The speakers

 

Conference Moderators

Aminda Leigh

Aminda Leigh is a British journalist with more than 25 years’ experience, half of which working for various BBC radio and TV channels. She moved to Italy in 2001, from where she runs her own business offering journalism, moderation, production and translation services for a wide variety of European and international clients. She specialises in environmental issues, culture and EU affairs. Aminda has made award-winning web-documentaries and news videos for the European Commission, among others. She has moderated entire conferences and individual sessions at major events - for example, EU Green Week and the European Business Summit - covering subjects such as the REACH regulations, animal welfare, the circular economy, green growth and climate change.

Rick Thompson

BBC Journalist, Editor and Manager.   Rick worked for BBC News for 27 years, first as a reporter, presenter and producer, then holding senior positions at the Regional, National, and International levels. He was Editor Newsgathering for BBC World Service Radio and Television, and helped to launch the 24-hour channel “BBC World”; for four years he produced the main BBC TV evening news programme, and before that was the Foreign News Editor for BBC Television. Rick is now the Visiting Professor of Broadcast Journalism at Birmingham City University. Rick has a longstanding keen interest in the 'European Project' and has advised European institutions on their communication strategies.  He has conducted training seminars on press relations, how to produce audiovisual material, and personal presentation skills for EU departments. In recent years he has been asked to chair many European conferences and seminars which require an up-to-date knowledge of EU policy. He has special interests in Politics, International Affairs, the Environment, Climate Change, Regional Development and Communication.

Opening address - Day 1

Karmenu Vella

Karmenu Vella is the Commissioner for Environment, Maritime Affairs and Fisheries. Before joining the European Commission, Mr Vella was Minister for Tourism and Aviation. He earned a master's degree in tourism management in 2000. From 2010 to 2013 he worked as Chairman for the Orange Travel Group and from 2008 to 2013 as group coordinator for the Labour Party Parliamentary Group. Mr Vella holds a bachelor's degree in architecture and civil engineering and was minister for public works from 1981 to 1983. Mr Vella becomes a member of the Maltese Parliament in 1976.

Session 1 - Animal Testing Today

Speakers:

Malcolm Macleod

Malcolm Macleod is Professor in Neurology and Translational Neuroscience at the Centre for Clinical Brain Sciences, University of Edinburgh, and Head of Neurological Diseases and Stroke at NHS Forth Valley. After undergraduate medical training (including a First Class Honours degree in Pharmacology) he trained in Internal Medicine before embarking on a PhD in the Butcher lab investigating the neuroprotective actions of FK506. This was followed by post-doctoral work in the Seckl lab defining a neuroprotective role for increased expression of the mineralocorticoid receptor. While this work continued he completed his training in Neurology, including a pivotal sabbatical year with Donnan at the National Stroke Research Institute, Melbourne, Australia. During this time he began an involvement with stroke clinical trials, and it was in an effort to identify suitable drugs for such clinical trials that he began to develop techniques to allow the systematic review and meta-analysis of data from animal studies. This led to the founding of the Collaborative Approach to Meta-analysis and Review of Animal Data from Experimental Studies (CAMARADES) in 2005. Since then these approaches have found application in a diversity of models, and the CAMARADES group, under his leadership, have build up considerable expertise in this area. He was on the writing committee for the Landis guidelines and is an investigator on the MultiPART program developing structures for multicentre animal studies. He is a member of the MHRA Commission for Human Medicines, and the UK Home Office Animals in Science Committee and is co Chief Investigator of EuroHYP-1.

Jarrod Bailey

Dr Jarrod Bailey, PhD is Cruelty Free International’s (formerly the BUAV) Senior Research Scientist. He received his degree in Genetics and Ph.D. in viral genetics from Newcastle University in the 1990s, then spent seven years investigating the possible causes of premature birth in humans. Since then, he has evaluated the scientific validity and human relevance of animal models in biomedical research and drug/product testing. He has reviewed the limitations of using nonhuman primates and other animals in various fields of research, including the testing of substances that can cause birth defects and cancer; the use of chimpanzees and other nonhuman primates in various forms of medical research including HIV/AIDS, cancer, hepatitis and neuroscience; the use genetically modified animals to research diseases such as cystic fibrosis, Alzheimer’s and Parkinson’s, among others; and the use of dogs, monkeys and other species in pre-clinical testing of new human drugs. He has authored several substantial scientific petitions and submissions of evidence to a variety of British, European and US inquiries into the validity of animal research, and nonhuman primate research in particular, and has taken part in many debates on animal research both in public and political arenas .

Andrew Knight

Andrew Knight is a ridiculously busy bloke. He is Professor of Animal Welfare and Ethics, and Director of the Centre for Animal Welfare, at the University of Winchester; a European and RCVS Veterinary Specialist in Animal Welfare Science, Ethics and Law; an American Veterinary Specialist in Animal Welfare; and a Senior Fellow of the UK Higher Education Academy. Excluding abstracts and letters Andrew has over 65 academic publications and a series of youtube videos on animal issues. These include an extensive series examining the contributions to human healthcare of animal experiments, which formed the basis for his 2010 PhD and his 2011 book The Costs and Benefits of Animal Experiments. Andrew’s other publications have examined the contributions of the livestock sector to climate change, vegetarian companion animal diets, the animal welfare standards of veterinarians, and the latest evidence about animal cognitive and related abilities, and the resultant moral implications. His informational websites include www.AnimalExperiments.info and www.HumaneLearning.info.

