EHA Articles

EHA supports the European Medicines Agency's investigation into risk based quality management of clinical trials

Mon, 20 Feb 2012 10:31:43 +0100

EHA has responded to the EMA’s call for comments on the reflection paper on February 15. In its response, EHA encourages the agency to continue to develop – along the lines described in the paper – a more systematic, prioritized, risk-based approach to quality management of clinical trials in support of the principles of Good Clinical Practice. However, EHA is keen to see that this development does not result in an increase of the administrative burden. Especially where academic trials are concerned, cost reductions and simplification are needed.
Related publications about EHA’s position on Clinical Trials: Revision of the Clinical Trials: No time to waste

Report "Haematology and the next European Decade"

Thu, 22 Dec 2011 10:01:13 +0100

Horizon 2020: The European Commission proposes the successor to Framework Programme 7

Fri, 02 Dec 2011 12:06:28 +0100

Horizons 2020 will pay “particular attention to ensuring a broad approach to innovation, which is not only limited to the development of new products and services on the basis of scientific and technological breakthroughs, but which also incorporates aspects such as the use of existing technologies in novel applications, continuous improvement, non-technological and social innovation.” It is divided into three objectives.
A budget of €24.6 billion is allocated to the first objective to support an 'Excellent science' in Europe. This objective includes the European Research Council (€14.1 billion), Marie Curie actions on skills, training and career development (€6.1 billion), and European research infrastructures, including e-Infrastructures, (€1.7 billion).
The second objective, 'Industrial leadership', with a budget of €17.9 billion, aims to help make Europe a more attractive location to invest in research and innovation.
The third objective, 'Societal challenges' will see €31.7 billion allocated to tackling the major issues affecting the lives of European citizens, including Health, demographic change and wellbeing (€8.6 billion – up from €6.1 billion in FP7). The priorities in Health research are:

Understanding the determinants of health, improving health promotion and disease prevention. Environmental, behavioural (including life-style), socio-economic and genetic factors, in their broadest senses will be studied
Developing effective screening programmes and improving the assessment of disease susceptibility
Improving surveillance and preparedness
Understanding disease
Using in-silico medicine for improving disease management and prediction
Treating disease (communicable, rare, major and chronic diseases) supporting the improvement of cross-cutting support technologies for drugs, vaccines and other therapeutic approaches, including transplantation, gene and cell therapy;
Transferring knowledge to clinical practice and scalable innovation actions
Better use of health data
Improving scientific tools and methods to support policy making and regulatory needs
Active ageing, independent and assisted living
Individual empowerment for self-management of health
Promoting integrated care

In addition, Horizon 2020 aims to implement simplification through a simpler programme architecture, a single set of rules, less red tape through an easy to use cost reimbursement model, a single point of access for participants, less paperwork in preparing proposals, fewer controls and audits, with the overall aim to reduce the average time to grant by 100 days. The proposal seeks the integration of research and innovation by providing seamless and coherent funding from idea to market and intends to create more possibilities for new entrants and young, promising scientists to put forward their ideas and obtain funding.
Horizon 2020 is a proposal to the European Parliament and Council who will, in the procedure of co-decision, decide upon the final legislation. This procedure may take up until the end of 2013.

Horizons 2020 will pay “particular attention to ensuring a broad approach to innovation, which is not only limited to the development of new products and services on the basis of scientific and technological breakthroughs, but which also incorporates aspects such as the use of existing technologies in novel applications, continuous improvement, non-technological and social innovation.” It is divided into three objectives.

A budget of €24.6 billion is allocated to the first objective to support an 'Excellent science' in Europe. This objective includes the European Research Council (€14.1 billion), Marie Curie actions on skills, training and career development (€6.1 billion), and European research infrastructures, including e-Infrastructures, (€1.7 billion).

The second objective, 'Industrial leadership', with a budget of €17.9 billion, aims to help make Europe a more attractive location to invest in research and innovation.

