12th EGA INTERNATIONAL BIOSIMILAR MEDICINES CONFERENCE 3-4 April 2014 – The Tower

Adrian van den Hoven Director General, EGA Adrian van den Hoven was appointed Director General of the European Generic and Biosimilar Medicines Association (EGA) on 1 September 2013. Before this he was Deputy Director General of BUSINESSEUROPE with responsibility for the International Relations and Industry departments. He worked as an International Relations researcher and adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor) prior to joining BUSINESSEUROPE in 2003. He received his doctorate in Political Science from the University of Nice, France in 2000.

Victor Lino Mendonça Head of Pharmaceutical Policy and Health Economics, EGA Victor Lino Mendonça is graduated in business administration and is the Head of Pharmaceutical Policy and Health Economics at the EGA - EUROPEAN GENERIC MEDICINES ASSOCIATION. He is responsible for Market Access area at the EGA. Before EGA he was Advisor to the Executive Board of Infarmed The Portuguese National Authority of Medicines and Health Products where he was responsible for the generic medicines policy. Prior to Infarmed, he was Advisor to the Health Secretary of State. Victor also worked as Product Manager at Boehringer Ingelheim Portugal and in the fast moving consumer goods area.

Salvatore D’Acunto Head of Unit, Food and Healthcare Industries, Biotechnology, DG ENTR, European Commission Salvatore d‟Acunto is a lawyer by profession. He graduated from the University Roma II – Tor Vergata in 1989 (Dottore in Giurisprudenza). In 1992 he obtained his Degree in International Politics (CERIS-ULB, Brussels) and in 2000 - Degree in European Law (European Studies Institute - ULB, Brussels). Salvatore joined the European Commission in 1993 where, as Administrator in the Directorate-General Internal Market, was in charge for services users' rights and for issues related with electronic commerce and television. In 2004 he became Deputy Head of Unit “Services 2” (Directorate-General for Internal Market) where he took part in negotiations of the proposal of Directive 2006/123 on Services (Bolkestein) and various actions in specific sectors (pharmacy, retailing, oil stations, gambling, privatisations, sport, tourism). In February 2009 he took up duties of Head of Unit "Services of general economic interest, passenger rights & infringements” in DirectorateGeneral for Mobility & Transport. Currently, Salvatore is Head of Unit for Food and Healthcare Industries, Biotechnology in the Directorate-General Enterprise and Industry that he joined in January 2012.

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Alan Sheppard Global Head Generics, Thought Leadership, IMS Health, UK Alan Sheppard is Principal, Global Generics, Thought Leadership at IMS Health. In this position he is responsible for providing insights into the effects of policies and procedures on the market dynamics that influence the utilisation of generic medicines. Alan has over 35 years experience within the pharmaceutical industry covering the full spectrum of innovative medicines, generics, biologics, vaccines and OTC medicines. Having held senior positions within sales and marketing, business development, and general management he has extensive experience in mergers and acquisitions, partnering, licensing, product development, manufacturing and R&D. Previous positions include: Executive Vice-President, Europe Generics, Dr Reddy‟s Laboratories Ltd, Vice-President, Global Corporate Strategy, Pliva, European Marketing Director, Medeva, General Manager, RhônePoulenc Rorer UK, General Manager, Institute Merieux.

Fernando de Mora, Prof, PhD, MBA Professor, Dep. of Pharmacology, Therapeutics and Toxicology, Autonomous University Barcelona, ES Fernando de Mora is a Professor at the Department of Pharmacology, Therapeutics and Toxicology of the Universidad Autònoma de Barcelona (UAB) in Spain (where he has held different professorship positions since 1988). He chaired the Medical School Pharmacology Department from 2005 to 2011. He holds a PhD in pharmacology. After pre- and postdoctoral research training at Utrecht Pharmacy School (The Netherlands), Southampton University Medical School (UK), and Harvard Medical School (USA), he established, and still leads, his own research team on preclinical allergy and asthma research at the UAB; a field in which he has published international papers. He HOLDS a Chicago University MBA SINCE 1999. As a faculty, he studied biosimilars from the scientific, regulatory and market perspectives. Since 2008 he has worked as an Academic Consultant, and a speaker on biosimilars for private laboratories, and public organizations (activities developed in more than 20 countries). From 2009 to 2012, he combined THIS ACTIVITY with HIS WORK AS MANAGING CONSULTANT of a university spin off company co-owned BY four entrepreneurs from the TOP Spanish pharmaceutical sector (Salupharma Biosimilars SA).

