EUROPEAN PERSPECTIVES IN PERSONALISED MEDICINE

12-13 MAY 2011

Square-Brussels Meeting Centre

MEET THE SPEAKERS

Tim AITMAN ........................................................................................................................................................ 6

Professor, Clinical and Molecular Genetics, Group Head and Head of Molecular Sciences, Imperial College London, UK ...................................................................................................................................... 6

Richard BERGSTRÖM ......................................................................................................................................... 7

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA) ............... 7

Thomas BEYER .................................................................................................................................................. 8

CEO, cmi-experts .......................................................................................................................................... 8

Association of Imaging Producers & Equipment Suppliers (AIPES) ............................................................. 8

Finn Børlum KRISTENSEN ................................................................................................................................. 9

Director, Centre for Evaluation and HTA, DACEHTA, National Board of Health of Denmark and Director of EUnetHTA ...................................................................................................................................................... 9

Angela BRAND ................................................................................................................................................. 10

Professor, Maastricht University and Director, European Centre for Public Health Genomics (ECPHG), Maastricht, the Netherlands ........................................................................................................................ 10

Deborah BRAUN ............................................................................................................................................... 11

Group leader R&D team in Oncology, bioMérieux ....................................................................................... 11

Anna BUCSICS ................................................................................................................................................. 12

Main Association of Austrian Social Security Institutions (HVB) ................................................................. 12

Fabien CALVO .................................................................................................................................................. 13

Deputy Director General and Director of research, French National Cancer Institute (INCa) .................... 13

Jean-Jacques CASSIMAN ................................................................................................................................ 14

Professor Emeritus, Katholieke Universiteit Leuven, Belgium .................................................................... 14

Ian CREE .......................................................................................................................................................... 15

Director, Translational Oncology Research Centre and Cancer Laboratory, Queen Alexandra Hospital, Portsmouth, UK ........................................................................................................................................... 15

John DALLI ...................................................................................................................................................... 16

Commissioner for Health and Consumer Policy, European Commission ................................................... 16

Romano DANESI .............................................................................................................................................. 17

Professor, Department of Internal Medicine, University of Pisa, Italy ......................................................... 17

Anne DE BOCK................................................................................................................................................. 18

Portfolio leader Oncology & Infection, Astrazeneca .................................................................................... 18

Isabel DE LA MATA ........................................................................................................................................... 19

Principal Adviser for Public Health at Directorate SANCO – Health & Consumers .................................... 19

Ruxandra DRAGHIA-AKLI ................................................................................................................................. 20

Director, Directorate Health, DG Research and Innovation, European Commission.................................. 20

Máire GEOGHEGAN-QUINN ................................................................................................................................ 21

Commissioner for Research, Innovation and Science, European Commission ......................................... 21

Olga GOLUBNITSCHAJA .................................................................................................................................... 22

Professor, Department of Radiology, University of Bonn, Germany ........................................................... 22

Secretary-General, European Association for Predictive, Preventive and Personalised Medicine ............ 22

Hinrich GRONEMEYER ...................................................................................................................................... 23

Professor and Research Director, French National Institute of Health and Medical Research (INSERM) . 23

Ivo GUT ............................................................................................................................................................ 24

Director, National Genome Analysis Centre, Barcelona, Spain .................................................................. 24

David HAERRY ................................................................................................................................................. 25

Board of Directors, European AIDS Treatment Group ................................................................................ 25

Alain HURIEZ .................................................................................................................................................... 26

CEO, TcLand Expression ............................................................................................................................ 26

Chairman, European Association for Personalised Medicine ..................................................................... 26

Carlo INCERTI ................................................................................................................................................... 27

Senior Vice President, Global Market Access, Genzyme ........................................................................... 27

Magnus INGELMAN-SUNDBERG ........................................................................................................................ 28

Professor of Molecular Toxicology, Department of Physiology and Pharmacology, Karolinska Institute, Sweden ........................................................................................................................................................ 28

John IONESCU .................................................................................................................................................. 29

Professor and Scientific Director, Special Clinic Neukirchen, Germany ..................................................... 29

Danube University Krems, Austria .............................................................................................................. 29

Jane KAYE ....................................................................................................................................................... 30

Director, Centre for Law, Health and Emerging Technologies, Oxford University, UK ................................ 30

Alastair KENT .................................................................................................................................................. 31

Chairman, European Platform for Patients’ Organisations, Science and Industry (EPPOSI) ..................... 31

Tim KIEVITS ...................................................................................................................................................... 32

CEO PamGene ........................................................................................................................................... 32

Chair, Personalised Medicine Taskforce, EuropaBio .................................................................................. 32

Ingrid KLINGMAN .............................................................................................................................................. 33

Chair of the Board, European Forum for Good Clinical Practice (EFGCP) ................................................ 33

Jonathan KNOWLES ......................................................................................................................................... 34

Professor of Translational Medicine, Ecole Polytechnique Fédérale de Lausanne and Professor in Personalised Health Care, Finnish Institute for Molecular Medicine, University of Helsinki ....................... 34

Vice Chairman, Caris Life Sciences ............................................................................................................ 34

Denis LACOMBE ............................................................................................................................................... 35

Director, European Organisation for Research and Treatment of Cancer (EORTC) .................................. 35

Catherine LARUE ............................................................................................................................................. 36

Business Unit Director, Bio-Rad .................................................................................................................. 36

Kerstin LINDBLAD –TOH ................................................................................................................................... 37

Professor, Comparative Genomics, Science for Life Laboratory, Uppsala University, Sweden and Scientific Director of Vertebrate Genome Biology, Broad Institute, USA .................................................................... 37

Milan MACEK.................................................................................................................................................... 38

Professor, Charles University, Prague, Czech Republic ............................................................................. 38

President, European Society of Human Genetics ....................................................................................... 38

Mirella MARLOW ............................................................................................................................................... 39

Programme Director, UK National Institute for Health and Clinical Excellence .......................................... 39

Clare MCGRATH ............................................................................................................................................... 40

Senior Director, HTA Policy, Europe, Pfizer ................................................................................................ 40

Thomas METCALFE .......................................................................................................................................... 41

Head, Science & Technology Incubator, Translational Research Sciences, Roche Pharma and Chair, Personalised Medicine Taskforce, European Biopharmaceutical Enterprises (EBE) ................................. 41

Detlef NIESE ..................................................................................................................................................... 42

Head External Affairs Global Development, Novartis Pharma .................................................................... 42

Elizabeth OFILI ................................................................................................................................................ 43

Associate Dean for Clinical Research, Professor of Medicine, Chief of Cardiology and Director, Clinical Research Centre, Morehouse School of Medicine, Atlanta, USA ............................................................... 43

Anders OLAUSON ............................................................................................................................................ 44

President, European Patients' Forum ......................................................................................................... 44

Marisa PAPALUCA AMATI ................................................................................................................................. 45

Section Head of Scientific Support and Projects, European Medicines Agency ......................................... 45

Katherine PAYNE ............................................................................................................................................. 46

Professor of Health Economics, University of Manchester, UK .................................................................. 46

Munir PIRMOHAMED.......................................................................................................................................... 47

Professor and Chair of Clinical Pharmacology, University of Liverpool and NHS Chair of Pharmacogenetics, UK ................................................................................................................................ 47

Krishna PRASAD .............................................................................................................................................. 48

Clinical Assessor, Medicines and Healthcare products Regulatory Agency, UK ........................................ 48

Damjana ROZMAN ............................................................................................................................................ 49

Head of the Centre for Functional Genomics and Bio-Chips, University of Ljubljana, Slovenia ................. 49

Andreas SCHUPPERT ....................................................................................................................................... 50

Director, Applied Sciences, Bayer Technology Services ............................................................................. 50

Matthias SCHWAB ............................................................................................................................................ 51

Professor and Chair of Clinical Pharmacology, Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany ............................................................................................................. 51

Markus SCHWAIGER ......................................................................................................................................... 52

Professor and Director of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Germany ...................................................................................................................................................... 52

Cees SMIT ........................................................................................................................................................ 53

Policy advisor, Patients Network for Medical Research and Health (EGAN) .............................................. 53

Rudolf STROHMEIER ......................................................................................................................................... 54

Deputy Director General, DG Research and Innovation, European Commission ...................................... 54

Charles SWANTON ........................................................................................................................................... 55

Group leader, Translational Cancer Therapeutics, London Research Institute, Cancer Research UK ...... 55

Mathias UHLÉN ................................................................................................................................................ 56

Professor, Science for Life Laboratory and Albanova University Centre, Swedish Royal Institute of Technology .................................................................................................................................................. 56

Axel ULLRICH ................................................................................................................................................... 57

Professor and Director, Department for Molecular Biology, Max Planck Institute, Germany ...................... 57

Anne VAN NEROM ............................................................................................................................................ 58

Coordinator of the Belgian Competent Authority for in vitro diagnostic medical devices, Scientific Institute of Public Health ........................................................................................................................................... 58

Anne-Mieke VANDAMME .................................................................................................................................. 59

Professor, Katholieke Universiteit Leuven, Head of Division Clinical and Epidemiological Virology, Rega Institute and University Hospitals, Belgium ................................................................................................. 59

Tim AITMAN

Professor, Clinical and Molecular Genetics, Group Head and Head of Molecular Sciences, Imperial College London, UK

Consultant Physician in the Imperial Academic Health Sciences Centre, Hammersmith Campus, holds a chair in Clinical and Molecular Genetics at the Imperial College London where he is Chair of the Section of Molecular Sciences and Group Head at the MRC Clinical Sciences Centre. He is Strategic Theme Leader for Genetics in the Imperial College Faculty of Medicine and chairs the Imperial Molecular Pathology Group, which he co-founded with others at Imperial in 2008. Imperial Molecular Pathology won substantial funds from the National Institute of Health Research (NIHR) to equip and refurbish a Laboratory for Molecular Pathology Research, which opened in January 2011. Professor Aitman is a Fellow of the Royal College of Physicians and Academy of Medical Sciences, and is a member of several external advisory boards including the Sir Jules Thorn Medical Advisory Committee and the editorial boards of Mammalian Genome, Physiological Genomics and BMC Bioinformatics. He was the Specialist Adviser for the House of Lords Science and Technology Committee‟s Inquiry into Genomic Medicine (http://www.publications.parliament.uk/pa/ld200809/ldselect/ldsctech/107/107i.pdf), and is currently a member of the Human Genetics Commission, the Government‟s advisory body on developments in Genetics.

