17^th BIOSIMILAR MEDICINES CONFERENCE
HOTEL OKURA, AMSTERDAM
28-29 MARCH 2019

Adrian van den Hoven Director General, Medicines for Europe Adrian van den Hoven joined Medicines for Europe as a Director General in September 2013. His priorities at Medicines for Europe are to stimulate competition in off-patent medicine markets, to foster market access for generic, biosimilar and value added medicines, to support policy measures for sustainable pricing, to promote high regulatory standards while ensuring that the associated costs can be integrated into market dynamics and to develop a coherent EU industrial strategy to support the long-term viability of the generic, biosimilar and value added medicines industries. Prior to joining Medicines for Europe, Adrian van den Hoven was Deputy-Director General of BUSINESSEUROPE where he was responsible for the International Relations department, covering trade negotiations and bilateral relations, and the Industry department, covering industrial, energy, environmental and research policy. He previously worked as an International Relations researcher and an adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor). He obtained his doctorate in Political Science from the University of Nice, France in 2000.

Ruth Lopert Health Policy Analyst Health Division, DELSA, Organisation for Economic Co-operation and Development (OECD) Ruth Lopert is a public health physician and pharmaceutical policy practitioner. She is also a chercheur associé principal at the University of Strasbourg and an adjunct professor in the Department of Health Policy & Management at George Washington University, where she was Visiting Professor in 2011-12 and a Harkness Fellow in Health Policy in 2006-07. From 2008-11 Ruth was the chief medical officer in the Australian regulatory agency, the Therapeutic Goods Administration (TGA). Prior roles include directing the pharmaceutical policy unit in the Department of Health; managing the operations of the Australian drug coverage program, the Pharmaceutical Benefits Scheme (PBS); and medical and policy adviser to the PBS formulary selection committee. Ruth is a Fellow of the Faculty of Public Health of the Royal Australasian College of Physicians, a foreign corresponding member of l’Academie Nationale de Pharmacie of France, and a former member of the WHO Expert Advisory Panel on Drug Policies & Management. She is the author of more than 80 articles and monographs on drug and therapeutics regulation, health and pharmaceutical economics and policy, health technology assessment (HTA), and issues at the intersection of trade, globalization, intellectual property, and access to medicines.

Peter Goliaš Director, Institute for Economic and Social Reform (INEKO) - Slovakia Peter Goliaš (1977) is Director at the think-tank INEKO (Institute for Economic and Social Reforms), a non-governmental nonprofit organization based in Slovakia. He has 16 years of experience in the field of socio-economic research and advocacy. The areas of his professional interest include public finance, pensions, health care, education and labor markets as well as promotion of democracy, market economy and transparency in the public sphere. Since 2002, Peter has coordinated numerous INEKO projects. He worked as a Consultant for the Slovak Ministry of Labour, Slovak Ministers of Education and Finance as well as for the Spanish private company interested to invest in the Slovak health care. He is an author of numerous studies and articles including the Analysis on the state and perspectives of wider use of biosimilar medicines in Slovakia published in 2018.

Judit Bidló Deputy Director-General, National Health Insurance Fund - Hungary Working Experience Novartis: working in sales and with clinical trials. Hungarian Association for Innovative Pharmaceutical Manufacturers: director. National Health Insurance Fund: - Department for Reimbursement, responsible for the formulation of the drug reimbursement system and budget allocation. Head of Department, Senior Expert. - Project manager: IT-development program in healthcare system One of the founders of the Hungarian Health Economics Association. Graduation: Pharmacist – Medical University of Semmelweis, Budapest Economist – West Hungarian University – postgraduate diploma Info-Bionics Engineering MSc - Pázmány Péter Catholic University

Flora Mulder Senior Policy Advisor, Ministry of Health, Welfare and Sports - The Netherlands Flora Mulder is a senior policy advisor at the Pharmaceuticals and Medical Technology Directorate. The main focus of her work is on reimbursement policies and other financial aspects of pharmaceutical care in the Netherlands.

Marta Pastor Fàbregas Health Economist, Catalan Heath Service I’ve been working for the Catalan Health Service for 16 years, most of these years dealing with pharmaceutical care policies. As an economist, my main role is trying to manage access and innovation to guarantee the sustainability of the public health system working together with clinic experts in a collaborative model. I’m part of a team focused on searching new innovative ways to fund the medicines such as the payment by results and risk sharing agreements. I’m also involved in the implementation of the register of treatments in order to guarantee the accomplishment of the criteria of use for each medicine, monitor the use of drugs linked to a diagnosis and assess health outcomes. Our aim is being able to improve health outcomes in a sustainable financing environment facing the uncertainties by innovating in management.

