ISTH2013NEWS

2013

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tiSSUE faCtOr pathWaY iNhibitOr aNd prOtEiN S »

iSth 2015 tOrONtO CONGrESSOvErviEW With Sam SChUlmaN »

WOmEN’S iSSUESiN thrOmbOSiS »

OptimiSiNG aNtiCOaGUlatiONiN thE EldErlY »

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Initiated in 1982, the BACH Awards recognize individuals who have made significant contributions to research and education in blood coagulation. The awards are presented in two categories:

• The Investigator Recognition Awards recognize ISTH members whose accomplishments are internationally regarded as exemplary models of excellence in research and teaching.

• The Distinguished Career Awards recognize ISTH members whose ca-reer contributions have significantly advanced the scientific community’s understanding of the diseases and disorders affecting hemostasis.

2013 Awards�Distinguished�Career• Lawrence Brass, MD, PhD• Philip G de Groot, PhD• Marcel Levi, MD, PhD• Peter Newman, PhD• Zaverio Ruggeri, MD

Investigator�Recognition• Wolfgang Bergmeier, MD• Christian Gachet, MD, PhD• Joseph Italiano, PhD• Bernhard Nieswandt, PhD• Thomas Renné, MD, PhD

at thiS EditiON Of thE iSth CONGrESS papErlESSCONfErENCiNG haS rEallY takEN Off.

Tweet of the day#iSth2013

Jane Skov @JaneSkov1

Impressive�plenary�talk�by�Denise�Wagner�at�#ISTH2013�including��amazing�pictures�of�neutrophils��casting�their�NETs

p. 7p. 4p. 3

rECipiENtS Of thEbiENNial aWardS fOr CONtribUtiONS tO hEmOStaSiS (baCh)

At this edition of the ISTH congress paperless conferencing has really taken off. Paper posters have completely been replaced by electronic poster boards, facilitating a more attractive visualiza-tion of research results and enabling video animation and interactive features on posters. During the manned poster sessions congress attendees can discuss posters on the 74 poster boards while having a drink and some snacks. Director

of innovation of the ISTH 2013 congress Tilman Hackeng is very satisfied with the overwhelming atmosphere in the central e-poster hall and says: “This is just what we expected. E-posters provide a plat-form for better interaction between the presenter and those who are interested in the poster. Also, people can see every poster any time during the congress, which is a great improvement compared to temporary paper display. Third time

ISTH congress visitor Elena Salabeno from Italy agrees with him and adds: “These electronic poster presentations are fantastic. I had a large attendance when showing my poster and everybody was able to clearly see my graphs and photographs.”.

AMC Disclaimer: http://www.amc.nl/disclaimer

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What tO dO aNd SEE iN amStErdam-tOUriSm tipS

Eat a raw herringYou simply must try raw herring. We don’t want to hear any excuses. The best time to try one is between May and July when the new catch hits the stands. There’s a quality fish stall or store around most corners. This fish is a bargain snack and makes for an authentic Dutch eating experience.

Artistic icons in a serene setting The Hermitage Amsterdam is the Dutch branch of the world-famous Hermitage in St. Petersburg, Russia. Located on the banks of the Amstel River, the Hermitage Amsterdam is a beautiful exhibition space and cultural education centre with a focus on Russian history and culture.Hermitage�Amsterdam�|�Amstel�51�|�Open�daily�10:00-17:00�|�www.hermitage.nl

Listen to the sounds of swingTonight, we’re taken back to the 1950s and the arrival of jazz in the venerable concert hall. American-born jazz vocalist and Grammy Award winner Kurt Elling follows in Frank Sinatra’s vocal steps with the Kurt Elling s(w)ings Frank Sinatra, emphasizing the singer’s loose and free style. But Elling – a true jazz singer, one of the last of his kind – is not an imitator: Sinatra’s interpretations are simply a starting point.Concertgebouw�|�Concertgebouwplein�10�|�Wednesday�3�July�20:00�|�24�to�42�Euros�|�www.concertgebouw.nl

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Tilman. It is a pretty unusual first name. Only seven men and boys in the Netherlands are registered having “Tilman” as their official first name, according to the Dutch First Name Database of the Meertens Institute. It is actually a Frisian name (Friesland is a province in the north of the Netherlands) and, according to the always helpful Wiki-pedia website, the strain is derived from the Oldfrisian word “til”, meaning good, fair or reliable. An appealing symbolic name to have when one is working in the field of biochemistry. It is also representative for the many contributions that the presenter of today has made to the field of thrombosis and haemostasis. “The Ratnoff-MacFarlane plenary lecture”, named after Drs Ratnoff and MacFarlane who are best known for their discovery of the coagulation cascade, will be given by professor Tilman Hackeng (Maastricht University, The Netherlands).

It is exactly 20 years ago (1993) that he defended his PhD thesis entitled “The protein C pathway on endothelial cells” at the Utrecht University. Thereafter he left the Neth-erlands to continue his career in the USA, where he worked as a Postdoctoral Fellow and later as a Senior Research Scientist at the Scripps Research Institute in La Jolla, CA. It is in these labs where his love for synthetic protein chemistry started. In 1998 he came back to the Netherlands on a Fellowship for the Royal Academy of Arts and Sci-

ences to work as a research fellow at the Department of Biochemistry at the Maastricht University. In 2002 he received a prestigious mid-career grant from the Netherlands Organisation for Scientific Research (NWO). Currently, he is head of the Department of Biochemistry were he studies the anticoagulant protein C/protein S/TFPI pathways and applies total chemical protein synthesis to the development of peptide/protein-based contrast agents for imaging of cardiovascular disease. He is a board member of the Cardiovascular Research Institute Maastricht (CARIM), and president of the Nether-lands Society on Thrombosis and Haemostasis.

