Dr Ruxandra Draghia-Akli is Director of the Health Directorate at the Research DG of the 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.
Paul Timmers is Director of the Sustainable & Secure Society Directorate in the European Commission Communications Networks, Content and Technologies Directorate General (DG CONNECT). Previously he headed the ICT for Inclusion and the eGovernment units. He was also member of the Cabinet of the European Commissioner for Enterprise and Information Society. Before joining the European Commission, he was a manager in product marketing and software development in a large IT company. He also co-founded a software start-up. He holds a PhD in theoretical physics from the University of Nijmegen, the Netherlands and a MBA from Warwick Business School, UK. He has widely published in the field of technology and policy, including a book on electronic commerce strategies and business models. He was a visiting professor and lecturer at several universities and business schools across the world including an EU Research Fellow at the University of North Carolina in the USA.
Michel Goldman is the Executive Director of IMI, he builds and promotes networks of innovation, in close collaboration with all stakeholders involved in pharmaceutical R&D. He supports the launch and successful continuation of collaborative programmes to foster research and development activities on more effective and safer therapies for patients across Europe. Michel Goldman is Professor of Immunology at the Faculty of Medicine of the Université Libre de Bruxelles (Belgium). His achievements in the fields of immune-mediated disorders and immune-based biotherapies resulted in more than 400 articles in peer-reviewed journals. In 2004, Michel Goldman started up the Institute for Medical Immunology (Charleroi, Belgium) as the first public-private partnership in the biomedical sector in Wallonia and he has been the first vice-president of the BioWin Health Cluster created to foster networks between industries and academic institutions in this region. From 2007 to 2009, he served the European Research Council as a member of the Advisory panel on Immunology and Infectious Diseases. In 2000, Michel Goldman received the Joseph Maisin Prize, a major award for clinical sciences delivered by the Belgian Fund for Scientific Research, and he held the Spinoza chair at the University of Amsterdam in 2001. He was recognized as ISI Highly Cited Scientist by the Thomson Institute for Scientific Information in 2006. Michel Goldman was awarded the degree of Doctor Honoris Causa of the Université Lille II (France) in 2007.
Ann is responsible for the Knowledge Management projects at the Innovative Medicines Initiative (IMI). IMI is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe and operates as joint undertaking between the European Union and the pharmaceutical industry association EFPIA. Between 1997 and 2009, Ann Martin held various management positions in the pharmaceutical industry in Biostatistics (UCB Pharma 1997-2001) and statistical programming (Novartis 2001-2005 and UCB Pharma 2005-2009), giving her a broad knowledge on drug development and extensive international experience with Europe, the US and India. Between 1987 and 1997, Ann worked for Bristol-Myers-Squibb both as a Biostatistician in multiple therapeutic areas, following a short period as research assistant at the University of Lancaster (1985-1987). Ann Martin holds a Masters degree in Sociology and Statistics from the London School of Economics and Political Science, UK.
Richard Perkins, studied Pharmacology at Leeds University in the UK. He is currently a Business Consultant with an extensive knowledge of the international pharmaceutical industry providing support services for process improvement, change management and staff development. He has worked in research and development within the Pharmaceutical, contract research and support industries for more than 30 years. He is currently the elected President of the eClinical Forum and founder and managing director of ConSept Consulting in France.
Mats Sundgren, MSc, PhD, Principal Scientist, Global Clinical Development, AstraZeneca R&D. Mats is a Principal Scientist and a R&D strategy specialist with more than 24 years of experience in management and research, both from the pharmaceutical industry, combined with a broad scope of different positions (Discovery, Development, Marketing, and Patent defence), and from academia (e.g. Biotechnology, R&D Management, Medical Informatics, eHealth and Life Science Innovation). He has expertise working within the area of Clinical Information Strategy function focusing on developing and implementing strategies for managing clinical information related to the e-health sector. Mats also bring expertise to the project by taking a holistic perspective of the pharmaceutical R&D process from start to end gained from his various roles in the pharma industry, and from his PhD research (Technology Management & Economics) in the areas of Innovation Management in Life Science. Mats also hold an MSc in Chemical Engineering with a specialization in biochemistry. In working for AstraZeneca, he is acting as a liaison officer and project manager around strategic information management initiatives both in Clinical but also on an R&D level. Mats were also chairing of the Efpia EHR task force 2008-2009 and represent AZ in IMI Knowledge Management group. He is also a Senior Research Fellow at Chalmers University of Technology & IT University of Gothenburg, Sweden, and has more than 50 publications in areas of Life Science, Biomedical Informatics, eHealth and Innovation Management.
