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Deep Biologic Exploration

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Deep Biologic Exploration FEBRUARY 2018 # 38 Upfront In My View Business Best Practice Does brand really matter Seeking efficacy answers Brexit: hoping for the best Join the crowdsourcing for pharma medicines? for inhalable drugs but planning for the worst revolution today! 13 18 – 19 34 – 39 42 – 45 Deep Biologic Exploration Experts discuss analytical advances that are easing biopharma characterization. 20 – 29 www.themedicinemaker.com Kelsey Kehrli Data Review Scientist PSG | Active ingredients Dynamic people Meet the experts you’ll enjoy working with and discover why we’re one of the biggest names in small molecule APIs. DCAT Week, March 19–22, Lotte NY Palace, New York CPhI North America, April 24–26, Booth 613, Philadelphia www.cambrex.com Custom development Generic APIs Controlled substances & manufacturing Online this Month Think Fast, Screen Faster Combinatorial chemistry and other procedures have produced large libraries of chemical compounds – the (re)activity of which needs to be assessed. High throughput screening (HTS) is already an important component of the drug discovery toolbox in that regard, but could it be better? Graham Cooks, Henry B. Hass Distinguished Professor of Analytical Chemistry at Purdue University, Indiana, USA, certainly thinks so. Read about Cooks’ work at http://tmm.txp.to/0218/Cooks Dengue Vaccine 101 In November 2017, Sanofi updated the product information about its Dengvaxia vaccine based on long-term data. Differences in vaccine performance were identified based on prior dengue infection; the vaccine was found to provide “persistent protective benefit against dengue fever” in those who had prior infection. Those who had not been previously infected by dengue virus may, in the longer term, experience more cases of severe disease upon dengue infection. Over 700,000 children in the Philippines were vaccinated with Dengvaxia in 2016, but the vaccination program was suspended after Sanofi’s announcement – and there are concerns in the Philippines that a small number of children may have died because of the vaccine. We examine the controversy on our website. Read more at http://tmm.txp.to/0218/Dengue www.themedicinemaker.comwwwwww.themeedic ISSUE 38 - FEBRUARY 2018 Contents Editor - Stephanie Sutton [email protected] Deputy Editor - James Strachan [email protected] Deputy Editor - Roisin Mcguigan [email protected] Content Director - Rich Whitworth 13 [email protected] Editorial Director - Fedra Pavlou [email protected] Publisher - Richard Hodson [email protected] Sales Manager - Helen Conyngham [email protected] Head of Design - Marc Bird [email protected] Junior Designer - Hannah Ennis [email protected] Digital Team Lead - David Roberts [email protected] Digital Producer Web/Email - Peter Bartley [email protected] Digital Producer Web/App - Abygail Bradley [email protected] Audience Insight Manager - Tracey Nicholls [email protected] Traffic & Audience Database Coordinator - Hayley Atiz [email protected] Traffic and Audience Associate- Lindsey Vickers [email protected] Traffic and Audience Manager - Jody Fryett [email protected] Social Media / Analytics Associate - Ben Holah [email protected] Events Manager - Alice Daniels-Wright [email protected] Marketing Manager - Katy Pearson [email protected] Financial Controller - Phil Dale [email protected] Accounts Assistant - Kerri Benson [email protected] Chief Executive Officer - Andy Davies [email protected] Chief Operating Officer - Tracey Peers [email protected] Change of address: [email protected] Hayley Atiz, The Medicine Maker, Texere Publishing Ltd, Haig House, Haig Road, Knutsford, Cheshire, WA16 8DX, UK General enquiries: www.texerepublishing.com [email protected] +44 (0) 1565 745200 03 Online This Month Upfront [email protected] Distribution: The Medicine Maker (ISSN 2055-8201), 10 A Goal in MiNDS and The Medicine Maker North America (ISSN 2514-7536), is published monthly by 09 Editorial Texere Publishing Ltd and is distributed in Are You Ready? 11 Trials of a Medicine Maker the US by UKP Worldwide, 3390 Rand Road, South Plainfield, NJ 07080 by James Strachan Periodicals postage paid at South Plainfield, NJ POSTMASTER: Send US address changes to 12 Business-in-Brief The Medicine Maker C/O 3390 Rand Road, South Plainfield NJ 07080. Single copy sales £15 (plus postage, cost available On The Cover Cover 13 What's in a (Brand) Name? on request [email protected]) Annual subscription for non-qualified recipients £110 FEBRUARY 2018 # 38 Upfront In My View Business Best Practice Diving deep below the 14 Cherchez la Femme? Does brand really matter Seeking efficacy answers Brexit: hoping for the best Join the crowdsourcing for pharma medicines? for inhalable drugs but planning for the worst revolution today! Reprints & Permissions – [email protected] 13 18 – 19 34 – 39 42 – 45 Deep Biologic Exploration The opinions presented within this publication are those of the authors Experts discuss analytical advances that are easing biopharma characterization. 