Paul Greenland, BSc, MBA Vice President – Biologics, Hospira UK Paul Greenland has been in the pharmaceutical industry for more than 20 years, working in a variety of commercial roles in both the European and Australasian markets. At Hospira he is responsible for the development and commercialization of the biologics business and has already coordinated the launch of Hospira‟s first two biosimilar products, Retacrit (epoetin zeta) and Nivestim (filgrastim). He is now preparing the launch of their recently approved biosimilar mAb, Inflectra (infliximab). Paul Greenland is an active member of the European Biosimilars Group (EBG) and chairs the Market Access Group (EBG-MAG).

Ken Walsh Manager Global Pricing Biopharma, Sandoz International GmbH, DE Ken Walsh leads Global Pricing and Market Access for Sandoz Biopharmaceuticals the world‟s largest biosimilar player based at their HQ in Holzkirchen, Germany. Ken joined Sandoz in 2012 from consulting where he gained over 10 years of global pricing and market access experience with leading firms such as GfK Bridgehead, Kantar Health and Cambridge Pharma (a unit of ims health) spread across the USA and Singapore. Ken holds an MA in Economics from Heriot-Watt University and an MSc in Finance from the Cass Business School, London.

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Claude Le Pen, PhD Professor Health Economics, Paris-Dauphine University, FR Professor Claude Le Pen is a French economist, graduated from HEC business school and holding a PhD in economics. He is professor at Paris Dauphine University where he is responsible for the Master “Economics and Management of the healthcare system”. His main research interests are in health policy and in pharmaceutical and medical technologies industries economics. He studies the economic regulation and financing of the health care system. In the 80s he contributed with Pr Emile Levy to develop the economic valuation of medical technologies in France. He wrote more than 100 articles in peer review scientific journals and several books, the last one published in 2012, on the French Health policy. He is and was a member of several state commissions. He is an independent consultant for several health institutions and for IMS-Health, the leading company for health statistics. He also frequently intervenes in medias on health matters.

Paul Chrisp, PhD, MRPharmS Programme Director, Medicines and Prescribing Centre, UK Paul Chrisp is Programme Director of the NICE Medicines and Prescribing Centre (MPC), which produces a comprehensive suite of guidance, advice and services for safe, efficient, high quality use of medicines. Paul has been with NICE since March 2009, where he was responsible for setting up the Institute‟s accreditation programme, which evaluates the processes used by organisations to develop guidance. Paul trained is a nonpracticing pharmacist and spent over 20 years in international medical publishing and communications, mainly focusing on appraisal, review and synthesis of evidence to aid quality healthcare decision making and the adoption of new medicines.

Piedad Ferré Technical Adviser, Spanish Ministry of Health, ES Piedad Ferré is a pharmacist, technical adviser in the Directorate General for Pharmacy and Health Care Products in the Spanish Ministry of Health, Social Services and Equality to support pharmaceutical policy issues at the national level. She is also involved in the assessment of medicinal products for fixing prices and reimbursement conditions with a broad expertise in this field. She has wide experience in the international environment and participates regularly in international groups for pharmaceutical issues at the Commission and Council level and other organisations dealing with pharmaceuticals.

