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Doing business in China is undergoing important changes

Pharma in China--calculated risk gone wrong

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.

To prevent missteps like these, carriers should:

Review and reinforce contracts with third-party delivery partners.

Ensure all drivers are trained in handling temperature-sensitive treatments.

Conduct routine audits to maintain compliance and quality standards.

Tracking technology provides real-time visibility

Today’s packaging and tracking technologies give consumers real-time visibility into their deliveries, a major leap from the static updates of five to 10 years ago. Mobile apps, GPS tracking, and instant notifications now offer moment-by-moment insights into a package’s journey, while smart sensors monitor conditions like temperature along with shock and humidity, which are critical for sensitive items like personalized medicines.

Beyond just tracking location, modern systems also predict potential delays and proactively communicate changes, building greater trust and confidence. In a world where speed, safety, and convenience drive consumer loyalty, real-time transparency is an expectation rather than a luxury.

In addition to enhancing transparency, these technologies are crucial for protecting the integrity of sensitive shipments, especially personalized medications that demand controlled temperatures and careful handling.

Many medications require strict temperature control to maintain their effectiveness, potency, and safety. Proper packaging plays a crucial role in ensuring that these medications remain stable during storage and transportation. This might include passive cooling systems like insulated boxes with gel packs or dry ice, or it could even include active systems like refrigerated shipping containers that maintain temperature control. Other options exist—think smart packaging that contains temperature sensors and GPS tracking for real-time monitoring.

Medications that include vaccines, biologics, and insulin often become ineffective or unsafe when exposed to temperatures that are too hot or too cold. This is because fluctuations in temperature can cause chemical or structural changes that render them ineffective. Insulin, for example, must be stored between 36°F and 46°F because exposing it to heat or freezing can cause it to lose its potency, making it less effective for blood sugar control in diabetes patients.

To mitigate risks, carriers are increasingly using predictive analytics to anticipate and adapt to disruptions. Whether it’s a snowstorm or extreme heat, these tools help reroute deliveries and preserve medication integrity.

Ensure quality of care every step of the way

As medicine becomes more individualized, the expectations placed on the delivery infrastructure rise as well. Logistics providers are no longer just moving packages—they are delivering highly sensitive and patient-specific therapies that often represent a critical part of someone’s care plan.

Meeting this challenge means investing in better training, more advanced technology and stronger partnerships throughout the supply chain. It requires a culture of accountability and precision at every touchpoint.

Personalized medicine is redefining healthcare. To fully realize its potential, the systems that deliver it must be equally modern, responsive and reliable.

Tim McClatchy is Vice President of Life Sciences at Kenco.

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.

How the Rise of Personalized Medicine Impacts Life Sciences’ Logistics

James D. Chambers, PhD, MPharm, MSc, is a health economist by trade. After earning his MSc in Health Economics from the University of York and his doctorate in that same focus with Brunel University’s Health Economic Research Group, he has gone on to pursue various endeavors along that track, most recently as a professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies and a health economist spokesperson for Organon.

 to uncover the latest regarding biosimilars—biologic medical products that are considering highly similar to their reference products—to lay out how in fact they can lead to cost reductions, while boosting patient access; their economic impact; challenges to implementation and recommendations for faster implementation; and emerging trends in the sector.

Could you elaborate on how biosimilars have the potential to reduce healthcare costs and increase patient access to treatments? What are the key factors driving these outcomes?

Biosimilars have the potential to reduce healthcare costs and increase patient access to essential treatments by offering more affordable alternatives to expensive biologics. Since 2014, biologics have made up 37% of net drug spending, totaling $120 billion,

 highlighting the need for cost-effective options. Globally, biosimilars have demonstrated success, particularly in Europe, where they provide 20% of treatment volume and drive savings from reduced list and net prices of the referenced medicines. In the US, biosimilars are projected to save the healthcare system $38.4 billion from 2021 to 2025,

 and have already provided more than 344 million additional days of therapy, expanding treatment access.

You mentioned that there are economic dimensions of biosimilars that are often less explored. Could you share some of the crucial economic factors that should be considered when assessing the full impact of biosimilars on the healthcare system?

Biosimilars introduce significant economic value, particularly by increasing competition in the biologic drug market. This competition drives down prices, undercutting reference product prices, thereby potentially reducing overall treatment costs and expanding patient access. By providing lower-cost alternatives to reference biologics, biosimilars also push reference biologic manufacturers to adjust their pricing strategies.