The third objective, 'Societal challenges' will see €31.7 billion allocated to tackling the major issues affecting the lives of European citizens, including Health, demographic change and wellbeing (€8.6 billion – up from €6.1 billion in FP7). The priorities in Health research are:

Understanding the determinants of health, improving health promotion and disease prevention. Environmental, behavioural (including life-style), socio-economic and genetic factors, in their broadest senses will be studied
Developing effective screening programmes and improving the assessment of disease susceptibility
Improving surveillance and preparedness
Understanding disease
Using in-silico medicine for improving disease management and prediction
Treating disease (communicable, rare, major and chronic diseases) supporting the improvement of cross-cutting support technologies for drugs, vaccines and other therapeutic approaches, including transplantation, gene and cell therapy;
Transferring knowledge to clinical practice and scalable innovation actions
Better use of health data
Improving scientific tools and methods to support policy making and regulatory needs
Active ageing, independent and assisted living
Individual empowerment for self-management of health
Promoting integrated care

5^th^ Focus in Paediatric Haematology-Oncology

Mon, 21 Nov 2011 11:01:19 +0100

The course, which is particularly aimed at specialist trainees in pediatric haemato-oncology, continued the same ethos which inspired the first four courses: the importance of close interactions between the participants and the teaching faculty, a strong emphasis on real cases and the scientific basis of disease and its treatment.

In this 5^th course there were thirty participants from thirteen countries including South America, the Middle East and Eastern Europe. The course was designed and led by Professors Andrea Biondi (Monza), Irene Roberts (London), André Baruchel (Paris) and Arndt Borkhardt (Dusseldorf). The invited faculty this year included P Bader (G), E Biagi (I), P Bolton-Maggs (UK), MT Daniel (F), K-M Debatin (G), J de la Fuente (UK), R Galanello (I), B Gibson (UK), M van den Heuvel (NL), A Iolascon (I), T Leblanc (F), M de Montalembert (F), K Schmiegelow (N), J Schwaller (CH) and C Zeidler (G).

The principal topics covered were acute leukaemia, myelodysplasia, bone marrow failure, haematopoietic stem cell transplantation, red cell disorders and consultative paediatric haematology, including diagnostic morphology, coagulation and neonatal haematology. In addition, there were compelling guest seminars by leaders in the field: Klaus-Michael Debatin ‘Cell death pathways in leukaemia therapy’, Jurg Schwaller ‘Targeting epigenetic mechanisms in AML’ and Achille Iolascon ‘New Insight into Congenital Dyserythropoietic Anaemias’. Furthermore, a unique and popular aspect of the course were the small group tutorials in hematological morphology, directed by Marie-Therèse Daniel, round the microscope.

The emphasis of this course is on problem-solving using real clinical cases and linking basic science to the clinic. An additional important objective of the course has always been to create a friendly and informal atmosphere to encourage exchange of scientific ideas for ongoing and future projects between the participants themselves and faculty members. Indeed these courses continue to lead to exchanges of trainees between countries to experience training and research in pediatric haematology in diverse environments and ultimately, we hope, to benefit the patients we care for.

Press Release "Crucial Directives must be revised to protect patients' interests and improve access to treatment"

Wed, 09 Nov 2011 15:40:19 +0100

This was a key message of a two-day conference, “Haematology and the next European decade”, hosted by the European Parliament and attended by doctors, researchers, parliamentarians, patients’ organisations and Commission officials.

The revision of the Clinical Trials Directive, which provides the regulatory framework for the testing of new drugs on humans, has reached its final stages before a draft law is proposed by the European Commission within the next few months, but some politically-sensitive issues still remain.

There is a clear consensus among all stakeholders that the existing processes are overly bureaucratic, costly and time-consuming. “If we want to keep modern scientific research in Europe, we need to modernise our Directive”, said Philippe Juvin MEP, the European Parliament’s rapporteur on the revision.

However, haematological researchers and patients’ organisations insist that seeking to reduce costs and simplify the rules in order to encourage more clinical testing in Europe must not compromise patient safety.

Also, the changes must aim to reverse the economic pressure on independent academic research – “squeezing academic research into a commercial strait-jacket” – and so facilitate a rich source of new treatments for blood-related diseases, especially rare forms of cancer.