Christopher Teale, BSc Vice President Europe, Market Access, Health, GfK Bridgehead, UK Chris Teale holds a BSc degree in Mathematics from Newcastle University, and also studied at Loughborough University (Management Information Systems) and INSEAD Business School (Marketing for International Business). Chris joined GfK Market Access in 2011 bringing with him extensive practical and academic experience within the pharmaceutical industry, across both Marketing and R&D, over a 30 year career. He has held a number of leadership positions at both Global and European level, having previously been Director of Global Pricing and Market Access (Oncology) at Astra Zeneca; Director Health Economics, Pricing, Reimbursement and Access (EMEA) at Allergan; Commercial Planning Manager at Fisons, and Portfolio Planning Manager at Ciba-Geigy in Switzerland. In his market access roles he successfully developed global pricing strategies for a wide range of products and therapy areas including personalised healthcare products (requiring both pharmaceutical and diagnostic reimbursement) and orphan drugs.

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Victoria Fine Patient, Psoriasense, UK Making Sense of Psoriasis. Victoria has had psoriasis and psoriatic arthritis for 14 years. As well as extensive inside knowledge of living with this disease every day for many years, Victoria works closely with the Psoriasis Association to support all aspects of their work. She has an extensive repertoire of media interviews including the See Psoriasis: Look Deeper campaign. Victoria spoke at the Abbott's roundtable event, held in Parliament, about psoriasis and has spoken for and on behalf of pharmaceutical companies as an expert patient. Victoria is a member of the Biosimilars Expert Forum and Global Psoriasis Steering Committee. She has also written many short courses to aid living with psoriasis and published several articles. Victoria founded Psoriasense in April 2012, in order to educate society about psoriasis, psoriatic arthritis and the effects it has on quality of life. Her aim is to show that psoriasis is far more than 'just a dry patch of skin'. Victoria hopes that curing ignorance and raising awareness will hugely affect the impact that psoriasis and psoriatic arthritis has on the person who is diagnosed and living with it. Psoriasense was developed with the view to helping make psoriasis more socially acceptable, reducing the problems psoriasis sufferers have to deal with every single day - or just making them easier to live with. Victoria concentrates her efforts on improving quality of life and access to effective treatment for patients as well as making sure there is advice, guidance and support available.

Joerg Windisch, PhD Chief Science Officer, Sandoz Biopharmaceuticals, AT and Chair of the EGA - European Biosimilars Group (EBG) Joerg Windisch has been working on the development of both, innovative and follow-on biologics for his entire professional career. He joined Sandoz in 1996 as a day one member of the company‟s biosimilars program and played leading roles in the development of Sandoz‟ Somatropin product (Omnitrope®), the first ever biosimilar medicine, as well as of the company‟s Epoetin alfa (Binocrit®) and Filgrastim (Zarzio®) products. Over 15 years, he built up an international technical development organization for biosimilars comprising several hundred experts. For the last 6 years, he has been focusing on the development of biosimilar monoclonal antibodies. Dr. Windisch is also the Chair of the European Generic medicines Association‟s (EGA‟s) European Biosimilars Group (EBG). The EBG represents the biosimilars industry in Europe. He has published extensively on biosimilars and biologics and holds numerous patents in the field. Dr. Windisch holds a Ph.D. in biochemistry.

Iordanis Gravanis Head of Evaluation Procedures C, Procedure Management Department, European Medicines Agency (EMA) Iordanis Gravanis is EMA Service Head of Evaluation Procedures C. He has worked at the EMA for almost 6 years managing oncology drug authorisations and post-authorisation drug lifecycle. He has also worked for 3 years in the secretariat of the Biosimilar Medicines Working Party. He holds a medical degree from the University of Ioannina, Greece and a PhD in Molecular and Cellular Pharmacology from Stony Brook University, USA.