Protein S, named after Seattle where it was first discovered, is a vitamin K-dependent protein that acts as a cofactor of the anticoagulant protein Activated Protein C (APC). However, protein S also exhibits anticoagulant activity in the absence of APC. In his lecture, Tilman will address what was originally described as “the APC-independent ac-tivity of protein S” and which was later uncovered to be a specific anticoagulant cofac-tor activity for Tissue Factor Pathway Inhibitor (TFPI) in the inhibition of factor Xa. After an historical perspective, the inhibition of extrinsic tenase complex as well as the role of platelet TFPI/protein S will be described. In addition the physiological importance of the TFPI/protein S anticoagulant pathway will be discussed.

As part of the excitement at this year’s Congress, the JTH unveiled its new, beautifully designed journal cover. This design will also be featured as part of its year State-of-the-Art issue. The new cover features modern imagery, updated branding and a crisp white background that allows the artwork and wording to pop off the page and engage readers with ease. See the new journal cover at the JTH desk in the ISTH booth, 500, or online in July.

08:00-09:30 Oral Communications Contact activation G106-107 Endothelial cells G104-105 Immune thrombocytopenic purpura Mondriaan II Inhibitor development in haemophilia A Auditorium Modifications in factors VIII, IX and XI Emerald New developments in thrombus formation Elicium 2 Non-inherited risk factors for venous thrombosis Elicium 1 Novel platelet receptors Mondriaan III Pregnancy and coagulation G102-103 Rare bleeding disorders - II E102 Recurrent venous thrombosis - II E104-107 Thrombin generation tests Mondriaan IV Von Willebrand factor – I Forum09:45-10:30 Ratnoff-MacFarlane Lecture Mondriaan I10:30-11:00 Coffee/Booth Visit11:00-12:00 State-of-the-Art Lectures New and old anticoagulants Mondriaan I Microparticles Mondriaan II Genetics: Humans and mice Elicium 1 Women’s issues in bleeding and thrombosis Elicium 2 Vessel wall biology Forum Gene therapy Auditorium12:00-13:00 Lunch/Booth Visit13:00-14:15 Abstract Symposia Contact activation 2.0 E104-107 Assays for haemostatic drugs Mondriaan III Platelet response to injury Mondriaan IV Thrombocytopenia Mondriaan II Genetics in coagulation G102-103

Thrombus resolution and stroke G104-105 Coagulation and complement Elicium 1 Treatment of von Willebrand disease Forum Major bleeding Auditorium Venous thrombosis and cancer Elicium 2 Clot structure E102 Thrombosis and haemostasis in the Asian-Pacific Emerald Thrombosis and haemostasis in the G106-107 developing world Nurses symposium E10814:30-15:30 Oral Communications Alternative treatments of haemophilia A Auditorium Coagulation factor XIII G106-107 Coagulation factor: Structure and function G102-103 Disseminated intravascular coagulation Mondriaan III Haemophilia B Forum Management of venous thrombosis Elicium 2 Microparticles Mondriaan IV Natural anticoagulants Emerald Novel approaches in vascular biology G104-105 Pediatric thrombosis Elicium 1 Platelet signalling - II Mondriaan II RNA and coagulation E102 Thrombophilia - I E104-10715:30-16:00 Coffee/Booth Visit 16:00-16:45 Plenary Lecture Mondriaan I17:00-18:30 ePoster Sessions ePoster area19:00-01:00 All Congress Party (Ticket needed) Beurs van Berlage

WEdNESdaY JUlY 3, 2013 | prOGram at a GlaNCE

The Ratnoff-MacFarlanePlenary Lecture:

Come to the Biogen Idec and Sobi booths to find out more about developments in haemophilia.

HG

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CO

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R E S“ I believe in innovation and the way you get to innovation is you fund research and you learn the basic facts”BILL GATES

E A RC H Booths:

204 & 255

thE iSth’S JOUrNal Of thrOmbOSiS aNd hEmOStaSiS (Jth) dEbUtS a NEW COvEr

MANAGE SUPPORTRESEARCH

Bayer and the Bayer Cross are registered trademarks of Bayer.© 2013 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.04/13 G.SM.HEM.05.2013.0027

We are committed to helping people with hemophilia because at Hemophilia Solutions by Bayer, we never lose sight of the human factor.

TAKE HOLD OF THE FUTURE

HemopHilia SolutionS

tips & funny facts about the dutch

How do you make and keep Dutch friends? It’s all in the body language plus a few natty lines. New acquaintances should be greeted with a handshake. As for longer-term friends, a 3-point kiss - that’s cheek- to-cheek-to-cheek, is commonplace. When leaving a Dutch home, always part with a dag (day), or shout a more informal doei (bye). Hug/cuddle at your own peril.

