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Intricate supply chains have been a part of medical life for decades –...
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Twisted system If you wanted to devise a test for how well pharma has optimised its logistics, you couldn’t do much better than asking the industry to build the supply chains for Covid-19...
Travel risk It’s not just shifting portfolios and expanding markets that supply chain strategies need to take into account. Our understanding of what constitutes an effective cold chain...
Vial bodies The global Covax initiative aims to produce two billion doses of Covid-19 vaccines by 2021 – without building any new factories. That’s going to take a lot of flexible,...
Black swan theory Covid-19 has ruthlessly exposed pharmaceutical supply chain issues, raising one huge question for companies and governments across Europe and North America: is it time to...
Development from home There’s nothing like a global pandemic for driving interest in remote drug development – but can computer-aided biology change how drugs are designed in the long term, or is it just...
Natural reaction There are 12 green chemistry principles. Using biocatalysis to synthesise pharmaceuticals fulfils the requirements of ten of them – with the other two not applicable. But...
Water solvable Pharmaceutical development is a delicate balance of stability, manufacturability and bioavailability. For all the advantages that lipid-based excipients (LBEs) bring to the...
Make it warp Given the rapid innovation in drug modalities and the jet engine that Covid-19 has strapped to concepts of patient-centred design and digital health, it looks increasingly unlikely...
A standardised approach Douglas Fiebig, PhD, senior partner of Trilogy Writing & Consulting, Frankfurt, Germany, discusses the challenges encountered when responding to medical writing RFIs.
A trial run What a difference a pandemic makes. Clinical trials that would previously have taken years to design and conduct have delivered results in under 12 months, and stages once...
Support systems For years, the patient-centric promise of the decentralised trial was little more than a utopian dream. But, with a global pandemic keeping people in their homes, 2020 brought the...
Get the gears turning The demand for comparator products in clinical trials is growing rapidly, but the sourcing models are uniquely susceptible to blockages in the supply chain. Jim Banks asks Steven...
Human chain As clinical trials have become more complex, the people that make up their operations teams and supply chains have had to shoulder increasing strain. Now, with workforce growth...
The race to digitize At the beginning of 2020, both AstraZeneca and Novartis – widely acknowledged as industry leaders in applying digital technologies to their trial processes – went public with...
Blindingly obvious? Deciding whether to use ‘blinding’ in a clinical trial is a difficult decision. As important as it is for reducing bias, it can make designing reporting and analysing studies...
The technology trap If it wasn’t there already, Covid-19 has pushed the emphasis on remote monitoring for clinical trials to the tipping point. Discussion of it is almost as ubiquitous as the smartphones...
Moving targets The FDA published its final guidance on ‘Adaptive Designs for Clinical Trials of Drugs and Biologics’ in November 2019, clearing the way for developers to use accelerated protocols...
Competition versus coalition In the most high-stakes cases, the right choice in comparator sourcing can determine market shape as much as market share. What is the best way forward when all competitors want to...
A matter of life and death Clinical trial supply professionals have long understood the importance of remaining agile in keeping up with increasingly complex trial demands. Now, with Covid-19,...
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