George Kollias

George Kollias is a Biologist, member of the Academy of Athens, Professor of Experimental Physiology at the Medical School of the University of Athens and elected President and Scientific Director of the Biomedical Sciences Research Center "Alexander Fleming". Prof. Kollias is an EMBO member since 2000 and Member of the EASAC Biosciences Steering Group since 2014. He was awarded the Carol-Nachman Award for Rheumatology (2014) and the first Galien Scientific Research Award at the Prix Galien Greece (2015). Prof. Kollias is renowned for proof of principle preclinical studies that led to the development of anti-TNF therapies for rheumatoid arthritis and has pioneered genetic approaches to advance knowledge on the molecular and cellular mechanisms driving chronic inflammation and autoimmunity. In 2014 he was awarded an Advanced ERC grant to study the role of mesenchymal cells in intestinal tissue homeostasis and pathophysiology. Beyond his research, his contributions have encompassed efforts for the development of biomedical infrastructures at a national and European level such as Infrafrontier.GR/Phenotypos on disease modeling (BSRC Fleming), and pMedGR on precision medicine (Medical School of Athens). In 2005 he founded the first CRO-biotech spin-off of BSRC Fleming, Biomedcode Hellas SA.

Additional panel members:

Roger Le Grand

Dr. Roger Le Grand is Head of Research Center for "Immunology of viral infections and auto-immune diseases" at the CEA, Inserm and Paris-Sud University, Fontenay-aux-Roses and Kremlin-Bicêtre, France. Since 2013 he is also a member of the scientific committee of the multidisciplinary network of vaccine researches COREVAC. The goal of his research throughout most of his life is to study host response to infections with the aim to understand basic mechanisms of immunology and develop new prevention strategies of human infectious diseases. His work is mainly based on the use of preclinical models, including non-human primate models of human diseases, and the development of advanced technologies in cytometry and in vivo imaging, with a continuing effort to translate findings in experimental models to the clinical practice.

Elliot Lilley

Elliot is a Senior Scientific Officer within the RSPCA Research Animals Department. He received his PhD in Pharmacology from King’s College London in 1997 and then began a 15 year career in the pharmaceutical industry; initially at the James Black Foundation and latterly at Novartis. In 2012, he joined the RSPCA research animals department where his main areas of work relate to promoting refinement, including reducing severe suffering, experimental design, and translational validity.  More information on our work towards ending severe suffering can be found here: www.rspca.org.uk/severesuffering. Elliot is a Fellow of the British Pharmacological Society and is animal ethics editor of the British Journal of Pharmacology.

Richard Frackowiak

Richard Frackowiak is a clinical neurologist who has spent his life researching the human brain with non-invasive brain imaging, notably in the Functional Imaging Laboratory he founded at UCL as foundation chair of cognitive neurology. At the end of his career, as head of the Department of Clinical Neurosciences (DNC) at the Université de Lausanne (UNIL) and its Centre Hospitalier Universitaire Vaudois (CHUV) and titular professor at the Ecole Polytechnique Fédérale de Lausanne (EPFL) he was  responsible for “Future Medicine” in the EU’s Flagship of Enterprise and Technology (FET) “The Human Brain Project”. His contributions have encompassed innovative techniques and investigation of normal and diseased human brain structure and function. His scientific output is highly cited with an h-index of 164; he has received the Ipsen, Wilhelm Feldberg and Klaus Joachim Zulch prizes.

Session 2 - Biomedical research: strengths & limitations of non-animal alternatives

Speakers:

Jan G. Hengstler

Jan G. Hengstler studied medicine in Mainz (1984-1990), became professor of pharmacology and toxicology in Leipzig (2003) and today is director of the Leibniz Research Center IFADO in Dortmund. He established hepatocyte in vitro systems that today are widely used to study enzyme induction as well as inhibition and toxic mechanisms. Jan Hengstler was among the pioneers to introduce Systems Biology and Modelling in Toxicology. His group has established the concept of experiments with artificial tissues. Here, tissue units are three-dimensionally reconstructed and functional principles, e.g. signaling networks or metabolic pathways are programmed into the individual cells to simulate consequences at the tissue, organ and organism level. Although integration of such mathematical models can reduce the numbers of required experimental animals, Jan Hengstler expresses the view that a full replacement of animals is currently not possible.

Stefan Platz

Stefan Platz is the Global Head and Vice President of Drug Safety and Metabolism within AstraZeneca’s Innovative Medicines and Early Development unit. In this role, Stefan is responsible for the non-clinical safety assessment of the drug candidates in discovery and development, leading a global team across Sweden, UK and the US.
Stefan has a degree in veterinary medicine from the University of Munich and is a German certified veterinary pathologist as well as Diplomate of the American Board of Toxicology. He started his career in 1996 at Boehringer-Ingelheim. Before joining AstraZeneca in February 2012, Stefan led the non-clinical safety organisations for Hoffmann-La Roche in both Basel and Palo Alto. During this time period he also had extended periods of strategic responsibilities for the early safety screening as well as biologics safety. Stefan is particularly interested in exploring novel approaches and technologies to better predict human safety based on in vitro and in silico data. Recent investments by AstraZeneca in microphysiological systems may help to understand safety risks in patients based on a dynamic cell system mimicking full organ functionality. Together with modelling and simulation of human data this might accelerate drug development and result in a reduction in number of animal used in preclinical testing.

Frank Staal

Frank Staal is Professor of Molecular Stem Cell Biology at the Leiden University Medical Center in the Netherlands. His research is centered around the differentiation of blood-forming stem cells (hematopoietic stem cells, HSCs) to the major disease fighting white blood cells, the T-lymphocytes, both under normal and pathological conditions. This work is focused on three research lines: HSC biology, which is studied in his group in human, mouse and zebrafish models; the development of T lymphocytes in the thymus and regulation of peripheral T cell function with emphasis on the role of Wnt signaling herein and the development of gene therapy for various types of human Severe Combined Immunodeficiency (SCID). Professor Staal is the handling editor of the journal “ Leukemia”  and also a member of the Health
Council Advisory committee to the minister of health to adapt/expand the neonatal screening program in The Netherlands. He also is member of the grant reviewing committee TOP grants ZonMW.