LEKKER!If you spend some time in the lowlands, you will definitely hear the word “lekker”. This seemingly innocent word is ubiquitous in the Netherlands.

“Lekker” in its original form refers to food and can be roughly translated as tasty or yummy. The Germans and Belgians still use “lekker” in this form, however, over time Dutch people have taken incredible liberties with the word and now essentially use it to describe, well, just about everything! A warm meal on a cold fall day can of course be “lekker”, but so can a feeling, an experience, a place and even a person! Word of warning: don’t go around calling your colleague “lekker” as the original translation of yummy or tasty still does apply!

As you see, lekker is a highly versatile little fellow and can be used in endless instances. You will see that the original translation does not always hold true:• lekkere broodje (tasty sandwich) – this is an easy one• lekker rustig (yummy calm, pleasant calm)• lekker weer (tasty weather, great weather)• niet lekker (not yummy, not nice, not well)• slaap lekker (sleep tasty, sleep well, sleep tight)• … and the list can go on!

tiSSUE faCtOrpathWaY iNhibitOr aNd prOtEiN S

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In 2013 Frits Rosendaal and Pieter Reitsma took over the editorship of the Journal of Thrombosis and Haemostasis (JTH), the official scientific journal of the ISTH, thereby ending the successful edi-torial period of Mike Greaves and David Lane. We speak with the new editors-in-chief about their view of JTH and their plans for the coming years. What do you like most as Editors in Chief?What is most interesting is the broad view of the field and the best impres-sion what is happening at the forefront of thrombosis and haemostasis research that one gets. What is most rewarding is the, albeit small, contribution one can make to improve papers and the visibility of the ISTH.

Why two editors rather than one?We have seen how well a dual editorship worked with Mike Greaves and David

Lane, and we believed we could improve on this concept even further, since we are in the same centre but from different dis-ciplines each giving our own perspective. Once a week, we discuss all submitted manuscripts (which have previously been distributed along the lines of ‘clinical’ and ‘basic’ by our editorial assistants) and de-cide which ones to send on to Associate Editors for further handling, and which ones to reject immediately.

What is the role of JTH in the ISTH? The ISTH is the leading organisation in the field of thrombosis and haemostasis and the Journal is its voice. An important aspect is that in contrast to many other specialty journals, there is not ‘a profes-sion’, like in, say, a journal of orthopae-dics, but many. We serve not only basic scientists and clinicians, but also people working in fields quite different from thrombosis and haemostasis per se, such as haematology, vascular medicine, pae-

diatrics, pulmonology, obstetrics, etc etc. The impact of a journal is not just deter-mined by its impact factor (which is now at 6.081), but also by the image of the journal as the voice of the ISTH. JTH is seen as a serious and authoritative jour-nal, and we will do what we can to keep it that way and to make it even better. What do you consider as the main tasks of the Editors in Chief and what changes do you envision for the future?The editors’ task is simple and limited: try to get the best papers submitted to the Journal, and try to select the best for pub-lication from those that are submitted. At the moment, we are also organising the ISTH 2013 Congress, so we decided to postpone any major new initiatives till after that. Luckily, there is no immediate need for major changes either, and it is good to get accustomed to the job first .

What will be the main features of the ISTH 2015 Congress? Canada has for several decades shared the leading role in thrombosis research.

This has often been achieved in international collaboration. We will expand this part-nership with other nations to provide the attendees with the newest and most impor-tant research data in thrombosis and hemostasis. The ISTH 2015 Congress will strongly encourage the young scientists and junior clinicians in our field to join and learn.

Will there be any specific innovations or new aspects introduced at the Congress? For the ISTH 2015 Congress, we will bring in neighboring specialties and hopefully

also attendees from these specialties. These include clinical cardiology, stroke neurol-ogy and transfusion medicine. The allied health professionals will have their program better announced and their track highlighted. The trainees will also experience an enhanced recommended track to guide them through the Congress.

What can you recommend to see and do in Toronto when attending the Congress? Toronto has the advantage of a centrally located convention center with many

hotels within walking distance. Moreover, this downtown area offers many theatres, museums and restaurants of various ethnicities. The 553 m high CN tower attracts 2 million visitors annually. For most of them a walk on a glass floor 342 m above ground satisfies their need of thrills. The most daring can do the edge walk, hands free 356 m above ground, but book it well in advance! At the base of the tower, Ripley’s Aquarium of Canada is about to open this summer. Also close to the convention center is the Hockey Hall of Fame. Two hours from Toronto you can see the beautiful Niagara falls, or travel north a few hours and experience true wild life in Algonquin Provincial Park - a quarter of Belgium in size. Learn more about Toronto here! http://www.seetoron-tonow.com.

iSth 2015 toronto CongressOverview with Congress president Sam Schulman

The ISTH 2013 Congress features a free mobile app for attendees. The app conveniently provides iPhone/iPad, BlackBerry, Windows, Android and other smartphone and tablet us-ers with on-the-go access to the ISTH 2013’s most exciting, informational and interactive features, such as program overviews, speaker and abstract infor-mation, general meeting and exhibitor information, venue and city maps. The Congress organizers are excited to provide this platform to attendees, and hope that all attendees will download it for themselves. The mobile app is now available via Apple and Google stores. Simply search “ISTH 2013” and download to today to begin using it right away!

iSth 2013CONGrESS app

AllDevicesAndroidiPhone/ipad

Jth StartS a NEW Era With EditOrS rOSENdaal aNd rEitSma

On the afternoon of July 2, 2013 the win-ners of the Access to Insight initiative were celebrated. Sponsor Novo Nordisk and members of the initiative’s Core Faculty and Review Board congratulated the candidates for their outstanding ap-plications and presented them with their award certificates.