Gustaf Befrits Coordinator Introduction of Biosimilars, Stockholm County Council - Sweden Gustaf is an administrator / health economist with the Stockholm County Council, which is the regional authority responsible for providing health care in the Stockholm region. He coordinates the introduction of biosimilars in Stockholm. Before joining the Stockholm County Council four years ago he was a health economist with the TLV, the Swedish government agency responsible for reimbursement of pharmaceuticals for five years. Before joining TLV Gustaf worked as a health economist with Medtronic and before that as a health economist with Pfizer. Gustaf represented Sweden in the project group on “Market access and uptake of biosimilars” which was part of the “Platform on access to medicines in Europe” under the European Commission. He was also health economist in the project team that performed a reimbursement review of TNF alpha inhibitors in Sweden. Gustaf holds a MSc in Health Economics from the Karolinska Institute in Stockholm and a BSc in Economics from the university of Lund, Sweden.

Beata Ambroziewicz President, Polish Union of Patient Organizations and Board Member of Polish Cancer Patient Coalition - Poland Member of National Development Council & National Health Council in Poland. For over 10 years associated with patient organizations, actively cooperates with PAGs, representatives of health-related institutions, Ministry of Health, National Health Fund, Patient Rights Ombudsman and others. Coordinates the implementation of nationwide projects financed from EU funds such as: "Citizens for Health" or "Social monitoring of implementation of oncological package”. Organizes and participates in many national and international conferences, symposia, trainings on health and patient advocacy. Promotes constitutional principles of subsidiarity, social dialogue and cooperation, openness, solidarity and mutual support of unions, associations, federations, foundations and other patient organizations. As a leader of umbrella organization - Polish Union of Patient Organizations "Citizens for Health", together with other patient representatives, aims to shape positive and respectful attitudes towards patients' organizations, build their reliable image, be one of the spokes persons for strengthening patient empowerment and multi stakeholder collaboration.

Stefan Hendriks Global Head Biopharmaceuticals, Sandoz Stefan Hendriks was appointed Global Head of Biopharmaceuticals at Sandoz in June 2018 and is part of the Sandoz Executive Committee. In this role, Stefan leads the organization that is responsible for the development and commercialization of biopharmaceuticals, including biosimilars. Sandoz has eight biosimilars approved in total, and under Stefan’s guidance, has launched three biosimilars in 2018 and continues to invest and expand the leading portfolio including into underserved therapy areas such as insulins. Stefan brings considerable experience in launch excellence and team leadership as well as brand and franchise management with over 20 years of serving in the pharmaceutical industry. He believes in unlocking the potential of each individual by focusing on a growth mindset, and creating an environment that is collaborative, curious and patient- and customer-centric. Prior to joining Sandoz Stefan worked at Bristol-Myers Squibb (BMS) where he held numerous country, regional and global roles across sales, marketing and general management for 15 years, and previously also worked for AstraZeneca. He has deep therapeutic area experience spanning immunology, oncology, endocrinology, virology, cardiovascular, and respiratory among others.

Fernando de Mora Professor of Pharmacology/Consultant on Biosimilars, UAB-Universitat Autònoma de Barcelona - Spain Fernando de Mora is Professor of Pharmacology at the Spanish Universidad Autónoma de Barcelona, where he obtained his PhD. He worked as a postdoctoral fellow at Harvard Medical School (USA), and shortly after obtained a Master in Business Administration (MBA) from the University of Chicago (USA). He acts as an academic Consultant and speaker in biosimilars science, regulation and market for healthcare administrations, and public and private organizations (biopharmaceutical industry).

Prof. Milan Lukáš (MD, PhD) Gastroenterologist - Czech Republic Prof. Milan Lukáš MD CSc was born in 1959 in Tábor. He graduated from the 1st Faculty of Medicine, Charles University Prague in 1994. He passed his board examination in gastroenterology in 1993. From 1993, he worked at the General Teaching Hospital in Prague, at the Clinic of Internal Medicine, specialising in inflammatory bowel disease. He has been the head of the ISCARE clinic since 2007 and he is also the Sr. Consultant of the ISACRE Clinical and Research Centre for Inflammatory Bowel Disease. Prof. Lukáš is the author of more than 250 publications in both Czech and foreign medical journals. He is the president of the Czech Gastroenterological Society and editor-in-chief of the journal “Gastroenterologie a hepatologie.” He is a member of several international organisations, including the American Gastroenterological Association, the European Crohn’s and Colitis Association and the International Organization for the Study of Inflammatory Bowel Disease.