Gerhard F Weinbauer

Gerhard F Weinbauer holds a PhD in biology and zoology with special expertise on reproductive physiology of primates. During 1983 - 1985 he received a fellowship from the Max-Planck-Society and thereafter joined the university. During 1986 - 2000 he acted as Head of the Animal Experimentation Department (rodents and primates) at the University of Münster and managed the institute's primate colony (macaque monkeys and marmosets). He joined Covance Laboratories Europe in Münster in August 2000 and acted as Head of reproduction toxicology, regulatory toxicology study direction, study reporting as well as method development and research. During 2009-2011 he acted as Global Chief Scientific Officer DART & Executive Director of Science for Nonclinical Safety Assessment. Since 2012 he acts as Vice President and Global Leader for DART focussing on all DART aspects across species and various Covance sites. Aside from the DART expertise, he has special expertise in primate toxicology, endocrine toxicology, pediatric safety assessment and in biopharmaceutical drug development. Society memberships comprise German Endocrine Society, Society of Toxicology, Japanese Society of Toxicology, Teratology Society and European Teratology Society. He has contributed more than 200 publications including original contributions, book chapters and reviews, edited ten books and acts as reviewer for many scientific journals and research supporting institutions. Since 2014 he is in the Editorial Board of Primate Biology. From 2006-2014 he served as Scientific Advisory Board Member for the German Primate Centre. Since 2016 he is a member of the HESI Board of Trustees. Prof. Weinbauer teaches reproductive physiology and medicine at the University of Münster including supervision of graduation students.

Additional panel members:

Thomas Hartung

Thomas Hartung, MD PhD, is Professor of Toxicology (Chair for Evidence-based Toxicology), Pharmacology, Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and University of Konstanz, Germany; he also is Director of their Centers for Alternatives to Animal Testing (CAAT, http://caat.jhsph.edu) with the portal AltWeb (http://altweb.jhsph.edu). CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (http://www.ebtox.com), the Good Cell Culture Practice Collaboration, the Green Toxicology Collaboration and the Industry Refinement Working Group. As PI, he heads the Human Toxome project (http://humantoxome.com) funded as an NIH Transformative Research Grant. He is the former Head of the European Commission’s Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy. He has authored more than 490 scientific publications.

Cees Smit

Cees Smit studied business economics at the Free University in Amsterdam. From 1978 till now, he has been member of the research project ‘Haemophilia in The Netherlands’ at the Leiden University Medical Centre (LUMC). From 1987 till 1998 he was co-ordinator of the Netherlands Haemophilia 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. In September 2015, he published together with Annemarie de Knecht – van Eekelen the book ‘De macht van de patiënt, baas over je eigen ziekte’. The book is so far only available in Dutch, but the English title would be ‘The power of the patient, boss of your own disease’. One of the issues discussed in this book is the increasing cooperation between patients, researchers and industry in the drug development process (Patient 3.0). For further information: info@smitvisch.nl / www.smitvisch.nl.

Nadia Rosenthal

Professor Rosenthal is Scientific Director of The Jackson Laboratory in Bar Harbor. She also holds a Chair in Cardiovascular Science at Imperial College London. She was awarded a PhD from Harvard Medical School, where she later directed a biomedical research laboratory, then established and headed the European Molecular Biology Laboratory (EMBL) campus in Rome. She was Founding Director of the Australian Regenerative Medicine Institute at Monash University, Melbourne and founded EMBL Australia as its Scientific Head. She has trained over 70 undergraduate, PhD students and postdoctoral fellows in her laboratory. She is an EMBO member, Fellow of the UK Academy of Medical Sciences, the Australian Academy of Health and Medical Science, and was an Australia Fellow. Professor Rosenthal is a global leader in the field of regenerative medicine. Her research has led to significant advances in the development of novel gene and cell-based therapies for muscle ageing and heart disease.

Session 3 - Regulatory testing: strengths & limitations of non-animal alternatives

Speakers:

Maurice Whelan

Prof. Maurice Whelan is head of the Chemical Safety and Alternative Methods Unit of the Directorate for Health, Consumers and Reference Materials of the European Commission's Joint Research Centre (JRC), based in Ispra, Italy. He also heads the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the JRC, established under EU Directive 2010/63 on the protection of animals used for scientific purposes to build on the 20 years of activities of ECVAM, the European Centre for the Validation of Alternative Methods. Priorities of his work include the development, validation and promotion of alternative approaches to animal testing both for regulatory safety assessment of chemicals (inc. nanomaterials) and for applications in biomedical research. Whelan is the EU co-chair of the OECD Advisory Group on Molecular Screening and Toxicogenomics that is responsible for the OECD programme on Adverse Outcome Pathways, and he is a member of the Steering Committee of the European Partnership for Alternative Approaches to Animal Testing (EPAA). He was awarded his Ph.D. in 1993 in Mechanical Engineering (design of orthopaedic knee prostheses) by the University of Limerick (Ireland) and holds an external appointment of visiting Professor of Bioengineering at the University of Liverpool (UK).

Warren Casey

Dr. Warren Casey is the Director of National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and Executive Director of the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). These groups work together to facilitate the development, validation, regulatory acceptance, and industry adoption of non-animal test methods. Prior to assuming his current position, Dr. Casey worked at GlaxoSmithKline for 15 years in a variety of roles, including: Manager of Pharmaceutical Microbiology, Head of In Vitro Biomarker Development, and Manager of Discovery and Investigative Toxicology. Dr. Casey received his undergraduate degree in biochemistry and his PhD in microbiology from North Carolina State University (NCSU), where he has been named a Distinguished Alumnus and also holds an adjunct professorship in the Department of Microbiology. He has been a Diplomate of the American Board of Toxicology (DABT) since 2007, received the 2016 Society of Toxicology Animal Welfare Award, currently serves as the vice president of the SOT In Vitro and Alternative Methods Specialty Section and co-chairs the OECD Validation Management Group – Non Animal.