Access to Insight is a funding initiative founded in 2008. Its goal is to promote research and education in haemophilia and other bleeding disorders by offering funding opportunities especially tailored to the needs of talented haemostasis phy-sicians and researchers. Every year there are three separate funding opportunities: one Basic Research Grant, one Award and one Training Scholarship, which are awarded to outstanding applications from physicians and researchers. The applica-tions are reviewed by an independent Re-view Board, which is headed by the Core

Faculty: Nigel Key, Christopher Ludlam, Stephanie Seremetis, and Ognenka Kozar Markovikj.

The recent prizes and recipients are:• The Basic Research Grant provides

funding of € 70,000 and is awarded to a project of basic science or translational research relevant to the understanding of the pathophysiology and treatment of haemostatic disorders. In 2012 Karin Fijnvandraat from Amsterdam and in 2013 Christina Baumgartner from Mil-waukee, Wisconsin received the grant for their interesting research projects.

• The Harold R. Roberts award for 2012 was awarded to Yesim G. Dargaud from Lyon and the Ulla Hedner award 2013 to Mettine Bos from Leiden for their excel-lent abstracts submitted to the WFH and ISTH conferences, respectively. The recipients of these awards receive €15,000. The reviewers and Nigel Key

from the Core Faculty complimented the scientists for their excellent work and meaningful results.

• The Access to Insight Training Schol-arship is awarded to physicians who would like to conduct training in the management of haemophilia and other haemostatic disorders in a renowned haemophilia treatment centre. Funding is available for a maximum of € 70,000 for 12 months.

Recipients of 6-months scholarships were: • Majid Naderi from Zahedan, Iran• Datta Dharmadhikari from Gaborone,

Botswana• Moe Hein from Mandalay, Myanmar • Martin Hendelmeier from Altdorf,

Germany

Christopher Ludlam from the Core Faculty expressed his belief that these

winners will strongly benefit from their training and improve management of haemophilia and rare bleeding disorders upon return to their home countries and institutes.

Novo Nordisk announced that an ad-ditional clinical research grant will be awarded from the next application cycle going forward. Ambitious health care professional providing care for haemo-philia and rare bleeding disorder patients, including nurses, physiotherapists, and psychologists will have the opportunity to receive funding of € 70,000 – 140,000 for a 12-24 month research project focusing on patient outcomes, quality of life, and social impacts of haemophilia and rare bleeding disorders.

Further information about the initiative is available at access-to-insight.com

aCCESS tO iNSiGht prizES fOr rESEarCh aNdEdUCatiON talENt iN haEmOStaSiS

Be sure to visit the ISTH 2015 website,

www.isth2015.org

over the coming months for additional details!

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Sekar (‘Sek’) Kathiresan, a clinical car-diologist and human geneticist, is the director of Preventive Cardiology at Mas-sachusetts General Hospital (MGH) and a genetics researcher in the Broad Insti-tute’s Program in Medical and Population Genetics. Furthermore, he is associate professor of medicine at Harvard Medical

School. He received his medical degree from Harvard Medical School in Boston, MA, USA, and completed his clinical training in internal medicine and cardiol-ogy at MGH. He pursued research train-ing in cardiovascular genetics through a combined experience at the Framingham Heart Study and the Broad Institute of

MIT and Harvard. In 2008, he joined the research faculties of the MGH Cardio-vascular Research Center and the MGH Center for Human Genetic Research.Dr Kathiresan’s research seeks to discover the genes responsible for inter-individual differences in the risk for cardiovascular disease (CVD) and particularly myocardial infarction (MI). Through genetic studies in populations, he and collaborators have discovered 45 gene regions related to the risk for hmyocardial infarction and 95 gene regions related to cardiovascular risk factors including blood cholesterol and triglycerides. By means of genetic studies in families, he has identified a gene responsible for extremely low levels of LDL cholesterol. He has utilszed gene variants to show that some means of rais-ing HDL cholesterol may not lower the risk of disease. Finally, he has identified a panel of gene variants that can be used to assess future risk for MI. In tandem with his research, his clinical focus is the pri-mary prevention of myocardial infarction in individuals with a family history of MI.