Prof. Peter van de Kerkhof Dermatologist - The Netherlands Peter CM van de Kerkhof is emeritus Professor of Dermatology and immediate past chairman of the department of Dermatology of Radboud University Nijmegen. He is currently the coordinating Medical Officer of the International Psoriasis Council and chair of the scientific advisory board of the Dutch burn association. He has been working for many years on the pathogenesis and treatment of psoriasis. He has published more than 700 publications in peer reviewed journals and has given many presentations on invitation at international conferences. He has served as president of the ESDR and EDF and was board member of various international societies. He is the past--‐president of the International Psoriasis Council. Current interests are: Pathogenesis and development of biomarkers for psoriasis Real clinical practise research Personalised medicine

Dr. Rosa Giuliani Oncologist - Italy Biography soon available.

Dr. Anton Franken Endocrinologist - The Netherlands Dr. Anton A.M. Franken is an endocrinologist (Isala hospital Zwolle) and clinical expert in regulatory affairs. He is a former board member of the Dutch Medicines Evaluation board (CBG-MEB)(205-2017) and scientific advisor of National Healthcare Institute (ZINL) (2013-2018). As a board member of the Biosimilar Netherlands (IBN) he is active in the field of education on biosimilars. Together with the Dutch Institute of Rational use of Medicines(IVM) he developed the BOM project: a national tailormade educational program for all target-groups in the Dutch hospitals.

Florian Turk Global Head Commercial, Sandoz and Vice-Chair of the Biosimilar Market Access Committee Prof. Dr. Florian Turk is the Global Head Commercial at Sandoz Biopharma. He has more than 15 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz, Florian held several roles responsible for business-to-business commercialization, market access, pricing, public affairs and health economics in Novartis Pharmaceuticals and GlaxoSmithKline. Florian also holds responsibilities as Honorary Professor at the Department for Management, University of Paderborn. Florian holds a Master of Science in Economics and a Doctorate in Business Administration from the University of Trier in Germany.

Ugo Trama Head, Pharmaceutical Policy Department, Region of Campania - Italy Biography soon available.

Warwick Smith Director General, British Biosimilars Association Warwick Smith is the Director-General of the British Biosimilars Association (BBA). He is a member of the Board and Executive of Medicines for Europe. The BBA is a sector group of the British Generic Manufacturers Association (BGMA) of which Warwick is also Director-General. The BBA was formed by the BGMA to give a clear forum for those manufacturers committed to the production and appropriate use of biosimilar medicines in the UK. As its Director-General, Warwick is a member of NHS England’s National Biosimilar Medicines Steering Group, which is the multi-disciplinary forum established by the National Health Service to advise on policy on the use of biosimilars. Warwick is a frequent commentator in the UK on the appropriate use of biosimilar medicines and their benefits for patient access.

Luca Morreale Senior Manager, HighPoint Solutions Luca Morreale is a Senior Manager supporting the European Life Sciences team based out of Geneva, Switzerland. He assists clients from big pharma, medical device to mid-and-emerging pharma as it relates to Pricing, Contracting and Tendering Strategy, Operations, and Technology. He’s a successful project manager in the areas of Commercial Excellence, Pricing, Contracting and Tendering, as well as a Subject Matter Expert involved in multiple implementations of Tendering, Contracting, GPM or CRM tools. In the past years, Luca has led a multitude of biosimilars landscape analyses, as well as global tender management assessments.

Anna Rose Welch Chief Editor, Biosimilar Development Anna Rose Welch is the chief editor of Biosimilar Development, an online publication featuring executive interviews and thought leadership columns about biosimilar industry trends and regulatory and commercialization challenges. In addition to speaking at several U.S. biosimilar conferences, she was also invited to Brazil in 2018 to address members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilars manufacturers about how to establish a national biologics and biosimilars policy. Her writing was featured in the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development, published by Springer in late 2018.

