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Labelling for life
We don’t often think of labelling as a risky behaviour, but incorrect 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.
Oncology's data puzzle
Oncology trials generate huge volumes of data from many different sources, and they do so over long periods of time. The payoff of demonstrating an effective therapy for cancer can be huge for patients and pharmaceutical companies, but collecting, cleaning, analysing and interpreting data from studies can be a challenge. Monica Karpinski speaks to Peter Hall, senior clinical lecturer in cancer informatics at the University of Edinburgh, and Charlotte Stuart, head of data management and information systems at the University of Southampton’s Clinical Trials Unit, to find out why certain data management challenges are unique to oncology trials, and how organisers and statisticians work to overcome them.
Innovations and hurdles
The discovery and development of CAR T-cell therapies will go down in the annals of medical history. But while remarkably effective against a range of cancers, these advanced therapies require a complex pipeline of production – one that first includes extracting components from the blood of patients. Andrea Valentino speaks to Federico Rodriguez Quezada, an industry veteran and consultant, and Dr Jeffrey Winters of the Mayo Clinic, to learn how the complexity presents challenges in the supply chain, and what can be done to get the finished product to patients quicker.
Centralised submission
The change from the Clinical Trials Directive to the Clinical Trials Regulation in Europe has been long and slow, but now that the new regime is in place there is one burning question – has it produced the improvements that regulators were expecting? Jim Banks puts that question to Alexander Roussanov, life sciences and privacy partner at law firm Arnold and Porter Kaye Scholer LLP, and Edyta Maciołek, regulatory affairs manager at JJP Biologics.
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 depend on a variety of factors. Oladimeji Ewumi discusses what these are with Dave Latshaw II, cofounder 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.
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