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In My View What Is the Fastest Route to a COVID-19

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In My View What Is the Fastest Route to a COVID-19 APRIL 2020 # 64 Upfront In My View NextGen Sitting Down With Tackling cancer with the What is the fastest route to a Overcoming viral vector Pharma forensic, human microbiome COVID-19 vaccine? challenges Stephen Tindal 07 10 – 11 40 – 42 50 – 51 www.themedicinemaker.com | Your molecule Our mission Drug substance | Drug product| Analytical services Discover why we’re the small molecule company, with end-to-end capabilities and experts you’ll enjoy working with. Valeska Taylor QC Analyst www.cambrex.com Fragile Pharma? As individuals, societies, industries, and governments, Editorial we must consider how well prepared we were for this pandemic – and start thinking about the next one f you are lucky enough to have avoided the more direct and devastating effects of COVID-19, a “lockdown” may feel almost peaceful – a time for quiet reflection. The one Iword that comes to my mind when mulling the upheaval caused by the global pandemic is “fragility.” In the modern age of online shopping (next – or even same – day deliveries!), how many of us have considered the need for an emergency stash? A lack of a replaceable food staple is one thing – but what if we can’t source medication for a chronic illness? What action do we take when the shelves run truly dry? Globalized supply chains certainly result in reduced prices in developed nations, but what happens when we can no longer import food or medicines? When such support systems start to unravel, the costs will be heavy – and there are no easy answers. Times like these remind us that risk isn’t an abstract concept – life- changing events evidently do happen in our lifetime. Viral outbreaks are not just an overused movie plot. Could we all have been better prepared? This is a question individuals, governments, and industries alike must face. The funding of (rapid) vaccine development is one area that will likely come under increasing scrutiny. Though we can only commend the scientists and engineers Reference involved in vaccine development for their hard work now and 1. AC Kalil, “Treating COVID-19 the foreseeable future, the endeavor is reliant on government – off-Label Drug Use, Compassionate Use, funding – as Eric von Hofe points out on page 10. He doubts that and Randomized Clinical Trials During money is currently in short supply, but does believe that developers Pandemics” (2020). Available at could be in a healthier position now, if they had received higher https://bit.ly/3bG8HZv. levels of funding in previous outbreaks. Similarly, Andre Kalil, 2. Time, “COVID-19 Vaccine Shipped, a professor of infectious diseases at the University of Nebraska and Drug Trials Start” (2020). Medical Center, argued that new therapies were not discovered Available at https://bit.ly/2JscaPd. during the Ebola outbreak because of a lack of randomized controlled trials (1). Kalil also highlights the unprecedented speed – “from concept to implementation in just a few weeks” – with which trials have been rolled out. The same could be said of Moderna’s SARS-CoV-2 vaccine, shipped for trials just 42 days after the genetic sequence was released (2). There may have been missed opportunities with previous outbreaks, but the pace of movement does suggest that some lessons were learned – perhaps pharma isn’t so fragile. Sadly, it sometimes takes a crisis to reveal where the cracks are. And the bigger the crisis, the more cracks we find. James Strachan Deputy Editor www.themedicinemaker.com Contents 36 03 Editorial Upfront In My View Fragile Pharma? by James Strachan 06 The latest news, views 10 Eric von Hofe believes that the and research – including a drug fastest route to a COVID-19 combination to mend broken vaccine is through synthetic On The Cover Cover bones faster, a stem cell cure for solutions HIV, and why the EMA is Celebrating the most influential offering free scientific advice for 11 China provides enormous people in the pharma industry companies working on opportunities, but companies COVID-19 treatments must keep track of the and vaccines “regulatory rapids,” says Matthias Bucerius ISSUE 64 - APRIL 2020 Feel free to contact any one of us: [email protected] Content Team Editor - Stephanie Sutton Kirstie Anderson (Commercial Editor) James Strachan (Deputy Editor) Maryam Mahdi (Associate Editor) Commercial Team Associate Publisher - Helen Conygham Helen Johnson (Business Development Manager) Sarah Griffith (Business Development Manager, North America) Kevin Vlad (Business Development Executive, North America) Design Team Head of Design - Marc Bird Hannah Ennis (Senior Designer) Charlotte Brittain (Designer) 08 Digital Team Digital Team Lead - David Roberts Peter Bartley (Digital