As biosimilars gain more market share, they reshape payer and provider decisions, leading to improved formulary coverage and promoting more cost-effective treatment options. This shifting market landscape underscores the potential of biosimilars to generate both direct savings and broader economic benefits, ultimately enhancing affordability and accessibility across the healthcare system.

Despite the potential benefits, biosimilars face barriers to adoption. What are the most significant challenges preventing their widespread use, and how can these be addressed at both the policy and market levels?

A major barrier to the adoption of biosimilars in the US is the variation in coverage policies across commercial health plans. My team’s 2019 study, using the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database—which includes specialty-drug coverage decisions from 17 of the largest US commercial health plans that make their decisions publicly available (covering 60% of commercially covered lives)—found that plans covered biosimilars as “preferred” in only 14% of decisions.

 More recently, a 2023 study revealed that 19.4% of biosimilar coverage decisions were more restrictive than those for their reference products.

 These restrictions are often due to rebate walls, where reference biologic manufacturers offer significant rebates to payers, making it harder for biosimilars to compete for formulary inclusion.

Another major barrier is the lack of education and familiarity with biosimilars among healthcare providers. Many physicians remain hesitant to prescribe biosimilars despite strong evidence supporting their safety and efficacy. Addressing these challenges requires stronger educational initiatives targeting both healthcare professionals and patients. Additionally, greater alignment of policies across stakeholders—such as payers, PBMs, and providers—will help reduce coverage inconsistencies and foster broader biosimilar adoption.

In your work with the Specialty Drug Evidence and Coverage (SPEC) Database, have you identified any emerging trends or patterns that suggest biosimilars will become a more integral part of healthcare in the near future?

In 2024, using the Specialty Drug Evidence and Coverage (SPEC) database, my team analyzed coverage, market share, and pricing data for seven originator products and 20 corresponding biosimilars. The analysis found that preferred coverage of multiple products increased from 30% to 76% between August 2017 and August 2022, signaling growing acceptance by health plans.

This shift indicates the increasing role of biosimilars in healthcare as healthcare plans recognize their potential for cost savings and expanding patient access. The market dynamics around biosimilars are also evolving. For instance, biosimilars with list-price savings (relative to reference products) of $15,000 or more per patient per year were less likely to be restricted in coverage, demonstrating that cost-effectiveness influences payer decision-making. Furthermore, the introduction of biosimilars in therapeutic areas like oncology and rheumatology is intensifying competition in markets traditionally dominated by high-cost biologics. As these trends continue, we anticipate that biosimilars will become more widely integrated into treatment regimens.

From a health economics perspective, what strategies or interventions would you recommend in order to incentivize faster adoption of biosimilars, particularly in markets where they are still struggling to gain traction?

To accelerate biosimilar adoption, a multifaceted strategy incorporating policy adjustments, education, and market dynamics is essential. A key intervention is adjusting coverage policies to better align with cost savings.

Although research indicates that biosimilars offering significant list-price reductions face fewer coverage restrictions, health plans may impose stricter policies in high-prevalence disease areas where they have negotiated favorable pricing for reference products. Reducing coverage restrictions on biosimilars with the highest cost savings could improve accessibility and drive wider adoption, particularly for conditions with high treatment costs.

Education for healthcare providers and patients is also crucial. It’s key to raise awareness of data and real-world evidence (where it exists) of biosimilars to address and correct potential misconceptions and build confidence in their use. This is why I am collaborating with Organon, a company with a commitment to biosimilars, to share insights and contribute to broader industry conversations, as fostering collaboration among key stakeholders, including payers, providers, policymakers, and industry leaders is crucial for creating a unified approach.

1. Yu T, Jin S, Li C, Chambers JD, Hlávka JP. Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans. 

. Epub 2023 Apr 1. PMID: 37004706; PMCID: PMC10287773.

2. Mulcahy A, Buttorff C, Finegold K, El-Kilani Z, Oliver JF, Murphy S, Jessup A. Projected US savings from biosimilars, 2021-2025. 

3. Chambers JD, Lai RC, Margaretos NM, Panzer AD, Cohen JT, Neumann PJ. Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans. 

 Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans. 

https://doi.org/10.1007/s40259-023-00593-7

James D. Chambers, PhD, MPharm, MSc, professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, dives into why biosimilars contribute to a reduction in cost and increase in patient access, while highlighting challenges to adoption. 

The Biosimilars Landscape Through the Eyes of an Economist

Over the past few years, the self-injectable pharmaceuticals market has soared to new heights, leaving pharmaceutical companies struggling to meet demand and keep up with changing industry dynamics. According to Research and Markets,

 the global self-injection devices market is expected to reach $67.29 billion by 2035, with a compound annual growth rate of 10.33% during the forecast period of 2025-2035.

With a rise in the adoption of biologics, growing demand for home healthcare options, and an increase in conditions such as diabetes and autoimmune disorders, self-injectables are here to stay, and brands are challenged with implementing manufacturing operations that will keep them ahead of the curve.

The rise in self-injectables has brought a certain set of challenges for pharmaceutical companies to overcome. With meeting patient demand more urgent than ever, combined with supply chain disruptions that can arise promptly, companies are faced with meeting high demand while maintaining quality and regulatory standards. Additionally, the complexity of self-injectables requires manufacturers to seek new production methods and machines that create, fill, and package these devices, shaking up existing processes and flow companies are accustomed to.

However, with challenges come strong opportunities for success. Let’s explore some of the key benefits for pharmaceutical and drug manufacturers to consider when expanding into the self-injectable market.

Historically, most patients have received drug injections from a doctor or pharmacy professional, but more recently, pharmaceutical companies have had the opportunity to interact directly with consumers. With the rise of medications like GLP-1s, consumers are showing increasing comfort with self-injectables, opening the door for consumers to bypass traditional channels and more efficiently secure the medications they need. By showing consumers the safety, ease of use, and convenience of self-injectable medications, pharmaceutical manufacturers are connecting with users directly and empowering them to take control of their health from the comfort of their own homes.

By communicating directly with consumers, pharmaceutical companies must consider the elements needed to ensure that users have all the information they need to correctly and comfortably administer self-injectable drugs. From the primary and secondary packaging to the materials and instructions included inside a package, companies must keep consumer-friendly packaging top of mind when broaching direct-to-consumer operations. Self-injectables and other medical device developments allow for exploration of new technology for dosing, and even medication tracking, adding to the complexity of production. Having a manufacturing line that can encompass the filling, packaging, and collation of products is a key element to streamlining operations, especially as drugs become more niche, and production runs become smaller and more focused.

Due to a rise in diseases and breakthroughs in treatments, pharmaceuticals have become increasingly tailored and complex, leading to the manufacturing of less volume in certain production runs. With an increasing variety of medications that pharma companies offer, there is also a need for increased flexibility in manufacturing operations.

By incorporating filling machines that able to easily switch from one application to another, pharmaceutical companies can boost efficiency, reduce production downtime, increase capacity, and better meet the needs of customers demanding a greater variety of products.

Flexibility of operations also comes with the specs of filling machines that are integral to pharmaceutical manufacturing. With demand for the injectable format on the rise, companies are challenged with adding lines and shifting facility layouts to accommodate appropriate machines. These machines often take up precious facility space, causing ripple effects in changes needed to be implemented for redesign.

Two of the most important components of pharmaceutical manufacturing are patient safety and quality assurance. As drugs become more complex and regulations become more stringent, companies must constantly find ways to ensure the safety and quality of their products.

Through collaboration with original equipment manufacturers (OEMs), pharmaceutical companies can incorporate modules into their equipment—such as electronic components and sensors—to provide checkpoints and visual inspections, reject stations, and processes to pinpoint the source of potential errors. This will allow any product issues to be flagged before they make their way into the hands of patients.

Data management plays a critical role in the prioritization of patient safety. By tracking products down to the component, capturing data throughout the manufacturing process, and monitoring equipment health, pharmaceutical companies can ensure systems are running smoothly and the highest quality products will be distributed to patients safely. Today, OEMs offer a range of digital solutions that can be linked to a customer’s manufacturing execution system software in order to enhance machine monitoring, data analytics, and predictive analysis to increase overall equipment effectiveness, while delivering more efficient and reliable production performance.

