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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.
Outsourcing
31 The shifting roles of CROs The dial has been shifting for some time now on how much research and development work is carried out in-house by pharmaceutical companies. While outsourcing in the industry was once synonymous with manufacturing at scale, much of the focus of contract organisations is now on assisting companies with drug development, hence the commonly used moniker CRO, or contract research organisation. The role of the CRO isn’t always monolithic however, and whether pharmaceutical companies opt for a full-service approach with their clinical trials, or cherry pick competencies to integrate within their own trial workflow, will
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depend on a variety of factors. Oladimeji Ewumi discusses what these are with Dave Latshaw II, co-founder and CEO of BioPhy, Penelope Przekop, CEO of PDC Pharma Strategy, and Mary Jo Lamberti, research associate professor at Tufts Center for the Study of Drug Development at Tufts University.
35 How to transition your study to CTR 536/2014 (CTR) Lumis Life Science
Packaging
36 Labelling for life We don’t often think of labelling as a risky behaviour, but incorrect
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information can be detrimental at every stage of the clinical trial supply chain, not to mention for patients once a product reaches its intended recipient. These risks are further intensified when it comes to cell and gene therapies, which often have strict specifications, like temperature control, that must be made clear on any packaging. Kim Thomas speaks to Zbigniew Szczepiorkowski, professor of pathology and laboratory medicine at Dartmouth College, to find out how the evolution of a standardised labelling system has been essential to ensuring the safety of subjects in clinical trials.
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