20 – 29 surface of biomolecules with and do not reflect the opinions of The Medicine Maker or its publishers, Texere Publishing. Authors are required to disclose any relevant financial analytical technologies. 15 Innovation: Your Way arrangements, which are presented at the end of each article, where relevant. © 2018 Texere Publishing Limited. All rights reserved. www.themedicinemaker.com Reproduction in whole or in parts is prohibited. Our Commitment, The Industry Leading Experience PCI Pharma Services – a market leader for integrated drug development and commercialization The foundation of a successful partnership is trust. At PCI, we dedicate our unwavering commitment to provide the industry leading customer experience. This focus enables us to be a trusted partner to 19 of the top 20 pharmaceutical companies in the world. We earn trust by providing our clients flexibility and responsiveness, outstanding operational performance, and the support of uncompromising quality and regulatory standards. By this commitment we deliver our clients an end-to-end development and commercialization solution including drug development and scalable drug manufacturing, integrated clinical trial services, and commercial packaging services. We are trusted to support lifesaving medicines destined to over 100 countries around the world. We invite you to learn more about what the PCI commitment can do for the success of your business. pciservices.com © Copyright 2017 PCI Pharma Services. All Rights Reserved Also co-located with: Register 18-20 April 2018 for FREE! Big Sight Exhibition Center, JRWRFSKLFRP East Hall 1, 2 and 3 | Tokyo, Japan jp2018 Why you must attend CPhI Japan 2018 1 2 3 Meet the Japanese pharma %XVLQHVV0DWFKPDNLQJ &RQIHUHQFHUXQQLQJ industry under one roof and Programme throughout the exhibition ÀQGWKHODWHVWWHFKQRORJLHV DQGLQQRYDWLYHSURGXFWV Build partnerships and Unrivalled, free of charge understand the access to insight and Connect, network & interact market - the crucial VXFFHVV LQIRUPDWLRQRQWKHORFDOPDUNHW with 500+ exhibitors IDFWRUVLQWKH-DSDQHVH and its regulations via from 26 countries market government workshops held at the event. Organised by: Japan’s most comprehensive pharmaceutical exhibition gotocphi.com/jp2018 34 42 50 In My View Report 16 Pharma companies have 30 Getting on the Fast Track: many priorities to balance and Manufacturing Training for are increasingly looking for Cell Therapies innovation in software to help, says David Harty. 18 According to David Lewis, if we Business are to reach new highs with inhaled drugs then questions 34 Hold me Closer, UK Pharma around efficacy must be answered. Brexit negations are ongoing, but pharma companies remain concerned about supply chains. Feature 20 Deep Dive into Best Practice Biopharmaceutical Analysis Where would the industry be 42 A Problem Shared… without analytical science? Open innovation can secure a Experts give their view on better future for R&D because the challenges of biopharma strength is found in numbers. characterization and the opportunities for further 46 Fumigation: Choose Sitting Down With innovation. Your Weapon! A former site fumigation lead offers 50 Nigel Darby, Advisor, his tips and tricks for overhauling GE Healthcare Life your fumigation system. Sciences, Sweden. www.themedicinemaker.com CELEBRATING THREE YEARS OF HUMANITY IN SCIENCE The Humanity in Science Award recognizes and rewards scientific breakthroughs that aim to have a real impact on humankind’s health and wellbeing. 2015 2016 2017 Peter Seeberger & Andreas Seidel- Waseem Asghar, Assistant Professor Richard Jähnke, Global Pharma Morgenstern, Directors at two at Florida Atlantic University, Health Fund (GPHF), developed and collaborating Max Planck institutes developed flexible sensors for the rapid continuously improved GPHF Minilab in Germany, developed an innovative and cost-effective diagnosis of HIV – and – a “lab in a suitcase,” enabling resource process to manufacture the most effective other infectious diseases – in point-of- poor countries to rapidly identify drugs to treat malaria from plant waste care settings.
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