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Steven Kozlowski, PhD Director, Office of Biotechnology Products, CDER, US FDA Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, at the Center for Drugs Evaluation and Research (CDER), FDA. OBP is responsible for the quality review of monoclonal antibodies and most therapeutic proteins at CDER. OBP also provides expertise on immunologic responses to therapeutic proteins and performs mission related research. Dr. Kozlowski received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. He studied the immune responses to proteins and peptides during his fellowship. Dr. Kozlowski joined the Division of Monoclonal Antibodies in 1993 and was tenured as a Senior Investigator in 2000. He has been involved in all phases of the regulatory process as a reviewer, from pre-IND product development through inspections, licensing and post approval supplements. Dr. Kozlowski served as the acting Director of the Division of Monoclonal Antibodies from 2004-2005. He has also served as an instructor and as an adjunct clinical reviewer at FDA. Dr. Kozlowski‟s research interests include the effects of drugs on the immune system. He is involved in ongoing policy development for biosimilars and Quality-by-Design approaches for the manufacture of biopharmaceutical products.

Jeewon Joung, PhD Deputy Director, Recombinant Protein Products Division, Ministry of Food and Drug Safety, KR Jeewon Joung received her Ph.D. degree in biology from Ewha Womens University, Korea in 1997. She joined the KFDA in 1993 as a scientific officer and has twenty years of experience in regulating the recombinant protein products. From 2008 to 2009, she was seconded to WHO and worked as responsible officer for establishing WHO guidelines on similar biotherapeutic products. Dr. Joung currently serves as the Deputy Director of recombinant protein products division in Ministry of Food and Drug Safety, Korea. Her duties at MFDS include the reviewing dossiers of recombinant protein products as well as biosimilar products in authorization, in clinical approval and in post marketing surveillance. She also has responsibilities for establishing evaluation guidelines and monographs for relevant products. For international regulatory convergence, she plays active roles in implementing „Biotechnological product roadmap‟ for APEC economies and in organizing „Biosimilar Working Group” in International Pharmaceutical Regulator‟s Forum (IPRF) under ICH.

Dr. med. Martina Weise Head, Unit on Diabetes/Cardiology, Federal Institute for Drugs and Medical Devices, Vice-Chair of the EMA Working Party on Similar Biological Medicinal Products (BMWP) of the CHMP and German CHMP Alternate, DE Martina Weise is a board-certified paediatrician with specific training in endocrinoloy including a 4-year Fellowship at the National Institute of Child Health and Human Development, NIH, USA and is a member of the Endocrine Society (USA). She received her doctoral degree from the J.W. GoetheUniversity of Frankfurt, Germany, in 1992 and has performed and published various clinical and laboratory studies, primarily in the field of growth and adrenal disorders. Dr. Weise joined BfArM in October of 2001, initially as head of the Unit on Endocrinology/Diabetes. She was member of the Research Board of BfArM fom 2004 to 2010 and member of the Efficacy Working Party of the CHMP from 2005 until its resolution in 2010, when she joined the Cardiovascular Working Party as endocrinological expert. She has been a member of the „Biosimilar‟ Working Party (BMWP) of the CHMP since its formation in 2004 and was appointed as Vice Chair in 2005. Dr. Weise also is an expert to the WHO regarding biosimilars and, besides drafting and revising EU guidelines on biosimilars, substantially contributed to the WHO Guidelines on Evaluation of Similar Biotherapeutic Products. Finally, Dr. Weise has been appointed as German CHMP Alternate in 2009. 5

Ivana Knezevic, PhD Scientist, Technologies, Standards and Norms Team Group Lead, Norms and Standards for Biologicals Department of Essential Medicines and Health Products (EMP) Health Systems and Innovation (HIS) Cluster, World Health Organization, CH Ivana Knezevic has twenty years of professional experience in standardization and regulation of biologicals. During the first seven years, the expertise in the production, quality control and overall evaluation of vaccines and biological therapeutics was developed at the national level. In 2000, Dr Knezevic joined WHO Biological Standardization Programme and since then her activities have been devoted to the standardization and evaluation of biologicals at the global level. This includes development and establishment of WHO International Standards as well as the assistance to the regulators, manufacturers and other users of these standards. Since 2006, she has been leading standardization of vaccines and biological therapeutic products. Dr Knezevic led development of WHO regulatory guidelines on various aspects of biological evaluation (ie, cell substrates for production of biologicals) as well as the recommendations for production, control and evaluation of selected vaccines, published in WHO Technical Report Series. In the area of biotherapeutics, she coordinated development of the WHO Guidelines on evaluation of similar biotherapeutic products (SBPs) and has initiated a series of workshops to facilitate implementation of guiding principles into regulatory and manufacturers' practice. Dr Knezevic is also the author of several publications that made broad audience aware of WHO initiative in the development, establishment and implementation of standards for vaccines and some other biological products. Dr Knezevic is Specialist in Medical Microbiology and Parasitology. She received her MD from the University of Novi Sad, MSc in Medicine (Microbiology) and PhD in Medicine (Virology) from the University of Belgrade, Republic of Serbia.