If the rise of self-injectable drugs has taught pharmaceutical companies only one lesson, it is that trends ebb and flow, and no one can perfectly predict where the industry will be even a few years in the future. Decades ago, pharmaceutical companies likely could have never imagined patients wanting to handle medication injections themselves. The total shift in sentiment to present-day demand emphasizes the crucial need for future-proofing machines and manufacturing processes.

Drugs of all kinds are getting smarter, resulting in growth opportunities for all types of pharmaceuticals, blending the line between pharmaceutical drugs and medical devices. The industry is evolving, and the success of drugs in new formats is paving the way for innovation across the board.

To keep up with this changing landscape, pharmaceutical companies must consider machines with flexible formats that can consistently be updated. Otherwise, they run the risk of becoming obsolete and facing a need for substantial investment in new equipment.

By having an open mind and aiming to stay ahead of the curve of changing industry dynamics, pharmaceutical manufacturers are poised to weather the challenges associated with a rise in the self-injectable format. With a willingness to stay in touch with consumer needs and finding the right OEM partner to support flexible operations, quality assurance, and futureproofing, companies can open the door to new possibilities for self-injectable drugs and beyond.

Stephen Robinson is a sales engineer with Coesia North America.

1. Self-Injection Devices Market by Product, by Usability, by Application, by Distribution Channel, and by Region. Research and Markets. December 2024. 

https://www.researchandmarkets.com/reports/6032673/self-injection-devices-market-product?utm_source=GNE&utm_medium=PressRelease&utm_code=8jmbpg&utm_campaign=2026100+-+Self-injection+Devices+Market+Forecast+to+Generate+Revenues+of+%2467.3+Billion+by+2035%3a+Analysis+by+Product%2c+Usability%2c+Application%2c+Distribution+Channel%2c+and+Region&utm_exec=jocamspi

As the adoption of biologics rises, demand for home healthcare grows, and conditions like diabetes and autoimmune disorders become more prevalent, self-injectables are here to stay.

How the Rise in Self-Injectables Is Impacting Pharmaceutical Manufacturing

For a child with autism spectrum disorder (ASD), effective care coordination across the required medical, physical rehabilitation, counseling, occupational, and speech providers is challenging, especially when the aim is to provide individualized care—at scale across many patients.

Genial Care, a healthcare company focusing on personalized interventions for children with ASD, provides a successful example of how generative artificial intelligence (GenAI) can solve this problem. GenAI monitors sessions with children and their families, synthesizes session records, improves the records’ quality, tracks each child’s progress, and shares this information with providers and the child’s family via an app-based interface. Plus, the company reduced the manual transcription time from approximately two hours per day to three minutes per session, allowing care providers more time to dedicate to their patients.

However, this is one of only a few examples of a life sciences or healthcare company breaking out of GenAI pilot purgatory. How did they do it? They focused on a practical, human-centered use case that easily integrated into daily workflows and could be efficiently scaled.

Why is the life sciences industry stuck in GenAI “pilotitis"? Several reasons come to mind:

Regulatory constraints around patient data

Risk aversion, stemming from a smaller margin of error related to life-altering decisions, which can be exacerbated by mistrust due to AI hallucinations and viewing AI as a “black box”

Lack of an enterprise-wide AI strategy and organizational readiness, often resulting in siloed efforts, wasted resources, and declining innovation efforts

Limited input from stakeholders, resulting in solutions that don’t solve real problems or fit into existing workflows

Choice of complex use cases with long implementation times and limited impact, resulting in slowed momentum

The light bulb moment: GenAI's potential to illuminate healthcare

The incandescent light bulb’s journey to widespread adoption perfectly illustrates the hockey stick-shaped trajectory of transformative technologies like GenAI. Initial development, which spanned decades from 1835 to Edison's commercialization in 1880, was followed by decades of infrastructure development (power plants, transmission lines) necessary for widespread use. This gradual ascent reflects the “entropy effect”—the disruption to established norms that slows adoption.

Similarly, AI's transformative potential in life sciences, while offering increased speed and accuracy in tasks like synthesizing unstructured data, continues to face resistance, leaving it in the slow ascent phase. To accelerate AI adoption, we can learn from other sectors already leveraging AI at scale.

By embracing practical, human-centered use cases, life sciences companies are breaking free from GenAI “pilotitis” and demonstrating how scalable AI solutions can help transform patient care and provider efficiency.

Kevin L. Jones, Faegre Baker Daniels

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