For newly recognized or genetically defined diseases, patient advocates often provide the only frame of reference for symptom progression and caregiver burden. This input is invaluable not only to developers and regulators but also to payers making reimbursement decisions. High-cost, innovative therapies must demonstrate broad impact across disease symptoms to justify value, and advocates help articulate which symptoms matter most to patients. Their contributions help define clinical endpoints that better capture treatment effectiveness, supporting both regulatory approval and reimbursement.

If formal patient input mechanisms at the federal level were removed, drug developers would lose a vital perspective at a critical decision-making stage. While engagement can continue informally—through interviews, surveys, and other methods—losing the regulatory touchpoint would weaken the system. Nonetheless, developers can and should continue gathering robust patient and caregiver insights and proactively share them with regulators. In doing so, they help bridge any gaps left by policy changes and sustain meaningful engagement that ultimately benefits all stakeholders—patients, developers, payers, and regulators alike. This collaborative approach remains essential to ensuring the development of effective, impactful therapies for rare and serious conditions.

Bruce Leuchter, CEO, Neurvati, discusses why patient engagement is essential to understanding rare diseases and driving the development of breakthrough therapies.

It’s no secret that the pharmaceutical industry is facing a myriad of challenges and disruption, such as complex, costly, and lengthy new drug development; global regulatory hurdles; more start-ups entering the market every day, increasing competition; new technology and data solutions; lingering supply chain disruption, and more. Pharma leaders need to think differently about how to run their businesses—and bring their people along with inevitable transformative change. As leaders look toward the future, the companies that will outpace and outperform their competitors will be those that can embrace and scale adaptability and agility in their operations.

In addition to a continued focus on growing drug pipelines, and the increasing use of artificial intelligence (AI) and data in research and development (R&D), pharmaceutical companies have a renewed focus on the supply chain. In 2024, major companies like Reckitt, AstraZeneca, and Novartis scoped out plans to expand their manufacturing footprint, and it’s likely that many others will follow suit in 2025. In a recent survey, 90% of pharma executives said they are investing in smart manufacturing to increase supply chain efficiency.

A common thread in all the top priorities is a high degree of uncertainty and a need to build flexible approaches to capture value and weather unpredictable market conditions. Having management strategies and systems that have adaptability at the core will be critical to success.

What we know about adaptable organizations

The highest performing organizations are, and will continue to be, those that create and nurture adaptability in a variety of ways. At the heart of it, this requires creating more leadership from more people—up, down, and across the business. There are three critical characteristics that adaptable organizations possess.

Change-friendly systems, structures, and processes

Adaptable organizations are those that have management systems in place that are open to and able to change, while being able to respond to emerging factors in the market, technology, and internal demands. They can establish formal systems and processes that balance efficiency and agility. For example, rather than adopting rigid three- to five-year strategic plans, they embrace principles-based decision making and ground their plans in assumptions about the future that are revisited frequently. They focus on outcomes over process. They target talent strategies with an emphasis on what will be needed for the future, rather than what worked in the past. When the formal management systems in place are more change-friendly, organizations can be more proactive in responding to new opportunities in the market, such as the use of AI to accelerate new drug development and smart devices along the manufacturing line.

Organizational culture emerges from the behaviors and norms that are reinforced over time. A focus on culture is not a “nice to have” and it is not about “employee perks” or “employee satisfaction.” The highest performing companies establish and nurture adaptable cultures, those that allow them to appropriately respond to both threats and opportunities. The core characteristics of these cultures include: taking a multi-stakeholder view (employees, shareholders, customers, vendors, and the community), embracing appropriate risk-taking, balancing both a short- and long-term view, and biasing towards proactivity even without perfect information.

Broad-based knowledge and skills for leading change

Often, talent development strategies focus on deepening technical skills. While these are important, they are not enough on their own, especially since the required technical skills are changing rapidly. Companies need to invest in helping their people build stronger change muscles, developing both the knowledge and the skills to apply that knowledge to their jobs. Skills such as the ability to articulate a compelling vision of the future, manage challenges to new ideas and ways of working, inspire and mobilize others even without direct authority, and implement strategies to overcome barriers to change are key to developing a workforce that creates a competitive advantage.