Karl Heinz Emmert, PhD Head Biosimilar Development, Teva Germany, DE and Vice-Chair of the EGA - European Biosimilars Group (EBG) Karl Heinz Emmert graduated in 1983 from Ulm University where he specialized in Neurobiology. After having worked as Research Assistant in Comparative Neurobiology at Ulm University, he joined Merckle GmbH, a company of the ratiopharm group as scientific associate. In 1990 he changed to the department of Development Management where he held various positions in the Development of small molecules and biosimilar products, amongst them Chief Scientific Officer of BioGeneriX AG and Managing Director of Merckle GmbH, both companies of the ratiopharm group. In 2006 he became Member of the ratiopharm Management Board responsible for the Biotechnology Business. Through the acquisition of ratiopharm Group he joined Teva where he took over responsibility of the Biosimilar Project Leaders. Karl Heinz Emmert is Member of the Teva ratiopharm Germany Executive Board. Karl Heinz Emmert is Member of the Teva ratiopharm Germany Executive Board. He acts as Vice-Chair of the European Biologics Group in the European Generic Association, assisting EU regulators in preparing European Biosimilar Guidelines.

Michael Soldan, PhD Regulatory Affairs Biosimilars, Boehringer Ingelheim Pharma, DE Michael Soldan Ph.D. is the Head of Regulatory Affairs Global Biosimilar Business Boehringer-Ingelheim. In this role Dr. Soldan is a member of the Biosimilar Executive Team at Boehringer Ingelheim and is responsible for the regulatory strategy of the Biosimilar Business. He served in increasingly senior roles within the Regulatory and Medical field in the biopharmaceutical industry at Biotest AG, Grünenthal, Chiron Vaccines and Aventis. Dr. Soldan holds a Ph.D. in pharmacology and has graduated in human biology and pharmacy.

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Suzette Kox, M.Sc., Pharm. Senior Director Scientific Affairs, EGA and Coordinator of the European Biosimilars Group (EBG), EGA Sector Group Suzette Kox is Senior Director Scientific Affairs of the European Generic medicines Association (EGA) and coordinator for the European Biopharmaceuticals Group (EBG), a sector group of the EGA and for the EMAEGA Working Group. She is also Vice-Chair of the Science Committee of the International Generic Pharmaceutical Alliance (IGPA). Suzette has been involved with biosimilars in the EU since 2001 and is the Programme Director of the EGA annual International Biosimilars Symposium. In her current position, she has given numerous presentations on the generic and biosimilar medicines EU regulatory framework at conferences around the world. Previously she worked for 10 years in regulatory affairs and management for the German company ratiopharm (now Teva) and was Chair of the EGA Regulatory & Scientific Affairs Committee and Member of the EGA Board and Executive Committee. She was also a visiting faculty member of the School for International Training: Department Development Studies and Public Health in Geneva, Switzerland. Before joining the generic medicines industry, she followed a hospital and retail pharmacy career. Along with a degree in pharmacy (Paris) she holds a postgraduate diploma in anatomypathology (Cochin Port Royal, Paris).