Producer Web/Email) Abygail Bradley (Digital Producer Web/App) Audience Team Audience Growth Strategy Manager Feature Reports – Brice Agamemnon CRM & Compliance CRM & Compliance Manager - Tracey Nicholls 16 The Power List 2020 14 The Rise of Liquid Hayley Atiz (CRM Assistant) We celebrate the finest Nanoparticles Commercial Support Team Internal Systems Manager - Jody Fryett medicine makers in the Dan Marr (Campaign Reporting Analyst), industry across three categories: 49 The Glass Quality You Seek Jennifer Bradley (Production Assistant), Lindsey Vickers (Project Manager - Webinars) Biopharmaceuticals, Advanced Does Exist Events Team Medicine, and Small Molecules Events Manager - Alice Daniels-Wright Jess Lines (Events Coordinator) Marketing Team Marketing Manager - Katy Pearson Sitting Down With Jo Baylay (Marketing Executive) Kevin O'Donnell (Marketing & Events Executive) NextGen Matt Everett (Social Media Manager) 50 Stephen Tindal, Director, Joe Box (Social Media and Marketing Assistant) 36 Fast-Farming Pharma Science & Technology, Catalent Accounts Team Kerri Benson (Accounts Assistant) Find out why one company is Pharma Solutions, Swindon Emily Scragg (Accounts Apprentice) using plants to accelerate the Human Resources manufacture and scale up of Human Resource Manager - Tara Higby new vaccines Management Team Chief Executive Officer - Andy Davies Chief Operating Officer- Tracey Peers Senior Vice President (North America) 40 Advanced Medicine: - Fedra Pavlou Replicating the mAb Financial Director - Phil Dale Commercial Director - Richard Hodson Success Story Content Director - Rich Whitworth What lessons has the industry learned from monoclonal Change of address [email protected] antibodies and how can these Hayley Atiz, The Medicine Maker, Texere Publishing Limited, be applied to cell and gene Booths Park 1, Chelford Road, Knutsford, Cheshire, WA16 8GS, UK General enquiries therapies? www.texerepublishing.com | [email protected] +44 (0) 1565 745 200 | [email protected] Distribution: The Medicine Maker (ISSN 2055-8201), 44 The Bumpy Road to a is published monthly by Texere Publishing Limited, Booths Park 1, Chelford Road, Knutsford, Cheshire, WA16 8GS, Cytomegalovirus Vaccine UK. Single copy sales £15 (plus postage, cost available on request [email protected]). Non-qualified annual Cytomegalovirus infects most subscription cost is £110 plus postage people during their lifetime, but Reprints & Permissions – [email protected] The opinions presented within this publication are those of the authors it’s taken decades for vaccines to and do not reflect the opinions of The Medicine Maker or its publishers, Texere Publishing. Authors are required to disclose any relevant be developed – and there is still 50 financial arrangements, which are presented at the end of each article, where relevant. © 2020 Texere Publishing Limited. All rights room for improvement reserved. Reproduction in whole or in parts is prohibited. 6 Upfront SPECIAL SERIES Advanced Medicine Upfront Research Trends Hot Topics at Innovation CAR-TCR 2020 Clinical trial confusion, off- the-shelf cell therapy, 24-hour CAR-T, and more In what may have been one of the last advanced therapy meetings to go ahead for some time, delegates met in London in late February for CAR-TCR. A central theme was the difficulty of conducting clinical trials in Europe compared with the US and China. Dolores Schendel, Medigene, pulled no punches during the first panel discussion of the event, telling the audience that Medigene needed nine academic centers The concerns were reflected in the be to supply the cells needed for such – not the expected three – for a “small figures presented by Pippa Gledhil therapies... phase I trial” in Germany, as well as a from Beacon Intel (see our infographic Elsewhere, Omar Ali, Visiting “crackerjack” team of lawyers. Schendel below) who reported that there were Lecturer at the University of suggested that the German situation was more than five times as many CAR- Portsmouth and Former Adviser to a microcosm for the whole of Europe, as TCR developers in China and the US NICE, spoke about the growth of different apheresis sites in Germany are compared with Europe. innovative reimbursement payment regulated by the different states. In terms of other hot topics at the models. Here, according to Ali, it is the Andre Choulika, CEO of Cellectis, also conference, off-the-shelf cell therapy was US that is falling behind because, even compared the experience of filing a patent certainly one – Choulika claimed that if insurers can get their heads around in the US to France. “On the US side you 2020 will be the “year of the allogeneic” the price, there is ambiguity over who had, like, 10 questions. On the French – as well as TCRs for solid tumors and pays when hospitals need more money
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