Murray Aitken Executive Director, IQVIA Institute for Human Data Science Murray Aitken is a senior vice president at IQVIA and the executive director of the IQVIA Institute for Human Data Science. Aitken is a renowned expert on critical healthcare issues around the world, including the role of medicine, the disruptive impact of technology, and the use of data science in improving decision-making and accelerating innovation. Throughout his 15-year tenure at IMS Health and QuintilesIMS, Aitken served in various roles responsible for healthcare insights, corporate strategy, and consulting and services. Previously, he was a partner at McKinsey & Company and during his career was based in Los Angeles, Seoul and New Jersey offices, covering a broad range of industries, including life sciences and consumer goods. He holds an MBA, with distinction, from Harvard University and Masters of Commerce from the University of Auckland in New Zealand.

Ivett Jakab Member of the European Health Parliament, Innovation & Value Committee Ivett Jakab (MSc) graduated as an Economist in 2014 (Corvinus University of Budapest). She received her master's degree in Health Economics in 2016 (Eötvös Loránd University, Budapest). During her studies she spent her internship in the Hungarian Organ Coordination Office (2014) and in the Hungarian Health Technology Assessment Office (2015). She has been working with patient organizations in the field of organ transplantation since 2010, currently as an advisor and project manager, leading the rehabilitation program for children. She has been involved in Syreon projects since 2015, and joined the company as a full-time researcher in 2017 at the Patient Policy Unit of Syreon. She graduated from the European Patients' Forum (EPF) Summer Training for Young Patient Advocates (STRYPA) program in 2018. She became a member of the European Health Parliament's (EHP) 4th edition in 2018, joining the Innovation and Value Committee. She joined the ISPOR Patient Centered Special Interest Group in 2018. Her research interests are in the evolving areas of health technology assessment (e.g. multi-criteria decision analysis, patient experience, medical devices) and patient engagement in healthcare decision-making. Her mission is to bring the perspectives of different stakeholders in healthcare closer together.

Drs. A.R. Schuurman MBA (Ad) Chairman, Medicines Evaluation Committee (MEDEV) Currently Ad is Senior Advisor International Affairs at the National Health Care Institute Netherlands (ZIN), organising the international collaboration and relations of ZIN. He is also part time operating as Senior Medical Officer at the European Medicines Agency (EMA) in London, to bridge the regulator world and payer world in Europa. In Brussels he is the President of the Medicines Evaluation Committee (MEDEV). Since 1999 Ad had several positions at ZIN, among which Head of the Reimbursement Department, covering all healthcare reimbursement issues in the Netherlands. Before that he acted as Deputy Director of the Dutch College of General Practitioners (NHG). He also worked for five years as Head of a patients’ association, Staff officer of a regional Institute for Mental Health and Head of a Geriatric Department. Ad is clinical psychologist, he also completed studies on Management consultancy and on business administration (MBA).

Erin Federman Commercial Head of Biologics Europe, Mylan and Chair of the Biosimilar Market Access Committee Erin Federman is Commercial Head of Biologics, Europe for Mylan. Erin is a senior-level, award-winning strategic marketer and problem solver with over 20 years sales and marketing experience across multiple industries and geographies. She has led strategic marketing initiatives for a broad range of biotech, pharmaceutical and technology products, from early development through launch and LOE with a particular focus on launch excellence, patient advocacy and market access. Specifically, she has led the launch preparation and roll-out of 9 new medical devices (global) and 3 pharmaceutical assets (2 global, 1 EU). Erin has worked for such leading healthcare focused organizations as Boehringer Ingelheim, Pfizer, Smiths Medical, and Fujifilm SonoSite. She has lived and worked in the U.S., Italy, the United Kingdom and Germany. Erin is originally from Cincinnati, Ohio and is based in Frankfurt, Germany.

Victoria Romero LIRE’s President, AGORA’s Chair and EULAR-PARE Liason Officer for Spain Works as freelance project manager and international representative and patient advocate. She is Chair of the board and EULAR liaison person of the Spanish Rheumatological League (LIRE) and Chair of the Agora Platform. She also works for several public institutions and schools doing seminars and workshops explaining and promoting universal accessibility and inclusion, trying to raise awarness about disabilities and invisible illnesses. Before she has worked in cultural management and international relations for many years and also was a teacher of Art History and Spanish, Italian and English languages for several public institutions around the world. She has a degree in Art History, Master of Arts in Education, Master in Management of the Cultural Heritage and a Master in the European Union. Presently she is studying a bilingual law degree in the believe that it will help her in her new professional path. She has worked, among other positions, as Cultural Attachée for the Consulate General of Spain in Mumbai (India), as professor at the Truman State University in Missouri (USA) and the University of Santiago de Compostela (Spain), and as educator at the National Museum of Science and Technology (Spain). She continues to give lectures, language classes and developing project that combine cultural mangment with social angle. She has had ostheoarthritis in her feet due to practicing ballet for 15 years since she was 3. She is also the main informal carer of her husband who has a severe ostheoarthritis in the dorsal area of the spine that provoked a spinal cord injury.