As part of its aim to highlight the positive impact of haematology research across a range of medical conditions, the conference – organised jointly by the European Cancer Patient Coalition and the European Hematology Association, the haematologists’ organisation – also discussed today the ongoing revision of the 2005 Directive relating to professional qualifications.

Both haematology researchers and patient organisations voiced concerns that respect for the free movement of medical professionals in Europe should not compromise standards of competence that could impact the safety and quality of patient care.

It is literally vital for patients that any new EU legislation should improve co-operation for more and better-targeted funding for research in haematology, allowing haematologists to secure the research resources they need to help patients access the best possible expertise and treatment. The conference therefore aims to create grass-roots momentum for collaboration by all stakeholders at European, national and regional level to ensure this happens.

Press Release: Better funding for research into blood diseases will save more lives

Wed, 09 Nov 2011 11:34:21 +0100

“Haematology is probably the area of medicine that has progressed the most in recent years”, said Professor Robin Foà of “La Sapienza” University of Rome. “For example, acute lymphoblastic leukaemia (ALL), the most frequent form of cancer in children, used to kill most children that had it. Before, we used to cure 20 to 30 percent of cases; these days, we cure 80 per cent of cases.” He added: “If we had more funding, we could definitely do more.”
This was one of the key messages on the first day of a two-day conference, “Haematology and the next European decade”, hosted by the European Parliament to highlight the positive impact of haematology research across a range of medical conditions, and the leading role it will have in the knowledge economy envisaged in the European Union’s 2020 Strategy.

Today the conference – attended by doctors, researchers, parliamentarians, patients’ organisations and Commission officials – also discussed the European Commission’s Green Paper on the Common Strategic Framework for the funding of research and innovation, which will affect how much of the €80 billion allocated in the next EU budget to all areas of research will go towards health.

Haematology – a discipline covering all blood-related areas, from frequent diseases like anaemia to rare cancers, including malignant and non-malignant diseases – is always at the forefront of medical research, both at its basic level and its application, which these days often involves working closely with the biotechnology industries.

It is literally vital for patients that any new EU legislation should improve co-operation for more and better-targeted funding for research in haematology, allowing haematologists to secure the research resources they need to help patients access the best possible expertise and treatment. The conference therefore aims to create grass-roots momentum for collaboration by all stake-holders at European, national and regional level to ensure this happens.

This is why initiatives like the Brussels conference, organised jointly by the European Cancer Patient Coalition and the European Hematology Association, the haematologists’ organisation, are crucial for raising awareness in the wider public, but also for sending a clear message to regulators, administrators, officials and MEPs that their voice needs to be heard.

Press Release: “Building the knowledge economy in the world of blood diseases: patients, professionals and Parliamentarians help make the new Europe.”

Wed, 09 Nov 2011 16:27:57 +0100

Brussels, 29^th August 2011

On the 30th & 31st of August a conference will be hosted in the European Parliament that will demonstrate the leading role haematology will have in securing the future knowledge economy envisaged in the Europe 2020 Strategy.

This will be revealed via an exploration of important interlinked legislative dossiers that will eventually realize the Strategy. The dossiers contain many issues which are of concern to both clinicians, their patients and their representatives.

Over the next two days we will explore these issues from a wide range of stakeholder perspectives seeking to set out clearly areas that are both contested and those upon which there is a consensus.

Addressing two of the three legislative dossiers on the conference agenda, the revision of the Common Strategic Framework (CSF) for funding research & innovation and the Clinical Trials Directive, will be their respective Rapporteurs Marisa Matias MEP and Philippe Juvin MEP.

Nessa Childers MEP, a high profile health committee member, will make her own contribution to the discussion of the CSF.

Commission representatives from relevant Directorates will also be present to discuss the dossiers and issues raised concerning them as they will for the Professional Qualifications Directive, the third legislative item to be covered.

This third dossier, in its Single Market policy ambition of the free movement of labour within the European internal market and its contribution to the development of a knowledge economy, need look no further for an illustrative example of its benefits than the Heamatology Curriculum.