Robert Kavlock

Dr. ROBERT J KAVLOCK Kavlock is the Deputy Assistant Administrator for Science in the US EPAs Office of Research Development (ORD) in Washington DC.   ORD is the scientific research arm of EPA, whose leading-edge research helps provide the underpinning of science and technology for the Agency.  He is responsible for overseeing the national research programs for the Office, which has 1700 staff located in 13 facilities across the US and an annual budget in excess of $500M.  His previous position was that of founding Director of the National Center for Computational Toxicology (NCCT) within EPA.  The NCCT has pioneered the application of modern molecular biology and computational sciences through its ToxCast program to bring high throughput methodologies to the study of chemical effects on biological systems.  Prior to that he spent 15 years as the Director of the Reproductive Toxicology Division in ORD where he focused on improving approaches to risk methods for non-cancer health outcomes.

Jan Willem van der Laan

Dr. Jan Willem van der Laan is senior assessor in Pharmacology and Toxicology for the Medicines Evaluation Board, located in Utrecht, the Netherlands. Jan was since 1990 in the Section Pharmacology and Toxicology Assessment at the National Institute for Public Health and the Environment (RIVM, Bilthoven). In this function he was responsible for the advice on non-clinical safety aspects for the Netherlands ‘College’, the Medicines Evaluation Board. He moved with this group in 2012 to the Medicines Evaluation Board located in Utrecht. He also is visiting staff member of the Leiden Academic Center for Drug Research, Division Toxicology, where he is working on a project on in vitro carcinogenicity testing approaches focusing on the role of nuclear receptors. He is chair of the EMA/CHMP Safety Working Party and also a member of the Nonclinical Working Group of the Pediatric Committee, giving advice about the need for juvenile safety studies.
Jan had long-standing  contributions to the International Conference on Harmonization on Carcinogenicity Testing. In 2015 he also became Regulatory Chair of the Expert Working Group on Juvenile Toxicity testing S11.

Additional panel members:

Derek J Knight

Dr Derek J Knight, who is British, has worked at the European Chemicals Agency (ECHA) since September 2008. As the Senior Scientific Advisor, he is responsible for providing the Deputy Executive Director with expert scientific and technical advice on matters relating to chemical regulation, with the focus on the EU REACH, CLP and Biocides Regulations and the operations of ECHA. Previously he headed a team of regulatory affairs professionals at a UK contract research organisation for almost 18 years, covering a wide range of regulatory schemes worldwide. He has also registered medicinal products and worked as a Technical Support Chemist. He has a broad understanding of the regulation of chemicals and is especially interested in approaches to hazard and risk assessment using non-standard data. He was on the Scientific Expert Panel of the SEURAT-1 research initiative ‘Towards the replacement of in vitro repeated dose systemic toxicity testing’ and he is a member of the Scientific Advisory Board of EU-ToxRisk. He is a Fellow of the Royal Society of Chemistry and Chartered Chemist, a Chartered Scientist and a Fellow of the Organisation of Professionals in Regulatory Affairs. His doctoral studies at the University of Oxford in the UK were in organosulphur chemistry.

Gianni Dal Negro

Dr Gianni Dal Negro is Worldwide Director 3Rs (Replacement, Reduction, Refinement) at GlaxoSmithKline Limited in the UK.  He is accountable for implementation and management of the global 3Rs plan at GlaxoSmithKline. In particular, he leads the process of identification, selection and funding of new opportunities with an impact on GSK’s R&D process and 3Rs. Gianni has 30 years of experience in Research and Development applied to both the regulatory and non-regulatory areas in the pharmaceutical sector. His responsibility covers all the business areas, including Biologicals and Consumer Healthcare products. The matrix structure he leads provides support to the different business units in identifying solutions to their unmet needs, making a thorough due diligence evaluation of possible relevant opportunities and preparing robust project proposals for funding. He also represents GSK in international committees and initiatives relevant to the 3Rs (science, legislation, regulatory requirements), among which EPAA, AISAL, FELASA and ICLAS.

Martin Paparella

Dr. Martin Paparella is with the Environment Agency Austria, Vienna and a European Registered Toxicologist (ERT). He functions as the Austrian National Coordinator of Testing Methods for OECD WNT, for the European Testing Methods Regulation and PARERE; he is the OECD WNT Vice chair and regulatory toxicologist for classification and risk assessment of biocides and chemicals. With a background in biotechnology and toxicology , Martin has 8 years of experience with the development and validation of toxicological in vitro methods, 3 of these years at the BOKU, 5 years at ECVAM (European Centre for the Validation of Alternative Methods, Joint Research Centre, Italy). Subsequently he acquired 13 years of experience as regulatory toxicologist through following involvements: Human health risk assessment of biocides for European regulatory processes, active participation in European Biocides Technical Meetings and related subgroups. Classification and toxicological hazard/risk evaluations in the REACH context. Lecturing and training in the field of human regulatory toxicology, e.g. at the Medical University Vienna, University of Applied Sciences Technikum Vienna and within European Twinning Projects. OECD WNT Vice Chair (2015-2017), Austrian National Coordinator of Testing Methods for OECD WNT (since 2014) and for the European Testing Methods Regulation and PARERE (preliminary assessment of regulatory relevance of new alternative methods, both since 2011), active contributions in this field of regulatory testing methods within related international working groups, with a focus on alternative approaches, specific interest in systematic uncertainty analysis of animal reference test data, see e.g. http://www.altex.ch/resources/epub_Paparella_of_1610241.pdf; http://www.altex.ch/resources/raltex_2013_2_131_144_Paparella1.pdf

Susanne Keitel

Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Following ten years in the pharmaceutical industry, she held variatious senior positions at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. Since October 2007, Susanne Keitel has held the post of Director of the European Directorate for the Quality of Medicine & HealthCare (EDQM), Council of Europe in Strasbourg. The EDQM is a leading organisation that protects public health by enabling the development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use. Its standards are recognised as a scientific benchmark world-wide. The European Pharmacopoeia is legally binding in member states.

