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In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research

Data from prior Phase II study showed signs of pridopidine slowing disease progression in patients with amyotrophic lateral sclerosis.

Prilenia Announces Plans to Initiate Global Phase III Study of Novel ALS Treatment

Pivmecillinam (Pivya) has a clinical cure rate of 95% in uncomplicated urinary tract infections and is recommended as a first-line option for treatment in many countries.

Antibiotic for Uncomplicated Urinary Tract Infections Granted FDA Priority Review

Critical factors need to be addressed for pharma stakeholders to realize the full potential of generative artificial intelligence.

Generative Artificial Intelligence Could Transform Healthcare if Challenges Are Addressed

Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.

CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel for Severe Sickle Cell Disease

The US healthcare landscape has dramatically transformed, accelerating trends that began a decade ago. The convergence of value-based care, digital health, and regulatory changes has fundamentally altered how life sciences companies must engage with integrated delivery networks (IDNs) and health systems. The traditional pharmaceutical commercial model, reliant on volume-driven sales, broad promotional campaigns, and key account management, has lost effectiveness in a market now dominated by consolidated provider organizations, standardized formularies, and outcomes-based reimbursement.

To remain relevant and competitive, pharmaceutical companies must move beyond incremental adjustments and embrace a systematic, partnership-driven approach to health system engagement.

This shift requires answering four foundational questions:

What is our differentiated value proposition for integrated health systems?

How do we identify and prioritize the right system partners?

What does successful, measurable collaboration look like?

How should we redesign our engagement model for long-term, mutual benefit?

Companies that act now to build robust, partnership-based engagement models will be best positioned to thrive as the US health economy continues its shift toward integrated, outcomes-driven care.

Opportunity and challenge in today’s market

The rapid consolidation among providers, spanning physicians, hospitals, and health plans has created formidable barriers for traditional pharmaceutical field teams. Access to decision-makers is tightly controlled, and the influence of individual prescribers has waned as care pathways and digital formularies dictate therapeutic choices. The widespread adoption of electronic health records (EHRs), AI-driven clinical decision support, and population health management tools further diminishes the impact of conventional sales and marketing tactics.

Simultaneously, the vertical integration of retail pharmacy, specialty distribution, and pharmacy benefit managers (PBMs) has eroded the leverage pharmaceutical companies once held through contracting. Health systems now demand clear, evidence-based demonstrations of clinical and economic value, ideally supported by real-world evidence (RWE) and digital health solutions that drive measurable improvements in patient outcomes.

While many pharmaceutical leaders recognize these shifts, few have developed actionable, system-oriented engagement strategies. Treating IDN engagement as an extension of key account management or focusing solely on cost-offset models fails to address the fundamental changes in health system economics and priorities. A new approach, rooted in partnership, data, and shared outcomes, is now essential.

Redefining the value proposition for integrated health systems

The provider business model has shifted decisively from volume-based to value-based care. Health systems are now evaluated on their ability to deliver better outcomes at lower costs, as measured by quality scores, population health metrics, and risk-based reimbursement contracts.

Pharmaceutical companies must align their value propositions with these priorities, moving beyond efficacy and safety to demonstrate how therapies improve disease-specific and population health outcomes; the impact of interventions on total cost of care (e.g., reducing hospitalizations, emergency visits, or surgical interventions); integration with digital health tools and care pathways to support adherence, remote monitoring, and patient engagement; and the ability to generate and share RWE that supports continuous improvement and regulatory compliance.

Discounting alone is unsustainable. Instead, pharma must be willing to tie reimbursement or contracting terms to real-world performance, sharing risk and reward with health system partners. This means developing value propositions that:

Connect drug utilization to expected clinical effects across all relevant service lines

Offer clear, measurable improvements in outcomes based on tangible interventions

Aligning with metrics that matter to providers (e.g., disease-specific outcomes, Triple Aim, quality scores)

Translate clinical gains into cost offsets or revenue upside for the health system

For example, a cardiovascular drug’s value should be assessed within the entire cardiovascular service line, considering its impact on hospitalizations and long-term health costs. Similarly, high-cost therapies for chronic diseases must demonstrate their ability to reduce downstream expenses, such as emergency care or surgical interventions.

Identifying and prioritizing the right partners

Integrated health systems are highly variable in structure, mission, and digital maturity. Effective partner identification requires a nuanced, data-driven approach that considers degree of integration (such as ownership of health plans, breadth of service lines, HER, and analytics capabilities); strategic priorities (e.g., population health, specialty care, digital transformation); decision-making structures (centralized vs. decentralized, clinical vs. administrative leadership); and willingness and capacity for innovation and collaboration.