Professor Aitman‟s research has combined the use of classical genetics with genome technologies to investigate the genetics of common complex human disorders. Amongst other findings, these studies led to identification of Cd36 as an insulin resistance gene and Ogn as a cause of cardiac hypertrophy, and to the finding that a new type of genomic sequence variation, gene copy number variation, at the Fcgr3 locus, is a cause of autoimmune glomerulonephritis and systemic lupus erythematosus. These studies illustrate ways in which use of genome technologies can give insights into the molecular basis of common diseases, and have potential for translation to advancing the diagnosis, prevention and treatment of these disorders.

Richard BERGSTRÖM

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)

Richard Bergstrom is a pharmacist by training. He received his MScPharm degree from the University of Uppsala, Sweden in 1988.

Until 1992 he worked at the Medical Products Agency as Assistant Head of Registration. He moved to Switzerland where he worked for nine years in regulatory affairs at Roche and Novartis. Before returning to Sweden in 2002, he was Director, EU Regulatory Strategy at Roche Basel.

For nine years he was Director-General of LIF, the Swedish Association of the Pharmaceutical Industry. During this time he was member of the Board of EFPIA and the Council of IFPMA, the international association based in Geneva. In Sweden he had several government appointments, incl. as vice chairman of the Board of the Karolinska Institute. He also served on the Board of IMM, the Swedish Institute against Corruption. Since 2006 he is an advisor to the WHO on Good Governance in Medicine.

Since April 2011 he is Director General of EFPIA, the European association for the research-based industry. In this capacity he also serves on the Board of IMI – the joint research undertaking between EFPIA and the European Commission.

Thomas BEYER

CEO, cmi-experts

Association of Imaging Producers & Equipment Suppliers (AIPES)

Thomas Beyer (Founder and President) holds a PhD in Physics and is co-developer of the first combined PET/CT system worldwide. He has a background in research and project management in academia and imaging industry. Thomas graduated in Physics at the Leipzig University (Germany) and got his PhD in Medical Physics from Surrey University (UK). During his studies he became involved in the development and clinical testing of the first PET/CT prototype (1992-2000) before joining Siemens/CTI PET Systems as an International PET/CT specialist. In 2002 he became a Research Associate in Nuclear Medicine and Radiology and PET/CT project manager at Essen University Hospital (Germany). In 2006 he became teaching professor (Priv-Doz) for Experimental Nuclear Medicine and joined Timaq medical imaging Inc, a Zurich-based Imaging CRO. In 2007 he moved to Philips Medical Systems as International Manager Clinical Science Nuclear Medicine. Thomas is a member of various national and international Medicine organizations, a co-opted member of the European Association of Nuclear Medicine (EANM) Physics Committee and Head of the New Technology working group at the Association of Imaging Producers and Equipment Suppliers (AIPES).

Finn Børlum KRISTENSEN

Director, Centre for Evaluation and HTA, DACEHTA, National Board of Health of Denmark and Director of EUnetHTA

Chairman of the executive committee, European Network for Health Technology Assessment (EUnetHTA) and director of its coordinating secretariat, National Board of Health, Denmark since 2009. Adjunct professor in health services research and health technology assessment at University of Southern Denmark from 1999. Formerly director of the Danish Centre for Health Technology Assessment (DACEHTA), National Board of Health, Denmark 1997–2009.

University graduate in medicine, PhD in epidemiology and medical specialities as primary care and public health physician. Involved with international projects in health services research, epidemiology, health technology assessment, and clinical practice guidelines since the 1980ies. Past chairman of the International Network of Agencies for Health Technology Assessment (INAHTA) (2003–2006), member of the ISPOR Board of Directors (2011-13). Project leader of EUnetHTA, (2006–2008; www.eunethta.net), editor of Health Technology Assessment Handbook (English, translated), 2007, and chief editor of three peer reviewed publication series from DACEHTA 1998–2009.

Angela BRAND

Professor, Maastricht University and Director, European Centre for Public Health Genomics (ECPHG), Maastricht, the Netherlands

Prof. Angela Brand, MD PhD MPH is Director of the Institute for Public Health Genomics (IPHG) at the Faculty of Health, Medicine and Life Sciences at Maastricht University, the Netherlands, and Director of the European Centre for Public Health Genomics (ECPHG).

Prof. Brand is Coordinator of the Public Health Genomics European Network (PHGEN), President of the Section Public Health Genomics within the European Public Health Association (EUPHA), Editor-in-Chief of the international journal Public Health Genomics, Executive Director of the Public Health Genomics international network GRaPH-Int, Associated Member of the international consortium Public Population Project in Genomics (P3G) on biobanking, Advisory Board Member of Alacris Pharmaceuticals, Advisory Board Member of OncoTrack (IMI), Scientific Consultation Group Member of the European Centre for Disease Prevention and Control (ECDC), and Co-Investigator of PIE (Pharmacogenomics & Innovation in Ethics) within the NIH Pharmacogenetics Research Network (PGRN).

Prof. Brand serves as Expert for various organizations such as the European Agency for Reconstruction, the OECD, WHO, the European Commission, the Netherlands Genomics Initiative (NGI), the German Robert Koch-Institut (RKI), Genome Canada, the European Science Foundation (e.g. Forward Look on Personalized Medicine). She is Fellow of the Rockefeller Foundation, USA, and of the 21st Century Trust of the Wellcome Trust, UK. She is Paediatrician and Specialist in Public Health Medicine, holds a PhD in pathology (Münster University, Germany) and a Master of Public Health (Johns Hopkins University, USA) and received her habilitation in Public Health Genomics (Bremen University, Germany).

Deborah BRAUN

Group leader R&D team in Oncology, bioMérieux

After a master in molecular and Cellular Immunology from the ENS Lyon university (1997, Deborah Braun started her career at the Pasteur Institute in Paris where she got a PhD in Immunology. Part of her PhD work took place at the Instituto Gulbenkian de Ciencia in Portugal. During this period Deborah Braun also taught Immunology at the Paris VI university. She then spent 2 years at the Immunoregulation laboratory at the Centre Hospitalier de l'Université de Montréal in Canada (2001-2003). After 3 additional years at the Pasteur Institute, she joined the IVD industry. Deborah Braun has been in bioMérieux for the last 5 years where she has been project and then program manager for innovative projects. Since last year, she is also responsible for a R&D team in Oncology.

Anna BUCSICS

Main Association of Austrian Social Security Institutions (HVB)

Anna Bucsics was born in Budapest, Hungary and lives in Austria. She received her medical degree from the Karl-Franzens-University of Graz, Austria, where she did postgraduate research work in neuropharmacology at the Department of Experimental and Clinical Pharmacology. She was also an instructor there until 1991.

After completing her training in internal medicine at the Hospital of the Order of St. John of God in Graz, she received her diploma as a specialist for Pharmacology and Toxicology.

In 1991 she moved to Vienna where worked as auditor for pharmaceutical expenditures at the Viennese Social Health Insurance and as a pharmacological consultant for the Main Association of Austrian Social Insurance Institutions, where she is now Department Head. She is a Member of the MEDEV Committee since 1998 and was its Speaker from 2001 to 2005. She was also an instructor at the Center of Financial Services and Public Utility Management, University of Vienna and is an occasional lecturer at the Vienna School of clinical Research. She has participated in European projects such as the Pharmaceutical Forum.

Fabien CALVO

Deputy Director General and Director of research, French National Cancer Institute (INCa)

Fabien Calvo, MD PhD, Deputy General Director of the National Cancer Institute, France, has been in charge of the Research Programmes since April 2007. Fabien CALVO is also the director of the Cancer Multi-Institutions Alliance (including INSERM, CNRS, Universities and University- hospitals) in France.

Previously resident and senior registrar of Paris Hospitals, research associate of the National Cancer Institute in Bethesda (NIH / NCI / DCT, USA), he specialised in oncology and haematology. He is currently a professor of pharmacology at the Denis Diderot Medical University in Paris.

He has been the director of the Saint-Louis Hospital CIC (clinical investigation center) and he was the director of INSERM unit 716 on the identification of new molecular targets for the treatment of cancer from 1995 to 2008. He is a member of the post-graduate school “oncogenesis fundamental basis”. He also headed the clinical research programmes in cancer in the Paris area. He has published more than 200 original and review articles.

He also worked as a coordinator of the cancer mission for the Director of the Research and Innovation department, Ministry of Research and Higher Education in 2006 and 2007.

His spheres of activity and interest are the biology of metastatic processes, especially proteases, translational research, preclinical pharmacology and early clinical trials in haematology and oncology.

Jean-Jacques CASSIMAN

Professor Emeritus, Katholieke Universiteit Leuven, Belgium

Jean-Jacques Cassiman was born on April 25, 1943 in Brussels. After his training as an MD with specialty in Paediatrics, he spent 5 years as a post doctoral fellow at the University of Stanford, CA. In 1984 he was appointed full Professor of Human Genetics and in 1999, division head of the Center for Human Genetics in Leuven, Belgium. Since 2008 he is emeritus professor of the KULeuven. He was director of the laboratory for forensic genetics and molecular archaeology and coordinator of EU projects on Cystic Fibrosis. He is Doctor honoris causa of the University of Medicine and Pharmacy of Cluj Napoca (Romania) and professor Honorario of the Catholic University Santiago de Guayaquil.

