Clinical supplies & logistics Unexpected I


magine you’re a pharmaceutical company, and you want to create a new small molecule drug product. Where do you begin? One place is the active ingredient – which is often manufactured in middle-income territories like Puerto Rico. Not that things are quite that simple. For though production can begin on the Caribbean island, various other materials must first be sourced, like piperidine from France and calcium phosphate from Belgium. Once the active ingredient is perfected, the nascent drug


events


You can’t forecast everything: the Covid-19 pandemic and the ongoing Russia-Ukraine war offered proof of that. And yet, despite some notable shortages, the pharmaceutical supply chain has proved largely resilient in the face of both disasters. Unfortunately, the same isn’t true of clinical trials, with conveners facing a range of theoretical and practical challenges. Andrea Valentino investigates how clinical trial organisers can better respond to unexpected events, speaking to Tom Cotter of Healthcare Ready, and Steve Jacobs from Global BioPharm Solutions.


can then be fully manufactured, probably in a developed country such as the Netherlands. But for that to happen, our network of nations must grow. Canadian wood pulp will need to be imported, as will Indian mineral acid and German vinylpyrrolidone. By the time you add in the (Greek) primary packaging and the (Japanese) secondary packaging, you’re left with a veritable UN security council of players across the supply chain. Now multiply our hypothetical supply chain


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Clinical Trials Insight / www.worldpharmaceuticals.net


Aleksandar Malivuk/Shutterstock.com


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