By Jay McHarg
The emergence of temperature-sensitive therapies whose efficacy and safety easily can be compromised by falling outside recommended specs has changed the way pharma manufacturers view the cold supply chain. Gone are the days when guesswork, trial and error, and unknown outcomes were the status quo and considered acceptable. Instead, much like in many other areas of the drug development continuum, the focus now is on data and how it can be unlocked and analyzed in real time to save money, time, and resources — while also better ensuring patient safety.
BEYOND QUALITY AND EFFICACY — TO INSIGHT
Everyone knows the high costs associated with any type of failure in drug development. In the transportation part of the process, reducing failure often equates to seeking solutions that can improve — and guarantee — high drug quality and efficacy upon delivery.
But it’s no longer necessary to rely on end customers, especially patients, to verify efficacy upon delivery. Thanks to advancements in technology, logistics management, and data analytics, it’s now possible to achieve up to 99 percent visibility into the transportation process, which presents even more opportunities.
Near-perfect visibility takes the guesswork and uncertainty out of a typical cold-chain journey. Now it’s possible to detect issues, optimize, and course correct well before a product ever reaches the end user. Thanks to data that is generated throughout a product journey, you can make informed decisions related to safety, efficacy, and efficiency. Also, having that ability enables you to adopt a “no-excuses” mindset when it comes to excursions and failures.
FROM INSIGHT TO ACTION
Gleaning actionable insights from data can help avoid costly or dangerous issues before they occur. By analyzing package and transport data over time, manufacturers could, for example, identify packages with high risk of failure before they leave the warehouse. This makes it possible for shipments to be optimized during pack-out based on location, temperature, and other seasonal variables.
PREPARING FOR THE FUTURE
While analyzing data extracted from loggers is an effective and far superior way to determine failure rates, versus the industry’s legacy formula of statistical “guesstimates,” there’s an opportunity to get even smarter across cold chains. The future lies in “smart boxes” that will soon give manufacturers near real-time visibility into forces outside their facility’s walls that affect product quality and efficacy.
These and related technologies promise to provide not only information on the authenticity of the product being shipped (chain of custody and serialization), but also real-time data on everything from location, temperature (inside and outside the box), and day and time of delivery to the person who received the package. This will provide logistics managers with instant alerts if a product goes out of spec, allowing them to recall or intercept a package or expedite the delivery of a replacement, minimizing disruption to the customer or patient.
UNLOCKING DATA FOR GOOD
The key to using data in any industry is unlocking its potential. The wealth of data generated across a cold chain has been largely untapped until now. We’ve reached the point where manufacturers can not only ensure quality and efficacy but also optimize the entire process in ways that benefit their business as well as those who rely on them. A data-driven system that is not only highly responsive, but also predictive and proactive, is good news to an industry — and its patients — who will increasingly rely on temperature-sensitive therapies in the coming decades.
JAY McHARG is CEO of AeroSafe Global.