His lecture will focus on the discovery of genes and coding variation elated to cardiuovascular disease in humans. Two major approaches—linkage analysis and genetic association—have been used. The choice of the optimal approach depends on the pattern of segregation, whether consistent with the ratios described by Mendel or more complex. Some forms of

CVD exhibit a simple pattern of inherit-ance suggestive of a single causal gene that confers a large effect on the phe-notype. For many of these Mendelian forms of CVD, direct DNA sequencing and linkage analysis have successfully yielded the causal gene and mutation. However, most cardiovascular diseases, such as MI, show a complex inherit-ance, suggestive of an interplay between multiple genes and nongenetic factors. Mapping gene loci associated with complex traits requires substantial levels of information and analysis, but since 2007, approaches to accomplish this goal have matured, and genetic mapping for complex traits in humans has become a reality, for instance by the application ofa systematic genome-wide screen of common variants (genome-wide associa-tion study (GWAS)). Although GWAS has identified several genetic markers associ-ated with CVD risk and cardiovascular risk factors, the observed effect sizes of these variants are generally smaller than may have been expected, and account for only a small fraction of the variance in disease risk (e.g. ~10% for CVD). Gene-gene inter-actions have been proposed as a poten-tial source of the remaining heritability. The importance of genetic markers, gene-gene interactions, and the usefulness of genetic information to understand biolog-ic mechanisms and to improve preventive cardiac care, will be discussed.

a rarE viEW Of COdiNGvariatiON aNd thE riSk Of mYOCardial iNfarCtiON

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Ever since Watson & Crick published their double helix model in 1953, physicians and biomedical researchers have sought to determine best ways of treating pa-tients with either hereditary or acquired defects in their DNA. Gene therapy has been the main focus of many research groups, and recently we are experienc-ing the first patients who are successfully treated, including those with haemophil-ia. To achieve these major breakthrough successes, researchers had to overcome certain barriers, including immune

responses (inhibitory antibodies), meth-ods of gene delivery, appropriate animal models, and sustained expression of the gene of interest.

In today’s State of the Art lecture, Dr Thierry Vandendriessche will provide a concise historic overview of some of the key studies that define the state of the art and discuss the different approaches that we can use to address the remaining bottlenecks. Those interested in the latest developments should certainly attend the

lecture, because Dr Vandendriessche will talk about new and improved strategies to boost the performance of gene therapy vectors for haemophilia using novel synthetic biology and computational approaches. Using these ‘out-of-the-box’ approaches, his group has now gener-ated some of the most robust vectors to date for gene therapy of haemophilia A and B.

With regard to your research, what chal-lenges will you be facing in the future?“One of the major challenges relates to the decreasing funds for (biomedical) research. In particular, I had previously obtained several EU grants in the con-text of the framework 6 and 7 programs. These past EU funding programmes offer a unique opportunity for academia and industrial stakeholders in Europe to har-ness complementary expertise and work together towards a common objective with important translational implications. This format allowed EU researchers to maintain a competitive position globally. However, securing EU funding has be-come increasingly competitive to the ex-tent that it is virtually impossible to make a distinction between the top ranked consortia solely on the basis of objective criteria. Consequently, the current format of the EU funding programs falls short of achieving its goals if only 1 or 2 consortia are selected for funding. In the long run, this may ultimately undermine the EU research pipeline and EU’s competitive-ness. A more sustainable funding format is needed that allows for more structural support in an EU-wide fashion similar in

format to some national funding initia-tives in specific EU countries.”

If money were not an issue, what collabo-rations would you like to set up?“The successful development of gene therapy from bench to bedside requires a multi-disciplinary approach. I would establish a comprehensive collaborative network that focuses on ‘finding the cure’ for haemophilia A and B. I think such a comprehensive collaborative network, possibly transatlantic, is important to har-ness the complementary expertise from molecular biologists, immunologists, clinicians, industrial stakeholders, regula-tors, and - last but not least - patient organisations and representatives. The ISTH conferences are an ideal forum to plant the seeds of such collaborations.”

NOVOISTH-5734_M03_CNews_Tuesday.indd5-21-2013 4:18 PMSAVED @:

NonePRINTED @:

CLIENT CODECLIENT

BLEEDTRIMSAFETY

# COLORS

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None267 mm x 185 mmNone

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FROM:bljbuttino5551 John Buttino / Chuck AaronBY:

FONTS, IMAGES & INKS IMAGESBraxton_Sitting_HR.tif (CMYK; 1058 ppi; 28.35%), NovoSeven-Logo-EU-CMYK.eps (44%), NN_2c_CMYK_Coated.eps (15.4%), PATIENT_Blue_SHORT.ai (72.38%), PATIENT_Blue_LONG.ai (72.38%), FRIEND_LightBlue_LONG.ai (72.38%), Stamp_HR.tif (CMYK; 581 ppi; 51.6%)

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JOB INFORMATION

INKS Cyan, Magenta,

Yellow, Black

Yeah!

OK, see you there!

Want to ride bikes to the park?

Cool, meet me by the slide.

NovoSeven® 1 mg (50 KIU) powder and solvent for solution for injectionNovoSeven® 2 mg (100 KIU) powder and solvent for solution for injectionNovoSeven® 5 mg (250 KIU) powder and solvent for solution for injectionNovoSeven® 8 mg (400 KIU) powder and solvent for solution for injectionComposition: Eptacog alfa (activated), Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology, 1 mg/vial, 2 mg/vial, 5 mg/vial, 8mg/vial (corresponds to 50 KIU/vial, 100 KIU/vial, 250 KIU/vial, 400 KIU/vial). 1mg/ml eptacog alfa (activated) after reconstitution.List of excipients:Powder: Sodium chloride, Calcium chloride dihydrate, Glycylglycine, Polysorbate 80, Mannitol, Sucrose, Methionine, Hydrochloric acid, Sodium hydroxideSolvent: Histidine, Hydrochloric acid, Sodium hydroxide, Water for injectionsIndications: treatment of bleeding episodes and prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:• patients with congenital haemophilia with inhibitors to coagulation factors