Harmonization of continuing medical education by ensuring it be mandatory and enforceable will, when combined with the Curriculum, assist greatly in ensuring the diminution of public concerns about patient safety.

In recognition of Poland’s occupancy of the Presidency Pawel Kowal MEP will open the Conference with a Welcome message followed by Elżbieta Łukacijewska MEP who will talk about haematology and its specialist clinicians.

As Elżbieta will relate; the real mystery is of public ignorance of haematology and the work of haematologists.

This disadvantages the profession and patients who struggle to articulate what haematology is and in what way it is different from its nearest perceived cousin oncology.

However the story they have to tell is a compelling one. It is of forever being at the forefront of medical research both at its most fundamental level where it meets molecular biology and also in the application of that research which often now involves working closely with the biotechnology industries.

There is some public consciousness of stem cells, the huge research effort devoted to revealing their mechanics, and the applicability of the knowledge gained just as there is of imatinib the most spectacularly successful targeted therapy to date.

Yet there is almost zero public recognition of the role played by haematologists in this story. This should, and must change.

Remedial work will commence when a range of speakers reveal the links between these specialities and their rich resulting outputs. This will also serve to illustrate the importance of cross disciplinary coordinated research with academic institutions from across Member States working together to build the future knowledge economy for Europe.

Regulators will also speak of the need to ensure patient safety, the maintenance of assurance and the need for assessment no matter what the context of a patient’s encounter with practices and products they are resourcing to secure a better healthcare outcome.

The support of patients is of vital assistance in discussion of all of these issues since they carry only the self interest of ensuring their survival before them.

The wider public has an instinctive empathy with them because of their awareness that they too might one day joint the ranks of, as one patient put it, “the club that no one wants to join”.

Securing that implicit support and having that transmitted through those “club” members carries weight beyond what can be perceived as the self interest of the professional.

A patient organization & professional association, welded together when jointly organizing events like theses, can send a clear message to regulators, administrators, officials and MEPs that their voice needs to be heard.

For further information please contact:

Denis Horgan, ECPC Head of External Affiars		Thom Duyvené de Wit, EHA Advocacy & Political Affairs
ECPC Head Office Tel.: +32 (0)4 72535104 +32 (0)4 72535104 Email: denis.horgan@ecpc-online.org		EHA Executive Office Tel.: +31 (0)6 11115056 +31 (0)6 11115056 Email: t.duyvenedewit@ehaweb.org

About EHA - European Hematology Association

European Hematology Association is an NGO that promotes excellence in clinical practice, research and education in European haematology. EHA is the representative of haematology and haematologists in Europe (members: 3000+, annual congress attendants: +/-9000 haematologists, Haematologica/The Hematology Journal: the primary general haematology journal in Europe). Further information can be found at http://www.ehaweb.org

About ECPC – The European Cancer Patient Coalition

The European Cancer Patient Coalition was founded in 2003 under the slogan "Nothing About Us, Without Us". It is committed to improving cancer prevention, screening, early diagnosis and best treatment, reducing disparity and inequality across the EU. ECPC seeks to ensure that policy makers, politicians, health professionals, the media and the general public recognise the serious nature of cancer and the need for concerted action to reduce unnecessary death and suffering. Further information can be found at http://www.ecpc-online.org

Dr A van Hylckama Vlieg Announced Winner of the first EHA-ISTH Joint Fellowship

Mon, 21 Nov 2011 15:44:28 +0100

The award of EUR 72,000 over two years is intended to support the study of the physiology of bleeding, coagulation or thrombosis. Dr. van Hylckama Vlieg’s proposal, Ageing of the venous valves and the risk of venous thrombosis in the elderly, aims to clarify which factors predict venous thrombosis in the elderly. The study, referred to as BATAVIA (Biology of Ageing and Thrombosis: Appraisal of Valve thickness and function, an In vivo Assessment, is an extension of her previous work with the AT-AGE (Age and Thrombosis: Acquired and Genetic risk factors in the Elderly) study.