Klaus Cussler

Dr. Klaus Cussler is the head of Veterinary Pharmacovigilance at the Paul-Ehrlich-Institut, Germany since 1987. His work an in-depth expertise concentrates on pharmacovigilance of immunological veterinary immunological medicinal products, licensing and batch control of bacterial vaccines, animal welfare and 3R methods. A veterinary surgeon by training, Klaus acquired a PhD in Immunology and also worked with the Landestierärztekammer Hessen, Germany as specialist in Veterinary Microbiology and Animal Welfare. His publication record holds more than 50 publications mainly in German language .

Session 4 - Reporting on European Commission actions 1 - 3

Speakers:

Susanna Louhimies

Susanna Louhimies works at the European Commission, the Directorate-General for the Environment since 1996. As Policy Co-ordinator she is responsible for the EU Directive on the protection of animals used for scientific purposes and any horizontal issues in relation to scientific, educational and regulatory use of animals. As an integral part of her portfolio she follows closely the implementation of the principle of the Three Rs (Replacement, Reduction and Refinement of animal use) in different policy areas. She is also responsible for the co-ordination of the regulatory acceptance of new and updated testing methods in the EU legislative framework for chemicals (REACH), as well as promoting their acceptance internationally, mainly through the work of the OECD.

Tracey Holley

Tracey Holley joined the European Commission's Joint Research Centre (JRC), based in Ispra, Italy, in 2015. Working in the Chemical Safety and Alternative Methods Unit of the Directorate for Health, Consumers and Reference Materials, Tracey has an integral role in the coordination of the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) scientific and stakeholder networks. Having started her professional life as a high school teacher, in 2008 she moved into scientific research at the John Innes Centre, Norwich (UK) where she worked on the biophysical characterisation of transcriptional regulators in Streptomyces coelicolor.  Tracey was awarded a PhD in biochemistry from the University of East Anglia (UK) in 2013 and subsequently worked in research and development in the private sector before relocating to Italy.

Ruxandra Draghia-Akli

Dr Ruxandra Draghia-Akli is Deputy Director-General for Research & Innovation at the European Commission, responsible for the Research Programmes. She serves as the Commission representative in the Governing Boards of most Joint Technology Initiatives of the EU with different industrial sectors. Dr Draghia-Akli joined the European Commission in 2009 as Director for Health Research in DG RTD. She has contributed considerably during these past years to the successes of the 'Health' Programme. She holds a MD degree and a PhD degree in human genetics from the University Carol Davilla, Romania and has participated in a fellowship programme in Genetics and Metabolic Pathology Department in "René Descartes" University in France, and a post-doctoral training in molecular biology at Baylor College of Medicine, USA. Before joining the Commission, Ruxandra worked in biotechnology companies, as Vice-President managing research programmes in the area of gene therapy and DNA vaccination.

Additional panel members:

Amalia-Irina Vlad

Dr. Amalia-Irina Vlad is the head of Sector Digital Patient in the Directorate-General for Communication Networks, Content and Technology, in the Health, Well-being and Ageing Unit. She is responsible for the modelling and simulation of diseases research area in FP7 and H2020 in DG CONNECT and involved in the coordination of the
e-Health research activities. She has worked as a specialist in haematology and molecular biology. She received a MD degree from Carol Davila Medical University, a Master Degree in "Biomolecules and experimental therapies" and a PhD in cellular biology from Paris 13 University.

Elke Anklam

Dr. Elke Anklam is a chemist, with specialisation in food, organic and radiation chemistry. After obtaining her PhD from the University Hamburg, Germany, she worked in various European Research Institutions and was a Teaching Professor at the Applied University of Fulda, Germany. Since 1991, she has been working at the European Commission's Joint Research Centre (EC-JRC). From 2006-2012, she was Director of the JRC-Institute for Health and Consumer Protection (IHCP) in Ispra, Italy and from 2012 – July 2016, Director of the JRC-Institute for Reference Materials and Measurements in Geel, Belgium. Since July 2016, she is the Director of the JRC-Geel site and the new JRC Directorate F: Health, Consumers & Reference Material (a merger of the former IHCP and IRMM), located at the JRC-Geel and JRC-Ispra site.

Adrian Smith

Adrian Smith is a British veterinarian, resident in Norway since 1980. He worked as a laboratory animal veterinarian at the Norwegian School of Veterinary Science for 30 years, where he developed a special interest in 3R-resources, became a Diplomat of the European College of Laboratory Animal Medicine (ECLAM) and held the Chair in Laboratory Animal Science. He left the Veterinary School in 2011 and is Secretary of Norway's 3R centre, Norecopa (http://norecopa.no).
His work has included responsibility for over 50 courses in Laboratory Animal Science, and the construction of a Multimedia Room using alternatives to animals for teaching purposes. He has also arranged many international meetings on the care and use of animals in research. He collaborates closely with the Norwegian authorities. This has included the development of national requirements for education and training in laboratory animal science and the draft of Norway's Regulations on animal experimentation, prior to EU Directive 2010/63. He is also on the Board of the Danish 3R-centre, which also serves as the National Committee. His main focus now is on the global dissemination of 3R-resources. With this in mind, Norecopa has constructed a comprehensive website (http://norecopa.no) and an intelligent search engine, with over 6,000 pages of 3R-resources, designed to be a one-stop-shop for all stakeholders worldwide.

Jan van der Valk

Dr. Jan van der Valk is trained in biomedical sciences. During his research career he was involved in establishing in vitro techniques. Later on he became involved in establishing the Netherlands Centre for Alternatives on Animal experiments in 1994 and has been involved in stimulating the development, acceptation and implementation of 3Rs models ever since. Since 2010, he coordinates the 3Rs-Centre Utrecht Life Sciences of the Utrecht University and University Medical Centre Utrecht. Dr. van der Valk is currently chair of the International Society of In Vitro Methods (INVITROM). He is also the chair of the education & training in laboratory animals science working group in the Netherlands advising the government, accreditation bodies, inspectorate and course organisers. He is also the Dutch member state representative on the Education and Training Platform for Laboratory Animal Science (ETPLAS), where he acts as vice-chair.

