Vice President of Life Sciences at Kenco.

Tim McClatchy, Kenco 

Personalized medicine demands precision logistics, with strict temperature control, real-time tracking, and regulatory compliance essential to ensure safe and timely delivery of patient-specific therapies.

Gaps in last-mile delivery and third-party training pose serious risks, especially when handling temperature-sensitive, irreplaceable treatments for critically ill patients.

Advanced technologies like predictive analytics and smart packaging are becoming vital tools to maintain the integrity of personalized medications while meeting the rising expectations for care and accountability.

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.

Articles

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

While it might not be as high profile as the consumer goods or food/beverage supply chains, the pharmaceutical supply chain is just as important—if not more so—and faces many of the same logistical challenges. Changing demand, evolving regulations, and general industry trends are forcing pharmaceutical logistics professionals to re-examine tried-and-true strategies through the lens of new technologies.

In particular, I see three challenges remaining top-of-mind for the pharma supply chain in the short, medium, and long-terms:

Short-term: Enforcement of the Drug Supply Chain Security Act

While it has been more than a decade in the making, the FDA appears to be on track to begin full enforcement of the Drug Supply Chain Security Act (DSCSA) come this November.

The DSCSA, designed to reduce the amount of counterfeit product reaching consumers, requires a multi-step verification process at each node along the supply chain. Manufacturers assign each prescription drug package a series of five serial numbers. Distribution facilities must be able to integrate their systems with the pharmaceutical manufacturer to ensure each package stored and shipped is consistent with the manufacturer’s serial numbers. And once the package reaches the pharmacy, the pharmacist must verify each packages’ serial numbers with the manufacturer’s serial numbers before filling any individual prescription.

The DSCSA’s thoroughness will certainly help provide peace of mind for patients, and it can help the pharmaceutical supply chain catch counterfeit drugs before they cause costly investigations and lawsuits. However, not everyone is ready for full enforcement. While pharma manufacturers and major drug store chains have the resources needed to obtain DSCSA-compliant serialization and electronic data interchange technology, smaller pharmacies may not be able to afford the upgrade.

The FDA has yet to offer a solution for these pharmacies. A January-February 2024 survey conducted by the American Pharmacists Association found only 14% of dispensaries were fully outfitted for compliance—and many of their respondents were independent pharmacies.

However, in a newer development, the FDA did issue an exemption until Nov. 27, 2026 for dispensers with 25 or fewer full-time employees that are licensed as pharmacists or qualified technicians.

Although the Healthcare Distribution Alliance has questions out to the FDA about how to help these pharmacies, there’s no solution in place yet. Logistics professionals should track FDA guidance in the coming months, including any delays of DSCSA enforcement.

Medium-term: Applying data to minimize supply chain disruptions

If there’s any message this decade has offered pharmaceutical supply chains, it’s “expect the unexpected.” COVID-19 interrupted manufacturing, then less than a year later tested Pfizer and Moderna as they worked to meet unprecedented demand for the COVID vaccine. More recently, the unexpected collapse of the Francis Scott Key Bridge forced immediate overhauls to traffic patterns, and increasingly intense weather could set production and delivery back weeks.

While logistics professionals may not be able to control the weather, they can leverage data to be better prepared for these events. Over the next few years, there will be a greater focus on building “control towers” within pharmaceutical supply chains, integrating both internal and external data to outmaneuver rapidly changing conditions.

For example, understanding which facilities are experiencing labor shortages can help pharma manufacturers prepare for product shortages and shift production if necessary. Monitoring the path of a hurricane can help manufacturers avoid shipping out time-sensitive product from an impacted distribution center.

Thinking globally, manufacturers are also likely to leverage external data to understand shipping patterns and requirements across countries. Tracking this information can help manufacturers understand when their product is likely to go through customs, while timing the shipment to avoid letting their product spoil because it arrived over the weekend.

Long-term: The logistical implications of more personalized medicine

As our understanding of disease has evolved, so has the pharma industry’s approach to treating patients. Drug manufacturers are moving away from one-size-fits-all medicines and toward treatments, such as injectables, engineered for specific patients. In fact, research suggests the market for injectable drug delivery is likely to grow at a compound annual growth rate of 8.6% through 2029.

But with the greater focus on more personalized medicine come new complications in how treatments are transported. Injectables require continual temperature control, so third-party logistics providers that are storing it need both extensive refrigeration space and monitoring technology to ensure the temperature never reaches unsafe levels—both expensive propositions. Shippers will need to invest in packaging that can keep injectables in safe conditions for long-distance travel.

In addition, delivery of more personalized medicine will require a strong chain of custody. In metropolitan areas, pharma manufacturers can tap delivery infrastructures through Amazon and similar companies to deliver sensitive medicines for the last mile. But in rural areas, where access to medical care can be more difficult to obtain, delivery is often outsourced to independent contractors, and there’s no guarantee their vehicles are equipped to deliver injectables safely. Chain-of-custody technology helps hold the entire supply chain accountable, and, in the event a medicine spoils, pinpoints where the lapse in safety occurred.

As the injectable drug delivery market continues to grow, pharmaceutical logistics professionals will turn their attention to how best to leverage these technologies—refrigeration, environmental monitoring, and chain-of-custody—while keeping their supply chain viable for more personalized medicine.

Challenges for a changing pharmaceutical industry

Moving medicines through the supply chain has always been a complex process, requiring added levels of security and environmental monitoring. But with the rollout of new regulations, and the shift to more personalized medicine, old strategies of shipping treatments simply won’t hold up to the scrutiny now placed on pharma logistics. In the short-, medium-, and long-terms, the onus will be on improved technologies—including serialization, refrigeration, and data control towers—to keep goods flowing smoothly and in line with stringent protocols. 

1. APhA Survey Shows Dispenser DSCSA Implementation Slow, but Encouraging. American Pharmacists Association. February 23, 2024. 

https://www.pharmacist.com/APhA-Press-Releases/apha-survey-shows-dispenser-dscsa-implementation-slow-but-encouraging

Waivers and Exemptions Beyond the Stabilization Period

https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

3. Injectable Drug Delivery Market Size, Share, & Trends Trends by Type (Device, Formulation), Therapeutic (Infectious Diseases, Cancer), Usage Pattern (Immunization), Administration (Skin, Musculoskeltal), Distribution Channel, Patient Care Setting, & Region – Global Forecast to 2029. 

https://www.marketsandmarkets.com/Market-Reports/injectable-drug-delivery-market-150.html

Various forms of technology—including in the serialization and refrigeration spaces—are necessary in order to keep goods flowing smoothly through the supply chain. 