Professor Derek Calam Chair of the INN Expert Committee at the World Health Organization, CH Derek Calam graduated in chemistry from Oxford University. After appointments with the Medical and Agricultural Research Councils, he joined the UK National Institute for Biological Standards and Control on its foundation, becoming head of the Chemistry Division Derek served as ViceChairman and Chairman of both the British and European Pharmacopoeia Commissions. He is an advisor to the MHRA and has served on the Commission on Human Medicines. His involvement with WHO extends over 30 years and he is currently Chairman of the INN Expert Group. Derek is Visiting Professor of Pharmaceutical Sciences at the University of Strathclyde.

Hans Ebbers, PhD Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, NL Hans Ebbers is post-doctoral Researcher at Utrecht University and programme lead of the Technology Transfer Hub for biotherapeutics at Utrecht University. He has worked as researcher at the department of pharmaceutics of Utrecht Institute of Pharmaceutical Sciences, Utrecht, the Netherlands and as a lecturer in drug development at the department of innovation sciences at the Copernicus Institute of Sustainable Development of Utrecht University. His research focuses on the safety evaluation of biopharmaceuticals, particularly biosimilars. He obtained Master‟s degree in Biomedical Sciences at the Vrije Universiteit of Amsterdam and a Master‟s degree in the science, technology and public management profile from the University of Amsterdam, the Netherlands. He obtained his PhD at the division of pharmacoepidemiology and clinical pharmacology of Utrecht University on the topic of regulatory challenges of biopharmaceuticals. Before starting his research at Utrecht University, he worked at the medical affairs department of a large global biotechnology firm (Centocor, a subsidiary of Johnson & Johnson).

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Sabine Brosch Business Lead EudraVigilance and International Standardisation in Pharmacovigilance, Head of Evaluation Procedures C, Procedure Management Department, European Medicines Agency (EMA) Monitoring and Incident Management, Pharmacovigilance Department, European Medicines Agency (EMA) Sabine Brosch obtained a Master Degree in Pharmacy and a Doctor of Natural Sciences Degree in pharmacology from the University of Vienna, Austria. She performed post-graduate studies in pharmacology at the University of Melbourne, Australia and Auckland, New Zealand. She worked as Assistant Professor at the Department of Pharmacology and Toxicology at the University of Vienna from 1988 to 1992 and thereafter in the Department of Pharmacovigilance at the Ministry of Health in Vienna, Austria. Sabine Brosch joined the EMA, in 1996 and served as Deputy Head of Sector for Pharmacovigilance, Post-Authorisation Safety and Efficacy of Medicines at the EMA from 2001 to 2009. From 2010 to 2013 she was Business Lead in EudraVigilance and International Standardisation in Pharmacovigilance and editor of the ISO Identification of Medicinal Products Standard (ISO 11615:2012). In 2014 Sabine Brosch took up a new role as part of the new Monitoring and Incident Management Services of the Agency.

Yasemin Dil Research and Policy Officer, International Alliance of Patients' Organizations (IAPO), UK Yasemin Dil supports IAPO's research and policy activities, as well providing project support, coordination and management for IAPO's internal and external project work. She joined IAPO in February 2012 as a researcher to conduct a systematic literature review on patient-centred healthcare indicators. Most recently developed a comprehensive Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients' Organizations. Yasemin has an MSc in Control of Infectious Diseases from London School of Hygiene and Tropical Medicine and a BSc in Biomedical Science from University College London.