Elliot Lilley

Elliot is a Senior Scientific Officer within the RSPCA Research Animals Department. He received his PhD in Pharmacology from King’s College London in 1997 and then began a 15 year career in the pharmaceutical industry; initially at the James Black Foundation and latterly at Novartis. In 2012, he joined the RSPCA research animals department where his main areas of work relate to promoting refinement, including reducing severe suffering, experimental design, and translational validity.  More information on our work towards ending severe suffering can be found here: www.rspca.org.uk/severesuffering. Elliot is a Fellow of the British Pharmacological Society and is animal ethics editor of the British Journal of Pharmacology.

Katrin Schütte

Dr Katrin Schütte currently is a policy officer at the EU Commission's Directorate for the Environment, with responsibility for certain aspects of the REACH regulation (Registration and Evaluation) as well as for the DIR 2010/63/EU on the protection of animals used for scientific purposes. Due to this dual responsibility she is involved in various aspects of the implementation of 3Rs in EU legislation. She is also member of the steering committee of EPAA (European Partnership for Alternative Approaches to Animal testing) and co-leader of the EPAA project team on Harmonization of 3Rs in Biological products.
Katrin has a degree in nutrition sciences from the University of Hohenheim, a PhD in neurobiology from the University of Heidelberg (DE) and is a Diplomate of the American Board of Toxicology (DABT) and European Registered Toxicologist (ERT). Before joining the Commission, she worked for 15 years as a toxicologist and regulatory affairs manager at Procter & Gamble in the consumer products sector. During that time she contributed to the Company's 3R efforts among others through validating the Chicken Enucleated Eye test for detergent products.

Opening address - Day 2

Julie Girling

Julie Girling has served as a Conservative Member of the European Parliament for South West England and Gibraltar since 2009. She is currently the Coordinator for the European Conservatives and Reformists Group on the Committee on Environment, Public Health and Food Safety. She also sits on the Committee on Agriculture and Rural Development, and the Committee on Women's Rights and Gender Equality. She currently sits on the Delegation for relations with South East Asia, and has previously served as Chief Whip for the Conservatives in the European Parliament. During her time in the European Parliament she has worked on a number of important legislative files covering areas such as air quality, food safety, reform of the Common Agriculture and Fisheries Policies, biodiversity, chemicals and animal welfare .

Session 5 - Responsible Research

Speakers:

Ulrich Dirnagl

The research of Ulrich Dirnagl is focused on stroke, cerebral blood flow regulation, and brain imaging. In preclinical models as well as clinical trials he and his coworkers and collaborators explore mechanisms by which brain ischemia leads to cell death, and develops novel methods to intercept mechanisms of damage in acute brain damage, as well as to foster regeneration and repair of the lesions.  He is particulary interested in how the brain protects itself (‘endogenous neuroprotection’), and how the brain interacts with other systems of the body after it has been injured. Closely linked to his interest in stroke pathophysiology is his interest in the coupling of regional blood flow to neuronal acitivity, the mechanism underlying functional brain imaging with MR and PET. Beyond imaging structure and function of the CNS he and his team are developing, validating and using techniques that allow the non-invasive imaging of brain biochemistry and molecular signaling. To this end they use optical, MR, and nuclear medicine approaches in mouse and man. To improve the predictiveness of preclinical translational research he is actively promoting the introduction of quality standards for experimental design and reporting, as well as international collaboration in large, phase III-type preclinical trials. At the Charité Universitätsmedizin Berlin Ulrich Dirnagl serves as Director of the Department of Experimental Neurology, Chief Executive Director of the Center for Stroke Research Berlin, Clinical program coordinator of the Excellence Cluter NeuroCure and the Berlin partner site of the German Center for Neurodegenerative Diseases (DZNE), as well as Program Director of the International Graduate Program Medical Neuroscience.

Vicky Robinson

Vicky has a PhD in developmental biology and spent five years as a post-doctoral scientist working on the development of the vertebrate hindbrain. She has worked in science policy since 2002 and has been chief executive of the NC3Rs – the UK’s national 3Rs Centre – since it was launched 12 years ago. The NC3Rs is the UK’s main funder of 3Rs research and its team lead a wide range of science programmes which focus on embedding the 3Rs in policy, practice and regulations across the life sciences sector. Vicky is responsible for the NC3Rs strategy and its delivery in practice.

Thomas Korff

Thomas Korff is a biologist and professor at the University of Heidelberg, Germany in the Institute of physiology and pathophysiology. His research covered endothelial differentiation, apoptosis and angiogenesis, and other aspects of tumour biology. Since 2016 he directs the working group Blood vessel remodelling at the above mentioned institute. During his career he received several research awards, including the Ursula M. Händel animal protection award in 2014.

Iain Hrynaszkiewicz

Iain Hrynaszkiewicz is Head of Data Publishing at Springer Nature where his team help develop research data publishing policies, features and services across Springer Nature publications. He is also publisher of Nature Research Group’s Scientific Data journal. In 2015 he launched Palgrave Communications, a multidisciplinary open access journal for humanities and social sciences and helped develop Palgrave’s open access books programme. Iain previously worked as Outreach Director at Faculty of 1000 and spent 7 years at the first open access publisher BioMed Central as an Editor and Publisher of multidisciplinary and evidence-based medicine journals and databases. He regularly leads and contributes to research/publishing community initiatives and working groups related to data sharing and reproducibility. He has published numerous articles, related to data sharing, open access, open data and the role of publishers in reproducible research.

Additional panel members:

Louiza Kalokairinou

Louiza Kalokairinou is a Policy Officer at the Ethics and Research Integrity Sector of DG Research Innovation of the European Commission; and a PhD researcher at the Centre for Biomedical Law and Ethics of the University of Leuven. Her PhD project focuses on the ethical and legal implications of commercial genetic testing. During the course of her PhD project, Louiza has been a visiting student researcher at Stanford University, and at Uppsala University.
Louiza holds a Bachelor degree in Law (Aristotle University of Thessaloniki), an LLM in Intellectual Property Law (Queen Mary University of London) and an MA in Bioethics (KU Leuven, Radboud University Nijmegen, and University of Padova). In the past, Louiza has worked as a legal trainee and as an intern at the Hellenic Republic National Bioethics Commission (Athens, Greece) and at the European Patent Office (Munich, Germany).

