ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data...

13
Life Sciences and Industry Magazine Autumn Edition 2016 | Volume 15 | 20 € ISSN 2364-2351 | A 60711 | Exosomes Nanovesicles take personalised medicine to the next level Longevity Endogenous biomarker points to an increased life expectancy Bioeconomy Can carbon dioxide emissions act as a feedstock for industry? CROs & CMOs Specialists and generalists in the expanding outsourcing market Sepsis The race against time Interview EMA‘s Senior Medical Officer Hans-Georg Eichler talks about the agency’s Adaptive Pathways pilot programme. FREE EXCERPT

Transcript of ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data...

Page 1: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

Life Sciences and Industry Magazine

Autumn Edition 2016 | Volume 15 | 20 €

ISSN 2364-2351 | A 60711 |

ExosomesNanovesicles take personalised medicine to the next level

LongevityEndogenous biomarker points to an increased life expectancy

BioeconomyCan carbon dioxide emissions act as a feedstock for industry?

CROs & CMOsSpecialists and generalists in the expanding outsourcing market

SepsisThe race against time

InterviewEMA‘s Senior Medical Officer Hans-Georg Eichler talks about the agency’s Adaptive Pathways pilot programme.

FREE EXCERPT

Page 2: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

45%

Register for a webinar and fi nd out more at www.healthindustries.sa.gov.au/trials

cashbackfor clinical trials

in AdelaideForty-� ve per cent of R&D costs will be reimbursed in

cash to eligible companies with an aggregated annual

turnover of less than A$20 million (approx. US$15 million).

Costs covered include clinical trials, analytics, study drug

manufacture, and other R&D. Adelaide also delivers clinical

trials ethics approval in an average of just six weeks, saving

six to nine months compared to trials in the US or Europe.

Page 3: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

4

Regional news

68 Northern Europe: Sweden, Denmark, Finland and Norway

70 Western Europe: France, Belgium, The Netherlands and the UK 72 Central Europe: Germany, Switzerland and Austria

76 Southern Europe: Italy, Spain, Portugal and Slovenia

78 Eastern Europe: Hungary, Poland, Czech Republic, Estonia and Slovakia

science & technology

86 Mortal span: study on centenarians links microcirculation biomarker to longevity

88 Swedish researchers identify inflammation switch; Making marine plastics a biofuel resource; Using autoantibodies to target autoimmune diseases; How calorie restriction can improve DNA repair

seRvice

44 Biopeople

91 News from partner associations: SBA, BIO Deutschland, DIA, EBN

96 Events97 Company index/Product98 Encore

European Biotechnology | Autumn Edition | Vol. 15 | 2016CONTENTS

insight euRope

6 Pesticide and biocide producers scrutinise laws drafted by the European Commission to ban harmful endocrine disruptors from EU markets

8 EMA tables new pharmaco­vigilance rules for biologics; GM soy flooding into the EU; Experts call for more international bio­ecomy collaboration

10 Adaptive Pathways: EMA faces criticism of HTA organisations after publication of final report

12 Experts recommend automatically interchanging originators with biosimilars; Heard in Brussels: Into the Brexshit

economy

23 EMA News

24 Cancer immune therapies: Novartis spins out CAR-T cell business; IP Flash

25 Update on clinical trials

28 Interview: Hans­Georg Eichler, European Medicines Agency, London, on Adaptive Pathways

33 Analyst commentary

34 Euro Biotech Stocks

36 Start­up story: Glycemicon AG, Brugg, Switzerland

Sepsis: Targeting a silent killer

coveR stoRy

For over three decades, attempts among drug developers to target the inflamma­tory pathways and symptoms of sepsis have been fruitless. New rapid diagnos­tics, rigourous patient stratification and drugs with novel modes of action are now on the horizon for treating the most costly cause of death in the industrial­ised world. Biotechs are pushing new ideas towards clinical testing, but there just isn’t enough funding available in the EU. Will US investors again pick up European innovation on the cheap?

