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Good Distribution Practice means that ‘track and trace’ is becoming indispensable for drug product integrity. Interactive Response Technologies may offer a potential solution.
It’s 2016: airplanes, ships, trains and even cars send a constant mass of sensor data to central servers. Almost 50% of the world’s population uses a smartphone. We communicate with these mobile computers continually, globally.
So what is the biopharmaceutical R&D industry doing in terms of data in the clinical trial supply chain? Ninety-nine per cent of all temperature controlled shipments are equipped with a validated temperature logger - which will be activated at point A, deactivated at point B, the data read out and then a PDF version of the temperature curve sent out by e-mail to facilitate manual drug release procedures.
Good Distribution Practice (GDP) has meant that ‘track and trace’ is becoming indispensable for drug product integrity. The market for biological products is also growing - consequently, cold chain solutions demand is also increasing.
A market report by Visiongain[i] estimates that, in 2013, the R&D pharmaceutical industry spent more than $6bn on cold chain storage and distribution - and will spend more than $10bn by 2017.
Interactive Response Technologies in the future may have the potential for data tracking from transport start to finish and fulfill the vision of real end-to-end (e2e) temperature tracking. This starts with facility monitoring (for instance, at the manufacturing site) and ends at the investigational site, and, in future, in the patient’s home. Temperature data is sent in frequent intervals, along with geofencing parameters, when the loggers connect to a telephone network. How does this work during flights? Quite simply, the loggers detect the environment, notice whether they can send out data or not and, in this case, they would collect data in flight and transmit it after landing. Such near real-time logging devices can also collect data on other environmental quality factors such as humidity, pressure, light (to detect a package being opened), and acceleration (used both to detect when in-flight but also to detect the package being dropped).
Where is the advantage over the traditional temperature loggers? The answer is in what you can do with the data. Temperature excursions, shipment delays and potentially damaged shipments can be detected before the shipment arrives at its destination. This could automatically trigger quarantining on arrival, or ordering of a replacement shipment, so that any impact to the clinical trial and the patients is minimized.
The collection of data on environmental factors throughout the supply chain of custody from manufacturer to sites/patients means that you could also produce an accumulated picture of those factors that can impact drug quality. What if a drug is out of temperature window for 10 minutes at a depot, 20 minutes at an airport, and a further 15 minutes at a site? Individually those excursion durations may not be cause for concern, but cumulatively they mean that the drug is potentially unsafe and should be quarantined.
Being able to track every step of the way can help avoid unpleasant surprises. Of course, some ‘what if’ situations have to be thought through - e.g. if a site pharmacy was located in a basement - but we are convinced that holistic thinking around real-time data tracking through the supply chain will simplify processes, create higher traceability and visibility, and ultimately reduce supply chain risks. And looking at the future of supply chain, this providing end to end visibility will provide great potential to conduct predictive analysis to support more accurate, probability based decision making.
Sanjay Vyas, Corporate Vice President and Global Head, Clinical Trial Supplies and Logistics, PAREXEL
[i] Clinical Trial Supply and Logistics: World Industry and Market Outlook 2015-2025, Visiongain.