Bart Vannieuwenhuyse is Senior Director Health Information Sciences at Janssen, Pharmaceutical Companies of Johnson and Johnson. He joined Janssen Pharmaceutica as a clinical trial monitor in 1985. In the course of his career with Janssen, Bart has held a variety of marketing and sales positions, both at local operating company level (e.g. the Netherlands) and at international level. While in the Netherlands he was one of the pioneers that started “Healthy Solutions” a J&J daughter company that focused on developing integrated services in the healthcare field. Later, he was in the core team that developed the initial CRM approach for Janssen EMEA. Between 1999 and 2003, Bart spent 4 years in the IM department of Janssen Pharmaceutica in the US, where he was responsible for the e-business initiatives and for the overall IM technical architecture. Bart joined the EMEA CRM Center of Excellence in April 2003, where he prepared the CRM Roadmap for the short to mid-term. In 2009 Bart was instrumental in developing a new customer-orientation project for Janssen Europe. In 2011 Bart joined the Janssen R&D group to focus on external eHealth / Health Information projects with external partners. Currently, Bart is coordinator of the EMIF (European Medical Information Framework) project.
Dipak Kalra is a Clinical Professor of Health Informatics at University College London. He plays a leading international role in research and development of electronic health record architectures and systems, including the requirements and models needed to ensure the robust long-term preservation of clinical meaning and protection of privacy. He has led the development of CEN and ISO standards on EHR interoperability, personal health records, EHR requirements, and has contributed to several EHR security and confidentiality standards. Dipak is involved in European research on EHR system quality labelling, semantic interoperability and clinical knowledge discovery. Dipak leads a EU Network of Excellence on semantic interoperability, and a project to develop a European roadmap on patient empowerment innovations. He and his UCL team are partners in EHR4CR, an Innovative Medicines Initiative on the re-use of electronic health record information for clinical research, alongside ten global pharmaceutical companies. EuroRec is the Managing Entity of EHR4CR. Dipak is President of the EuroRec Institute and a Director of the openEHR Foundation.
Christian Ohmann, PhD, is head of the Coordination Centre for Clinical Trials (KKS) at the Medical Faculty of the Heinrich-Heine-University (HHU) Düsseldorf (Germany) and has extensive experience in conducting clinical research. He serves as chair of the network committee and of the working group on data management of the EU-funded European Clinical Research Infrastructures Network (ECRIN). He represents the Network of the German Coordination Centres for Clinical Trials (KKS Network), is the German KKS representative for ECRIN and is on the board of directors of the German Health Care Research Network (DNVF).
Petra Wilson joined the International Diabetes Federation as Chief Executive Officer in November 2013. The International Diabetes Federation (IDF) is an umbrella organisation of over 200 national diabetes associations in over 160 countries. It represents the interests of the growing number of people with diabetes and those at risk. The Federation has been leading the global diabetes community since 1950. Prior to her appointment at IDF, Petra was Director of the European Healthcare and Life Sciences team in Cisco’s Consulting Services, focussing on helping health and care providers develop their strategies for making good use of communication and collaboration technology. Previously, she was deputy director of the European Health Management Association (EHMA), a membership organisation committed to improving healthcare in Europe by raising standards of managerial performance in the health and care sectors. Prior to EHMA, Petra worked for the European Commission in its eHealth Directorate. She worked specifically on the European eHealth Action Plan, which commits all Member States of the European Union to adopting road maps for the implementation of Connected Health solutions. Petra also advised the Commission on legal and ethical issues surrounding use of information technologies in healthcare. Originally trained in law, Petra spent several years as a lecturer and Senior Research Fellow at Nottingham University, UK, specialising in healthcare law. She has a Ph.D. in public health law from Oxford University, and has published widely on the legal aspects of using information technologies in healthcare. Originally from the UK, she is fluent in English, German, and French.