Dr. med. Sumant Ramachandra, PhD, MBA Senior Vice President and Chief Scientific Officer, Hospira, USA Sumant Ramachandra brings 20-plus years of healthcare experience and strong leadership abilities to his role as senior vice president and chief scientific officer. Ramachandra has made career leading scientific advancements for some of the industry‟s largest pharmaceutical companies, including Merck, Pharmacia, Pfizer and Schering-Plough. As an R&D business leader, he set in motion several therapy programs that would benefit patients living with cancer – such as Camptosar® (irinotecan hydrochloride injection) and Aromasin® (exemestane tablets) at Pfizer, and Temodar® (temozolomide capsules) at Schering-Plough. He was responsible for formulating innovative strategies and executing R&D plans that resulted in successful U.S. Food and Drug Administration (FDA) approvals. Ramachandra's award-winning work is also widely recognized through publications. He has participated in a multitude of scientific studies on tumor cell biology and immunology as well as authoring book chapters about basic cell biology and oncology. He has also filed several product patents for various cancer treatments and the use of antibodies in cancer therapy. In addition, Dr. Ramachandra has appeared in the PharmaVOICE 100, which recognizes top leaders in the health sciences, as well as Diversity MBA Magazine’s “Top 100 Under 50 Diverse Executive Leaders” and Crain’s Chicago Business’ “40 Under 40.” He earned a bachelor's degree in biochemistry from Rutgers University, graduating with high honors. Dr. Ramachandra then pursued a combined M.D. /Ph.D. degree from the University of Medicine and Dentistry-New Jersey Medical School, receiving the University's Medal of Excellence and subsequently conducting his residency at the Harvard-affiliated Massachusetts General Hospital. Ramachandra also earned an MBA at Wharton Business School.

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Dr. med. Pekka Kurki, PhD Research Professor, Finnish Medicines Agency, alternate member of the EMA management board and national expert of the BMWP, FI Pekka Kurki, acts as a research professor at the Finnish Medicines Agency (Fimea). Previously, he has had various positions in the Finnish regulatory agency, including senior medical officer, head of section, and head of department (licensing). Dr. Kurki's clinical speciality is internal medicine with sub-speciality in rheumatology. He has a teaching affiliation to the University of Helsinki (clinical immunology). His scientific interests include also cell biology, rheumatology and regulatory science. Before joining the Finnish regulatory agency in 1997, Dr. Kurki worked in the pharmaceutical industry (clinical research) for nine years, both in Europe and in the U.S.A. He has had several scientific positions at the European Medicines Agency (EMA), including the membership and co-opted membership of the Committee of Human Medicinal Products (CHMP, 2000-7), chairmanships of the working parties for comparability (2002-3), biosimilars (BMWP, 2004-7), cell therapy (2002-4), and cell-based medicinal products (CPWP 2005-7). In addition, he was the chair of the ad hoc group for xenogeneic cell therapy (2001-3), a member of the biologicals working party (BWP, 1998-9) and a member of the ad hoc innovation Think Tank group of EMA (2005-7). Currently, he is an alternate member of the EMA management board and a national expert of the Biosimilar Medicines Working Party (BMWP).

Dr. med. Javier Cortés, PhD Head Breast Cancer Program, Vall d’Hebron University Hospital, Barcelona, ES Dr. Javier Cortes received a degree in Medicine and Surgery from the Universidad Autónoma de Madrid (1996). He continued his studies at the University of Navarra, specialising in Medical Oncology at the Clínica Universitaria de Navarra, where he continued as Assistant in the Department of Oncology from 2002. He was Associated Professor of Oncology in the Faculty of Medicine at the University of Navarra during that period. Dr. Cortés was awarded the title of Doctor in Medical Oncology from the University of Navarra in 2002. Since 2003, he has worked in the Department of Medical Oncology at the Hospital Vall d' Hebron, Barcelona, where he is Coordinator of the Teaching and Training Programme for Residents in Oncology and Senior Specialist in the Area of Breast Cancer with a special interest in New Drugs Development. He also is Head of the Breast Cancer Unit and the Melanoma Unit. In addition, he has two masters‟ degree: “Medical Direction and Clinical Management” by the Universidad Nacional de Educación a Distancia (UNED) and “Research methodology in Health Sciences” by the Universidad Autonoma de Barcelona and a degree in “Statistics in Health Sciences” by the Universidad Autonoma de Barcelona. Dr. Cortes is the author of more than 100 publications, especially about breast tumours and new drugs and more than 150 communications at different conferences. He actively participates in the development of numerous national and international clinical investigations, especially in relation to drugs directed against molecular targets and new chemotherapy agents, and he is an ad hoc reviewer of various oncology journals. Dr Cortés is an active member of the Spanish, European, and American Societies of Medical Oncology (SEOM, ESMO, ASCO), a member of the Scientific Committee of the European Society of Medical Oncology and the Scientific Committee of SOLTI group.