He was secretary-general of the European Society of Human Genetics (1993-99); liaison officer for the ESHG to the International Federation of Human Genetics

Societies (2002-2008) and President of the ESHG form 2008-2009. Since 2010 he is chair of the Vlaamse Liga tegen Kanker. He is secretary of EPPOSI (European Platform for Patient Organizations, Science and Industry); vice-president of IST (Flemish Institute for Science and Technological aspects of the Flemish Parliament) and vice-president of the Belgian Cystic fibrosis Society. He is the chair of the Fund for rare diseases and orphan drug of the King Baudouin Foundation. He is a member of the Federal Commission on medical and scientific research on embryo‟s in vitro.

He was coordinator of the EU-funded network of Excellence EUROGENTEST, which aims at harmonizing and improving the quality of genetic testing in the EU.

Ian CREE

Director, Translational Oncology Research Centre and Cancer Laboratory, Queen Alexandra Hospital, Portsmouth, UK

Professor Ian A Cree BMSc, MB ChB, PhD, FRCPath, FRCOphth

Ian Cree is Director of the Efficacy and Mechanism Evaluation programme for the UK National Institute of Health Research Evaluation Trials and Studies Coordinating Centre, and also Director of the Translational Oncology Research Centre at the Queen Alexandra Hospital in Portsmouth. Trained as a general pathologist with a PhD in immunology, Ian's research career has been based on investigating disease mechanisms to improve diagnosis and treatment. This has involved him designing, conducting and leading clinical trials as well as a number of large multicentre studies. Ian's current research interests are mostly cancer-related but previous studies have included infectious disease, asthma, and ophthalmology. He has published over 200 papers, and two books.

For the last 20 years, Ian has been involved in developing predictive methods to allow individualised therapy of cancer. New diagnostic technologies are now set to deliver better individual outcomes and improved cost effectiveness for the NHS across a wide range of diseases. Ian is has recently been involved in the implementation of mutation testing services, including external quality assurance schemes, and intra-operative assessment of breast cancer sentinel nodes.

John DALLI

Commissioner for Health and Consumer Policy, European Commission

John Dalli served as a Cabinet Minister in the Maltese Government since 1987 having been first elected to the House of Representatives of Malta on behalf of the Nationalist Party in 1987. He has served as Parliamentary Secretary for Industry (1987-1990), Minister of Economic Affairs (1990-92), Minister of Finance (1992-1996, 1998-2003) Minister of Finance and Economic Affairs and Minister of Foreign Affairs and Investment Promotion (2004). Between March 2008 and February 2010, John Dalli served as Minister for Social Policy which includes the Health, housing, employment and industrial relations portfolio.

As a qualified accountant, Dalli has also worked in the private sector in Malta and abroad, both in industry and as an independent consultant.

In February 2010 John Dalli was appointed as European Commissioner responsible for Health and Consumer Policy.

Romano DANESI

Professor, Department of Internal Medicine, University of Pisa, Italy

Romano Danesi completed his MD degree in 1983 and a PhD in anticancer therapy in 1986. He specialised in medical oncology and in clinical pharmacology. He is currently professor of pharmacology at the University School of Medicine of Pisa (Italy), where he is also the director of the Translation and Clinical Pharmacology unit. Prof Danesi coordinates a research team on translational pharmacology and pharmacogenetics. Since 2009, he chairs the Ethics Committee of the University Hospital of Pisa. Prof Danesi has served as an expert on various occasions, including for the European Commission.

Anne DE BOCK

Portfolio leader Oncology & Infection, Astrazeneca

Anne De Bock has over twenty- five years of experience in regulatory affairs currently as European portfolio leader at AstraZeneca for its oncology and infection portfolio.

Active participant in several workgroups of the European Biopharmaceutical Enterprises association (EBE) such as the Personal Health Care group, the Orphan Drug Committee, and the Regulatory and Technical Committee.

Also active member of the Biotherapy Development Association (BDA), a not-for-profit organization whose primary focus is to develop targeted cancer therapies in oncology using biological and other targeted agents.

Isabel DE LA MATA

Principal Adviser for Public Health at Directorate SANCO – Health & Consumers

Isabel de la Mata was born in Bilbao (Spain). She graduated in Medicine at the University of Basque Country in 1983 and holds post-graduate degrees from the University of Leuven and Paris VI. She is specialist in Preventive Medicine and Public Health.

She worked at the Ministry of Health of Spain and at the Regional Departments of Health in the Basque Country and in Madrid. She has an experience working with International Organisations, such as the WHO, Pan American Health Organisation and Inter-American Development Bank.

From 2004 until February 2008 she worked at the Permanent Representation of Spain to the EU.

Ruxandra DRAGHIA-AKLI

Director, Directorate Health, DG Research and Innovation, European Commission

Previously, Ruxandra Draghia-Akli served as Vice President of Research at VGX Pharmaceuticals (now Inovio) and VGX Animal Health.

Dr. Draghia‟s research activities have focused on molecular biology, gene therapy and vaccination. She is recognised as a global leader in the field of nucleic acid delivery for therapeutic and vaccination applications. She is an inventor on more than a hundred patents and patent applications.

Throughout her career, Dr. Draghia has published numerous scientific papers and reviews in the areas of electroporation, plasmid components, growth and development, immune stimulation, vaccination, health, and well-being. She served as ad-hoc reviewer for granting agencies, annual meetings for gene therapy and endocrinology societies, and scientific journals in Europe and the USA.

Dr. Draghia received an M.D. from Carol Davilla Medical School and a Ph.D. in human genetics from the Romanian Academy of Medical Sciences. Dr. Draghia also completed a doctoral fellowship at the University of Rene Descartes in Paris and a post-doctoral training at Baylor College of Medicine (BCM), Houston, Texas, USA, and served as faculty at BCM.

Máire GEOGHEGAN-QUINN

Commissioner for Research, Innovation and Science, European Commission

Máire Geoghegan-Quinn became the European Commissioner with responsibility for research, innovation and science in February 2010. As part of her specific work responsibilities, she has been appointed by the President of the European Commission Jose Manuel Barroso to draw up a research and innovation plan for the European Union by autumn of this year. Commissioner Geoghegan-Quinn also has political responsibility for the operation of the 7th EU Research and Technological Framework Programme 2007–2013, which is the largest publicly funded research programme in the world.

Between the period March 2000 and February 2010, Máire Geoghegan-Quinn served as a member of the European Court of Auditors.

Between 1975 and 1997, Máire Geoghegan-Quinn was a member of the Irish Parliament (Dáil Eireann). In 1979, she became the first woman to be appointed as a cabinet Minister since the foundation of the Irish state and she served as a Minister with responsibility for the Gaeltacht until 1981.

Between the period 1987-1991, Máire Geoghegan-Quinn served as the Irish Government Minister with responsibility for European Union affairs. She oversaw the preparation of the Irish Presidency of the European Union in 1990, which took place in the immediate aftermath of the collapse of communism in Eastern and Central Europe. During this Presidency, she was the Irish representative at meetings of the Council of Foreign Affairs Ministers. She also chaired Ministerial meetings of the Budget, Telecommunications, Culture and Development Aid Councils.

Between 1992–1993, she served as the Irish Minister with responsibility for Tourism, Transport and Telecommunications. During this period, she supported measures to open up competition in the Irish airline sector.

Between 1993–1994, she was the Irish Minister for Justice. She was one of the negotiators of the Downing Street Declaration which was signed between the Irish and the British Govenments in December 1993. This declaration paved the way to bringing peace to the island of Ireland.

Between 1997-2000, Máire Geoghegan-Quinn served as a non-executive director of both Aer Lingus and of the Ryans Hotel Group. She was a T.V presenter, a columnist in the Irish Times newspaper and she served as a part time business consultant.

She is a former member of the Governing Authority of the National University of Ireland Galway.

In 1996, she authored a book entitled 'The Green Diamond'.

Prior to entering politics in Ireland in 1975, Máire Geoghegan-Quinn qualified and worked as a primary school teacher.

Olga GOLUBNITSCHAJA

Professor, Department of Radiology, University of Bonn, Germany

Secretary-General, European Association for Predictive, Preventive and Personalised Medicine

Olga Golubnitschaja has studied music, journalism, biotechnology and medicine – all Diplomas with excellent marks and gold medals; later she was awarded with fellowships for biomedical research in Paediatrics and Neurosciences (Medical Centres in Austria, Russia, UK, Germany, The Netherlands, and Switzerland). Currently she is an active Professor at several European Universities and in International Programmes for Personalised Medicine. Author of more than 200 international publications in the field; Awards: National & International AvHumbold-Fellow since 1994; The Highest Prize in Medicine 1996 Austria, Eiselsberg-Prize1997 Austria; “Teacher of the Year 2005” in European “Socrates / Erasmus”- Programme; Secretary-General of “European Association for Predictive, Preventive & Personalised Medicine” (EPMA in Brussels, www.epmanet.eu), Editor-in-Chief of “The EPMA-Journal” and of the world-first book with the overall-concept of “Predictive Diagnostics & Personalised Treatment”, NSP, New York 2009; she is Editor of the new (2011-2014) book-series “Advances in Predictive, Preventive & Personalised Medicine”, Springer; European Representative in the EDRN-Network at the NIH / NCI in Washington D.C. http://edrn.nci.nih.gov

Hinrich GRONEMEYER

Professor and Research Director, French National Institute of Health and Medical Research (INSERM)

Hinrich GRONEMEYER is research director at the Institute of Genetics, Cellular & Molecular Biology (IGBMC) in Strasbourg-Illkirch. Trained as chemist he did his PhD in Biochemistry at the RUB Bochum, Germany, and joined as post-doc the team of Pierre Chambon (Strasbourg, France), where he became head of the departments „Cell Biology and Signal Transduction‟ and „Cancer Biology‟ in the newly founded IGBMC. He is Research Director (Class „Exceptional‟) of the French National Institute of Health and Medical Research (INSERM) and was Privatdozent at the University Karlsruhe. Hinrich Gronemeyer had extensive collaborations with the pharmaceutical industry (Bristol Myers Squibb, Roussel-Uclaf, Schering AG, etc.) and has been involved in evaluations and brainstormings of several major companies. His 189 publications received an average citation of 83.34 and an h-factor of 59.