IMPRINT European Biotechnology (ISSN 2364­2351) is published quarterly by: BIOCOM AG, Lützowstr. 33–36, D­10785 Berlin, Germany, Tel.: +49­30­264921­0, Fax: +49­30­264921­11, 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, Sascha Karberg; 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; Graphic Design: Michaela Reblin; Production editor: Benjamin Röbig; Printed at: Königsdruck, Berlin; 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 pre­paid 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 publisher. Cover Photo: © YinYang/istockphoto.com. ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

14

Pict

ure:

Yin

Yang

/ist

ockp

hoto

.com

FREE EXCERPT

Page 4: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

5

BiosimilaRs

Extracellular vesicles: Better than stem cells?Disregarded for decades, exosomes are now understood to be a key element in communication between cells. Discov­eries around the nano­sized bubbles are revolutionising not only the field of diagnostics. With their ability to mimic stem cells, EVs could also help open the doors to novel therapeutic concepts.

European Biotechnology | Autumn Edition | Vol. 15 | 2016 CONTENTS

editoRial

What is reality? Anonymised real-world data that com-plement data from randomised clinical trails (RCTs) can help companies in-vestigate how their medicines are be-ing used in clinical practice. Boehring-er Ingelheim used them in a post-mar-keting study on patients who receive its blood thinner Pradaxa (dabigatran) antidote Praxbind (idarucizumab). While at the end of August, Takeda started the ever-largest observational study (5,000 patients) to track patterns in disease presentation, patient charac-teristics, treatment and outcomes in patients with multiple myeloma.

The correlations found are aimed at informing treatment decisions, select-ing appropriate patient groups, and evaluating patient benefit. The regula-tory consequence of this switch to Big Data collection from medical records, however, may end in a mix of costly RCTs and real-world data in the drug authorisation process (see p. 28).Real-world data could also inform pa-tient stratification in developing new therapies for sepsis, the world's most costly medical complication (see p. 14). And data collected by companies is even helping to establish links be-tween genes, habits and longevity (see p. 86). There's still a major open ques-tion, though. Will data-driven correla-tion sciences – and thus computers – one day be able to describe biological reality, and complement experience-driven medical know-how?

Thomas Gabrielczyk

Editor­in­Chief

economy

The CO2 opportunityAlthough most people still view car­bon dioxide (CO2) as a climate killer, industry is beginning to realise that CO2 could actually provide an abundant, low­cost feedstock for carbon­based processes. A number of Carbon Capture and Utilisation (CCU) schemes are evaluating the many different pathways that could play a role in the field in the future.

SPECIAL

80

Pict

ures

: Qia

gen

(top)

, Pho

toba

nk/f

otol

ia.c

om (m

iddl

e), c

assis

/fot

olia

.com

(bot

tom

)

38

CMOs & CROs47 Intro: Damned to outsource50 Update for production in Pichia52 Ethics approval in just six weeks in

Adelaide56 CHOvolution – an innovative

development platform58 The future of the biotech

outsourcing market60 Preventing resistance sequences

in AAV vector systems62 User-centred solutions for optimis-

ing clinical trials management66 The many faces of fucose

FREE EXCERPT

Page 5: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

12 European Biotechnology | Autumn Edition | Vol. 15 | 2016

Pict

ure:

EBN

InsIght EuropE

Heard in BrusselsIn the Brexshit

Brussels Well, those bloody idiots in the UK managed to do it – talk themselves from decades of hysteria about straight bananas (entirely fabricated by one B Johnson during his time as a journal-ist in Brussels) into ac-tually voting to leave. The UK can now be-stride the world once more, free from the shackles of EU tyran-ny, ready to reassume the economic, social and moral magnifi-cence of its colonial heyday. Look out Zimbabwe, hope you kept all those Rho-desia passports and hey US, they are expecting you back in the same condi-tion in which they left you. Form an or-derly queue.

Imbeciles

Of course this is great for science, as Brit-ain was ACE at that – no need for any kind of plan there. As I was repeated-ly told by Brexit campaigners, science and scientific collaboration just happen, they don’t need any kind of funding and common framework to help it along. The UK certainly doesn’t need any ex-perts, as the whole country was told by the Justice Secretary Michael Gove – so all those pesky Nobel prize winners who said Brexit was a stupid idea can just go back to looking pretty in a lab coat.