Brecht Claerhout holds a master degree in electronics engineering. He has previously been active in FOSS development as author of a major network security tool (Sniffit). He has worked at the IMEC (Interuniversity Microelectronics Center) and RAMIT (Research in Advanced Medical Informatics and Telematics) research groups. Brecht is currently CEO of Custodix, one of the first Trust Service Providers in the world focusing on data protection, and has been actively involved in a large number of European research projects mainly dealing with the health data integration. Recent projects in include EHR4CR (Electronic Health Records for Clinical Research, 2011-2015), INTEGRATE (Driving Excellence in Integrative Cancer Research through Innovative Biomedical Infrastructures, 2011-2014), P-Medicine (From data sharing and integration via VPH models to Personalised Medicine, 2011-2015) and EURECA (Enabling information re-Use by linking clinical REsearch and Care, 2012 - 2015). Brecht has published several conference and journal papers on the subject of security and privacy protection and semantic integration of clinical data.
David is leading software development at Custodix, an SME primarily active in the health and life sciences domain that offers tools and services for securing sensitive data and protecting privacy. He has experience with building service-oriented architectures for healthcare applications, such as data collection platforms, clinical trial and EHR software. He has participated in several past and ongoing local (Flemish IWT) and European (FP6,7) research projects such as INFOBIOMED (NoE), ACGT (IP) and ENSURE (CP). In these projects, he has worked on privacy protection solutions and generic policy driven security and privacy protection services. In the EHR4CR project he is responsible for the work packages on Architecture and Integration (WP3) and Data Protection, Privacy and Security (WP5).
Andreas Schmidt, M.Sc., ECPM, Dipl. Pharm. Med. SwAPP, MCPM. Andreas is acting Manager European External Collaborations in Product Development Innovation Management at F. Hoffmann-La Roche Ltd with more than 20 years of experience in the pharmaceutical industry, primarily serving clinical development functions. Beyond this, Andreas has been working in various other fields within the drug development process including Leadership Management, Information Management, Portfolio Management, on a variety of Informatics projects, Cardiac Safety and Global Services in Emerging Growth Markets. Furthermore, Andreas has more than 10 years of working experience in academic health care institutions. Andreas’ functional and subject matter expertise experience include various clinical development centric roles such as European Clinical Team Leader for neuroprotective compounds, Business Consultant to a Clinical Imaging group and Global Lead Operations Manager in Translational Medicine responsible for the cardiac safety in clinical programs. His Information Management centric roles include Global Document, Digital ECG and Image Management Systems project leadership. He also has Business Modelling and Process Engineering experience. His Leadership and People Management experience include Program Director for Development Global Services to drive a program of off-shoring Pharma Development functions, Global Project Lead of a Pharma Development wide, cross functional Document Management project with >100 team members, Global Head Portfolio Management, Global Head Business Information Management. His Professional Development activities include Master of Science (Dipl. Psychologe) of the University of Technology Berlin-Germany, Diplomas in Pharmaceutical Medicine of the European Centre of Pharmaceutical Medicine and the Swiss Association of Pharmaceutical Professionals, a Certificate in Management from Henley Management College, England, and a Master's Certificate program in Project Management awarded by The George Washington University, USA.
- Organiser and Chair, ‘Workshop on Future of Privacy and Ministry of Justice consultation’ UCL, London, Sept. 2010
- Organiser and Rapporteur, Workshop on ‘Critical Issues for Electronic Health Records’ Wellcome & Nuffield Trusts, London, 2007
- Organiser and Chair, ‘Workshop on Article 29 Data Protection document WP131’ UCL, London, 2007
- Organiser and Chair, ‘Governance of Medical Research Databases’, Royal College of Physicians, London, 2004
- Department of Health Confidentiality Code of Practice Working Group, 2001 - 2002
- Organiser and Rapporteur, ‘The future of the Pharmaceutical Industry’ symposium, Cambridge December 2001
Nikolaus Forgó, born 1968 in Vienna (Austria) studied law and philosophy in Vienna and Paris. 1997 he received a Doctor iuris for a dissertation on legal theory. From 1990-2000 he worked as an asssistant at the law school of the University of Vienna and was inter alia responsible for the ICT-infrastructure there. In 1998 he founded a postgraduate-program (www.informationsrecht.at) on ICT-law in Vienna and has been the head of this program since then. In 2000 he became Professor of Law at the Leibniz Univerity of Hannover (www.jura.uni-hannover.de), since 2007 he has been acting as the director of the Institute for Legal Informatics there (www.iri.uni-hannover.de). He has broad research, teaching and consulting experience in all fields of ICT-law, mainly in data protection, copyright and electronic contracts.
