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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...
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...
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...
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...
Innovation in inhalation Blue and brown inhalers have become synonymous with asthma, but inhaling doses of medication is something we might see more of as drug developers look at inhalation as a strategy to...
Polysorbates and their alternatives Unlike small-molecule drugs – which are typically chemically synthesised – biologics are large, complex molecules derived from living organisms. The downside of this is that these...
A green future for peptides The use of peptides has been growing at pace during the past couple of decades, owing to their high likelihood of regulatory approval and probability of success in clinical trials....
Air or sea? The majority of the world’s pharmaceuticals are transported by sea freight, owing to its substantially lower cost. The predominant reason for using air freight instead is urgency, but...
The viscosity problem It’s no surprise that the physical characteristics of an injectable substance will have a bearing on how it functions inside the body. But exactly what those effects are may not be...
The right selection A large portion of pharmaceutical manufacturing happens outside of the premises of the companies who brand and sell drug products. According to some sources, it could be as high...
Sustainability in mind Reaching carbon neutrality by 2040 will require a lot more of pharmaceutical companies than reducing CO2 emissions, water and electricity. Coordinated effort is required...
Pharma 4.0 Tools that take advantage of advances in AI and machine learning, alongside other burgeoning technologies, are often marked with a ‘4.0’ suffix to denote that it’s part of the...
How well-written clinical study protocols get drugs to patients faster In the world of drug development and approval, time is of the essence. But beginning the process with a poorly written protocol will only impede teams before a study has even begun....
Blind faith Trial designs can vary signifi cantly when it comes to how much knowledge the personnel and participants involved have. But to what end does this serve? Furthermore, what’s required...
Lessons in logistics Even before the pandemic, researchers were moving away from in-person clinical trials and towards digital alternatives, and the trend was only escalated by the required lockdowns...
Augmented with AI The process of organising and running a clinical trial comes with several challenges, and a significant portion of the cost can be attributed to the operational conduct of the trial....
A hot-headed decision The process of transporting pharmaceutical products to clinical trials has many moving parts, all of which bring potential risk. Between the pharma companies, their logistics partners...
Central intelligence Central laboratories have become a crucial part of running global and multi-regional clinical trials. Drug developers place a great deal of trust in these partner organisations,...
Comparator Sourcing Comparator drugs are a crucial part of clinical trials everywhere; helping researchers understand exactly how their inventions fare against the competition, or even when drugs can...
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