Lindsay Marshall

Lindsay completed a BSc (Hons) in Biological Sciences at Stirling University in 1992, followed by an MSc in Cellular and Molecular Pathology at Dundee University. She stayed in Dundee for her PhD, supervised by Dr Anil Mehta, Clinical Reader in the School of Medicine. Throughout this, her research has focussed on the physiology, cell biology and immunology of human respiratory epithelium, specifically in relation to the pathophysiological changes observed in cystic fibrosis (CF) lung disease. Her post-doctoral studies, at the Department of Medical Specialties, Southampton University and then the School of Pharmacy and Biomedical Sciences at Portsmouth University, investigated inflammatory responses, repair processes and innate immunity of the human airways. Her research throughout her academic career at Aston University, where she was a Senior Lecturer in Immunology, continued the theme of human respiratory defences, with the development of multi-cellular, in vitro models of human airways. It is Lindsay’s view that the availability of validated and robust human models are vitally important since they provide a useful and much needed testing platform for novel drug candidates, whilst removing the requirement for animal testing. Her academic research was funded by the CF Trust, the NC3Rs, Dr Hadwen Trust and The Humane Research Trust.

Beth Thompson

Dr Beth Thompson is Senior Policy Adviser at the Wellcome Trust. Wellcome is a global foundation dedicated to improving health and spends around €1 billion a year to support research, education and public engagement. Beth leads Wellcome’s policy and advocacy work on research regulation, including the use of animals in research and the impact of the EU Data Protection Regulation. In 2010, Beth was seconded to the UK Academy of Medical Sciences to produce a major report on the regulation and governance of health research in the UK. Beth started her career in science policy at the Royal Society of Chemistry, before joining Wellcome in 2009. Beth undertook her PhD and postdoctoral research at the Medical Research Council Laboratory of Molecular Biology in Cambridge and holds a degree in Natural Sciences (Biochemistry) from the University of Cambridge.

Merel Ritskes-Hoitinga

Merel Ritskes-Hoitinga is professor in Evidence-Based Laboratory Animal Science at Radboud university medical center, Nijmegen, The Netherlands. She graduated as a veterinarian in 1986 from Utrecht University, The Netherlands. She has since been dedicated to the improvement of the quality of science and animal welfare of laboratory animals. In 1992 she became Animal Welfare Officer and received her PhD degree at Utrecht University. She worked at the Unilever Research Laboratory from 1988-1996, and then accepted a job as assistant professor at the University of Southern Denmark in Odense. From 1997-2005 she became professor in Laboratory Animal Science and Comparative Medicine at that same university. From 2005 on she has been appointed professor in Laboratory Animal Science at Radboud university medical center of Nijmegen. She has served in a number of international boards among which  FELASA and the Laboratory Animals Ltd. Currently she is secretary-elect of ECLAM. In 2012 she founded SYRCLE, dedicated to systematic reviews of animal studies (www.syrcle.nl). Systematic reviews of animal studies lead to the implementation of the 3Rs, a more evidence-based choice of animal models and better translational transparency on the value of animal studies for human medicine.

Session 6 - The Future: the way forward /part 1

Speakers:

Mark Viant

Mark Viant is a Professor of Metabolomics in the School of Biosciences at the University of Birmingham, UK, Executive Director of Phenome Centre Birmingham and Director of the NERC Biomolecular Analysis Facility, two of the UK’s national metabolomics centres. As a passionate advocate for the growth of the metabolomics community, he leads training and outreach through the Birmingham Metabolomics Training Centre and as the ELIXIR-UK Sector Lead for metabolomics. Mark is also a past President of the International Metabolomics Society. His research programme and interests encompass the development of optimised analytical and computational workflows for metabolomics and the applications of these technologies to investigate the metabolic pathways underlying toxicity and disease, both in the context of human and environmental health. He is particularly fascinated by chemical and nanomaterial toxicology in ‘non-animal’ invertebrate model organisms, for example Daphnia, and the translation of metabolomics based ‘discovery’ research into mechanistically based tools for chemical safety and environmental diagnostics. Mark has co-authored over 150 publications and his work has recently been recognised by the award of a 2015 Lifetime Honorary Fellowship of the International Metabolomics Society “In recognition of his pioneering work in environmental metabolomics and for his sustained service to the Society. His vision revolutionized the Society’s operations and reputation, expanding its reach to all corners of the world.”.

Reyk Horland

Since 2010 Reyk is actively involved in the development of TissUse’s Multi-Organ-Chip platform for culture analysis of drug candidates, cosmetics, chemicals and consumer products. He currently holds the position of Head of Business Development at TissUse. Prior to TissUse Reyk studied Biotechnology at the Technische Universität Berlin and specialized in Medical Biotechnology. During his academic career he was involved in various tissue engineering programs, all with a focus on commercialisation of the respective products.

Xavier Gidrol

Xavier Gidrol received is PhD in Molecular and Cell Biology from Aix-Marseille University in 1984. He performed post-doctoral research at Harvard School of Public Health and at the Institute of Molecular and Cell Biology, Singapore. He was specialized in transcriptional regulation of gene expression. He got a tenure position at INRA France, and then served as Associate Director of R&D at Xenometrix Inc.  a spin-off start-up from Harvard University, where he got interested in global approaches and genomics. He then joined in 2000 the newly created Functional Genomics Laboratory at France’s Atomic & Alternative Energy Commission (CEA) in Paris and managed it until 2008. This laboratory focused on large scale functional genomics approaches to analyze proliferation/differentiation balance in oncology. In 2009, he was appointed director of a new laboratory, “Biomics” at CEA in Grenoble, to use microsystems for cell biology, where he focuses on large scale RNAi-based functional genomics screens, 3D organoids and miRNA in oncology. Since 2015, he manages both Biomics team and ”Large Scale Biology Laboratory” at CEA Grenoble.  Xavier Gidrol authored or co-authored more than 100 publications.