VIII or IX >5 BU;• patients with congenital haemophilia who are expected to have a high

anamnestic response to factor VIII or factor IX administration;• patients with acquired haemophilia;• patients with congenital FVII defi ciency;• patients with Glanzmann’s thrombasthenia with antibodies to GP IIb-IIIa

and/or HLA, and with past or present refractoriness to platelet transfusions.Posology:Haemophilia A or B with inhibitors or expected to have a high anamnestic response:Mild to moderate bleeding episodes (including home therapy):Early intervention has been shown to be effi cacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds. Two dosing regimens can be recommended:1) Two to three injections of 90 µg per kg body weight administered at three-

hour intervals. If further treatment is required, one additional dose of 90 µg per kg body weight can be administered

2) One single injection of 270 µg per kg body weightThe duration of the home therapy should not exceed 24 hours. There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.

Serious bleeding episodes:An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated. The following dose varies according to the type and severity of the haemorrhage. Dosing frequency should initially be every second hour until clinical improvement is observed. If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days. Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated. A major bleeding episode may be treated for 2 - 3 weeks but can be extended beyond this if clinically warranted.Invasive procedure/surgery:An initial dose of 90 µg per kg body weight should be given immediately before the intervention. The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the fi rst 24 - 48 hours depending on the intervention performed and the clinical status of the patient. In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days. The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment. Patients undergoing major surgery may be treated for up to 2 - 3 weeks until healing has occurred.Acquired Haemophilia:NovoSeven should be given as early as possible after the start of a bleeding episode. The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight. Following the initial dose of NovoSeven further injections may be given if required. The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed.The initial dose interval should be 2 - 3 hours. Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged to be indicated.

Factor VII de� ciency:The recommended dose range is 15 - 30 μg per kg body weight every 4 - 6 hours until haemostasis is achieved. Dose and frequency of injections should be adapted to each individual.Glanzmann’s thrombasthenia:The recommended dose is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours). At least three doses should be administered to secure effective haemostasis. The recommended route of administration is bolus injection as lack of effi cacy may appear in connection with continuous infusion. For those patients who are not refractory, platelets are the fi rst line treatment for Glanzmann’s thrombasthenia.Contraindications: Hypersensitivity to the active substance, or to any of the excipients, or to mouse, hamster or bovine protein.Interaction with other medicinal products and other forms of interaction: Based on a non-clinical study it is not recommended to combine rFVIIa and rFXIII. There are no clinical data available on interaction between rFVIIa and rFXIII.Undesirable effects:Rare (> 1/10,000, < 1/1,000): Disseminated intravascular coagulation and related laboratory fi ndings including elevated levels of D-dimer and decreased level of AT, coagulopathy, hypersensitivity, headache, arterial thromboembolic events (myocardial infarction, cerebral infarction, cerebral ischaemia, cerebral artery occlusion, cerebrovascular accident, renal artery thrombosis, peripheral ischaemia, peripheral arterial thrombosis and intestinal ischaemia), angina pectoris, nausea, injection site reaction including injection site pain, increased fi brin degradation products, increase in alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin.Uncommon (> 1/1,000, < 1/100): Venous thromboembolic events (deep vein thrombosis, thrombosis at i.v. site, pulmonary embolism, thromboembolic events of the liver including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superfi cial thrombophlebitis and intestinal ischaemia), rash (including allergic dermatitis and rash erythematous), pruritus and urticaria, therapeutic response decreased, pyrexia.Inhibitory antibody formation: In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven® or FVII in patients with congenital haemophilia A or B with inhibitors. Development of inhibitory antibodies to NovoSeven has been reported in a post-marketing observational registry of patients with congenital FVII defi ciency.Not known: Intracardiac thrombus, anaphylactic reaction, � ushing, angioedema.Overdose: Three cases of overdose have been reported in patients with haemophilia in 13 years. The only complication reported in connection with an overdose was a slight transient increase in blood pressure in a 16 year-old patient receiving 24 mg rFVIIa instead of 5.5 mg. No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann’s thrombasthenia. In patients with factor VII defi ciency, where the recommended dose is 15 – 30 µg/kg rFVIIa, one episode of overdose has been associated with a thrombotic event (occipital stroke) in an elderly (> 80 year) male patient treated with 10 – 20 times the recommended dose. In addition, the development of antibodies against NovoSeven and FVII has been associated with overdose in one patient with factor VII defi ciency. The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred.Storage: 3 years shelf life when product is stored below 25°C. 2 years shelf life when product is stored below 30°C. Store powder and solvent vial / pre-fi lled syringe below 30°C. Store powder and solvent vial / pre-fi lled syringeprotected from light. Do not freeze. It is recommended the product be used immediately after reconstitution.Way of delivery: Medical prescription.Authorisation holder: Novo Nordisk A/S, Bagsvaerd, Denmark.Date of last revision: April 2013.

For more detailed information please consult the EMEA product information.

Novo Nordisk® is a registered trademark owned by Novo Nordisk A/S. NovoSeven® is a registered trademark owned by Novo Nordisk Health Care AG, Thurgauerstrasse 36-38, 80 Zürich, Switzerland, Tel +41432224300.