Hinrich GRONEMEYER has long standing experience in the field of nuclear receptors, with a particular focus on the functional characterization and modulation of retinoid receptors in health and disease. His team has contributed to pioneering work on the structural and functional analysis of nuclear receptors and signal propagation to the transcription and epigenetic machineries, and its modulation by the design of ligands with different functionalities. Presently, his team studies nuclear receptor action from a systems biology perspective to reveal the temporal regulation of gene networks and program diversification by epigenetic actors. The basic research done in his group has been always been linked to disease; in this respect several novel paradigms for cancer therapy have been developed, including the recognition of cancer-selective apoptosis in retinoid and epigenetic drug therapies or the recently reported “autonomous rexinoid apoptosis”. Over the recent years his team has developed and optimized technologies to facilitate genome-wide disease-relevant transcription factor and epigenomics studies, including ultra-small sample sizes, and to comprehensively investigate the rapidly expanding RNA universe.

Hinrich GRONEMEYER is coordinator of the 6th FP project EPITRON (Epigenetic treatment of neoplastic disease) and partner in several other EU HEALTH projects. He has coordinated the HERMES („Human Epigenome Research for Medicine and European Science‟) consortium in the context of the High Impact Initiative on the Human Epigenome.

Ivo GUT

Director, National Genome Analysis Centre, Barcelona, Spain

Ivo Gut took on the direction of CNAG in January 2010.

He qualified in Chemistry at the University of Basel in 1985 and obtained a PhD in Physical Chemistry from the same university in 1990. Then he joined the research group of Prof. Irene Kochevar at Harvard Medical School as a research fellow.

Between 1993 and 1996 he was research fellow with Dr. Stephan Beck at the Imperial Cancer Research Fund in London. Later, at the Max-Planck-Institute for Molecular Genetics he led a group in the Department for Vertebrate Genomics of Prof. Hans Lehrach. In the 11 years before joining the CNAG he worked at the Centre National de Génotypage of the Commissariat à l'Energie Atomique in Evry, France, first as Head of Technology Development and later as Associate Director under Prof. Mark Lathrop.

His research interests are high-throughput nucleic acid analysis, sequencing, SNP genotyping, genomics, genetics, nucleic acid and protein analysis methods (molecular biological techniques and chemical modification), implementation of methods, automation and analysis. He is the author of over 100 research papers, inventor of 24 patents and patent applications, founder of 4 biotech companies (Genom Analytik GmbH, Biopsytec GmbH and Epigenomics AG, Integragen SA). He is the coordinator of the 12M€ EU FP7-funded Integrated Project READNA on DNA sequencing technology development.

David HAERRY

Board of Directors, European AIDS Treatment Group

Information will soon be available

Alain HURIEZ

CEO, TcLand Expression

Chairman, European Association for Personalised Medicine

Alain Huriez is founder and chairman of EPEMED since 2009 (www.epemed.org) the European Personalised Medicine association to advance the cause of personalised medicine and high value molecular diagnostic markers in Europe.

Alain Huriez is also since mid 2006 Chief Executive Officer of TcLand Expression SA (www.tcland-expression.com) a leading molecular diagnostic company in immunology he co-founded with several scientists in Nantes.

From early 2003 to mid 2006 Alain was CEO at Neovacs SA, a company developing therapeutic vaccines. Alain brings an experience of general management and financing in the biotechnology sector, in various executive positions as Associate Partner Biotech at Truffle Capital, a €220m VC fund (2002-2003), Vice-President Quintiles Europe, the world's largest CRO (1999-2002), in charge of the Biotechnology Consulting Group, a separate entity that he founded, specialized in offering strategic counsel to biotechnology listed companies in Europe and the USA.

Alain brings also fifteen years of experience in biotech drug development, from pre-clinical to registration.

Alain is M.D., holds a Post Graduate degree in Business Administration (MBA), a Statistics degree from the University of Paris VII, and a Masters of Pharmaco-Economics from the University of Paris I Sorbonne.

Prior to joining the Pharmaceutical Industry, he worked 1 year as head of an emergency room in a large teaching hospital and practiced 2 years as General Practitioner.

Alain supports and triggers several biotechnology initiatives in the area of biomarkers and theranostics, is Vice President of LEEM Biotech Committee since 2005 and member of the Personalized Medicine task force of EBE.

Carlo INCERTI

Senior Vice President, Global Market Access, Genzyme

Dr. Incerti serves as Officer of Genzyme Corporation, where he oversees Global Market Access (GMA), which includes Global Regulatory Affairs and Compliance, Corporate Quality Systems, Global Patient Safety and Risk Management, Global Strategic Pricing & Health Outcomes, Global Policy Programs and Global Health Technology Assessment Strategy.

The mission of the Global Market Access Group is to facilitate and enable patient access for Genzyme‟s products through an integrated global strategy. GMA functional area operates as a continuum to enhance the value proposition of Genzyme‟s products, thus ensuring a successful “product journey” from the development stage through the administration of therapy.

Dr Incerti is a Board Certified Endocrinologist, who started his career in the medical profession as a staff member and then as Associate Professor at the Department of Endocrinology of Modena University Hospital in Italy. He joined Genzyme in 1992 as Medical Director Europe and then was promoted to Senior Vice President Biomedical and Regulatory Affairs Europe. In this tenure he successfully led the European Clinical and Regulatory Affairs group in gaining a Marketing Authorisation Approval in Europe for all of the Genzyme products developed so far. In 2003 he assumed the responsibility for the whole EU R&D group as Head Research & Development Europe, which then included also Latin America. Dr Incerti has also served as Chairman of the Board of Directors of Genzyme Srl in Italy and of Genzyme Europe BV in The Netherlands.

He is currently Vice President of EBE (European Biotechnology Enterprises), member of the Board of EFPIA (European Federation of Pharmaceutical Industries and Associations) and Vice Chairman of the Governing Board of IMI (Innovative Medicine Initiative), a Joint Undertaking between the EU Commission and EFPIA, which oversees the management of EU research funds for a total of 7 Billion Euro.

Magnus INGELMAN-SUNDBERG

Professor of Molecular Toxicology, Department of Physiology and Pharmacology, Karolinska Institute, Sweden

Magnus Ingelman-Sundberg serves as Chairman of the Recruitment committee at Karolinska Institutet and is a member of The Nobel Assembly at Karolinska Institutet. He was Chairman of the Editorial Board of Pharmacogenetics and Genomics 2005-2010 and is Chairman of the Microsomes and Drug Oxidation organisation. He has 350 original papers, 18 700 citations and an h-factor of 74. He is ranked as the 4th most highly impact researcher of 4,000 in the field of drug metabolism (www.cytochrome.net ) and one of the worlds most cited authors within the category Pharmacology http://isihighlycited.com/ .Ingelman-Sundbergs group identified the first example of stable gene duplication and gene amplification in the human genome in 1993 and identified the ultrarapid metaboliser (UM) phenotype for CYP2D6 and CYP2C19. The current research is centered about genetic predictors for drug response and adverse drug reactions.

John IONESCU

Professor and Scientific Director, Special Clinic Neukirchen, Germany

Danube University Krems, Austria

Prof. John Ionescu is Scientific Director and founder of the Spezialklinik Neukirchen (Bavaria, Germany) for the treatment of allergic, skin and environmental disorders in agreement with the principles of nutritional and environmental medicine. He received 1983 his PhD in medical biochemistry at the University of Saarbrücken, Germany, and conducted several research programmes in atopic disease, psoriasis, arthritis and MCS syndrome.

His 160 bed facility (www.spezialklinik-neukirchen.de) is fully integrated in the official hospital system and the treatment fees are reimbursed by all German and Austrian health insurances.

The original diagnostic and therapy procedures of his cortisone-, cytostatic and radiation-free concept have been reported in more than 200 scientific papers in Germany, Europe, USA and Asia. Current research involves the investigation of redox and free radical reactions as well as of genetic polymorphisms in cancer, dermatological and environmental patients.

Between 1998 and 2006 he served as Professor of Applied Laboratory Medicine at the Capital University, Washington DC and since April 2007 he is acting as Visiting Professor for Nutritional Medicine at the Donau University in Krems, Austria. Since March 2009 Prof. Ionescu is a member of the Commission for Environmental Medicine of the German Ministry of Health in Berlin.

Jane KAYE

Director, Centre for Law, Health and Emerging Technologies, Oxford University, UK

Dr. Jane Kaye is a Director of the Centre for Law, Health and Emerging Technologies at Oxford: HeLEX at the University of Oxford. She obtained her degrees from the Australian National University (BA); University of Melbourne (LLB); and University of Oxford (DPhil). She was admitted to practice as a solicitor/barrister in 1997 and is member of the University of Oxford‟s Faculty of Law. She is also on a number of international expert committees and scientific advisory boards. She is on the editorial boards of Law,

Innovation and Technology, the Journal of Law and Information Science and Genomics, Policy and Society. In 2011 the book written with her colleagues will be published by Hart – Kaye J, Gibbons, SMC, Heeney C. Parker M. And Smart A, Governing Biobanks: Understanding the Interplay Between Law and Practice.

