Contents Cover story In this issue 13
8 News & numbers The headlines and figures impacting the sector.
Regulatory 10 Reap the benefits
Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, looks at what should be considered to optimise the designing and writing of a good protocol.
Clinical supply & logistics 13 Next-gen vaccines
The lockdowns of 2020 and beyond led to economic disruption on a scale not seen outside of wartime, and the imperative to reduce some of this damage led to the fastest vaccines ever produced. But now the world has discovered what’s possible with governments, industries and suppliers all working towards the same goal – will vaccine production change forever? Monica Karpinski asks Kevin Sample, senior consultant at GHX, and Carlos Cordon, professor of strategy and supply chain management at IMD business school.
Clinical Trials Insight /
www.worldpharmaceuticals.net
16 A game-changing digital platform PCI Pharma Services
19 Optimise trial supplies and post-trial patient access Clinigen
21 Trial at home 23
Clinical trials have historically been done at hospitals or clinics, with subjects and researchers convening to get results. But with the rise of new technology – to say nothing of the pandemic – things are changing
fast. Instead of trooping to investigation centres, subjects are increasingly undergoing trials in their own homes, using sophisticated equipment to beam data back to doctors. Naturally, this approach offers a number of ethical and practical benefits. Yet it’d be wrong to suggest that the direct-to-patient model is straightforward, especially when it comes to supply chains. Andrea Valentino talks to Gaurav Agrawal, life sciences partner at McKinsey, and Órlaith Burke, ‘data in health’ innovation portfolio lead at Accenture, to learn more.
Logistics
23 Cash in on opportunity Adaptive trial designs have enabled clinical research to keep up with Covid-19, but their operational costs and complexities might be harder to justify once the pandemic has passed – unless we’ve been thinking about them the wrong way. New research suggests greater use of adaptive trials can lower the overall cost of drug development and create new opportunities for generating value in healthcare. Isabel Ellis finds out more from Stephen Chick, the Novartis chaired professor of healthcare management at INSEAD, and Jörg Mahlich, market access and government affairs lead at Miltenyi Biomedicine.
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