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European Biotechnology | Summer Edition | Vol I S S N 2 3 6 4 - 2 351 | A 6 0 711 | Interview Hospira’s Paul Greenland talks European about the launch Life Sciences and of the first mAb Industry Magazine biosimilar and the new challenges in Biotechnology Summer Edition 2015 | Volume 14 | 20 € development. Financing European biotech companies have added crowdinvesting to the fi nancing toolbox Nagoya Protocol Poor implementation of benefi t sharing could block Tracking biotech innovation in Europe Antibiotics New EU fi nancing instrument to close funding gap in high- stealthy risk antibiotic development EuroBioFairsCompass The unique guide to the top life killers sciences events in the second half of 2015 FREE EXCERPT Liquid Biopsy 4 CONTENTS European Biotechnology | Summer Edition | Vol. 14 | 2015 FREE EXCERPT COVER STORY INSIGHT EUROPE REGIONAL NEWS 6 European Commission opens 42 Northern Europe: fl oodgates for GM imports Sweden, Denmark, Finland, and Norway 10 First genome-edited crops to be stamped non-GMO by Member 44 Western Europe: States; Heard in Brussels France, Belgium, The Netherlands and the UK 12 European Commission and Euro- pean Investment Bank set to 46 Central Europe: launch new fi nancing instrument Austria, Germany and Switzerland for high-risk antibiotics develop- ment; Horizon2020 call focuses 48 Southern Europe: on personalised medicine; UK lags Italy, Spain, Portugal, Cyprus & Malta behind EU in fi ght against cancer; MEPs demand no dilution of EU life 50 Eastern Europe: sciences rules through TTIP Poland and the Czech Republic ECONOMY PICK & MIX 22 Interview: Paul Greenland, 51 Expert conference on Hospira Vice President of Biologics progress made in marine biodiscovery 14 25 Update on clinical trials SCIENCE & TECHNOLOGY 28 DIA Euromeeting defi nes upcoming Fishing malignancy challenges in healthcare: ATMPs, 56 Toxins for fi ghting cancer personalised meds, and biosimilars from the stream 57 Bioengineers take protein A hurdle 29 EMA News For over a century, oncologists have 58 3D cancer biobank screening struggled to understand how cancer 30 IPO update: EU companies go gives insights into drug resistance develops resistance to treatments. Now west, US biotech goes east; IP Flash novel ultrasensitive techniques that allow SERVICE them to track cancer mutations and cir- 31 Analyst commentary culating tumour cells in the bloodstream 82 Biopeople are raising hopes that testing could soon 32 Euro Biotech Stocks detect initial signs of tumour resistance 83 News from partner associations: and response to treatment, as well as reli- 34 Start-up stories: Swecure AB EBN; SBA; BIO Deutschland; DIA ably predict therapy outcomes. Though Stockholm & Gothenburg it’s early days yet, Life Sciences and Big 88 Events Pharma fi rms are partnering to validate 40 Interview: Ernesto Bertarelli, 89 New products; Company index liquid biopsy methods in clinical trials. Co-Chair, Bertarelli Foundation 90 Encore IMPRINT European Biotechnology (ISSN 2364-2351) is published quarterly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, Email: [email protected], Internet: www.eurobiotechnews.eu; Publisher: Andreas Mietzsch, Editorial Team: Thomas Gabrielczyk (Editor in Chief), Derrick Williams (Co- editor), Uta Mommert, Dr Martin Laqua, Julie Colthorpe, Dr Bernd Kaltwaßer; Advertising: Oliver Schnell, +49-30-2649-2145, Christian Böhm, +49-30-2649-2149, Andreas Macht, +49- 30-2649-2154; Distribution: Marcus Laschke, +49-30-2649-2148; Printed at: H. Heenemann GmbH & Co. KG; Graphic Design: Michaela Reblin. European Biotechnology Life Sciences & Industry Magazine is only regularly available through subscription at BIOCOM AG. Annual subscription fees: € 80.00, Students € 40.00 (subject to proof of enrolment). Prices include VAT, postage & packaging. Ordered subscriptions can be cancelled within two weeks directly at BIOCOM AG. The subscription is initially valid for one year. Subscriptions will be renewed automatically for one more year, respectively, unless they are cancelled at least six weeks before the date of expiry. Failures of delivery which BIOCOM AG is not responsible for do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied and proliferated by electronic means without the prior written consent of the pub- lisher. Supplements: EBD Group, BIOCOM AG/DECHEMA. Cover Photo: © kikkerdirk, fotoliaxrender, vege/fotolia.com. ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany. European Biotechnology | Summer Edition | Vol. 14 | 2015 CONTENTS 5 FREE EXCERPT FINANCE BIODIVERSITY EDITORIAL Fundraising with The challenges Innovation has always challenged soci- schools, not sharks ety and law – and vice versa. The lat- est and most ambiguous case has In the past several months, Life Sciences been the intervention in human germ companies all over Europe have suc- lines with genome editing. In May, EU cessfully capitalised on crowdinvesting and US policymakers underscored the schemes. EURO BIOTECH introduces the importance of upholding the current most relevant campaigns and summa- ban (see p. 3) after Chinese research- rises the prevailing business models of ers revealed failed testing in the area high-fl ying platforms. on non-viable embryos. But what if it had worked? Is a ban acceptable if you could save an embryo with a le- thal gene defect? Other modern quan- daries are being posed by biotech 52 breeds derived from techniques so new that they’re not covered by cur- rent EU law (p. 10). Balancing out the Limits are easier to set in emerging fi elds like liquid biopsy, where blood Nagoya Protocol could soon tell us which cancer thera- pies are most appropriate (see p. 14). The EU’s regulation for the implementa- EURO BIOTECH asked industry leaders tion of the Nagoya Protocol is seeking about the best ways to validate the ap- to establish a clear access and benefi t- proach. They told us implementation sharing regime, but scientists and indus- was key – just like their counterparts in 36 try leaders are highly concerned about the area of biodiversity legislation, certainty and clarity. where the Nagoya Protocol is set to take effect (p. 52). Fortunately, there are plenty of areas where society can still count on re- turns from innovation, and innovators SPECIAL on plenty of reinvestment (p. 12, 36). Making innovation perceptible to society is crucial to maintaining a EU Event Compass viable life sciences sector in Europe. 61 Navigating conferences And only that acceptance will help us 62 Nordic Life Science Days, Stockholm strike the right balance between regu- 64 4th Conf. on CO as Feedstock for lation and scientifi c freedom. 2 Fuels, Chemistry, Polymers, Essen 66 European Biotech Week 68 BioJapan 2015, Yokohama 70 Bioinnovation, Gdansk 72 BIO-Europe, Munich 74 DIA Europ. Biosimilar Conf., London 76 PharmaLab Congress, Neuss 78 3rd International mRNA Health Conference, Berlin Thomas 80 EuroPLX Pharma Partnering Gabrielczyk Conference, Athens Editor-in-Chief 10 INSIGHT EUROPE European Biotechnology | Summer Edition | Vol. 14 | 2015 FREE EXCERPT No-GMO wave Heard in Brussels AGRIBIOTECH In 2012, the EU’s “New Nagoya – protecting resources with paperwork Techniques Working Group” (NTWG) submitted its fi nal report on novel biotech BRUSSELS European October and has to methods for genetic manipulation of crops Biotechnology Net- be implemented. to the European Commission. Its report in- work had the good And when I say im- vestigated if crops designed by novel tools fortune to moderate plemented, I mean such as genome editing or gene silenc- the 8th Berlin Confer- into all legal systems, ing, are GMOs that must be approved and ence on IP in Life Sci- and Europe has many safety assesed under EU law. However, ence, which this year more of those than until now, the Commission had not made had a focus on nat- a simple headcount a political decision on the matter. The US ural products. “That of countries. Spain is company Cibus has now created prece- will be interesting,” my favourite example, dents. In Germany it has already received I thought to myself, where Nagoya will be deregulated status for its herbicide-toler- thinking about the implemented by each ant “SU canola” from the federal authori- world of complex of the 17 autonomous ty BVL. This means, that Cibus can imme- structures and chal- communities. So, sam- diately plant and market its crop without lenging development CLAIRE SKENTELBERY pling natural resourc- any need to label it as a GMO. The com- pathways. “Interest- Secretary General of the Euro- es in Spain (including pany has also fi led for deregulated state in ing” soon paled into pean Biotechnology Network those found in marine Spain, Sweden, Finland, Ireland and the insignifi cance as I fell ecosystems) could in- UK in order to safe up to US$15m for an headlong into the tiger trap that is the volve discussions with ALL the regions in EU GMO approval. In March, the German Nagoya Protocol, coming soon folks to which your bacteria, nematode or plant Agriculture Ministry rejected objections a country near you. can be cultivated, and that is a lot of pa- by anti-GMO campaigners from Testbio- For those of you uninitiated in such perwork in a wide variety of dialects. tech who claimed Cibus method was GM. matters, the Nagoya Protocol is a global Europe is woefully underprepared If other regulators follow the German ex- programme with the extremely relevant for the level of stringency required by ample, a wave of genetically engineered intention to regulate access to genetic re- Nagoya, most countries aren’t ready for “no-GMOs” are set to enter the bloc. sources and ensure the sharing of bene- October because they didn’t pay atten- fi ts arising from their utilisation.
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