Maarten van Baelen Market Access Director, Medicines for Europe Medicines for Europe’s goal is to improve health by ensuring better access to treatment for patients in Europe and beyond. As Market Access Director for the Generic, Biosimilar and Value-Added medicines groups, the objective of Maarten’s team is to shape in the EU a dynamic and sustainable market environment. Maarten joined « Medicines for Europe » in 2011 as Medical Affairs Manager. In his life before the association, he worked in the pharmaceutical industry providing pharmacovigilance consultancy and in the medical device industry liaising with Key Opinion Leaders. He combined these roles while working weekends in a community pharmacy. Maarten is a pharmacist by education and holds an MBA from “Solvay Brussels School of Economics and Management” and “École des Ponts Paris Business School”.

Marc-Alexander Mahl President, Medicines for Europe Marc-Alexander Mahl is heading since 2011 the global Business Unit Generic Drugs at Fresenius Kabi. Since he joined Fresenius in 2001 Marc had multiple global and regional management positions in Medical Devices, Marketing and the Generics & Standard Solutions business of Fresenius Kabi with the responsibility to create a globally balanced, profitable and sustainably growing generic drugs business for Fresenius Kabi. Marc´s mission outside of Fresenius Kabi is to make the European generics business again more attractive for pharmaceutical companies and local investments in manufacturing. Being a physician by training Marc completed in 2001 his specialization in transfusion medicine / blood banking. In 2008 Marc received his eMBA degree from INSEAD (Fontainebleau/Singapore).

Paul Chamberlain Member of the NDA Advisory Board, NDA Paul CHAMBERLAIN is a biopharmaceutical product specialist, having worked on the development of therapeutic proteins since 1983, with companies such as Amgen and SmithKline Beecham. His experience with biosimilars development dates back to 2002, and includes multi-disciplinary regulatory considerations for 18 different molecular entities. He specializes in understanding structure-activity and structure-immunogenicity relationships for diverse types of biopharmaceutical modalities. He is a Member of the NDA Advisory Board (www.ndareg.com).

René Anour Senior Medical Assessor, AGES - Austria and Observer Member of the EMA Biosimilar Medicinal Products Working Party René Anour is working as a senior clinical expert for the Austrian Federal Office for Safety in Health Care, where he is involved in centralised Marketing Authorisations and EMA Scientific Advice. He participates in the EMA’s Biosimilar Working Party and is the manager of National Scientific Advice at the Austrian Regulatory Agency.

Niklas Ekman FIMEA - Finland and Vice Chair EMA Biosimilar Medicinal Products Working Party Dr Niklas Ekman has a background in molecular cell and cancer biology. After joining the Finnish Medicines Agency (FIMEA) in late 2006, he worked the next 11 years as a quality assessor for biological medicinal products. His main activities and responsibilities included assessments of European Medicines Agency (EMA) centralized marketing authorization applications, scientific advices, as well as national clinical trial applications. Currently, Dr Ekman is the head of the biological section at the Finnish Medicines Agency. At EMA, Dr Ekman is the vice-chair of the Biosimilar Medicinal Products Working Party (BMWP) and the Finnish alternate member of the Biologics Working Party (BWP).

Alex Kudrin Biopharmaceutical Consultant Dr Alex Kudrin holds MD, PhD, MBA, MRCP and FFPM. He has completed the specialty training in General and Pharmaceutical Medicine in the UK. He was employed at various senior positions in clinical development of immunotherapy agents in pharma and biotech industry. Between 2007-2012, he was employed as a Medical Assessor in the Licensing Division at MHRA in London participating in clinical evaluation, scientific advice and approval of various biotechnology products, including monoclonal antibodies, biosimilars, vaccines, blood products, and advanced cell therapies. Between 2013-2016 he held position of a Vice-President and Head of Global Development at Celltrion Inc in Korea leading development and registration efforts for biosimilar infliximab: Remsima/Inflectra in the US, EU, Canada, Australia and other territories. He has also led clinical development leading to EU and US approvals of Celltrion's biosimilar rituximab, Truxima and biosimilar trastuzumab, Herzuma. He also consulted and assisted in development of biosimilar adalimumabs, and new generation of biosimilar products. Currently he is biopharmaceutical consultant based in the UK. He is an author of 75 publications including papers on biosimilars, and cancer immunotherapy.

