Nicholas Saraceno, Editor

How DSCSA Is Transforming Supply Chain Data Exchange

 roundtable discussion, Nicholas Saraceno, editor of 

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

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

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

helping reduce healthcare spending and improve the affordability of medications.

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

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

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

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

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

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

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

Videos

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

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

Resilience, which is the concept of defying adversity and recovering from hardship, is connected to one’s health and well-being. Image Credit: Adobe Stock Images/Jaman_Visual.com

Resilience, which is the concept of defying adversity and recovering from hardship, is connected to one’s health and well-being.

 However, on the other hand, via behavioral, inflammatory, metabolic, and pathways, acute and chronic stress can speed up biological aging, along with the risk of chronic disease.

Capabilities that enhance resilience by decreasing the intensity of distress, aiding recovery from stress, and encouraging healthy behaviors could potentially play a role in shaping downstream outcomes. One example of comes in middle-aged adults—there’s been an association between higher resilience and reduced hypertension risk over 10 years for this particular age group.

There have been instances where qualitative research has examined the personal experiences of resilience during the COVID-19 pandemic—a time in which being able to act fact when treating a COVID infection can provide a high success rate for decreasing the risk of severe disease and hospitalization.

Gaps in measuring resilience during COVID-19

However, quantitative measures of coping capacity and observable resilience indicators are rather underexplored. Having said that, a cross-sectional study published in 

 sought to explore the factors related to self-reported resilience during the pandemic across various racial and ethnic groups.

Black and Hispanic participants reported higher resilience during the COVID-19 pandemic compared to White participants, while American Indian and East Asian participants reported lower resilience.

Higher education, income, marriage, and private insurance were strongly linked to greater resilience, while being female, unemployed, or having diabetes were linked to lower resilience.

Findings underscore the need for systemic interventions addressing social and structural inequities to enhance resilience across diverse populations.

This study pulled data from the Collaborative Cohort of Cohorts for COVID-19 Research (C4R) study, consisting of 14 established cohort studiesthe United States aimed at analyzing cardiovascular, pulmonary, and neurological health. The investigators homed in on the “bounce-back” aspect of resilience—also known as “the self-perceived ability to recover from adversity,” which according to the Brief Resilience Scale (BRS), is the main component of resilience.

Participants provided informed consent for COVID-19–related follow-up activities that were aligned with cohort-specific protocols, such as verbal, remote, and written methods. The study featured participants who had responded to the resilience question on C4R questionnaire that were completed between the January 2021 and February 2023 timeframe. Although data was originally examined from October 2023 to May 2024, an updated analysis occurred from August 2024 to April 2025.

The primary outcome was self-reported resilience during the COVID-19 pandemic, which was gathered from one BRS item: “I tend to bounce back quickly after hard times.” Those who responded “agree” or “strongly agree” were consiered resilient, while participants who responded “neutral,” “disagree,” or “strongly disagree “were considered not resilient for the sake of the study.

It’s important to point out that the BRS is a six-question questionnaire, but only one item was included as part of C4R survey as a way to limit the participant burden.

Overall, the cross-sectional study featured a total of 31,045 participants (18, 672 [60%] women; 10 ,746 [34.6%] aged <65 years), from 14 US prospective cohorts, and 23,103 of them (74.4%) self-reported resilience.

Key findings: Racial and social disparities in resilience

Black and Hispanic participants had statistically significantly higher prevalence ratios of resilience compared with White participants, while American Indian and East Asian participants had lower prevalence ratios (10% and 24%); higher education, being married, higher income, and private insurance were associated with greater resilience.

When compared with White participants, Black and Hispanic participants had a higher prevalence of self-reported resilience (adjusted PR [aPR], 1.04; 95% confidence interval, or CI, 1.02-1.06; aPR, 1.08; 95% CI, 1.06-1.11; respectively), while American Indian and East Asian participants had lower prevalence (aPR, 0.90; 95% CI, 0.86-0.94; aPR, 0.76; 95% CI, 0.68-0.84; respectively).

Higher education, marriage, higher income, overweight status, and private insurance were connected to greater resilience. Meanwhile, being female, unemployed, or having diabetes were connected to lower resilience. One’s COVID-19 vaccination and infection status did not display any significant association, although racial and ethnic differences impacted how factors like hypertension and insurance status were linked resilience.

The study authors concluded that “this cross-sectional study provided important insights into factors associated with self-reported resilience during the COVID-19 pandemic in a large, diverse US sample. Our findings highlight significant racial and ethnic differences in self-reported resilience and underscore the importance of social and structural factors. Higher education, income, and social support were consistently associated with greater resilience across racial and ethnic groups, highlighting the need for policies and interventions that promote access to these resources. The partial mediation of racial and ethnic disparities by social determinants of health further emphasizes the role of systematic inequities and the need for equity-focused approaches to promoting resilience in the face of adversity.

“As the world continues to grapple with the impacts of the COVID-19 pandemic and other crises, understanding and promoting healthy resilience is important. The findings of this study illustrate the complex interplay of individual, social, and structural factors that shape resilience and emphasize the need for strategies that move beyond individual-level interventions to address broader systemic inequities. Building a more resilient, equitable, and just society requires not only supporting individuals but also dismantling the structural barriers that create vulnerability.”