5146_NovoSeven_May 2013_ISTH 2013 Journal Ad

Prescribing Information

NovoSeven® responds with speed to control their bleeds1–4

For people with congenital haemophilia with inhibitors…

NovoSeven®, the � rst and only recombinant bypassing agent, resolves bleeds rapidly and effectively1–4

References:1. Bysted BV et al., Haemophilia 2007; 13(5): 527 – 532. 2. Windyga J et al., Ef� cacy and safety of rFVIIa, used as comparator in development of a new rFVIIa analogue: data from a phase 3 trial on vatreptacog alfa in haemophilia patients with inhibitors. Poster presented at: WFH 13th International Musculoskeletal Congress 2013; 2013 April 18–21, Chicago, IL, USA. 3. Young G et al., Haemophilia 2008; 14(2): 287 – 294. 4. NovoSeven® Summary of Product Characteristics.

Braxton Nelson, 9 years old, has congenital haemophilia with inhibitors and likes to ride his bike and play the drums.

Please see adjacent page for Prescribing Information.

This is an advert.

NOVOISTH-5734_M03_CNews_Tuesday.indd 1 5/24/13 10:39 AM

Despite the clear differences between the sexes with respect to the occurrence of venous thromboembolism, many stud-ies on aetiology, diagnosis and treatment have focused on men. Therefore, several aspects of the diagnostic and therapeu-tic management of women with venous thrombosis are uncertain. The life time risk of venous thromboembolism is simi-lar for men and women, but women are at higher risk during their fertile years, when they are exposed to reproductive risk factors, e.g. hormonal contraception and pregnancy. Professor Saskia Middeldorp’s research has focused on these differences between men and women and in her State of the

Art lecture on Wednesday the 4th of July she will discuss specific women’s issues in venous thromboembolism. Her lecture will emphasise many knowledge gaps regarding women and thrombosis that urgently need to be addressed. She will do so by discussing three specific clinical questions in relation to venous thrombo-embolism and female sex. First, the contribution of hormone use to venous thromboembolism. Oral contra-ceptives are a well established risk factor for venous thromboembolism; however, careful prescribing of safe preparations can reduce the risk of hormone-related venous thromboembolism. Professor Middeldorp will also address some uncer-tainties with respect to the risk of certain low-dose progestagens and transdermal hormone preparations. Secondly, she will discuss the diagnosis, treatment and prevention of pregnancy-related venous thromboembolism.

Diagnostic and management strategies which apply to the non-pregnant popula-tion are not suitable for pregnant women. For instance, there are no definitive data on the ruling out of venous thromboem-bolism during pregnancy using a clinical probability assessment combined with the D-dimer test. Therefore, excluding pulmonary embolism in pregnant women without the need for diagnostic imag-ing is not possible, which will expose these women to substantial radiation at a young age. She will also discuss the optimal duration and intensity of anticoagulant treatment and prophylaxis of pregnancy-related venous thromboembolism with low mo-lecular weight heparin (LMWH). For preg-nant patients, several aspects of the use of therapeutic doses of LMWH remain controversial. These include the uncer-tainty whether a pre-pregnancy weight can be used to determine the appropriate

dose of LMWH, whether monitoring of anti-Xa levels or dose adjustments are required as the pregnancy progresses and body weight increases.Thirdly, professor Middeldorp will review anticoagulant therapy in women with unexplained recurrent miscarriages. Several studies have shown that antico-agulants offer no benefit in these women and should not be prescribed. However, it is not known whether anticoagulation prevents recurrent miscarriage in throm-bophilic women or women with severe pregnancy complications like HELLP syndrome. Many question for women with regard to their risk of venous thrombosis remain. The State of the Art lecture by professor Saskia Middeldorp discusses the knowl-edge gaps in 2013 and is a must for every clinician treating pregnant women with venous thrombosis.

WOmEN’S iSSUESiN thrOmbOSiS

GENE thErapY fOr haEmOphilia:fiNallY arrivEd?

Editors ISTH2013 News• Louise Bannon (ISTH)• Goda Choi• Alev Karasu• Maurits van Montfoort• Dafna Groeneveld• Mandy Lauw• Tobias Bonten• MCI-Amsterdam• Frits Rosendaal• Marcel Levi

Design• wardtaal.com

Photography• martinstacho.com

Print• JPPJ

NOt a mEmbEr YEt?JOiN thE iSth aS a NEW mEmbEr at thE CONGrESS aNd rE-CEivE a SpECial Gift

Membership in the ISTH is impor-tant at every stage in your career. With more than 3,500 members in 84 countries around the world, the ISTH provides you with the opportunity to become part of a global membership community of specialists in bleeding

and clotting disorders. And, if you be-come a member while at the Congress, you will receive a very special ISTH gift and will be entered into a raffle to win an iPad Mini. Don’t wait! The ISTH offers numerous benefits, including subscription to the ISTH’s highly-regarded publication, Journal of Thrombosis and Haemostasis (JTH), timely information regarding throm-botic and bleeding disorders, targeted educational programs, discounted rates, networking opportunities and access to e-learning platforms.

Learn more about membership in the ISTH onsite at the congress at booth 500 or online at www.isth.org.