Knuckleheads

The UK currently has a strong sector, but for how much longer, given its 1.7% GDP spent on R&D (OECD) is lower than the EU average, bottom of the G7 and far be-hind Germany’s 2.8%? EU funding and

collaboration is a vi-tal part of that – espe-cially for UK universi-ties, which dominate EU programmes, and the UK will be walk-ing away from that if freedom of move-ment is compromised. Once you weaken the innovation base, the industry that grows from it will follow, and it is not just about the money, it is about col-laboration and abili-ty to lead internation-al research. The UK

will be unable to attract great scientists if their career path is limited, regardless of domestic funding levels.

he impact on UK science has already started. Scientists for EU has record-ed more than 40 cases of UK univer-sity researchers being asked to leave project consortia for H2020 deadlines after June 23, and we can expect a big drop in UK presence in projects, par-ticularly as coordinators. In big compa-nies, planned posts are being relocated into the wider EU, while scientists from mainland Europe are declining job of-fers. The EMA will pack its bags in Lon-don and take with it the skilled com-mercial regulatory community that has grown up around it, while the planned EU patent court won’t even start. Final-ly, structural funds to help regions de-velop better scientific capability are al-ready on hold, even before Article 50 is triggered. Suck it up Wales – you get what you voted for.

National excellence is an internation-al game, especially in science. Being proudly independent/insanely delud-ed (delete as applicable) comes with a price and the UK does not have the cur-rency to pay the bill.

Claire skentelBery Secretary General of the Euro-pean Biotechnology Network

Signal from Australia Biosimilar suBstitution In Europe, the Finnish, german, Dutch and Irish Medicines Agencies have clearly taken a stance on the interchangeability of bio­similars under supervision of physicians when well­documented. however, nei­ther a member state agency nor the Euro­pean Medicines Agency (EMA) itself has ever backed automatic subsitution at the pharmacy level. Although “the theoreti­cal basis for adverse effects is weak”, ac­cording to niklas Ekman from the Finn­ish Medicines Agency (FIMEA), and albeit “clinical crossover studies conducted [so far] have given no evidence of adverse effects due to a switch from a reference product to a biosimilar”, Europeans tend to be cautious.

Discussions on the topic at the interna­tional level are now set to be revivified by a recent decision of Australia’s phar­maceutical Benefits Advisory Committee (PBAC). In August, one month after the therapeutic goods Administation (tgA)granted market authorisation to samsung Bioepis’ biosimilar Brenzys (etanercept), the experts gave pharmacists the authori­ty to substitute the copycat biologic (mar­keted by Merck & Co) for its reference product, Enbrel (etanercept), marketed by Amgen and Pfizer.

The PBAC said Brenzys “could be marked as equivalent” to Enbrel on the Australian Pharmaceutical Benefits scheme (pBs), allowing the biosimilar tnF inhibitor’s substitution to treat all in­dications for which both drugs are ap­proved: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and non­radiographic axial spondyloar­thritis. PBAC noted that a prescriber may choose to not permit substitution of the biosimilar.

the biosimilar was first approved in south Korea while Eu authorisation for “Benepali“ was given by the EMA this February.

FREE EXCERPT

Page 6: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)
Page 7: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

15

Pict

ures

: Dr_

Kate

ryna

/fot

olia

.com

(lef

t); Je

na U

nive

rsity

Hos

pita

l (rig

ht)

SepSiSeuropean Biotechnology | Autumn edition | Vol. 15 | 2016

tient outcomes (see graphic p. 16, table p. 18). That’s why doctors at iCUs focus on stopping the consequences of sepsis. Standard of care includes:

surgical removal of the centre of in-››

fectionantimicrobial/antibiotic therapy››

stabilisation of blood pressure, circula-››

tion and organ perfusionsupport of organ function.››

New tests and biomarkers for early diagnosis

But there is some reason for optimism, according to Konrad Reinhart, the found-ing president of the Global Sepsis Alli-ance and author of 800 scientific papers on the subject. He believes that at least a quarter of all sepsis deaths in the in-dustrialised world are preventable if sep-sis can only be diagnosed and treated earlier or prevented. “Sepsis is the most common preventable cause of death,” he told Euro pEan BiotEchnology. “eve-ry hour sepsis is not diagnosed increas-es the probability it will kill the patient by 2%. Recognising the early signs of sepsis is therefore crucial. Sepsis is an emergen-cy situation: the faster you act, the bet-ter the chance for a good outcome.” Ac-cording to the expert, there are now tests on the horizon that could identify the un-derlying (mostly bacterial) infection and pathogen within 2-6 hours. Today’s gold standard – aerobic and anaerobic blood culture followed by bacterial culture for…

›› Read the full story in the printed issue.

When he was born in 1947, nobody could have predicted that the baby born Cassius Clay

would become a three-time boxing world heavyweight champion who would win 56 out of 61 matchups, with 37 knock-outs. Last spring, Muhammed Ali – a.k.a. “The Greatest” – lost his final fight. The 74-year-old champion, who suffered from parkinson’s disease in later life, died of septic shock at a hospital in the south-western US city of phoenix.