Dr van Hylckama Vlieg’s proposal was selected from 18 competitive submissions for this joint program of EHA and ISTH. “We are very pleased with the number of high-quality research proposals received in response to this initiative in its first year,” said Dr Ian Peake, Co-Chair of the EHA-ISTH Joint Fellowship Review Committee and a past president of ISTH.

“I am very happy to receive this award, said Dr van Hylckama Vlieg. It is an honor to be the first recipient of this unique collaboration between ISTH and EHA.”

Since 2009, Dr van Hylckama Vlieg has served a joint appointment as Senior Clinical Researcher with Leiden University in the Netherlands and the University of Washington in Seattle, Washington, USA. Her research has been focused on the combined effect between hormone use, such as contraceptives and hormone replacement therapies, and statins. Her general research interests have been on venous thrombosis, a common condition of clotting in the veins.

Prior to 2009 Dr van Hylckama Vlieg was a Clinical Researcher in the Department of Clinical Epidemiology at Leiden University Medical Center. She completed her PhD at Leiden University in 2003 and was a post-doctoral research fellow at Addenbrooke’s NHS Trust Hospital in the UK. Dr van Hylckama Vlieg’s work has been published in a number of international journals, including Blood, Journal of Thrombosis and Haemostasis, Arteriosclerosis, Thrombosis, and Vascular Biology and the British Medical Journal. She has been awarded a number of grants and prizes from organizations such as the Dutch Heart Foundation, Foundation LeDucq, and the British Society for Haematology, among others.

The call for applications for the next EHA-ISTH Joint Fellowship is open on the websites of EHA and ISTH.

EHA Awards 2011 at the 16^th^ Congress of EHA in London

Sun, 20 Nov 2011 15:15:24 +0100

Bob Löwenberg will be the fourth recipient of the Jean Bernard Lifetime Achievement Award which was presented for the first time at the 13th Annual Congress in Copenhagen. This award was established to honor outstanding physicians and scientists for their lifetime contribution to the advancement of hematology.

Bob Löwenberg is Professor of Hematology at the Erasmus University in Rotterdam and is known for his seminal contributions to the pathobiology, diagnosis and treatment of acute myeloid leukemia.

Between 1982-1990 he has been the scientific director of the Daniel den Hoed Cancer Center, Rotterdam, and between 1990-2011 he was Chairman of the Department of Hematolog at the Erasmus University Medical Center in Rotterdam. Professor Löwenberg has extensively published (~600 publications, 14000 citations) in leading scientific journals and during decades significantly contributed to the area of stem cell transplantation, molecular diagnostics and developmental therapeutics.

Bob Löwenberg holds and has held various leading positions. He is on the editorial board of several international journals, including The New England Journal of Medicine and he is section editor for Acute Leukemia for UptoDate. He is one of the founders and past president of the Dutch-Belgian Cooperative
Group on Hemato-Oncology in Adults (HOVON Cooperative Group) and currently is the chair of the HOVON leukaemia trial group. Furthermore he was one of the founders and has served as President of the European Hematology Association (EHA). He has also served as president of the International Society of Experimental Hematology and the International Society of Hematology.
Between 2002 and 2008 he was the chairman of the Medical Advisory Council of the Dutch Royal Academy of Arts and Sciences and currently serves as the Chairman of Scientific Advisory Board of the European School of Haematology. Bob Löwenberg has received various honors. He is an elected member of the Royal Academy of Sciences and Arts of The Netherlands. In 2011 he was honored by the Queen: Knight of the Royal Order of the Netherlands Lion. In 2008 at the 50th annual meeting of the American Society of Hematology (San Francisco) he was invited to present the Ham Wassermann Lecture. Bob Löwenberg has been awarded the Dr P Muntendam Dutch Cancer Prize (2004), the Jacqueline Seroussi Memorial Cancer Research Award (Tel Aviv, 2006), the Bob Pinedo Cancer Prize (Amsterdam, 2008), Celgene Career Achievement Award for Clinical Research in Hematology (Orlando, 2010) and the Erasmus University Medical Center Award (Rotterdam, 2011) for his scientific achievements in leukemia.
Professor Löwenberg will be handed the award at the 16th Congress of EHA on Saturday June 11 during the Presidential Symposium which begins at 14:00.

