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

Two Labs’ Michael Rowe assesses the industry’s level of preparation, including challenges stakeholders have encountered along the way. 

DSCSA Compliance Has Arrived. Now What?

These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

Smart Packaging in Pharma: Driving Adherence and Safety Through Digital Innovation

Peer Exchange: How Pharma Can Detect Supply Chain Failures Before They Happen (Episode 3)

 roundtable discussion, Nicholas Saraceno, editor of 

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

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

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

helping reduce healthcare spending and improve the affordability of medications.

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

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

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

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

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

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

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

In the third part of this roundtable discussion, a panel of thought leaders explore the value of serialization, data sharing, and predictive analytics in identifying potential quality issues before they arise.



Peer Exchange: Understanding the Pharma Supply Chain (Episode 1)

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing the strategies that are most effective in ensuring resilience across the global supply chain.

How Regulatory Mandates Influence Technology

, Kirsten Newquist, Identiv’s CEO, defines “smart pharma packaging” as the integration of technology into pharmaceutical packaging to enhance product identification, tracking, and patient engagement. She explains that packaging primarily involves embedding technologies such as RFID radio-frequency identification (RFID) or Bluetooth low energy (BLE) into pharmaceutical containers. These technologies assign a unique digital ID to each package, enabling serialization, which is critical for tracking and traceability across the global supply chain.

This digital ID allows stakeholders—from manufacturers to pharmacists and patients—to verify a drug’s authenticity at every step of its journey. This significantly reduces the risk of counterfeit drugs entering the system, as products can be authenticated upon delivery or administration. Newquist emphasizes that this kind of smart packaging not only strengthens supply chain security but also fosters better patient engagement, offering real-time data that can support dosage verification and proper usage.

Additionally, she notes a secondary dimension of smart packaging: smart drug delivery systems. These include technologically enhanced devices like auto-injectors, smart pillboxes, or connected syringes, which offer further layers of verification and ensure patients receive the correct medication and dosage. While this may go beyond traditional packaging, it aligns with the broader goals of improving safety, compliance, and confidence in the pharmaceutical supply chain.

Overall, smart pharma packaging plays a crucial role in combating drug counterfeiting by improving transparency and traceability from production to patient use. By embedding intelligence into packaging and delivery systems, the pharmaceutical industry is better equipped to protect product integrity and ensure patient safety in an increasingly complex global supply chain.

Newquist also comments on the role embedded product intelligence plays in maintaining cold chain integrity, and why is this so critical for pharmaceutical safety and efficacy; how regulatory mandates, such as the Drug Supply Chain Security Act (DSCSA), influence the adoption of smarter packaging technologies across the industry; some of the biggest challenges pharmaceutical companies face in implementing this infrastructure, and much more.

How are regulatory mandates, such as the DSCSA, influencing the adoption of smarter packaging technologies across the industry?

These regulatory mandates, they can be game changers in terms of people adopting this type of technology, because these are difficult systems to implement and they require upfront investment. They require a lot of partners working together—there's a lot of complexity to make these work. When they're regulated, that puts some real fire behind actually having to implement these things.

Specifically, RFID technology is definitely one way that these regulations can be adhered to and can be moved forward. We've definitely seen more interesting questions and people wondering how this can really benefit DSCSA implementation. Serialization is required at the package unit level. RFID can automate some of this, and really help to scale up some of these ways of compliance. It can also provide some additional benefits as well as just compliance with the regulation. They can also help in terms of traceability, inventory management, providing real-time analytics. We definitely have seen that these regulations create a lot of interest and a lot of people are exploring how to implement these solutions so that they can be in compliance.

In the third part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, shares the ways in which regulations, including DSCSA, are impacting the adoption of smarter packaging technologies across the industry.

Embedded Product Intelligence’s Role in Maintaining Cold Chain Integrity

What role does embedded product intelligence play in maintaining cold chain integrity, and why is this so critical for pharmaceutical safety and efficacy?

In addition to a digital ID, you can also embed sensors into the smart packaging, so you can embed temperature sensors, humidity sensors, pressure sensors, and obviously, probably the most critical for cold chain management is temperature sensors.

What this really enables you to do—especially if you're using active-sensing technology in combination with RFID—is really be able to track in real time the temperature of these very expensive, organic pharmaceuticals that are really driving the industry growth today. I think it's absolutely a critical part of what smart packaging can do, and as you said, the rise of personalized medicine, the rise of all these organic compounds that are being developed by the pharmaceutical industry, they absolutely do require very careful monitoring throughout the supply chain.

I think this technology that enables not only the digital identification—but can also include sensors to monitor temperature—can be a real game changer, by ensuring that these drugs are being taken through the supply chain at the appropriate temperature. By getting this information in real time, if they see that it's not being maintained at the proper refrigeration level, there’s actually things that they can do to ensure it gets back into refrigeration to really maintain the compliance that they need for the right temperatures. We think that's a really important part of the smart packaging trends.

In the second part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, describes why this technology is essential for pharmaceutical safety and efficacy.

Traceability

Latest News