Each of the characteristics outlined above can be cultivated through deliberate action. There are a set of key strategies that will help address change friendly systems, adaptable culture, and broad-based knowledge and skills.

The first step toward addressing the disruptive factors facing the pharmaceutical industry is for senior leaders to get hyper-clear on the opportunities ahead, why you are positioned to seize those opportunities, and why you must act now. For example, it is undeniable that AI has the potential to dramatically accelerate new drug development by assessing large and disconnected data sets, analyzing relationships between these data sets, and prompting new hypotheses to be tested.

 It can also be utilized to anticipate the effectiveness of various drugs, assess side effects, identify target populations, and explore alternative uses for drugs already on the market. But how AI is implemented, and what benefits it will unlock, need to be tailored to each organization—where it is today, the capabilities already in place, and where the business is looking to go in the future. Shaping this narrative around the opportunities it can unlock, rather than being reactive and focusing on the challenges it presents, is critical.

It's not enough to be aligned in theory; leaders need to be actively engaged in making the opportunity a reality. They need to communicate way more than leaders typically assume is necessary. Deliver the message in multiple forums, through multiple modalities, and continue to beat the drum. Then, find ways to demonstrate meaningful action, and remove barriers that could get in the way of others taking action. And, recognize that this “action” may actually mean stopping efforts that are not aligned or contributing to the desired future state.

When leaders are aligned and truly activated, you will enable much faster, and bolder, decision making.

Responding to disruptive factors in the industry cannot stop at the executive level. Keeping up with the pace of change requires contribution from people at all levels and across all functions. Find opportunities for employees to not just execute ideas that come from the top, but rather, create space for them to identify opportunities, surface ideas, and then experiment with implementing these new ideas. When employees are empowered and engaged in this way, you can create a sense of passionate buy-in and ownership.

A global vaccine company did this exceptionally well. After facing numerous warning letters from the FDA, they recognized the need to shift their culture, imbuing a sense of ownership across the business around a “quality mindset.” Senior leaders articulated their opportunity, acknowledging that this mindset would allow them to save more lives, and then unleashed the power of the workforce to make it a reality. Employees from the manufacturing lines to R&D to corporate shared functions all came together to create a movement, enabling the surfacing of a host of ideas. Shop floor workers co-developed training, new standards around QDCI boards, and more, leading to zero operator errors at their site. Others experimented with new ways to label samples, retube machines, and engage their peers—all leading to significant reductions in defects, thousands of work hours saved, and more than 5,000 people actively engaged in the effort. At the end of the transformation, the FDA deemed the transformation one of the most successful turnarounds they had ever witnessed.

While many employees will get onboard with new ways of working, especially if the opportunity is framed in a compelling and inspirational way, there will always be skeptics. To build momentum, demonstrate progress and ensure efforts are driving meaningful results (not just “feel good” activities). It is imperative to not only track wins along the way but to intentionally engineer them. Start with the end in mind and then work backwards to determine critical milestones, leading indicators, and desired behaviors that will enable the ultimate goal. Once these are identified, use the power of the workforce to make these proof points a reality, and make a point of spotlighting them when they happen. Not only will this create a wave of momentum that helps bring skeptics along, but it will also help develop an unrelenting focus on value.

Navigating the choppy waters and disruption facing the pharma industry will require organizations to foster more adaptability. To keep up with customer demands, emerging technology, and shifting regulatory changes, pharmaceutical leaders need to evolve how work gets done. Investing time in aligning and activating leaders and then engaging the workforce to drive new ways of working and meaningful results is critical to unlock and maintain a competitive advantage. In today’s world, adaptable organizations are going to be leaps and bounds ahead.

Gaurav Gupta is managing director and head of R&D, while Vanessa Akhtar is managing director and head of consulting, both at Kotter.

