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Looking out for Children NOVEMBER 2014 # 03 Upfront Best Practice NextGen Sitting Down With Welcome to drug How to uncork biopharma Electrochemical acceleration William Chin, PhRMA development in space bottlenecks with gusto of pharma R&D Executive Vice President 10 32 – 34 42 – 44 50 – 51 Looking Out For Children Kids have the right to safe, effective medicines. Jenny Walsh explains how drug makers can meet the needs of their smallest customers. 20 – 26 Most Compact QbD-driven Process Development with the DASbox® Mini Bioreactor System With working volumes of 60 to 250 mL > Parallel set-up of 4, 8, 12 or more the DASbox is the optimal tool for bioreactors advanced cell culture and microbial > Perfectly suited for microbial and cell process development and Design of culture applications Experiments (DoE) applications. > Liquid-free exhaust condensation All critical parameters can be precisely > Fully mass fl ow-controlled gas controlled. www.eppendorf.com Eppendorf® and the Eppendorf logo® are registered trademarks of Eppendorf AG, Hamburg, Germany. DASGIP® and DASbox® are registered trademarks of DASGIP Information and Process Technology GmbH, Juelich, Germany. All rights reserved, including graphics and images. Copyright ©2014 by Eppendorf AG. tmm_epp_ad_210x266_2014_12.indd 1 17.11.14 13:37 Online this Month Making European Regulations Work A report released by Escher’s TI Pharma platform claims that the European regulatory system for medicines can be used in a more “efficient and effective manner.” At a first glance it may seem as if the report is damning the system but that certainly isn’t the case. Read our summary online to find out what issues were identified. Read it online: tas.txp.to/0314/euroregs A New Approach to MRSA Supercomputers to the Rescue We report on the first endolysin registered for human use against methicillin- On page 35, Catherine Akers examines resistant Staphylococcus aureus (MRSA) on page 12. Online, we bring you an the challenges of adverse drug events interview with a clinical microbiologist, Bjorn Herpers, so that you can find for biologic medicines. On our website out more about phage endolysins and why some people believe that they are a you can read about the efforts of promising new strategy in the fight against drug-resistant bacteria. researchers to tackle side effects much Read it online: tas.txp.to/0314/mrsa earlier in the drug development process. Looking for ways to ‘red flag’ candidate drugs for serious side effects, a team from Lawrence Livermore National Laboratory has used supercomputers to link proteins to side effects. Read it online: tas.txp.to/0314/supercomp Contents 35 50 In My View 10 16 Carsten Brockmeyer considers opportunity in an expanding biosimilars market 17 How can we predict the true cost 03 Online This Month Upfront of drug development? Ayman Chit believes he has the answer 10 The Final Frontier? 07 Editorial 18 Steve Thomas shares the joys of a Big Bad Pharma? 11 Access All Areas knowledge repository that never by Charlotte Barker forgets, retires or leaves the company 12 Battle of the Superbugs 08 Contributors 12 Care to ‘Patent Dance?’ Feature 13 Regulators Target Ebola On The Cover 20 What About the Kids? NOVEMBER 2014 # 03 14 Dosing to Circadian Rhythm For a long time, the needs of Upfront Best Practice NextGen Sitting Down With Welcome to drug How to uncork biopharma Electrochemical acceleration William Chin, PhRMA development in space bottlenecks with gusto of pharma R&D Executive Vice President 10 32 42 – 44 50 – 51 “Look out – children ahead!” children were neglected in drug Looking Out For Children Kids have the right to safe, effective medicines. Jenny Walsh explains how drug makers can meet the needs of their smallest – and most vulnerable – customers.? 20 – 26 – we explore the world of pediatric development - are things finally drug development. looking up for our most vulnerable patients? ISSUE 03 - NOVEMBER 2014 Editor - Charlotte Barker [email protected] 12 Associate Editorial Director - Rich Whitworth [email protected] Associate Editor - Stephanie Sutton [email protected] Associate Editor - Roisin McGuigan [email protected] Associate Editor - Michael Schubert [email protected] Senior Designer - Marc Bird [email protected] Chief Executive Officer - Andy Davies [email protected] Chief Operating Officer - Tracey Peers [email protected] Publisher - Richard Hodson [email protected] Audience Development Manager - Tracey Nicholls [email protected] Digital Content Manager - David Roberts [email protected] Traffic and Administration Manager -Claire Lally NextGen [email protected] 42 Electrifying R&D Acceleration: Mac Operator