Uwe Gudat Head of Clinical Safety & Pharmacovigilance, Fresenius Kabi Uwe Gudat received his medical degree from the Philipps-University of Marburg, Germany. He is licensed in internal medicine specializing in metabolic disorders, training under Michael Berger in Düsseldorf Germany. Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis and Merck Serono. He has led global clinical development teams, acted as global medical brand director, led global clinical due diligence teams for in-licensing, guided oversight over clinical trial designs, product safety assessments and first in man transitions. Currently he serves as Head of Clinical Safety & Pharmacovigilance at Fresenius-Kabi SwissBioSim.

Karsten Roth (Dr.) Director Clinical Operations and Pharmacovigilance, Mundipharma-Biologics Karsten Roth leads the clinical development and pharmacovigilance teams at Mundipharma-Biologics, former Cinfa Biotech. He is responsible for the development and implementation of preclinical, clinical and post-approval clinical activities and oversees the pharmacovigilance activities at Mundipharma-Biologics. He led the preclinical and clinical development activities for the Biosimilar peg-filgrastim Pelmeg® from initial planning until EC approval in Nov. 2018. Karsten has over 22 years of experience in the pharmaceutical industry, having held various international executive positions with a strong focus on clinical development and medical affairs across several therapeutic areas. In his former positions, he contributed to several Biosimilar marketing authorization submissions for the US and EU, presentations at FDA, PMDA and EMA meetings, and was setting up and leading global advisory boards. Karsten holds a PhD in biochemistry, a postgraduate degree in pharmaceutical medicine and a master’s in project management from the George Washington University.

Emer Cooke Director Regulation of Medicines and other Health Technologies, World Health Organization In November 2016 Emer Cooke was appointed as Head of Regulation of Medicines and other Health Technologies with the World Health Organization (WHO) in Geneva. In this role, Ms Cooke is responsible for leading WHO's global work on regulation of health technologies (medicines, vaccines, diagnostics, vector control products and devices), coordinating the regulatory teams (Norms and Standards, Prequalification, Regulatory Systems Strengthening), and working with member states and international partners to assure the quality, safety and efficacy of appropriate health technologies. Ms Emer Cooke obtained her degree in pharmacy from Trinity College, Dublin in Ireland. She has additional Masters degrees in Science and in Business Administration, also from Trinity. During the period from 1985 to 1988 she worked in a number of positions within the Irish pharmaceutical industry before moving to the Irish drug regulatory authority as a pharmaceutical assessor in 1988. In 1991 she joined EFPIA, the European pharmaceutical industry association as Manager of Scientific and Regulatory Affairs in Brussels. From September 1998 to July 2002, she worked in the Pharmaceuticals unit of the European Commission, following which she was appointed as Head of Sector for Inspection at the European Medicines Agency (EMA) in London. Towards the end of 2008, Emer took on the newly created post of International Liaison Officer. She became Head of International Affairs in the context of EMA's reorganization and remained in this position until November 2016.

Bernardo Moreira Health Survey Specialist, ANVISA - Brazil I was graduated at 1999 as pharmacist by Federal University of Rio de Janeiro. I have concluded my master's degree in 2002 and my doctor degree in 2006 both in biochemistry field at Federal University of Rio de Janeiro. I have been working at Anvisa since 2007 as health surveillance specialist. Between 2007 and 2017, i had worked at Office of Biological Products. During this years, i have performed marketing authorization and post-market authorization evaluation, besides participation in norms and guidelines elaboration. From 2017 to January/2019 I had worked at General Office of Inspection, responsible to perform GMP inspections of biological products and APIs. Since February/2019, I have been working at General Office of Medicines and Biological Products. So, I have lot of experience in evaluating marketing authorization dossiers, including biosimilars, mainly as quality/CMC reviewer of biotechnological/biological products.

