Not too long ago, “ambient,” “room temperature” and even “controlled room temperature” (CRT) were considered synonymous and, as they were considered more or less resilient again temperature excursions, were provided little to no thermal protection across the supply chain. However, this is beginning to change. Increased regulatory focus, an improved understanding of how inappropriate storage conditions impact product integrity and the increased volume of temperature sensitive CRT biosimilars/biologics have pushed manufacturers to pay just as much attention to room temperature products as they do traditional cold chain drugs.
This being said, transporting room temperature drugs is not without its challenges. Though it may sound counterintuitive, safeguarding room products from temperature excursions can actually be more expensive and difficult than protecting their cooler counterparts. From reasons raging from costs to simple effectiveness, one simply just can’t apply the same solutions and methodologies to ambient products as they do those that require refrigeration.
With this in mind, below we’ve outlined the key challenges and solutions associated with protecting CRT and ambient drugs across the supply chain.
Though still in its infancy, the global precision medicine market already accounted for roughly $43.59 billion in 2016 and is estimated to reach $141.70 billion by 2026, according to a 2017 market intelligence report by BIS Research, titled "Global Precision Medicine Market- Analysis and Forecast, 2017-2026." Furthermore, in 2017, the FDA broke a record for the most new drug approvals, the majority of which were for personalized medicines.
But what does this mean for cold chain leaders? We asked the 2019 Cold Chain Spring speaker faculty about the challenges and innovative opportunities associated with the personalized medicine supply chain. Highlights include:
The temperature controlled life sciences supply chain landscape has never been riper for disruption. Though the pharmaceutical industry has changed dramatically over the past 30 years, the pharmaceutical supply chain has remained largely unchained. However, with the influx of biologics and personalized medicine, the growing costs of R&D, increased global regulatory pressure and numerous other emerging trends, the pharmaceutical supply chain is only expected to grow in complexity and expense for the foreseeable future. Given all of the challenges ahead, we asked our Cold Chain Spring 2019 speaker faculty what new, innovations and solutions are on the horizon that could help the reinvent the pharmaceutical cold chain industry as we know it. The following is an overview of the top 3 technologies poised to usher in the next era of temperature-controlled life sciences logistics: Artificial Intelligence, Blockchain and Advanced Analytics.