For instance, large academic medical centers may offer tightly integrated, service-line-driven decision-making, while distributed community hospital networks may rely more on corporate leadership and local market dynamics. The system’s mission, local provider landscape, and financial alignment with physicians all influence the feasibility and structure of potential collaborations.

Mapping these factors enables pharmaceutical companies to prioritize partnerships with systems most likely to benefit from and co-invest in collaborative programs, rather than simply targeting those with the highest sales volume.

Defining and measuring successful collaboration

Success in health system collaboration is defined by the alignment of long-term objectives and the ability to measure and communicate mutual value. Effective collaborations typically fall into one or more of the following categories:

Direct operational cost improvement (e.g., reducing readmissions, optimizing drug utilization)

Joint research and RWE generation (e.g., pragmatic trials, outcomes studies)

Digital health and care coordination support (e.g., remote monitoring, patient engagement platforms)

Clinical pathway co-development (e.g., AI-driven protocol optimization)

Each partnership should be designed to produce tangible, publishable results that can inform broader system strategy and regulatory compliance. For pharmaceutical companies, benefits include improved access, brand differentiation, and risk mitigation as health systems gain greater influence over drug selection and utilization.

The business case for investment in these partnerships extends beyond immediate sales. Durable collaborations can secure formulary access, foster clinical momentum, and create operational integration that is difficult for competitors to displace. Moreover, investing in these relationships allows companies to navigate ongoing system reforms and evolving market dynamics.

Legacy engagement models—fragmented by channel and focused on sales volume—are increasingly obsolete. The new model requires cross-functional teams with expertise in clinical science, data analytics, digital health, and value-based contracting. It also calls for incentive structures aligned with partnership objectives (e.g., outcomes achieved, program adoption, RWE generated), and adaptive engagement strategies tailored to the structure and maturity of each health system partner.

One also cannot forget about the regular, structured input from health system stakeholders to co-design and refine initiatives.

For example, academic medical centers may require highly scientific, research-oriented teams, while community-based systems may benefit from teams skilled in operational improvement and local relationship-building. Internal management structures should mirror the organization and objectives of the health system partner, whether service-line, research, or population health-focused.

Crucially, pharmaceutical companies must proactively seek input from system partners in shaping engagement models, objectives, and tactics. This collaborative approach transforms the relationship from adversarial to mutually beneficial, positioning industry representatives as resources to achieve shared goals.

Organizational implications and the path forward

The transition to partnership-based engagement is a significant undertaking, requiring new capabilities, organizational structures, and cultural change within pharmaceutical companies. Early adopters will be able to shape the future of healthcare delivery, while those who delay risk being sidelined as health systems consolidate purchasing power and clinical decision-making.

The shift from promotion to partnership is now a defining trend in US healthcare. Pharmaceutical companies that embrace this reality by building system-oriented value propositions, prioritizing the right partners, designing measurable collaborations, and reinventing their engagement models will secure a durable competitive advantage in the evolving health economy. The time for action is now; those who move decisively will shape the next healthcare innovation and delivery era.

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.

In order to succeed in today’s outcomes-driven healthcare landscape, pharmaceutical companies must move from traditional sales models to strategic, measurable partnerships with integrated delivery networks (IDNs).

Bridging the Gap Between Strategy and Practice in IDN Partnerships

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

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Trending Data & Response Plans in the Cleanroom Setting

Informa’s Access USA conference from Philadelphia continued with its first panel discussion of the conference. Amy Niles, chief mission officer of the PAN Foundation—a national charitable foundation and healthcare advocacy group—was joined by Bill Allen, a patient and family advisory council member with PAN Foundation; Susan Neff, aging services supervisor and SHIP/MIPPA with the Pennsylvania Department of Aging; and Dan Sherman, founder and president of the NaVectis Group, and a financial navigator for Lacks Cancer Care.

Titled “Moving the Needle on Awareness of the Medicare Part D Reforms,”

 its name does a wonderful job of foreshadowing potential coverage points. The premise of the session dates back to fall of last year, when the PAN Foundation conducted a national poll expressing that 87% of Medicare beneficiaries had not seen, read, or heard any sort of information concerning about the Medicare Part D reforms that took effect Jan. 1, 2025. Since that time, this year, PAN decided to once again release a poll with Medicare beneficiaries as a way to measure the value of educational outreach, so this session provided a deeper dive into these efforts.

Specifically, PAN Foundation wanted to understand the awareness and knowledge levels of Medicare beneficiaries both before and after CMS conducted its outreach in advance of the Medicare Part D cap—which ensures that individuals with Medicare Part D plans will not pay more than $2,000 in out-of-pocket costs for covered prescription drugs within a year—and the Medicare Prescription Payment Plan (M3P).

