From the editor On the web...


Keep up with the latest developments in the pharmaceutical industry by visiting www.worldpharmaceuticals.net


Clinical Trials Insight Volume 1 2022


Editorial


Editor Peter Littlejohns peter.littlejohns@progressivemediainternational.com Sub-editor Nikki Peach Group art director Henrik Williams Designer Martin Faulkner Production manager Dave Stanford Head of content Jake Sharp


Commercial Sales manager Nathan Park


nathan.park@progressivemediainternational.com Client services executive Derek Deschamps Managing director William Crocker


Clinical Trials Insight is published by Progressive Media International.


Registered in England No. 06212740.


40-42 Hatton Garden, London, EC1N 8EB, UK www.ns-healthcare.com www.worldpharmaceuticals.net


ISSN 2050-3067 © 2021


All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying or otherwise, without prior permission of the publisher and copyright owner.


While every effort has been made to ensure the accuracy of the information in this publication, the publisher accepts no responsibility for errors or omissions. The products and services advertised are those of individual authors and are not necessarily endorsed by or connected with the publisher.


SUBSCRIPTIONS Single issue price: UK £38 EU €59 US $78 RoW $78 One year: Two year:


Tel: +44 845 073 9607 (local rate) Fax: +44 207 458 4032


Email: cs@progressivemediainternational.com Progressive Media International, Riverbridge House, Ground Floor, South Tower, Anchor Boulevard. Crossways, Kent DA2 6SL


Printed by Stephens & George Print Group Images used under licence from Shutterstock.com


epending on where you are in the world, the summer heat might be unforgiving right now, especially if you’re not fortunate enough to own an air conditioning unit. In lieu of a switch to turn the heat down, many have to rely on tried and tested methods to avoid heat stress conditions like heat stroke. Much like the human body, excursions in temperature can have a profound negative impact on investigational medicinal products as they travel along the supply chain to patients, either at their homes or at clinical trial centres. To make the oversight of temperature excursions even more challenging, some medicines become ineffective with even slight increases. The Pfizer BioNTech vaccine is an extreme example here, requiring ultra-cold temperatures between –90°C and –60°C during transportation. It is for this reason that the pharma industry has IRT (Interactive Response Technology), and in our lead article on page 17 of this issue, Monica Karpinski talks to three supply chain experts to find out some of the risks of excursions, and how IRT combined with other technology allows companies to react to them quickly. People often think about clinical supply logistics as the journey of products from factory to site, but there’s a final piece of the puzzle, which some feel doesn’t get the attention it deserves. Reverse logistics, or the reconciliation and destruction of investigational medicinal products, is an important aspect of running a clinical trial. On page 14, Andrea Valentino learns from experts at PCI Pharma Services and Marken why the field of reverse logistics is important, and what’s been holding it back from developing alongside the rest of the sector. Other topics explored in this issue include what makes an effective clinical trial management system, extracting value from serialisation and the human and economic cost of labelling errors in clinical trials.


Blowing hot and cold D


Peter Littlejohns, editor


UK £58 EU €92 US $119 RoW $120 UK £93 EU €144 US $190 RoW $191


For reprint, e-print and licensing enquiries Please contact: Media Licensing Co, The Grange, 3 Waverley Road, Farnham, Surrey, GU9 8BB. Tel: +44 203 773 9320 or email info@medialicensingco.com


Clinical Trials Insight / www.worldpharmaceuticals.net 3


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53