1. Ogungbe O, Wang T, Balte PP, et al. Self-Reported Resilience During the COVID-19 Pandemic. 

2. Saraceno N. Study Connects COVID-19 Treatment Disparities to Gaps in Testing and Virtual Access. 

. July 11, 2025. Accessed July 18, 2025. 

https://www.pharmaceuticalcommerce.com/view/study-connects-covid-19-treatment-gaps-testing-virtual-access

Articles

The study reveals that resilience varies significantly by race, education, income, and insurance status, highlighting the role of social determinants and systemic inequities in shaping health outcomes.

Racial, Social, and Economic Factors Drive Resilience During COVID-19 Pandemic, Study Finds

The Hidden Challenge of Reporting Counterfeit Medicines

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

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

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

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

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

Why has the underreporting of falsified medicines been such a prominent issue?

I think there's a very significant issue related to under reporting. Obviously, it's connected to the awareness issue. But I think the consumer behavior, is that if you do go on to the internet or social media and you buy a medicine, you recognize, okay, something's wrong, either the packaging or you took it and nothing happened, or whatever the case may be, I think there's a reluctance to report that because you're almost embarrassed that you were scammed.

They just may not know where to report it. I think that's the key messaging that goes on is creating the awareness, how do I report it, and really encouraging people to report. It's interesting, too. When you look at like the PSI data, you see that in the US, surprisingly (this data is public on their website), if you look regionally, the United States has the most incidents, and people say, how is that the case? How was it not China? Well, it's because our customs regime, our defenses are better. People are more likely to report.

In the fourth part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, describes the prominence of underreporting falsified medicines. 

The Biosimilar Void

, Murray Aitken, executive director of the IQVIA Institute for Human Data Science, explains the extensive process behind developing the “Global Use of Medicines Outlook Through 2029” report. The creation of this comprehensive resource spans several months and integrates proprietary IQVIA datasets, including the MIDAS (Market Intelligence Data Analytics Solution), market prognosis, and forecast link tools. The report combines robust data analytics with global expert insights to produce a holistic view of the pharmaceutical landscape.

Aitken emphasizes that a key part of the process involves gathering input from IQVIA’s network of experts across the world, each bringing localized perspectives on evolving trends in medicine use, access, and policy. These expert insights are then synthesized by an internal analytics team responsible for compiling the vast volume and value data.

In terms of metrics, the report estimates that 3.6 trillion defined daily doses of medicines were consumed globally in the past year. Additionally, the worldwide expenditure on medicines is projected to be approximately $1.8 trillion at list prices in 2024. Aitken notes that while there are some data gaps, IQVIA’s methodology includes filling in missing information using statistically sound models and expert validation.

The ultimate goal of the report is to provide all healthcare stakeholders—governments, policy makers, pharma executives, and researchers—with a clear, data-driven understanding of where medicines are being used, how frequently, and at what cost. Aitken concludes by expressing pride in his team’s efforts and the value the report brings in shaping discussions around global health policy, drug affordability, and resource allocation.

He also comments on how pharma companies should revise their market access and pricing models to align with the evolving landscape; strategies manufacturers should adopt to balance investment in innovation with lifecycle management in order to maintain sustainable growth; how the competitive landscape will evolve within these high-impact therapeutic areas, the role patient access and reimbursement play in shaping adoption; what he anticipates for the biosimilar adoption curve in key markets over the next five years; and much more.

Despite the strong pipeline of innovation, biosimilars continue to deliver significant cost offsets, especially in mature markets. What do you anticipate for the biosimilar adoption curve in key markets moving forward?

Over the last five years in the US, we've had some issues in terms of the way in which the biosimilar market has evolved. In the case of the Part B drugs, hospital-infused drugs, and so on, we have the pricing mechanism that is really not designed for biosimilars, and which is driving costs and prices down in the marketplace to the point where they may be actually too low. For Part D drugs, we have formulary management that goes on by the PBMs, which in some cases, is restricting access to the lower-cost biosimilars. These are distortions in the market that we think are not ideal, and they should be addressed in order for biosimilars to play a key role.

In Europe, we have a version of the same sort of mechanisms where pricing has been driven to very low levels, to the extent that we now have what we are referring to as the biosimilar void. This is when we look in the pipeline of new biosimilars being invested in by similar manufacturers for the next wave of biologics that will lose exclusivity, we see a lot of gaps. We see a void. We're not seeing as much investment, both in the manufacturing capacity or in the R&D to bring new biosimilars into the market.

That lack of investment means there will be less competition from biosimilars, and ultimately, that isn't desirable for the health system, for patients, and I think it's something that does need to be addressed rather urgently, so that we can create an environment where biosimilars have an important, meaningful role to play in the context of the overall system.

In the fourth part of his Pharma Commerce video interview, Murray Aitken, executive director, IQVIA Institute for Human Data Science, outlines what he anticipates for the biosimilar adoption curve in key markets moving forward.