Session 6 - The Future: the way forward /part 2

Speakers:

Tony Lahoutte

Prof Dr Tony Lahoutte is head of the department of nuclear medicine at the university hospital (UZ) Brussels and head of the molecular imaging research unit at the Vrije Universiteit Brussel (VUB) in Belgium. He obtained his medical degree in 1998 and started his research activities in combination with a residency program in nuclear medicine. His current research is focused on the development and clinical translation of molecular imaging probes and targeted radionuclide therapies for the detection and treatment of cancer. Prof Dr Tony Lahoutte is vice-president of the European Society of Molecular Imaging.

Christine Mummery

Christine Mummery is Professor of Developmental Biology at Leiden University Medical Centre. Her research concerns multidisciplinary approaches to understanding heart and vascular development, the differentiation of pluripotent stem cells into the cardiac and vascular lineages and using these cells as disease models. She is a member of the Royal Netherlands Academy of Science, authored a popular book “Stem Cells: Scientific Facts and Fiction” and is editor in chief of the ISSCR journal Stem Cell Reports.

Marco Viceconti

Professor Marco Viceconti holds the chair of Biomechanics at the Department of Mechanical Engineering of the University of Sheffield, UK, and serves as Executive Director of the Insigneo Institute for in silico Medicine (www.insigneo.org), a joint initiative of the University of Sheffield and the Sheffield Teaching Hospital NHS Foundation Trust. He is also professor associate in the department of Oncology and Metabolism. Marco is an expert of musculoskeletal biomechanics in general, and in particular in the use of subject-specific modelling to support the medical decision. He is one of the key figures in the Virtual Physiological Human (VPH) community: he is the President of the VPH Institute, an international no-profit organisation that coordinates this research community, and has recently concluded the coordination of the Avicenna action, which road-mapped the emerging topic of “in silico clinical trials”, where subject-specific modelling is used in the development and assessment of biomedical products.

Additional panel members:

Philippe Detilleux

Dr. Philippe Detilleux is the Global Head of Preclinical Safety at Sanofi R&D in France. He holds a Veterinary Medicine degree from the University of Liège, Belgium, and received his MSc and PhD in Veterinary Pathology from Iowa Sate University, Ames, Iowa. He has over 25 years experience in preclinical safety evaluation in the pharmaceutical Industry, first as toxicologic pathologist, then as head of a large non-clinical safety department and now as global head for Preclinical Safety at Sanofi. He is board-certified in Veterinary Pathology, member of various professional societies and frequent lecturer in toxicologic pathology and preclinical drug development. In the context of the Innovative Medicine Initiative (IMI2), Philippe Detilleux is the current chair of the EFPIA Translational Safety Strategic Governing Group (TS-SGG).

Nick Meade

Nick Meade is Director of Policy at Genetic Alliance UK, the national charity of over 180 patient organisations supporting all those affected by genetic conditions, and a member of the Patients' Network for Health and Medical Research (EGAN - egan.eu). Genetic Alliance UK's and EGAN's policy work focuses on research and innovation to facilitate progress towards cures and treatments for unmet health need, on the commissioning of healthcare services and access to therapies, on genetic testing and genomic technologies, and on reproductive choice. Genetic Alliance UK runs the Rare Disease UK campaign and the SWAN UK (Syndromes Without A Name) group which supports families of children with undiagnosed conditions; Nick plays a key role in both of these projects. Nick represents patients on panels and committees in the UK and Europe, including NHS England, UK Rare Disease Forum, UK Genetic Testing Network, National Institute for Health and Care Excellence (NICE) and the European Medicines Agency.

Concluding remarks

Daniel Calleja Crespo

Mr Calleja is Director General of DG Environment from 1 September 2015. He was Director General of DG Internal Market, Industry, Entrepreneurship and SMEs from 1 January 2015 until the 31 August 2015. He was Director General of DG Enterprise and Industry, Special Envoy for SMEs from 2012 to 2015. He was Deputy Director General of DG Enterprise and Industry, from 2011 to 2012, in charge of internal markets for goods, competitiveness and innovation, SMEs and entrepreneurship, international negotiations and tourism. He is the Special Envoy for SMEs. He was Director for Air Transport at the EC from November 2004 to February 2011, in charge of the single European aviation market and its external dimension. He has successfully negotiated, on behalf of the EU, the EU-US Open Skies Agreement. He was the Chairman of the Air Safety and the Single Sky Committees and Chairman of the Board of the SESAR Joint Undertaking. Between 1999 and 2004, he was Head of Cabinet of the Vice-president of the EC, Mrs. de Palacio, responsible for Transport, Energy and relations with the EP. During this period, he participated actively in the elaboration of the EU transport policy, notably in the launching of the Transport White Book, the Single European Sky, the creation of the European Air Safety Agency (EASA) and the Galileo program. Between 1995 and 1999, he was the Head of Cabinet for Commissioner Oreja, responsible for institutional affairs, and for the Amsterdam Treaty negotiations. In 1995, he was the legal adviser in the Cabinet of the President of the EC, responsible for Transport, Competition, State Aids and the control of the application of Community Law. Between 1993 and 1994, he advised the Transport Commissioner in the area of liberalisation of air transport, State aid cases concerning the restructuring of airlines, the first directive on groundhandling, the implementation of the third air package and the CRS regulation. Between 1986 and 1993, he was Member of the Legal Service of the Commission and he represented the institution in numerous cases before the European Court of Justice. He is the author of several publications. He has lectured in European Law in several universities and institutes of various Member States. He has a degree in Law and in Business Administration from the University of Comillas, Madrid.