Yasuhiro Kishioka Deputy Review Director, Pharmaceuticals and Medical Devices Agency (PMDA) Dr. Kishioka is Deputy Review Director in the Office of Cellular and Tissue-based Products of the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA). Since joining PMDA in 2008, his main work is the quality/CMC review of biotechnological/biological products. His areas of expertise also include biosimilars and he has been actively engaged in various international activities on these areas such as WHO, APEC, ICH and IPRP. Dr. Kishioka has been assigned as the ICH Q12 topic leader of Japanese regulatory authority. He holds a Ph.D from Hokkaido University in Meat Science with emphasis in Molecular Biology.

Gillian Woollett Senior Vice President and Head FDA Policy and Regulatory Strategy Practice - Avalere Health She provides the "prequel" of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate Centers for Medicare & Medicaid Services and healthcare policy/business world. Prior to joining Avalere, Gillian was chief scientist at Engel & Novitt, LLP, and was vice president, Science and Regulatory Affairs, at the Biotechnology Industry Organization (BIO). She joined BIO after being associate vice president at the Pharmaceutical Research and Manufacturers of America. She has been an appointee on federal advisory committees to the CDC and the Department of Commerce. Trained as a molecular biologist/immunologist, Gillian publishes in peer-reviewed literature on biotechnology topics and is a frequent speaker on emerging biosciences and their ability to support better and more focused therapies. Gillian has a DPhil in immunology from the University of Oxford and an MA and BA in the natural sciences tripos (biochemistry) from the University of Cambridge.

Elena Wolff-Holz Medical Assessor, Paul Erlich Institute - Germany and Chair of the EMA Biosimilar Medicinal Products Working Party Elena Wolff-Holz is an MD at the Paul-Ehrlich-Institut with expertise in development of biosimilars and therapeutics for cancer and autoimmune diseases. She is Chair of the Biosimilar Medicinal Products Working Party (BMWP) of the Committee for Medicinal Products for Human Use (CHMP) and also serves as Alternate Member of the Scientific Advice Working Party (SAWP) of the CHMP. Overall, Elena has 20 years of professional experience, including 14 years in the biotech industry where she held various positions in clinical development and medical marketing functions at Centocor Inc (now J&J) and Amgen in the US and in Germany. Her work has resulted in several (co-) authorships in scientific journals and several presentations at (inter-)national conferences. Elena is a physician by training with an M.D. degree from Heidelberg University and a postdoctoral fellowship at Harvard Medical School.

Joerg Windisch President & CEO Polpharma Biologics Dr. Windisch is President & CEO at Polpharma Biologics, a privately-owned company which develops and manufactures biosimilars and innovative biologics. The Polpharma Biologics Group has associated sites in Poland, the Netherlands and Germany. Prior to becoming CEO, Dr. Windisch served as Chief Operating Officers (COO) in charge of R&D, Technical Operations and Quality. He also serves on the Board of Directors of Outlook Therapeutics Inc., a biotech company headquartered in New Jersey. Before joining Polpharma Biologics, he was Chief Operating Officer (COO) at Affimed NV, a NASDAQ-traded biotech company which develops innovative bi- and trispecific antibodies as immune cell engagers to treat various kinds of cancer. Prior to that, Dr. Windisch spent almost 20 years at Novartis/Sandoz where he most recently served as Chief Scientific Officer (CSO) for Sandoz Biopharmaceuticals. He was a key figure in developing the first biosimilars approved in Europe and the US. During his tenure at Sandoz he also served as chairman of Medicines for Europe's Biosimilar Medicines Group for several years.

Julie Maréchal-Jamil Director Biosimilars Policy & Science - Medicines for Europe Since October 2015, Julie has been leading the Biosimilar Medicines Group, a sector group of Medicines for Europe. Her work consists of creating and nurturing partnerships with experts in pharmaceuticals and across healthcare systems, balancing interests for a resilient and sustainable healthcare framework. The main objectives are to support and facilitate the design, evolution and implementation of policies aimed at creating efficiency gains and greater access to health services and products for patients. From January 2019 on, she'll co-chair of the Biosimilars committee of the International Generic and Biosimilar medicines Association (IGBA) focusing on convergence of global policies and standards. Her knowledge and understanding of the scientific, regulatory and health policy environment at EU and international levels, as well as of the functioning of the EU ecosystem, greatly supports her effective engagement with all the players involved. Prior to this, Julie was part of Medicines for Europe's regulatory and scientific affairs team for 8 years, with responsibilities in the areas of Quality, Compliance, Environment, Health & Safety as well as Bioequivalence. With a MSc in Pharmacology, she previously worked in the pharmaceutical industry.