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Dr. med. Paul Emery Professor, Arthritis Research UK Professor of Rheumatology Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds, UK and Director, Leeds Musculoskeletal Biomedical Research Unit Leeds Teaching Hospitals NHS Trust, UK Dr. Paul Emery is the Arthritis Research UK Professor of Rheumatology and Director of the Leeds Institute of Rheumatic and Musculoskeletal Medicine and the Director of the Leeds Musculoskeletal Biomedical Research Unit at Leeds Teaching Hospitals Trust, U.K. Professor Emery was President of EULAR 2009-2011. He has served on the editorial boards of all the major rheumatology journals. He was inaugural President of ISEMIR (International extremity MRI society). He is an NIHR Senior Investigator. He is a recipient of the Roche Biennial Award for Clinical Rheumatology; the Rheumatology Hospital Doctor of the Year award 1999; and EULAR prize 2002 for outstanding contribution to rheumatology research. In 2012 he was awarded the Carol Nachman Prize. Professor Emery‟s research interests centre around the immunopathogenesis and immunotherapy of rheumatoid arthritis, SpA and connective tissue diseases. He has a special interest in the factors leading to persistent inflammation. He has published over 900 peer-reviewed articles in this area.

Dr. med. Hartmut Link Professor West-Palatinate Clinical Centre, Dept. Hematology and Oncology, DE Dr. Hartmut Link is medical director at the West - Palatinate Clinical Centre, Department of Haematology and Oncology, Kaiserslautern, academic hospital of Mainz University and Heidelberg University Germany He graduated from Tübingen University, Germany, where he received his training in internal medicine and joined the research group on leukaemia and immunogenetics. He specialised in haematology and oncology at the Medical University Hannover, Germany, and established the clinical bone marrow transplantation programme, where he also became senior physician, and qualified as professor of medicine. Professor Link‟s research interests include therapy of acute myeloid leukemia, stem cell transplantation, infections in immunosuppressed patients, supportive care with haematopoietic growth factors, and clinical trials in haematology and oncology. He has authored numerous peer reviewed journal articles and textbooks on leukaemia, supportive care and infectious diseases, serves as reviewer for international journals and as editor of medical internetpublications. He is also engaged in developing and implementation of guidelines in haematology, oncology and supportive care. Professor Link is a board member for consultant education. He is an active member of several professional and scientific medical societies, including the Anaemia Working Party of the European Organisation for Research and Treatment of Cancer, the European Group for Blood and Bone Marrow Transplantation, and the Multinational Association of Supportive Care in Cancer.

Dr. med. Stan Bukofzer, PhD Corporate Vice President and Chief Medical Officer, Hospira, USA Dr. Stan Bukofzer serves as Hospira‟s Chief Medical Officer. He is responsible for providing strategic & operational direction for Clinical Development, Pharmacovigilence & safety and Medical Affairs. He received his MD from the University of Witwatersrand in South Africa. He also received his board certification in internal medicine and also gastroenterology and hepatology. After completing his studies, he served in the military and practiced in both academia and private practice. He was on the executive committee of SA Gastroenterology Association and founding member of Children‟s Liver Disease Foundation in SA. Dr. Bukofzer started his pharmaceutical career at Abbott Laboratories where he held a variety of positions with increasing responsibility, including Global Venture Head for Abbott‟s anti-infectives. He last served as Divisional Vice President and Head of Global Medical Affairs, and was responsible for all Affiliate Medical and Scientific Departments, Abbott‟s Physician Development Program, 10

international clinical operations , Global Publications and Global HEOR. Prior to joining Hospira, Dr. Bukofzer was Vice President of Medical Affairs at Astellas where he had responsibility for 7 therapeutic areas including oncology, immunology, hematology, anti-infectives, dermatology, cardiovascular and transplant. In this role he had the opportunity of leading a new standalone corporate entity, Astellas Scientific & Medical Affairs Inc.

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