Her research involves investigating the relationships between law, ethics, and practice in the area of emerging technologies in health. The main focus is on genomics with an emphasis on biobanks, privacy, data-sharing frameworks, global governance and translational research. Her full profile is available at http://helex.medsci.ox.ac.uk/

Alastair KENT

Chairman, European Platform for Patients’ Organisations, Science and Industry (EPPOSI)

Alastair Kent is the Chair of the European Platform for Patient Organisations, Science and Industry (EPPOSI). This is a multi-stakeholder platform for the exploration of aspects of common concern in European science and health policy. He is the President of the European Genetic Alliances Network (EGAN), which brings together national alliances of patient organisations supporting those affected by serious and life limiting genetic disorders, and the Director of Genetic Alliance UK the British patient alliance. He has been a patient advocate for over 20 years, and was recently awarded an OBE for services to healthcare in the UK.

Tim KIEVITS

CEO PamGene

Chair, Personalised Medicine Taskforce, EuropaBio

Tim Kievits started his career in 1985 in the department of Human Genetics at the University of Leiden. He joined Organon Teknika‟s viral diagnostics R&D group in 1990. After leaving his position as Director Technology of the Nucleic Acid Diagnostics Business Area, he spun-out an innovative microarray technology, founding PamGene in 2000. Serving as CEO at PamGene he secured investments from international venture capital funds, local and private funds (in 2000, 2003 and 2008). With his team he focuses on the development of unique functional biomarker microarray tests enabling the best match between patients and targeted medicines in oncology.

Ingrid KLINGMAN

Chair of the Board, European Forum for Good Clinical Practice (EFGCP)

Dr. med. Ingrid Klingmann FFPM, FBCPM studied medicine in Germany and specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine.

After having joined pharmaceutical industry as medical advisor, she held senior management positions in different international contract research organisations and was responsible for operational, scientific, regulatory and business aspects of international clinical research projects from Phase I to Phase IV. Since January 2003 she has her own pharmaceutical development and site management support consulting company. From January 2004 to July 2007 she was also CEO of two investigative sites in London, UK, performing clinical trials in acute and chronic pain as well as musculo-skeletal diseases.

Dr. Klingmann is a founding member and currently Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP) as well as Co-Chair of the EGAN/EFGCP Working Party “Patients‟ Roadmap to Treatment”. On behalf of EFGCP she was the Project Coordinator for the FP7-funded ICREL project on measuring the impact of the current clinical trials legislation on clinical research in Europe and she coordinated the programme committee of the EFGCP Annual Conference 2010 “Aspects of Personalised Medicine for Society – A Challenge Yet to be Met”.

She is a founding member of the Association for Applied Human Pharmacology (AGAH) in Germany where she also established and chaired the Ethics Working Party of this organisation dealing with ethics and GCP issues in Human Pharmacology in Germany; today she is chairing AGAH‟s regulatory affairs working party and is President; and in the Drug Information Association (DIA) she was a member of the Steering Committee Europe (now Advisory Council Europe), a former chair person of the SCE, a Member of the Board, a Member of the Foundation Board, and speaker, session chair and programme committee member for numerous conferences of the DIA.

Dr. Klingmann chairs the clinical research module of the post-graduate Master in Regulatory Affairs course at the University of Bonn, Germany and the Diploma Course on Clinical Trial Practices and Management at the University of Basel, Switzerland.

Jonathan KNOWLES

Professor of Translational Medicine, Ecole Polytechnique Fédérale de Lausanne and Professor in Personalised Health Care, Finnish Institute for Molecular Medicine, University of Helsinki

Vice Chairman, Caris Life Sciences

Dr. Knowles was Head of Group Research and Member of the Executive Committee at Roche up to the end of 2009. He was a member of the Genentech Board for the last 12 years and a member of the Chugai Board for seven years. Dr. Knowles was also the chairman of the Corporate Governance Committee of Genentech. Dr. Knowles focused the company on key disease biology areas of high medical need and in-depth understanding of molecular pathology of disease. Under his leadership, the company developed and implemented a strategy of highly effective therapies based on personalized healthcare and built one of the best pharma pipelines in the sector.

He was for 5 years the Chairman of the Research Directors‟ Group of EFPIA (European Federation of Pharmaceutical Industry Associations) and was the first chairman of the Board of the Innovative Medicines Initiative, a unique public-private partnership between 28 Pharmaceutical companies and the European Commission with a budget of more than 2 Billion Euros over five years.

Jonathan Knowles holds a Distinguished Professorship in Personalized medicine at FIMM (Institute for Molecular Medicine Finland) at the University of Helsinki, was recently appointed Professor of Translational Medicine at EPFL in Switzerland,and has been appointed to a Visiting chair at the University of Oxford. In addition, he is a Member of the European Molecular Biology Organization and a Visiting Fellow of Pembroke College Cambridge. He is also a Member of EMBO.

Dr. Knowles attended Magdalen College School in Oxford and received a First Class Honours Degree in Molecular Genetics from the University of East Anglia in Norwich, England. He received his Ph.D. in Genetics of Mitochondria with Professor G. H. Beale F.R.S. from the University of Edinburgh in Scotland.

From the beginning of 2010, Dr. Knowles joined the Board of Caris Life Sciences, an international cutting edge molecular diagnostics company based in Irving, Texas. He is currently a Vice Chairman of Caris, and is focused on the development of revolutionary new blood based diagnostics for cancer and other serious diseases.

Jonathan Knowles remains very excited by the short term prospects for more personalised medicine as he believes this is the best and perhaps only way in which effective new therapies can be created.

Denis LACOMBE

Director, European Organisation for Research and Treatment of Cancer (EORTC)

Denis Lacombe, MD, MSc

In 1988 Dr. Lacombe graduated as MD from the University of Marseilles (France). He was granted for a Master Post-doctoral Fellowship at the Roswell Park Cancer Institute, Buffalo, NY, USA for Fundamental and Clinical Pharmacokinetics from 1989-1991.

From 1991 to 1993 he worked as Clinical Research Adviser in charge of the development of a new drug in oncology in the pharmaceutical industry. He was especially involved in the management of the phase I and phase II studies in Europe.

Since September 1993 he is working as Clinical Research Physician at the European Organisation for Research and Treatment of Cancer (EORTC) in Brussels. Between 2003 and 2009 he was a Clinical Research Physician for the Head & Neck Tumor Group. He is still a Clinical Research Physician for the Brain Tumor and the Lung Groups.

Between 1993 and 2006, Dr. Lacombe was in charge of coordinating the Regulatory Affairs Unit ensuring compliance to the regulatory framework.

Until 2007, as Assistant Director Medical Affairs, he coordinated the EORTC New Drug Development Team (NDD Team) which supported EORTC clinical groups conducting new drug development studies from protocol development to publication.

Since November 2007, he has been appointed as Scientific Director of the EORTC.

Amongst his activities, he is responsible for the Early Project Optimization Department (EPOD) dedicated to helping the groups in the development of studies in phase with EORTC‟s guidelines and strategy. He is still involved in the development of EORTC procedures to comply with the evolving regulations.

Since November 2010, he has been appointed as Director Headquarters of the EORTC

Catherine LARUE

Business Unit Director, Bio-Rad

After a Ph.D in Immunology, Catherine Larue began her career at Sanofi, Montpellier France in the cardiovascular R&D department.

She then joined Sanofi Diagnostics Pasteur, at Chaska MN (USA) for 3 years where she was responsible for Assay Development. She returned to Paris, France as a Director R&D for Sanofi Diagnostics Pasteur, then for Bio-Rad.

She completed an Executive MBA in 2003 and since, she had worked for 7 years as a Director of Business Unit at Bio-Rad.

She is an author of 85 publications and filed 13 patents. Her main expertise relies on cardiovascular and neurodegenerative biomarkers.

She serves in standardisation committees at AACC and IFCC; she also chairs the Biomarkers group in the Competitiveness Bio-cluster (Medicen, Paris).

Kerstin LINDBLAD –TOH

Professor, Comparative Genomics, Science for Life Laboratory, Uppsala University, Sweden and Scientific Director of Vertebrate Genome Biology, Broad Institute, USA

At the Broad Institute Kerstin is responsible for the 29 mammals project to annotate the human genome for functional constraint as well as for a large number of vertebrate genome projects several of which emphasize the detection of selective sweeps. She also leads the dog disease-mapping group. Her group has developed several SNP chips that have been used to identify canine disease genes.

In Uppsala, Kerstin‟s research emphasizes the dog as a comparative model for human diseases. Her group is mapping over 20 diseases including cancer, autoimmune, cardiac and neurological diseases. Many of the findings are now being translated to human patients cohorts. She is an active participant in and on the Steering Committee of the LUPA consortium an FP7 project aiming to map human complex traits using dog a as a model.

Kerstin is also the Director Science for Life Laboratory Uppsala, a novel strategic research center with the vision of being an internationally leading center that develops, applies, and provides access to large-scale technologies for molecular biosciences with a focus on translational medicine and on evolutionary and systems biology.

An author on over 100 papers, Kerstin has received several scholarships and awards from the Svenska Institutet Scholarship for Research Abroad and the Swedish Medical Research Council and the prestigious European Young Investigator award (EURYI), Fernström‟s price and the Lilly och Sven Thureus pris.

Kerstin received her Ph.D. from the Department of Molecular Medicine, Karolinska Institute, Sweden, in 1998 studying trinucleotide repeat disorders.