Sepsis is a life-threatening condition that arises when the body’s response to an in-fection injures its own tissues and organs. it occurs when the body’s local response to an invasion and microbial toxins – in Ali’s case a respiratory infection – expands to the entire body. The condition is a ruth-less, silent killer. Somewhere in the world, someone dies of it around every four sec-onds. in the nations of the South, collat-eral damage caused by the systemic in-fection is greatest. every year, six million babies and 100,000 mothers from the poorest part of the world die from sep-sis, in the throes of symptoms that include uncontrolled inflammation, vascular leak-age, severe hypo tension, organ damage and shock. it’s the most common cause of death by infection there. But even in countries with well-equipped iCUs such as the US, about 260,000 of the 1.1 mil-lion patients who are diagnosed with sep-sis each year die. With annual costs es-timated at US$24bn in 2013 – US$3.4bn more that two years before – sepsis thera-py and post-treatment eat up a whopping 7% of the US healthcare budget. in eu-rope, which counts 1.2 million sepsis in-

fections each year, the situation is no bet-ter. Around 40% of all iCU patients die from the amok immune response.

Due to its complex etiology, there is still not a single drug approved for mar-ket that could stop the condition’s inex-orable march. Since the 1980s, drug de-velopers have carried out more than 60 late-stage clinical trails with sepsis drugs that target the molecules triggering host response, but most failed to improve pa-

? What measure is most key in your opinion to prevent deaths

from sepsis?

! Time. Every hour it remains undiagnosed increases the prob-

ability it will kill a patient. So the faster you act, the more probable a good outcome. Currently, there is a range of diagnostic biomarkers in clinical development that could trig-ger a revolution in treatment by ac-celerating pathogen detection and diagnosis of sepsis and organ failure.

KonRad ReinhaRt Founding President, Global Sepsis alliance

Fooling a silent killerSepSiS Although policymakers have grown loud about antibiotic resistance – which current-

ly kills about 80,000 people per year globally – they mostly ignore sepsis, which claims ten times

as many lives. Despite a significant lack of funding for clinical validation, a new generation of di-

agnostics and therapeutics is in the pipeline that promises targeted patient selection and better

outcomes within the next five years.

FREE EXCERPT

Page 8: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

Das Life Science-Geschäft von Merck verfügt über:• Ein erweitertes globales Netzwerk, das mehr als 66 Länder einschließt• Eine erstklassige E-Commerce-Plattform für unkomplizierte Bestellungen• Ein großes Portfolio mit mehr als 300.000 ProduktenMit vereinten Kräften werden wir Wissen und Know-how und beste Ressourcen bereitstellen.

Weitere Informationen unter merckgroup.com/life-science

EXPERTElife science-

Die führenden Life Science-UnternehmenMerck Millipore + Sigma-Aldrichhaben sich zusammengeschlossen, undmit unserer führenden E-Commerce-Plattform und unserem weltweitenVertriebsnetz können wir auch IhrBusiness vereinfachen – damit Sie sichIhrer Aufgabe widmen können,die größten Herausforderungenvon Life Science zu meistern.

und E-Commerce-Marktführer

Merck, Merck Millipore, MilliporeSigma und das bunte M sind Marken der Merck KGaA und ihrer Tochterunternehmen.Sigma-Aldrich ist eine Marke der Sigma-Aldrich Co. LLC und ihrer Tochterunternehmen.Copyright © 2016 Merck KGaA. Alle Rechte vorbehalten.

Der Life Science-Geschäftszweig von Merck tritt in den USA und Kanada als MilliporeSigma auf.

CORP-16-12679_IntegrationAd_A-Merck_210mm x 297mm_GERMAN.indd 1 5/17/16 9:02 AM

Page 9: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

38 European Biotechnology | Autumn Edition | Vol. 15 | 2016BioEconomy

Pict

ure:

Pho

toba

nk/f

otol

ia.c

om

Climate danger – and opportunityCarbon Capture and utilisation Perceptions of CO2 have undergone a remarkable change

in the past few years. Although most people still view the gas as a climate killer, Carbon Capture

and Storage (CCS) recently began to appear to provide viable options for disposal. Now industry

is beginning to realise that CO2 could provide an abundant, low-cost feedstock for carbon-based

processes as well. A number of Carbon Capture and Utilisation (CCU) schemes are evaluating the

biological, chemical and physical pathways that could play a role in the field.