2013NetherlaNds

XXIVCONGress

Wednesday JUlY 3

Page8

Balancing the Dynamics of Anticoagulation

www.CoagulationCenter.com

© Daiichi Sankyo Europe GmbH ∙ Zielstattstr. 48 ∙ 81379 Munich ∙ Germany Phone +49 89 78080 ∙ Fax +49 89 7808288 ∙ service@daiichi-sankyo.eu · www.daiichi-sankyo.eu

An innovative educational resource for healthcare professionals

The State-of-the-Art lecture of Wednes-day 3 July will be provided by Elaine Hylek from the Boston University Medi-cal Center, Boston, USA. Dr Hylek will present her most recent work on antico-agulant treatment in the elderly.

Elaine M. Hylek received her MD from the University of Pittsburgh School Of Medicine and a Masters in quantitative methods in Public Health from Harvard University School of Public Health. Dr Hylek completed her residency training in internal medical at Massachusetts General Hospital and Harvard Medical School in Boston, Massachusetts. She is currently the Director of the Thrombosis and Anticoagulation Service at Boston University Medical Center.

The incidence of thrombotic disorders increases with age, and use of long-term anticoagulation has increased in elderly patients. Vitamin K antagonists (VKAs) are the only oral anticoagulants currently available for the long-term prevention of stroke in patients with atrial fibrillation, and the primary VKA is warfarin. Howev-er, although effective, warfarin is associ-ated with various challenges to its use in routine clinical practice. There are several pharmacological and physiological fac-tors that influence its therapeutic efficacy and safety, especially in the multimorbid geriatric population.

Regardless of the evidence that warfa-rin is effective, numerous studies have shown that it is underused in patients

with atrial fibrillation, particularly in elderly patients. Risk of haemorrhage and erratic control are frequently cited reasons for physicians not prescribing an-ticoagulants to patients in this age group. And, as a result, states Dr Hylek, a leading anticoagulant authority, there is a press-ing need for convenient new well-tolerat-ed and effective oral anticoagulants that do not require frequent dose adjustment and routine coagulation monitoring.

Dr Hylek says: “Anticoagulation treat-ment has changed in the past years, as several promising new drugs have been approved, such as dabigatran, a direct thrombin inhibitor, and inhibitors of fac-tor Xa such as rivaroxaban, apixaban, PRT054021, YM150 and DU-176b. These

drugs have been shown to be at least as good as, if not better than, warfarin in the prevention of embolic stroke in patients with atrial fibrillation and treatment of venous thrombosis. These anticoagulants may offer benefits and increased con-venience for elderly patients. No need for routine monitoring may be a beneficial consequence of the predictable pharma-cology of new agents, but the ability to accurately measure a drug effect when needed would be highly desirable.”

Optimising anticoagulation in the elderly is still challenging, and new anticoagulant drugs have not been extensively studied in the multimorbid geriatric population. For example, the risk of falling and bleed-ing may be higher among elderly pa-tients, which makes it difficult to balance the risks and benefits of anticoagulation. Cognitive decline could argue against anticoagulation, because the success of anticoagulation depends partly on the patient’s understanding of the risks and benefits of this medication and mainte-nance of INR within therapeutic range.

In summary, it cannot be denied that the new oral direct factor inhibitor anticoagu-lants offer pharmacokinetic characteris-tics of interest to patients and clinicians. However, there are enough unknowns at the present time to caution healthcare providers. Certainly, Dr Hylek could en-lighten us all during her State-of-the-Art lecture on Wednesday.

The Nursing programme at the ISTH was initiated at the XX ISTH conference in Sydney, Australia in 2005, to provide a unique forum for nurses internationally to share practice related knowledge pertain-ing to disorders of haemostasis in both paediatric and adult populations. To date, the ISTH and its congress organising committees recognise that nurses play a key role in the care of and in promot-ing adherence in patients with chronic disorders of haemostasis. Nurses are vital in their role to assess, educate, advocate, and optimise care for patients and are integrally involved in clinical research.On Saturday and Sunday preceding the ISTH 2013 congress the Nurses Forum presented a comprehensive programme of presentations focused at nursing activities in the area of thrombosis and haemostasis. There were several presen-tations focusing on practical aspects on clinical work in haemostasis and throm-bosis, such as injections in small children, e-learning and telemedicine applications, treatment adherence, and family care. From all presentations it was clear that nurses are important members of the care team because of their direct involve-ment in information flow, and by virtue of their direct, one-on-one interactions with patients and their families . Interactions

necessarily include the need to educate on the nature of the disease, choice of appropriate products used to treat, techniques for self-therapy, indications for acute treatment versus on-the-spot prophylaxis, availability of home care services, financial coverage for treatment and life planning (career selection, partici-pation in sports, etc). The programme very well illustrated the purpose of the ISTH Nurses Forum, i.e to promote, support, and sustain sharing and adoption of, evidence-based practice; thereby facilitating knowledge translation to direct patient care. This will be provid-ed globally through mentorship to nurses in their role to teach, coach, individualise, and intervene in applying evidence based practice to meet the unique needs of pa-tients with disorders of haemostasis.

In addition, the Nurses Forum will sup-port systematic evaluation and dis-semination of practical and actionable standardised or targeted interventions for this unique patient population that is provided by nurses.

Form more information refer to: https://www.isth.org/?page=NursesBackground

NUrSES fOrUm atthE iSth CONGrESS

OptimiSiNGaNtiCOaGUlatiONiN thE EldErlY