Milan MACEK

Professor, Charles University, Prague, Czech Republic

President, European Society of Human Genetics

Professor Milan Macek Jr. MD, DSc is the chairman of the largest academic medical genetics institution in the Czech Republic (ublg.lf2.cuni.cz). He is also the President of the Czech Society of Medical Genetics (www.slg.cz), Board member of the European Society for Cystic Fibrosis (www.ecfs.eu) and the current President of the European Society of Human Genetics (www.eshg.org). His major specialty comprises DNA diagnostics in pediatric genetics with a particular focus on cystic fibrosis which serves as a paradigm for rare diseases. His institute is a "clearing centre" for dissemination of knowledge gathered within various international projects, such as CF Thematic Network, EuroGentest, to all interested fellows from Central and Eastern Europe and his laboratory was awarded the FP5 EU Marie Curie Training Site. Prof. Macek did his first postdoc at the Institut of Human Genetics in Berlin (under the guidance of prof. J. Schmidtke and prof. K. Sperling), continued as a postdoctoral fellow at the McKusick-Nathans Centre for Genetic Medicine, Johns Hopkins University in Baltimore (under the mentorship of prof. G. R. Cutting) and during that time he was also a fellow at Harvard School of Medicine in Boston. He has been involved in 26 international grants, so far (e.g. DGzBM-Germany; NIDDK and DHHL-USA; APAPE-France; EU - FP4: INCO-BIOMED, FP5: Copernicus II, CFChip, CRMGEN, CFThematic Network, COGENE, FP6: EuroCareCF, EuroGentest, Snip2Chip, Micro2DNA, NeuroproCF, EuroCareCF or Phoebe and FP7: TechGene, DG Sanco – ENCE-LAM, Ecorn-CF, RTDF secretariat, RD Platform). He was the local host of the 2005 European Society of Human Genetics conference (www.eshg.org/eshg2005) and of the 2008 European Cystic Fibrosis Conference (www.europeancfconference.org), both held in Prague. Prof. Macek is national coordinator of Orphanet (www.orpha.net) and has been the chief advisor of the Czech EU Council Presidency (www.eu2009.cz) under which the “EU Council recommendation on an action in the field of rare diseases“was adopted in June 2009. Currently, he serves on the EUCERD (www.eucerd.eu) committee and has been involved in the establishment of the Czech National Strategy for Rare Diseases (http://ec.europa.eu/health/rare_diseases/national_plans/detailed/index_en.htm).

Mirella MARLOW

Programme Director, UK National Institute for Health and Clinical Excellence

Mirella Marlow joined NICE in 2004, having previously worked for 15 years in senior roles for various payers in the English National Health Service, commissioning general acute, mental health and specialised services. She managed NICE‟s Interventional Procedures Programme (assessing the safety and efficacy of novel procedures) and latterly has led the planning and development of new programmes at NICE for evaluating medical devices and diagnostics.

Mirella has an MBA and a Masters in Medical Ethics and Law from Keele University, where her interests included the ethics of measuring the cost-effectiveness of interventions to improve the safety of healthcare, and legal cases relating to healthcare rationing. She is a contributor to work with the European Network for Health Technology Assessment (EUnetHTA) on integrating ethical considerations when determining the value of health technologies.

Clare MCGRATH

Senior Director, HTA Policy, Europe, Pfizer

Following a brief period as a university lecturer in Physiology, I joined Clinical R&D at ICI Pharmaceuticals (now Astra Zeneca) where I worked for 9 years managing clinical development programmes and latterly, staffed portfolio planning and decision support.

From 1993 to 1998 I established and was MD of Mapi Values, a CRO specialising in Outcomes Assessment. During this time, I worked with most of the large Pharmaceutical companies and with many key academics in this field.

In 1998, I was recruited by Pfizer to establish an Outcomes Research Function in Europe which I then extended to other regions in the company over a period of 9 years during which I was responsible for all of the OR to support development decisions, P&R submissions and phase IV programmes.

In 2007 I took on the full time role of HTA policy and am currently responsible for aligning Pfizer‟s external engagement with internal decision making. I have been active in HTA policy research since 2005 and participate in various forums to discuss and shape the role of this discipline in decision making in health care.

Thomas METCALFE

Head, Science & Technology Incubator, Translational Research Sciences, Roche Pharma and Chair, Personalised Medicine Taskforce, European Biopharmaceutical Enterprises (EBE)

Tom Metcalfe works within the Translational Research Sciences group of Roche‟s Pharma Research and Exploratory Development organization. Tom has been in this role since January 2010. Previously (2007 until 2010) Tom was head of Roche‟s Personalized Healthcare Portfolio, a joint program between Roche‟s Pharmaceutical and Diagnostics divisions, which had the goal of driving Personalized Healthcare concepts forward across the Roche Group. From 2004 until 2007 Tom was Head of the Roche Biomarker Program, a program with similar goals.

Since it‟s inception in mid-2010 Tom has also been chair of the European Biopharmaceutical Enterprises‟ Task Force on Personalised Medicines.

Prior to these appointments Tom held a number of senior management positions within the Roche Molecular Diagnostics Business Area of Roche Diagnostics, located in Pleasanton, California. These responsibilities included leading the development of a Clinical Genomics business and Business Development (2001 – 2003) and leadership of the Regulatory, Clinical Affairs and Project Management functions (2003 – 2004). Tom studied Biochemistry at King‟s College, London University in 1982 and gained an MBA from the Open University, UK in 1996. Tom worked for Roche Diagnostics in Europe from 1993 to 2001 where he held a variety of positions of increasing responsibility with a number of Business Areas of Roche Diagnostics, culminating in his appointment in 1998 as Head of Global Marketing for Roche Applied Sciences. Tom has lived and worked in Switzerland, Germany and California during his career with Roche.

Detlef NIESE

Head External Affairs Global Development, Novartis Pharma

Detlef Niese is head of Global Development External Affairs at Novartis Pharma A.G responsible for policy and ethical issues concerning drug development. He is a licensed pharmacist and physician with board certification in internal medicine and specialisation in Clinical Immunology. He received a research based doctoral degree in immunogenetics from the faculty of Medicine, University of Bonn.

As a research fellow Dr.Niese was member of an International research group working on the genetics of the human MHC region with specific interest in the genetic basis of diseases. Following his residency in internal medicine Dr.Niese was appointed head of Clinical Immunology and Clinical Pathology at the university hospital of Bonn (Germany). Following 18 years in research and medical service Dr.Niese joined Clinical Research and Development of Sandoz AG in 1992 which later became Novartis AG. He held positions of increasing responsibility in Clinical R&D. Since 2003 he is responsible for External Affairs in Clincical R&D and since 2008 in Global Development.

Dr.Niese is member of the Faculty of Medicine of the University of Bonn, Germany, teaching Internal Medicine and Clinical Immunology. He also teaches at the faculty of medicine, university of Basel, Switzerland and is a member of the Executive Board of the Pharma Center at the university of Basel.

Dr.Niese represents Novartis on several International Organisations, and serves as Secretary of the Novartis Foundation for Biological and Medical Research.

From 2003-2004 Dr.Niese was a member of the expert group for the European Commission on Legal, Societal, and Ethical Issues of Genetic Testing.

Elizabeth OFILI

Associate Dean for Clinical Research, Professor of Medicine, Chief of Cardiology and Director, Clinical Research Centre, Morehouse School of Medicine, Atlanta, USA

Elizabeth O. Ofili, MD, MPH, FACC is a Professor of Medicine, and Chief of Cardiology, at Morehouse School of Medicine. She also serves as the Associate Dean of Clinical Research, and Director of the Clinical Research Center. Dr. Ofili is known for her expertise in the field of cardiovascular medicine and health disparities with a focus on translating discoveries to benefit patients.

Dr. Ofili is the national PI of the WARFARIN study, which was recently approved by the Center for Medicare and Medicaid (CMS) as the first large scale randomized clinical trial to evaluate gene identification ability to predict patient response and improve safety when dosing warfarin, the world‟s leading anti-blood clotting drug. Through the WARFARIN study and other diagnostic and risk identification profiles, Dr. Ofili is working collaboratively with Dean Sproles, CEO of Iverson Genetic Diagnostics, to advance personalized approaches to health and health care delivery.

A passionate advocate for the inclusion of minorities in biomedical research, she has helped to raise over $150 million in research funds, to support research infrastructure and training at Morehouse School of Medicine. She has trained or mentored over 50 post doctoral fellows and faculty, and over 30 undergraduate and high school seniors. She is a recipient of over 50 scientific, service and health policy awards including: the Dr. Daniel Savage Scientific Award from the Association of Black Cardiologists; the Nannette K. Wenger Award for Health Policy-WomenHeart Advocacy Group and the National Library of Medicine Exhibit: Changing the Face of Medicine, the Rise of America‟s Women Physicians. She was recognized as one of America‟s leading physicians by Black Enterprise Magazine; Physician of the Year, by the US Congressional Health Advisory Board; the nation‟s top 25 female physicians by Heart and Soul Magazine, and Who’s Who in Black Atlanta. She serves on the Board of Directors of Georgia BIO, Georgia‟s Life Sciences Company and the Cardiovascular Board of the American Board of Internal Medicine. Dr. Ofili is the past president of the Association of Black Cardiologists, and has published over 130 scientific papers and book chapters appearing in national publications such as The Journal of American Medication Association, the New England Journal of Medicine, Circulation, and the Journal of the American College of Cardiology.

Anders OLAUSON

President, European Patients' Forum

Anders Olauson was involved in the founding of the Agrenska Centre in 1989. He served as director until 2004 and since then has been chairman and chief executive officer. He is responsible for establishing The Agrenska Virtual International Academy, a research centre for rare disorders.

Anders is particularly concerned with the impact of rare conditions on children and their families. His work involves contact with both national and regional legislative bodies on the subject of rare disorders. He is also in contact with representatives of hospitals, education and labor unions as well as other key players in the field of rare diseases.

Anders has been a member of the board of Eurordis from 1999 until 2010, and was president from 1999 to 2001. He currently represents Eurordis as a member of the board of the European Patients‟ Forum (EPF). He has been president of EPF since June 2005.