›› Read the full story in the printed issue.

FREE EXCERPT

Page 10: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

80 European Biotechnology | Autumn Edition | Vol. 15 | 2016DiAgnostics & thErApy

Pict

ure:

Qia

gen

Extracellular – and extraordinaryExosomEs Even though they’re in the nanometer range, extracellular vesicles (EVs) could start

to make it big in the next few years. Long ignored as “cell debris”, the tiny bubbles have now been

recognized as a key component in the complex communication between cells. EVs carry genet­

ic material and proteins throughout the fluids in the body, and have biological properties com­

parable to stem cells – but apparently safer. They could serve as vaccines, carry cancer immuno­

therapies, or play a role in regenerative medicine. Ideas and potential markets are growing fast.

›› Read the full story in the printed issue.

FREE EXCERPT

Page 11: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

97Company indexeuropean Biotechnology | autumn edition | Vol. 15 | 2016

Knack to sealCandor BIoSCIEnCE Liquid plate Sealer® animal-free is a coating stabiliser without animal-derived ingredients for an-tibodies and antigens coated on polysty-rene or glass-surfaces.

after immobilisation of the antibodies or antigens and blocking, Liquid plate Sealer seals the plates with a uniform stabilising layer, demonstrating good solubility and without affecting the assay afterwards.

Liquid plate Sealer can be used for sta-bilising coated eLiSa plates, immuno-chromatographicy test strips (lateral flow assays), affinity chromatography columns, protein arrays and for similar applica-tions.

due to the fact that Liquid plate Seal-er animal-free does not contain animal-

derived ingredients it is a suitable coating stabiliser for veterinary diagnostics.

Liquid plate Sealer animal-free is ready-to-use and available in bottle sizes of 50 ml, 125 ml and 500 ml. it is applicable for research kits and for commercial eLiSa kit production.

ContaCtCandor Bioscience GmbHtel.: +49 (0)7522 7952 70Fax: +49 (0)7522 7952 [email protected]