Professor Douglas Higgs

The EHA Board has selected Douglas Higgs for the José Carreras Lecture at the 16th Congress in London. Douglas Higgs is Professor of Molecular Hematology at the University of Oxford in the United Kingdom. His work has established the molecular basis of alpha thalassaemia explaining the inheritance and thereby enabling the diagnosis of these common conditions throughout the world. Using alpha globin as a model his laboratory has established many of the important principles underlying human molecular genetics.

Douglas Higgs qualified in Medicine at King’s College Hospital Medical School in 1974 winning the KCH Senior Scholarship and trained there as a hematologist. He joined the MRC Molecular Hematology Unit (University of Oxford) in 1977 and, mentored by David Weatherall and John Clegg, was awarded a DSc (Med) in 1990.

He is a Fellow of the Royal College of Physicians (1993) and the Royal College of Pathologists (1994). Douglas Higgs is currently Professor of Molecular Hematology (1996) at the University of Oxford. He is Director of the MRC Molecular Hematology Unit (2000) and Deputy Director of the Weatherall Institute of Molecular Medicine (2005).
Professor Higgs is known for his contributions to understanding the molecular basis of thalassaemia. This work has determined the inheritance of these common hematological disorders and the mechanisms by which they arise, including critical point mutations, homologous and illegitimate recombination, and via transacting mutations.
This led to the first descriptions of many mechanisms of human disease including telomeric rearrangements and mutations in chromatin remodeling factors. His laboratory has used extensive analysis of the globin gene locus to establish many of the principles by which genes are switched on and off during normal hematopoiesis and in hematological diseases. Much of the work underpins our understanding of the general principles underlying human molecular genetics. Douglas Higgs has published extensively over three decades in leading hematological and scientific journals in particular contributing to our understanding of inherited disorders of the red cell.

The work of his laboratory has been acknowledged in awards related to basic science, human genetics and hematology. He was elected as a Fellow of the Academy of Medical Sciences (2001), a member of EMBO (2006) and a Fellow of the Royal Society (2005). He has received the Mack Foster Award (European Society of Clinical Medicine), the Graham Bull Prize (Royal College of Pathologists), the 2005 Carter Medal (British Society of Human Genetics), the 2009 British Society of Haematology Gold Medal, and presented the 2010 Weiner Lecture (New York BTS) and Ham Wasserman Lecture in 2004 (American Society of Hematology).
Professor Higgs will present his lecture during the Opening Ceremony of the 16th Congress of EHA on Friday June 10 at 13:15.

About the EHA Annual Congress

After 15 congresses and constantly increasing number of delegates, the 16th Congress of EHA will take place in London. Hematology is a specialty that covers everything to do with blood: its origin in the bone marrow, diseases (in the production) of blood and their treatments. The latest data on research and development within the wide spectrum of hematology are presented. The Congress is aimed at health professionals working in or interested in the field of hematology. The scientific program topics range from stem cell physiology and development, to leukemia; lymphoma; myeloma; diagnosis and treatment; red blood cells; white blood cells and platelet disorders; hemophilia; thrombosis and bleeding disorders as well as transfusion and stem cell transplantation. Last year the congress in Barcelona welcomed over 9,000 participants.

Contact

EHA Executive Office
Ineke van der Beek, Petra Stork
E-mail: communication@ehaweb.org
Mobile: +31(0)6 2011 1055

New at EHA 15: EHA-JSH Joint Symposium

Mon, 21 Nov 2011 10:51:04 +0100

On behalf of JSH Dr Toshiki Watanabe will speak about "Molecular pathogenesis of ATL". Dr Herman Einsele presents EHA with his lecture "New treatments strategies for EBV-associated LPD as a model for immunotherapy of virus-associated/induced tumors". The symposium is chaired by the President of JSH Yuzuru Kanakura and Robin Foà President of EHA.