Anders represented EPF in both steering committee and at The Pharmaceutical Forum, which was established by DG Sanco and DG Enterprise in 2005.

Agrenska was in 2005 appointed member of ECOSOC within United Nations, with “special consultative status”.

Since 2006 Anders is a member of the advisory group for Health Research within DG Research. In 2005 Anders was accepted as a researcher within the PhD program at Gothenburg University.

The Swedish Government appointed Anders September 15th 2008, to be a member of the Advisory Council at The National Board of Health and Welfare.

Anders Olauson received HM The King of Sweden‟s Medal for his valuable contributions in the field of disability. Anders was presented with the King‟s medal 8th size, with the Seraphim Ribbon at the Royal Palace in Stockholm, the 28th of January 2010.

Marisa PAPALUCA AMATI

Section Head of Scientific Support and Projects, European Medicines Agency

Marisa Papaluca joined the European Medicines Agency (EMA) in late 1994 and occupied various positions as Scientific secretary of the Biotech Working Party (BWP), Deputy Head of the Sector Biologicals and Biotech Products and of the Safety and Efficacy Sector in the Pre-Authorisation Human Unit. She coordinated the CHMP Working Parties on Gene Therapy (GTWP) and the Working Party on Similar Biological Medicinal Products (BMWP).

Since the end of 2009 Marisa Papaluca is Head of Section for Scientific Support and Projects in the Sector Human Medicines Special Areas, Unit Human Medicines Development and Evaluation. The Section is in charge of providing scientific input and support across the EMA on statistics and clinical trials methodology, non-clinical development, Environmental Risk Assessment, Nanotechnology, Pharmacogenomics and Business Pipeline.

As member of the Pharmacogenomics Working Party (PGWP) Secretariat and Chair of the EMA‟s Innovation Task Force Marisa Papaluca has been in charge of regulatory and scientific activities in the field of innovative pharmaceuticals development with special scientific interest on Advanced Therapies and genomics for the Agency at EU and international level. She also holds the position of Professor on Pharmacogenomics at the Faculty of Medicine in Rome – Tor Vergata University.

Katherine PAYNE

Professor of Health Economics, University of Manchester, UK

Katherine was awarded a personal Chair in Health Economics at The University of Manchester in August 2010. She has over 16 years experience working as an academic health economist with different clinical research groups (pharmacy, psychiatry, genetics). Four years ago, Katherine joined the Health Sciences - Methodology Group, which allowed her to develop applied and methodological grants. In 2007, she was awarded an RCUK Academic Fellowship to focus on the evaluation and valuation of genetic technologies including pharmacogenetic tests. She has expertise in the use of qualitative and quantitative methods to value and evaluate health care services, which forms the basis for the methodological and applied work in her Fellowship. Ongoing and recent projects include: identifying and costing pathways of care for people with inherited ataxia; building an economic model to identify the most appropriate interval for breast cancer screening; preliminary economic evaluation of high-throughput whole genome sequencing technologies and economic evaluations of pharmacogenetic testing. Recent examples of my work in stratified medicine include a prospective randomised trial and economic evaluation of TPMT testing for azathioprine and two health technology assessments of CYP2D6 testing for (1) patients treated with antipsychotics and (2) women with breast cancer treated with tamoxifen.

Munir PIRMOHAMED

Professor and Chair of Clinical Pharmacology, University of Liverpool and NHS Chair of Pharmacogenetics, UK

Munir Pirmohamed qualified in Medicine in 1985, obtained a PhD in Pharmacology in 1993, and was appointed Consultant Physician at the Royal Liverpool University Hospital in 1996. He was awarded a Personal Chair in Clinical Pharmacology at The University of Liverpool in 2001, and in 2007, was appointed to the NHS Chair of Pharmacogenetics. He is also Head of Department of Molecular and Clinical Pharmacology and Director of the Wolfson Centre for Personalised Medicine. Professor Pirmohamed is a Member of the Commission on Human Medicines and Chair of its Pharmacovigilance Expert Advisory Group. His main area of research is in pharmacogenetics and drug safety, where he has published over 250 articles. He is funded by the UK Dept of Health, NIHR, MRC, Wellcome Trust, Wolfson Foundation, and the EU FP7 programme. The aim of the research is to maximise the benefits of drugs and minimize their harms. This is being achieved through the use of different strategies ranging from improvements in prescribing to the development of genetic and other tests for predicting drug response.

Krishna PRASAD

Clinical Assessor, Medicines and Healthcare products Regulatory Agency, UK

Dr Prasad is currently a senior clinical assessor at the MHRA, the UK regulatory Agency and a practising cardiologist with a special interest in cardiovascular medicine, CV genetics, risk stratification and personalised medicine. He is a member of the pharmacogenomics working party of CHMP and has continued to work in developing regulatory documents in this area. He has keen a interest in enhancing the interaction between academia, regulators and the other stakeholders. He is also a member of the cardiovascular subgroup of the Efficacy Working party of the CHMP and currently EU/CHMP representative for the ICH process relating to the E-14 guidance document on QT/QTc evaluation. He is a member of the steering group of the UK Pharmacogenomics and Stratified-Medicine Network. He participates in the stakeholders group for drug-device combinations within the MHRA and has close interaction with colleagues from the devices sector both for cardiovascular devices and for diagnostics and companion diagnostics related to Pharmacogenomics.

Prior to joining the regulatory agency, he was a British Heart Foundation supported Research Fellow and Lecturer in Cardiology with specific interest in heart failure, arrhythmia and cardiomyopathy. He has a number of publications including peer review papers, book chapters and editorials.

Damjana ROZMAN

Head of the Centre for Functional Genomics and Bio-Chips, University of Ljubljana, Slovenia

Prof. Dr Damjana Rozman (1960) is a full professor of Biochemistry and Molecular Biology at Faculty of Medicine, University of Ljubljana, Slovenia, and Head of the Centre for Functional Genomics and Bio-Chips, the Slovenian National Microarray Facility. She was trained as B.Sci. organic chemist (1983) and Ph.D. biochemist (1994) at University of Ljubljana and did her post-doctoral training (2005–07) in USA at Vanderbilt University, School of Medicine. In 2004–05 she was a Visiting Scholar at IGBMC, Strasbourg, France and is since 2002 Visiting Professor at School of Medicine, University of Zagreb, Croatia. D. Rozman was principal investigator of many Slovenian and international research projects, including scientific coordination of the FP6 project »Steroltalk« (2005-08) and the Slovene part of the FP7 Marie Curie ITN project “FightingDrugFailure” (2009-13). She is among leaders of the functional genomics efforts in Slovenia in the last 10 years. For special achievements in biochemistry and molecular biology she received the Slovenian National Science Award (Zois Award) in 2009. D. Rozman is engaged in education, from undergraduate teaching of Biochemisty and Molecular Biology for students of medicine and dental medicine, to graduate courses of Functional Genomics, etc. Six Ph. D. students graduated under her supervision from 2002, eight are currently performing their Ph.D work. She published over 70 papers in fields of biochemistry and molecular biology, endocrinology and metabolism, reproduction biology, pharmacology & pharmacy with over 900 citations and h-index 18. Her current research interests include studies of the cross-talk of cholesterol homeostasis, drug metabolism, cAMP signalling and the circadian regulation in the liver and adrenal. By applying functional genomics and systems biology approaches in mouse models and in human samples, she aims to understand this complex interplay in different genetic backgrounds and physiological settings, to determine mechanisms leading to cholesterol-related metabolic disorders in human individuals. D. Rozman is active in Slovenian and international expert committees, such as Slovenian Biochemical Society (Management Board), International Advisory Board for Meetings on Cytochromes P450s, two committees of International Society for Studies of Xenobiotics (ISSX) and at the EU, BMBF (Germany) and MVZT (Slovenia) advisory committees for further development of personalised medicine, systems biology and systems medicine.

Andreas SCHUPPERT

Director, Applied Sciences, Bayer Technology Services

Prof. Dr. Andreas Schuppert is the key expert for industrial mathematics at Bayer Technology Services GmbH in Leverkusen, the technology company of Bayer AG. Additionally he holds a Professorship for Data Based Modeling in Computational Engineering Sciences at Aachen Institute for advanced Studies in Computational Engineering Sciences (AICES) at RWTH Aachen University.

He received his diploma in Physics and his PhD in mathematics from University Stuttgart in 1984 and 1988, respectively. Additionally he has a degree in economics with focus on operations research. 1988 he joined corporate research of the former Hoechst AG and 1998 he moved to corporate engineering of Bayer AG.

His research was focused on data- based modeling in material sciences, chemical engineering sciences and systems biology. His main ambition is the development of hybrid model structures combining artificial intelligence model components with mechanistic models and system structure. The application focus was on modeling of reactive chemical processes and materials. Today his research activities are the development of hybrid mathematical approaches which enable to establish model-based biomarkers for clinical applications in treatment of complex diseases as well as optimization and control of cellular engineering in stem cell research.

Matthias SCHWAB

Professor and Chair of Clinical Pharmacology, Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany

Information will soon be available.

Markus SCHWAIGER

Professor and Director of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Germany

Markus Schwaiger, MD, received his medical training at the Medical School of the Free University of Berlin, Germany, and completed a fellowship at the division of nuclear medicine, UCLA School of Medicine, Los Angeles. He served as assistant professor of radiological sciences, division of nuclear medicine, UCLA School of Medicine, professor of medicine, division of nuclear medicine, University of Michigan and professor and director, department of nuclear medicine, Technische Universitaet of Munich, Germany. He was 2002- 2010 dean of the School of Medicine, Technische Universitaet Muenchen, Germany. He has published 622 peer-reviewed publications in international scientific journals, 96 book chapters and 866 abstracts and has been invited to give 511 presentations.