1. Breakthroughs or bottlenecks? Pharma industry outlook, trends and strategies for 2025. 

https://www.zs.com/insights/pharmaceutical-trends-2025-outlook-ai-supplychain-and-beyond#:~:text=Pharma%20companies%20are%20investing%20heavily,AI%20in%20R%26D%20for%202025

2. Artificial intelligence is taking over drug development. 

https://www.economist.com/technology-quarterly/2024/03/27/artificial-intelligence-is-taking-over-drug-development

Why driving results from such strategies—amid industry disruption—will be critical to success.

Building Agility and Adaptability Into Pharma Operations

As personalized medicine moves from innovation to mainstream, the burden of precision delivery falls on third-party logistics providers (3PLs) and carriers. These therapies are not one-size-fits-all—they are custom-built treatments based on an individual’s genetic makeup, lifestyle, and environment. The goal is maximum efficacy through highly tailored care.

What was once a standardized approach to medication is now an individualized therapy, and that transformation demands a delivery system as specialized as the treatment itself. Every shipment must arrive intact, temperature-controlled and on time because with personalized medicine, even minor lapses can compromise patient outcomes.

Unlike traditional medications, personalized therapies can't be quickly replaced if a shipment fails. Reproducing a customized treatment takes time—a delay that can be critical for patients often battling serious illnesses. For them, a missed dose isn't just inconvenient; it can mean a setback in treatment or a missed window for optimal effectiveness.

With the drug delivery industry continuing to grow, forward-thinking carriers are strengthening their chain of custody and increasingly adopting tools like predictive analytics, temperature-controlled packaging, and real-time tracking to keep shipments safe enough to withstand long-distance travel.

Below are some areas for providers and logistics companies delivering personalized medicines to consider.

Law aims to protect the integrity of medication

Protecting the integrity of medications, especially personalized ones, requires in-depth knowledge of industry legislation.

The Drug Supply Chain Security Act (DSCSA), enacted by the FDA regulation in 2013, was designed to safeguard the US pharmaceutical supply chain from counterfeit, contaminated, stolen, or otherwise harmful drugs. It helps protect patients from receiving incorrect or injurious drugs, enhances the security of our nation’s drug supply, and enables a more seamless flow of data between supply chain partners.

While this regulation applies to all prescription drugs, its importance is amplified when it comes to personalized medicine. Every product must be traceable, from manufacturer to pharmacy, using serial numbers and detailed documentation. Carriers must not only understand this legislation but actively ensure their systems and partners align with it to avoid breaches that could compromise patient safety.

Yet not all stakeholders fully comply, and I have experienced gaps in execution firsthand.

Challenges in home delivery of personalized medicines

A decade ago, a family member of mine asked that an injectable drug be delivered to her home. However, the driver left her mediation in the mailbox like it was a bill or a magazine, even though it was temperature-sensitive and should have been brought to the door. Medications like this one can become ineffective or unsafe if left in extreme heat or cold.

Although those delivering pharmaceuticals are better trained today, 3PL providers must ensure drivers are properly instructed so that they don’t drop custom-engineered treatments and dash. Major carriers have the necessary infrastructure to move medications within and between metropolitan areas, but it gets trickier and costlier when the carrier must deliver pharmaceuticals to rural areas and only has the time to make a handful of stops.

In this scenario, the company might outsource the delivery to an independent contractor. If so, the smaller delivery service must understand the importance of correctly delivering temperature-sensitive medications. Otherwise, the driver could place the delivery on the front porch, out in the elements, or in the mailbox like what happened with my family member.

And while all medications should arrive intact and on time, the stakes are especially high when the treatment is personalized and tailored to an individual’s specific health needs.

As this medical approach continues to become more widely adopted, the industry must adapt to help provide precise, compliant, temperature-controlled delivery of highly individualized treatments.

By Alan Kennedy, Executive Director, Team-Up

Articles

Latest Updated Articles