Web/Print - Peter Bartley [email protected] Mark Taylor and Susana Da Report Silva Torres tell us why they are Social Media / Analytics - Stephen Mayers electrochemistry converts. [email protected] 28 The Medicine Maker × Catalent Applied Drug Delivery Institute Connecting the Dots in Published by Texere Publishing Limited, Booths Hall, Drug Delivery Profession Booths Park, Chelford Road, Knutsford, Cheshire, WA16 8GS, UK 48 Our Unholy Alliance: Science and business - tenacious partners Best Practice in a shaky marriage or eternally General enquiries: www.texerepublishing.com bound non-identical twins? [email protected] 32 Pass Me a Bottle Opener: +44 (0) 1565 752883 Downstream processing has [email protected] become the biopharma bottleneck. Can we get things moving again? Sitting Down With Distribution: 35 Safety First - Sizing Up Biologics 50 William Chin, Executive Vice The Medicine Maker is distributed worldwide through 17,000 printed copies to a targeted Side Effects: Catherine Akers President, Scientific and European and North American mailing list of explores the pitfalls of post- Regulatory Affairs, industry professionals and 60,150 electronic copies worldwide. marketing surveillance for Pharmaceutical Research and ISSN 2055-8201 biologic medicines. Manufacturers of America (PhRMA). Intelligence and user friendliness combined. Our latest rocking bioreactor system. The single-use ReadyToProcess WAVE™ 25 bioreactor system delivers reliable cell culture performance for working volumes up to 25 L. The intuitive UNICORN™ software, together with advanced sensors and intelligent control strategies, combine ease of use with accurate and stable control. upstream downstream single-use services In your quest for reliable and accurate cell culture performance, we are a partner like no other. GE works. www.gelifesciences.com/BioProcess GE and GE monogram are trademarks of General Electric Company. BioProcess, ReadyToProcess WAVE, and UNICORN are trademarks of General Electric Company or one of its subsidiaries. © 2014 General Electric Company – All rights reserved. First published Apr. 2014. GE Healthcare Bio-Sciences AB. Björkgatan 30, 751 84 Uppsala, Sweden Big Bad Pharma? Editorial The Ebola media frenzy has reminded the public how selfish our industry is. But, somehow, that doesn’t sound quite right... he ongoing Ebola outbreak seems to have highlighted the pharmaceutical industry’s continuing reputation problem. While some commentators have praised drug makers’ swift response (1), others have blamed companies Intelligence and user friendliness combined. for not developing a vaccine earlier, accusing them of putting profits Tahead of patients (2). Our latest rocking bioreactor system. Public opinion still puts pharma well below technology, retail and energy sectors (3), and the only healthcare field less trusted by patient The single-use ReadyToProcess WAVE™ 25 bioreactor system delivers advocacy groups are for-profit health insurers (4). Why are pharma reliable cell culture performance for working volumes up to 25 L. The intuitive companies – who manufacture life-saving drugs – so unpopular? UNICORN™ software, together with advanced sensors and intelligent control Certainly, a number of high-profile scandals, involving corruption, strategies, combine ease of use with accurate and stable control. cover-ups and dodgy deals, have seriously damaged the industry’s reputation. But perhaps the most pervasive criticism arises from the upstream downstream single-use services tension between profits and people, business and society. Specifically, In your quest for reliable and accurate cell culture performance, we are in the case of Ebola, newspaper columnists, academics and even the WHO have attacked the pharmaceutical industry for failing to devote a partner like no other. sufficient resources to finding a vaccine. GE works. However, for defenders of the industry, these accusations seem wide of the mark. Firstly, pharma companies have been conducting work in this area – both Johnson & Johnson and GlaxoSmithKline have vaccines under development, for example. Secondly, while Ebola is unquestionably a terrible disease, until now outbreaks have been small, affecting at most a few hundred people. Until this year, fewer people were dying of Ebola than seasonal flu. Meanwhile, diseases such as malaria, HIV/AIDs and TB kill millions every year. Even if pharma didn’t have to consider profits, is it really surprising that only a few References companies have chosen to focus on Ebola? 1. M. Matthews, “Since The Ebola Outbreak, I believe the majority of pharma industry employees are very aware Who‘s Bad-Mouthin‘
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