aB Science Sa (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23abbott diagnostics (GeR) . . . . . . . . . . . . . . . . . . . . . . . . 18abbVie inc. (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26abivax aB (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34ablynx nV (B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26acumen Research Laboratories (SG) . . . . . . . . . . . . . . . . 18adaptimmune Ltd. (UK) . . . . . . . . . . . . . . . . . . . . . . . . . 23adrenomed aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . 17, 22advanced Biotherapeutics Consulting SaR . . . . . . . . . . . 23affymetrix Ltd. (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44agennix aG (GeR/USa) . . . . . . . . . . . . . . . . . . . . . . . . . 18akari Therapeutics plc (UK) . . . . . . . . . . . . . . . . . . . . . . 23alcon Corp. (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26alexion europe SaS (F) . . . . . . . . . . . . . . . . . . . . . . . . . . 23alga pangea GmbH (aT) . . . . . . . . . . . . . . . . . . . . . . . . . 74alligator Bioscience aB (Se) . . . . . . . . . . . . . . . . . . . . . . 69alteco medical aB (Se) . . . . . . . . . . . . . . . . . . . . . . . . . . 22am-pharma B.V. (nL) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20amgen inc. (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18analytiCon discovery GmbH (GeR) . . . . . . . . . . . . . . . . 72araclon Biotech (eS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27areva med (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69asahi Kasei pharma (Jp) . . . . . . . . . . . . . . . . . . . . . . . . . 20astraZeneca aB (Se/UK) . . . . . . . . . . . . . . . . . . . . . . . . . 25athena Vision Ltd (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . 23axon neuroscience Se (Cy) . . . . . . . . . . . . . . . . . . . . . . 79Batavia Biosciences (nL) . . . . . . . . . . . . . . . . . . . . . 49, 58Baxalta (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23, 26Bayer aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26, 44Bayer Healthcare aG (GeR) . . . . . . . . . . . . . . . . . . . . . . 74Bd Life Sciences (USa) . . . . . . . . . . . . . . . . . . . . . . . . . 18Bio-Rad Laboratories (USa) . . . . . . . . . . . . . . . . . . . . . . 44Biocartis Sa (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Bioceros Holding nV (nL) . . . . . . . . . . . . . . . . . . . . . . . 78BioCom aG (GeR) . . . . . . . . . . . . . . . . . . . 21, 27, 31, 90Biogen idec (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . 27, 44BioGenes GmbH (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . 54Biomerieux (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Biotest aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Boehmert & Boehmert (GeR) . . . . . . . . . . . . . . . . . . 24, 89Brahms aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Brain aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Bristol myers Squibb (USa) . . . . . . . . . . . . . . . . . . . . 25, 70CandoR Bioscience GmbH (GeR) . . . . . . . . . . . . . . . . 97Cellectis Sa (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Celonic aG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . 51, 56Celyad Sa (B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Chemops menges (Si) . . . . . . . . . . . . . . . . . . . . . . . . . . 76Cinfa Biotech SL (eS/GeR) . . . . . . . . . . . . . . . . . . . . . . . . 77Comdis for eU-Consortia (GeR) . . . . . . . . . . . . . . . . . . . 84Covestro deutschland aG . . . . . . . . . . . . . . . . . . . . . . . . 41Curetis n.V. (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Cytosorbents (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Cytune pharma SaS (F) . . . . . . . . . . . . . . . . . . . . . . . . . . 78deCHema ausstellungs-GmbH (GeR) . . . . . . . . . . . . . . 37dia europe (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11dionex aG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44drooms GmbH (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . 85earlybird Venture Capital (GeR) . . . . . . . . . . . . . . . . . . . 74editas medicine (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . 76eisai europe Ltd. (UK) . . . . . . . . . . . . . . . . . . . . . . . . 18, 23eli Lilly (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18epidarex Capital (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . 79epirus Biopharmaceuticals (USa) . . . . . . . . . . . . . . . . . . 78eppendorf aG - Bioprocess Center europe (GeR) . . . . . . . 7europaBio /european Biotech Week (B) . . . . . . . . . . . . . 29european Biotechnology network (B) . . . . . . . . . . . . . . . 31exosome diagnostics GmbH (GeR) . . . . . . . . . . . . . . . . 84exosomics Siena (iT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84exovita Bioscience (USa) . . . . . . . . . . . . . . . . . . . . . . . . 82expedeon protein Solutions (UK) . . . . . . . . . . . . . . . . . . 72Ferring international Center Sa (CH) . . . . . . . . . . . . . . . . 20FGK Clinical Research GmbH (GeR) . . . . . . . . . . . . . . . 62Finox Biotech aG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . 78Fresenius medical Care (GeR) . . . . . . . . . . . . . . . . . . . . . 83FUJiFiLm diosynth Biotechnologies (USa) . . . . . . . . . . . 55Galvani Bioelectronics (UK) . . . . . . . . . . . . . . . . . . . . . . 44Gamamabs pharma S.a. (F) . . . . . . . . . . . . . . . . . . . . . . 27Gedeon Richter Ltd. (HUn) . . . . . . . . . . . . . . . . . . . 78, 79Generali deutschland Holding aG . . . . . . . . . . . . . . . . . 74Genmab a/S (dK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Genomix4Life (iT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77GenSight Biologics (F) . . . . . . . . . . . . . . . . . . . . . . . . . . 70Gilead Ltd. (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68GlaxoSmithKline (UK) . . . . . . . . . . . . . . . . . . . . . . . 23, 44Global Bioenergies Sa (F) . . . . . . . . . . . . . . . . . . . . . . . . 41Glycemicon aG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Gna Biosolutions GmbH (GeR) . . . . . . . . . . . . . . . . . . . 44Gyros aB (Se) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Hansa medical aB (Se) . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Health industries South australia (aUS) . . . . . . . . . . . . Cp2High-Tech Gründerfonds (GeR) . . . . . . . . . . . . . . . . . . . 83Hologic diagnostics Solutions international (USa) . . . . . 44HS Life Sciences (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . 71iCoS Corporation (USa) . . . . . . . . . . . . . . . . . . . . . . . . . 18igenomix (eS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76immago Biosystems Ltd (UK) . . . . . . . . . . . . . . . . . . . . . 69immudex a/S (dK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88immunoQure aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . 71innovate UK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88isomerase Therapeutics Ltd (UK) . . . . . . . . . . . . . . . . . . . 68Janssen Biologics B.V. (nL) . . . . . . . . . . . . . . . . . . . . . . . 68Kadmon pharmaceuticals (USa) . . . . . . . . . . . . . . . . . . . 44Lek d.d. (Si) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Leo pharma a/S (dK) . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Life Science austria LiSa (aT) . . . . . . . . . . . . . . . . . . . . . 75Luminex (iT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18m+W Central europe GmbH (GeR) . . . . . . . . . . . . . . . . 61malvern (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82merck & Co. (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25merck KGaa (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25merck millipore (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . 73merigen Research srl. . . . . . . . . . . . . . . . . . . . . . . . . . . . 77miacom diagnostics GmbH (GeR) . . . . . . . . . . . . . . . . . 19midiagnostics (USa/B) . . . . . . . . . . . . . . . . . . . . . . . . . . 44mLm medical Labs GmbH (GeR) . . . . . . . . . . . . . . . . . . . 9molzym GmbH & Co. KG (GeR) . . . . . . . . . . . . . . . . . . 19neste Jacobs oy (Fi) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68nodthera Ltd (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79nordic nanovector aS (n) . . . . . . . . . . . . . . . . . . . . . . . 69norgine B.V. (nL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71nostrum Biodiscovery (eS) . . . . . . . . . . . . . . . . . . . . . . . 77nova-institut GmbH (GeR) . . . . . . . . . . . . . . . . . . . . . . . 43novartis aG (CH) . . . . . . . . . . . . . . . . . . . . . 24, 26, 68, 76novo nordisk a/S (dK) . . . . . . . . . . . . . . . . . . . . . . . 26, 68nRW.Bank (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74octapharma aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . 26ono pharmaceutical Co. Ltd (Jp) . . . . . . . . . . . . . . . . . . 70opiS s.r.l. (iT) . . . . . . . . . . . . . . . . . . . . . . . . . . . 27, 62, 64oribase (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78oxitec Ltd. (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70packard Biosciences (UK) . . . . . . . . . . . . . . . . . . . . . . . . 44particle metrix (GeR). . . . . . . . . . . . . . . . . . . . . . . . . . . . 82perkin elmer (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Pfizer (USA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25, 74Pfizer CentreOne (USA) . . . . . . . . . . . . . . . . . . . . . . . . Cp4pharmamar S.a. (eS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26pharmathen S.a. (GR) . . . . . . . . . . . . . . . . . . . . . . . . . . . 23pharnext SaS (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70plasmidFactory GmbH & Co.KG (GeR) . . . . . . . . . . . 57, 60polpharma biologics (pL) . . . . . . . . . . . . . . . . . . . . . 59, 78proBioGen aG (GeR) . . . . . . . . . . . . . . . . . . . . . 63, 66, 67proteogenix Sa (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Qiagen nV (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Recordati S.p.a. (iT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Rentschler Biotechnologie GmbH (GeR) . . . . . . . . . . . . . 53Richter-Helm BioLogics GmbH & Co. KG (GeR) . . . . . . . 46Roche aG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19, 25Rodos BioTarget GmbH (GeR) . . . . . . . . . . . . . . . . . . . . 74Roquette Group (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Samsung (Korea) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Sandoz aG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . 26, 76, 77Selvita sp. z o.o. (pL) . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Sotio a.s. (CR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Spectral medical (USa) . . . . . . . . . . . . . . . . . . . . . . . . . . 22SphingoTec GmbH (GeR) . . . . . . . . . . . . . . . . . . 17, 86, 87SpiroChem (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36SR-Tiget (iT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76STaT diagnostica & innovation (eS) . . . . . . . . . . . . . . . . 19Swedish orphan Biovitrum (Se) . . . . . . . . . . . . . . . . 26, 27Swiss Biotech association (CH) . . . . . . . . . . . . . . . . . . . Cp3SyGniS pharma aG (GeR) . . . . . . . . . . . . . . . . . . . . . . . 72Takeda pharmaceuticals (Jp) . . . . . . . . . . . . . . . . . . . . . . 18Targovax aS (n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26TauRx Therapeutics (UK) . . . . . . . . . . . . . . . . . . . . . . 27, 79Teva pharmaceutical industries Ltd. (iL) . . . . . . . . . . . . . 23ThermoFisher Scientific (USA) . . . . . . . . . . . . . . . . . 18, 44ThromboGenics nV (B) . . . . . . . . . . . . . . . . . . . . . . . . . 26TxCell S.a. (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Unicyte (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83uniQure BV (nL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Valeant pharmaceuticals inc. (Cdn) . . . . . . . . . . . . . . . . 71Valneva Se (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Vetter pharma-Fertigung GmbH & Co.KG (GeR) . . . . . . . 25Videregen Ltd (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Viomedo (GeR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74VTU Technology GmbH (aT) . . . . . . . . . . . . . . . . . . 50, 67xigen pharma Sa (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . 36ZaB Brandenburg economic development Board (GeR) 13ZHaW - Zurich University of applied Sciences (CH) . . . 64