There were two waves of research, including:

 Research conducted in June 2024 with 1,006 adults on Medicare/Medicare Advantage

 Research conducted in January 2025 with 1,001 adults on Medicare/Medicare Advantage

After analyzing both waves, these only represent a sliver of the findings, but the awareness of both reforms increased by 27% from June 2024 to January 2025, while awareness among all the surveyed groups (people with chronic conditions, people with disabilities, those eligible for the Low-Income Subsidy, white Medicare beneficiaries, and Medicare beneficiaries of color) also rose. Further, 66% of Medicare beneficiaries want to learn more about these reforms.

Beneficiaries are no more or less likely to believe the Part D reform or the M3P would be personally helpful to them.

Regarding Part D findings, over 1 in 3 Medicare beneficiaries (35%) reported unaided awareness of the cap, an increase from 1 in 10 (11%) in Wave 1. When aided (having a description of what the reform entails), nearly 7 in 10 (69%) realized they’ve heard of it, an increase from 40% in Wave 1, while 37% are at least somewhat familiar, up from 14% in Wave 1.

“I think the Part D cap is particularly helpful for the individuals with rare diseases, chronic diseases,” said Niles. “They're used to spending thousands and thousands of dollars out of pocket, and now, that has come down to $2,000. It's going to be very beneficial for that individual. Tommy [Bramley] also talked about the peace of mind that it gives people. That is true. You never know when you may be diagnosed with a chronic disease or a rare disease, and having that peace of mind is very helpful.”

In terms of the Medicare Prescription Plan (M3P), which allows one to spread OOP prescription drug costs over the course of a year as opposed to paying them all at once at the pharmacy, there continues to be a lack of understanding—2 in 5 beneficiaries still don’t under the plan well. And arguably even more shocking—1% of the people polled by PAN have opted into the payment plan to date.

When asked about his experience with opting into M3P and as an individual Niles that could benefit from the Part D cap, benefit, Allen—who’s been living with prostate cancer since 2004—described his experiences from a patient perspective.

“Well, the first thing that you encounter is that being retired and then having to have access to medications is very expensive for my disease. The most typical thing was you get inundated with a lot of papers at the beginning of the October enrollment period,” he explained. You're getting your annual notice of change from Medicare. You're getting information from agencies to pick a supplemental or advantage plan—there're a lot of steps. There's a lot of salesmanship going on at this time when you're trying to make a decision.

“… I'm on Medicare with an insurer supplement. My wife is on Medicare with another insurer. I got a letter in the mail. She got a conversation from a physician's assistant in the doctor's office. She felt like, 'I don't know what this means.' I got a five-page letter, and I'm trying to read through and make a decision, do I opt in or opt out. We never thought to communicate together because we thought this only applies to my plan. And when I asked her about it, she said, ‘I had no idea what it meant.’ … So that's a lack of communication just in a household. Can you imagine what the communication is in mass?

Niles then posed the question to the panel: if you had the opportunity to speak to Congress or to speak with CMS, today or tomorrow, what recommendations and changes would you like to see, either with the Medicare reforms or the Medicare Part D design in general?

“We wish that they could change the name from Medicare Prescription Payment Plan to ‘Option’ instead of ‘Plan’ because the word plan also is used for stand-alones for Medicare Advantage and Medigap. … And I wholly agree with what Tommy presented earlier about the stand-alone plans,” Neff commented. “We hope that CMS can bolster them because there are still people who want to have Medigap with a stand-alone. They don't want to go to Medicare Advantage, we're seeing. We only have 14 left, and we see the prices of those plans—with their premiums being very, very high, so we hope that CMS takes some action to bolster those stand-alone plans.”

As for Sherman, it all comes down to education.

“Let's just be honest here, insurance companies are not excited about this program … There is no meat behind the requirement for the Part D enrollee to actually reimburse the insurance company,” he pointed out. “The only thing that can happen is that they'll kick them out of the prescription payment plan. I think I read somewhere that they're predicting at least a 30% loss in this, that they're not going to get reimbursed … I know providers might not like to hear what I'm going to say, but I would like that there actually is a requirement that providers need to provide education about this, at a certain threshold. It can't be for every single prescription, but for me, to be as proactive as possible is what's going to be the most beneficial.”

1. Niles A, Allen B, Neff S, Sherman D. Moving the Needle on Awareness of the Medicare Part D Reforms. March 18, 2025. Access USA (general session). Philadelphia.

The conference’s first panel offers insight on the current state of awareness among beneficiaries of the Part D cap and Medicare Prescription Payment Plan via the PAN Foundation’s latest research.

Andy Studna

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