Cees SMIT

Policy advisor, Patients Network for Medical Research and Health (EGAN)

Cees Smit (1951) studied business economics at the Free University in Amsterdam.

From 1978 till now, he has been member of the research project „Hemophilia in The Netherlands‟ at the Leiden University Medical Centre (LUMC).

From 1987 till 1998 he was co-ordinator of the Netherlands Hemophilia Society, from 1998 till 2002, he worked in the mental health area.

In January, 2003 he received an honorary doctorate from the college of deans of the University of Amsterdam in recognition for his work on patient participation, haemophilia and medical biotechnology.

In recent years, he wrote several books on ageing with chronic diseases, like haemophilia and hiv. „Ageing with haemophilia‟, was published in English in 2007. The book „Ageing with hiv‟ is written in Dutch and was published on December 1, 2009 during World Aids Day.

Rudolf STROHMEIER

Deputy Director General, DG Research and Innovation, European Commission

Born 1952 in Würzburg (Germany), he studied law and economics in Würzburg and Bonn which he finalised by a thesis about the European Monetary System.

In 1979 he started his career as teaching assistant at the Department of Civil and Commercial Law at the University of Würzburg but joined in 1980 the Bavarian Liaison Office to the Federal Government in Bonn. Following a 2-years detachment to the Development Policy department of the European Commission, he established the Bavarian Information Office in Brussels and became its first Director.

From 1987, he served in the three Cabinets of Regional Policy, later Budget Commissioner Peter Schmidhuber till 1995 when Agriculture Commissioner Franz Fischler nominated him his Deputy Head of Cabinet. After becoming Head of Division in DG AGRI in 2000, he joined the Cabinet of Commission President Prof. Romano Prodi in 2003 as Adviser i.a. for Industry, Agriculture and Environment Policies.

Till his nomination as Deputy Director-General in DG RTD early 2010, he served from 2005 as Head of Cabinet of Telecommunication and Media Commissioner Viviane Reding.

Charles SWANTON

Group leader, Translational Cancer Therapeutics, London Research Institute, Cancer Research UK

Charles Swanton FRCP BSc PhD

Charles completed his PhD in 1998 at the Imperial Cancer Research Fund Laboratories on the UCL MBPhD programme before completing his medical oncology and CR-UK funded post-doctoral training in 2008. Charles is a consultant medical oncologist in the Breast and Drug Development Units at the Royal Marsden Hospital with an interest in early phase drug development for the treatment of specific subtypes of metastatic breast cancer. Charles is also a Group Leader at the CR-UK London Research Institute in the Translational Cancer Therapeutics laboratory, funded by CR-UK and the MRC, focussing on understanding mechanism of drug resistance using high throughput RNA interference functional genomics approaches.

Mathias UHLÉN

Professor, Science for Life Laboratory and Albanova University Centre, Swedish Royal Institute of Technology

Mathias Uhlen is Professor at the Royal Institute of Technology (KTH), Stockholm, Sweden and he is the Program Director of the Human Protein Atlas program. He has over 300 peer-reviewed publications in the field of biotechnology with a focus on the use of affinity-reagens for life science research. Scientific achievements include the development of the affinity tag concept (1983), protein A (1984), streptavidin magnetic beads (1988), affibodies (1996), pyrosequencing (1998), the human protein atlas (2005) and bacterial surface display for epitope mapping and binder selections (2008).

Dr Uhlen leads the Protein Atlas effort with two main sites in Sweden and three sites in Asia (Korea, China and India) with more than 100 full-time researchers. He is co-Director of the HUPA Antibody Initiative (HAI) and he is a member of the Royal Swedish Academy of Engineering Science (IVA), the Royal Swedish Academy of Science (KVA), the European Molecular Biology Organization (EMBO) and member of the Human Proteome Organization (HUPO) council.

Dr Uhlen received his PhD from the Royal Institute of Technology in 1984, he did a post-doc at the EMBL (Heidelberg, Germany) and become full professor in 1988 at KTH and Vice President of the KTH in 2001. He has founded eight biotechnology companies, including Pyrosequencing, Affibody and Atlas Antibodies. Dr Uhlen has obtained numerous honors and awards, including the Akzo Nobel prize (2005) and the ABRF award (2009).

Axel ULLRICH

Professor and Director, Department for Molecular Biology, Max Planck Institute, Germany

Professor Axel Ullrich was trained as a biochemist at the University of Tuebingen (Germany) and earned a Ph.D. in Heidelberg in Molecular Genetics in 1975. After a postdoctoral tenure at the University of California, San Francisco, he joined Genentech in 1978. His work in the field of signal transduction research has elucidated major fundamental molecular mechanisms that govern the physiology of normal cells and allow insights into patho-physiological mechanisms of major human diseases such as cancer. Since 1988, Professor Ullrich has been Director of the Department of Molecular Biology at the Max-Planck-Institute of Biochemistry in Martinsried and in addition since 2004 he is Research Director of the Singapore OncoGenome Project. He is an Honorary Professor of the Second Military Medical University (Shanghai, China) and the University of Tuebingen (Germany) and elected member of the European Molecular Biology Organization (EMBO), the German Academy of Natural Scientists “Leopoldina” and the American Academy of Arts and Sciences (AAAS). For over 30 years Professor Ullrich has been a leader in genomics-based molecular medicine, translating basic science discoveries into medical applications. This led in the mid eighties to the development of Humulin (human Insulin for the treatment of diabetes; Lilly), the first therapeutic agent to be developed through gene-based technology and the first biotechnology product ever. Another biotech product that is based on Professor Ullrich‟s work is Herceptin, the first target-directed, gene discovery-based cancer therapy for the treatment of metastatic breast carcinoma (Genentech/Roche). His third contribution to biomedicine, SU11248/SUTENT, was conceived on the basis of discoveries in his laboratory at the Max Planck Institute of Biochemistry and developed by SUGEN/Pharmacia and Pfizer. It was approved by the FDA (1/2006) and the EMEA (7/2006) for the treatment of Gastro Intestinal Stromal Tumors and Renal Cell Carcinoma (Pfizer). Among numerous other honors and awards Professor Ullrich received the Robert Koch Prize of the German Cancer Society, the Bruce F. Cain Memorial Award of the American Association of Cancer Research, the King Faisal Prize of Medicine, the Warren Alpert Prize of Harward Medical School, the 2007 Prince Mahidol Award of Thailand and the AACR-Pezcoller Award for Cancer Research 2008. Professor Ullrich‟s scientific work has been published in more than 500 articles in international journals and with over 75000 citations he is one of the ten most cited scientists over the past 25 years worldwide.

Anne VAN NEROM

Coordinator of the Belgian Competent Authority for in vitro diagnostic medical devices, Scientific Institute of Public Health

Anne Van Nerom started working at the Scientific Institute for Public Health (WIV-ISP) in Brussels, Belgium, in 2001, where she built up the Belgian Competent Authority for in vitro diagnostic medical devices. She is a member of several expert and working groups of the European Commission and of the Competent Authorities for medical devices. She has been co-chair of the Compliance and Enforcement (COEN) working group. Anne is actively involved in the revision and redaction of legal documents and guidelines. She is a member of the Board of the Central Management Committee, established in September 2011 during the Belgian Presidency. She has a PhD in veterinary science from the Faculty of Veterinary Medicine, Ghent University, Belgium

Anne-Mieke VANDAMME

Professor, Katholieke Universiteit Leuven, Head of Division Clinical and Epidemiological Virology, Rega Institute and University Hospitals, Belgium

Prof Dr Anne-Mieke Vandamme was trained as biochemist, and holds a PhD in sciences since 1986. She joined the Rega Institute at the Katholieke Universiteit Leuven in 1990, where she started a unit on virus genetic testing for clinical practice. Together with Professor Van Ranst, she founded a new division, Clinical and Epidemiological Virology.

Anne-Mieke Vandamme and her team perform research on the molecular epidemiology of HIV, HTLV and HCV, on HIV and HCV drug resistance (genotyping, phenotyping) in clinical context, and on bioinformatics (data mining, phylogenetic analysis) technology. In the fields of HIV molecular epidemiology and drug resistance, she has an extensive and widely recognized expertise. She is participating in several European projects (ENVA, SPREAD, EHR, Virolab, CHAIN). She supported the development of a few widely used (bioinformatics) tools, the Rega HIV Drug Resistance algorithm, the Rega HIV typing and subtyping tool, and recently also RegaDB, a free and open source software for collecting and sharing HIV epidemiological, clinical and virological data. She has around 280 publications in international journals such as Lancet, Nature Medicine, PNAS, Journal of Virology, Trends in Microbiology, half of them with first and/or last author from the lab. Around 430 abstracts presented at International Meetings.

In addition to her research activities, Anne-Mieke Vandamme is organizer of the yearly International Bioinformatics Workshop on Virus Evolution and Molecular Epidemiology (16th in 2010), is co-initiator and co-organizer of the European HIV Drug Resistance Workshop (8th in 2010), is coordinating the European HIV Drug Resistance Guidelines initiatives, is Head of a Bioinformatics unit at the „Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa, Lisboa, Portugal, and co-founded a Bioinformatics company (MyBioData) dedicated to database and datamining software. She also teaches Evolutionary Genetics and Bioinformatics at the Katholieke Universiteit Leuven.

The process towards personalised medicine, aimed at better predicting, preventing and treating or curing diseases based on a patient's individual characteristics, is gaining pace in Europe. However, a long term structured approach to foster innovation in this area and to facilitate the rapid uptake of personalised medicine into clinical practice is lacking.

The conference brings together stakeholders involved in all areas of personalised medicine and aims at identifying key challenges where actions are needed at European level to progress research, development and implementation of personalised medicine in health care.