FREE EXCERPT

Page 12: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

SWISS BIOTECH DAY 2017The leading Life Sciences Conference in Switzerland and Annual General Assembly of the Swiss Biotech Association

APRIL 9, 2013SIX Swiss Exchange, ConventionPoint, Zurich

APRIL 9, 2013SIX Swiss Exchange, ConventionPoint, Zurich

4 MAY 2017Basel Congress Center

Mark your calendar for next year’s Swiss Biotech Day, the leading biotechnology conference in Switzerland. Don’t miss the chance to meet 500 senior experts from industry and academia in the life science sector from across Europe.

In 2017, this premier event will once again offer a high qua-lity conference programme and dedicated one-to-one part-nering opportunities. So save the date and become part of the constantly growing Swiss Biotech Day next spring.

Pre-register online at www.swissbiotechday.ch to be one of the fi rst to receive all information on programme, exhibitors and the partnering system as soon as it is available.

Media Partner:Organised by:

@

“WHITE BIOTECHNOLOGY” WORKING GROUP

Leading chemical companies are exploring the op-portunities that have been opened up by modern bio-technology, especially in the field of “white” or indus-trial biotechnology. And they are also applying thesetechnologies, wherever it makes sense. The SBA takessuch initiatives seriously and has formed a workinggroup specifically dedicated to white biotechnology.The Swiss Industrial Biocatalysis Consortium is animportant partner in this effort. The group includesleading multinational companies that support whitebiotechnology as a pillar of economic growth. Theplanned activities are in agreement with OECD strategies.In partnership with the Swiss Biotechnet (see pages14/15) the SBA develops training programmes and use-ful support tools for the industry. It is of importancethat the industry specifies its training needs so thatthe academic side can create tailor-made education.This strategy ensures that the industry gets the rightworkforce with the right education. The SBA profitsfrom the marketing alliance “Swiss Biotech” (see box)in a multiplied form. Thanks to Swiss Biotech, the

sector is internationally visible. The project-specificparticipating companies (most of them young and in-ternationally less savvy) find a comprehensive partnerwhich is helping to put them in the public window.The participating Life Science Regions are importantinternal carriers of the dynamics in the Biotech sec-tor, thus enhancing the common understanding of theindustry. This and more knowledge is brought intoEuropa Bio, the European Biotech Association, wherethe SBA is an active member.

22

SWISS BIOTECH...

...is an alliance of four leading Biotech regions ofSwitzerland (Bio Alps, BioPolo Ticino, Basel Areaand Greater Zurich Area). They have combined ef-forts to streamline interests of the national biotechsector. The SWX Swiss Exchange holds a leadingposition in terms of lifescience listings and offerscompanies from that industry – be they located inSwitzerland or abroad – access to an international-ly recognised financial marketplace. The initiativewas co-founded by the SBA which also managesthe executive office of Swiss Biotech.

Domenico Alexakis is Executive Director of the Swiss Biotech Association.

...ONE BIOTECH CLUSTER

For further information please visit www.swissbiotechassociation.ch

www.swissbiotech.org

SAVE THE DATE

Pic

ture

: © F

C B

asel

189

3

Pic

ture

: © R

ynac

her/

htt

ps:/

/com

mon

s.w

ikim

edia

.org

/wik

i/File

:Bas

ilisk_

Wet

tste

inbr

ücke

.JP

G (C

C B

Y-S

A 3

.0);

GN

U F

ree

Doc

umen

tatio

n Li

cens

e

Supporting Partners:In cooperation with:

Sponsors:

Page 13: ISSN 2364-2351 | A 60711 | Interview · PDF fileISSN 2364-2351 | A 60711 | ... plement data from randomised clinical trails (RCTs) ... its blood thinner Pradaxa (dabigatran)

When it’s

YOUR compound, every step matters.

Bringing together the best of

www.pfizercentreone.com

DRUG PRODUCTAPI

PC1-16-0005-210x275mm-May, 2016 © 2016 Pfizer Inc. All rights reserved. Pfizer CentreOne is a Trademark of Pfizer Inc.