Prof. Martin Dugas is Director of the Institute of Medical Informatics at the University Hospital in Münster, Germany, a 1400-bed academic facility. He holds a doctoral degree in human medicine from the Technical University of Munich as well as a diploma in computer science. He is a board-certified medical informatician and biometrician with industry experience (Siemens Medical Health Services, USA). Within the EHR4CR project he is co-leading the workpackage on pilots. His research interests focus on informatics methods for personalized medicine, in particular regarding Electronic Health Records (EHRs) and cancer research.
Marc Cuggia, MD, PhD, is an assistant professor at Rennes1 University and a hospital practitioner at the University Hospital of Rennes. His domain of expertise is the semantic interoperability in health information systems. He is the coordinator of the French ANR TecSan ASTEC (Automatic Selection of clinical Trials based on Eligibility Criterion ) project whose objective is to develop methods to map patient data to eligibility. He worked as a post doctoral fellow at Edinburgh university in 2009 (School of informatics). His contribution focused on comparing automatic recruitment methods in clinical trials.
Neelam is a business consultant (NeelamConsulting, previously Lilly) with a vision to support organisations in improving and sustaining business performance and capabilities. Neelam has had 25 years of experience working in the global pharmaceutical industry and UK Healthcare environment. Initially starting her career in Pharmacovigilance at GSK and then Lilly. Her introduction to medical was whilst she was in HR, partnering with leaders to implement strategy and manage change within the European medical organization. Neelam joined the UK medical organization in 2007, initially responsible for UK clinical research and then for regional operations in UK, Ireland, Belgium and Netherlands. Neelam’s focus in the UK has been to attract more research in two ways; increasing productivity and performance internally as well as to influence the external environment. The latter goal drove her to take an external secondment to the UK National Institute of Health Research, Clinical Research Networks, where she led a national project to streamline the network feasibility process. Her most recent position at Lilly was Global Director of Clinical Operations Strategy, where she facilitated the creation of a 5 year transformation strategy to streamline clinical operations as well as to bring our customers and patients to the heart of what we do.
Maria A Englund is director of Karolinska Trial Alliance, KTA. Her working experience:
KTA is a Clinical Research Center at Karolinska University Hospital in Stockholm. KTA is conducting clinical trials and support for both academia and industry in all phases (0-IV). KTA consist of three units; KTA phase 1, KTA Support and KTA Prim.
Professor Dr. Georges J.E. De Moor studied Medicine and specialised in Clinical Pathology and Nuclear Medicine at the State University of Ghent (Belgium), where he also obtained his PhD in Medical Information Science. He is head of the Department of Medical Informatics and Statistics at the State University of Ghent, Belgium, where he teaches Health Informatics, Medical Statistics, Decision Theory and Evidence Based Medicine. As president of RAMIT (Research in Advanced Medical Informatics and Telematics), he has been involved in both European and International Research and Development projects (+85), as well as in Standardisation activities. For seven years, Prof. De Moor acted as Founding Chairman of CEN/TC251, the official Technical Committee on standardisation in health informatics in Europe. Prof. De Moor has also founded a number of companies of which he is chairman or C.E.O. (e.g. MediBridge, Custodix, TeleTendo…). In 2004, he was elected President of the European Institute for Health Records (EuroRec). In Belgium, Prof. De Moor chairs a number of official Committees, among which the Health Telematics Committee of the Belgian Ministry of Health and Social Affairs, as well as a number of scientific and professional organisations. Dr. De Moor is also head of the Clinical Pathology Laboratory of the St-Elisabeth Hospital in Zottegem. He has edited seven books related to ICT in Health and published over 200 articles in scientific journals.