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Members of the European Expert Group on Orphan Drug Incentives

The multidisciplinary and cross-functional expert group brings together representatives of the broad  rare disease community, including researchers, academia, patient representatives, members of the investor community, rare disease companies and trade associations.

Prof Dr Maurizio Scarpa (Co-Chair)

Coordinator, ERN for Rare Hereditary Metabolic Diseases (MetabERN)

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Prof Dr Maurizio Scarpa is currently the Coordinator of the European Reference Network for Hereditary Metabolic Diseases (MetabERN). He has extensive expertise as a basic scientist in genetics and biotechnology and as a clinician in the diagnosis and treatment of paediatric rare disorders, in particular neurometabolic diseases. He is especially interested in developing innovative health approaches for the diagnosis and the treatment of metabolic inherited diseases and he is also collaborating with major biotech companies as external independent expert to this purpose. Prof Dr Scarpa published about 140 international peer reviewed clinical and scientific papers, book chapters and reviews.

@maurizioscarpa

Dr Renate Sommer (former Co-Chair)

Former MEP

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Dr Renate Sommer is a former German Christian Democrat MEP (1999-2019) and member of the EPP Group in the European Parliament. She has been a prominent member of the Committee on Environment, Public Health and Food Safety (ENVI). She has been active on rare disease topics as an MEP since the introduction of the OMP Regulation in 2000. Between 1984 and 1989 she worked as an academic assistant at Bonn University and between 1989 and 1992, she was agricultural policy officer for the German Farmers Union in Bonn. Between 2005 and 2013 she was a member of the Committee of Experts on Agriculture and Food Safety of the Christian Democratic Union (CDU) in Germany. She currently serves as Senior Advisor to CONCILIUS.

Prof Dr Annemieke Aartsma-Rus

Professor of Translational Genetics, Leiden University, Medical Centre

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Prof Dr Annemieke Aartsma-Rus is a professor of translational genetics at the department of human genetics at the LUMC. She has a visiting professorship at the John Walton Muscular Dystrophy Research Center at the Institute of Genetic Medicine of the Newcastle University (UK). In 2014 Annemieke Aartsma-Rus was accepted in the Jonge Akademie (the junior section of the Dutch Royal Academy of Sciences, consisting of the 50 most prominent scientists of under 45). In 2009 she received a prestigious VIDI grant. In 2011 she received the Duchenne Award for her work and dedication in the Duchenne field. Since 2016 she was elected as the most influential scientist in the field of Duchenne muscular dystrophy 5 consecutive times based on publications of the past 10 year by Expertscape. In 2020, she was recipient of the EURORDIS Black Pearl Award.

@oligogirl

Mr Diego Ardigò

Head of Research & Development, Global Rare Diseases, Chiesi

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Diego Ardigò  is currently the Head of Research & Development of Global Rare Diseases at the Chiesi Group. Before this role, he was leading Chiesi’s development projects in rare diseases and advanced therapies and has more than 10 years of experience in drug development, spanning from pre-clinical to commercial phase. Before joining the industry, he worked at the University of Parma (Italy) in the field of cardiovascular and metabolic genomics, and as free-lance consultant for various academic institutions. He joined Chiesi in 2010, where he acted as Clinical Lead in the registration of the first stem cell therapy in EU and led the cross-company team (with uniQure BV) treating the first patient with a commercial gene therapy in EU. Diego is serving as chairman of the Therapies Scientific Committee of IRDiRC (International Rare Diseases Research Consortium) and board member of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).

Mr Simon Bennett

Director, Global Regulatory Policy EU, Biogen Idec

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Simon Bennett works for Biogen Idec as the Director for Global Regulatory Policy EU. Mr Bennett has a long history with the company as he has worked for Biogen Idec for seventeen years accumulating experience in the pharmaceutical industry. Biogen Idec’s goal is to lead in innovative scientific research aiming at defeating neurological diseases.

Mr Peter Bogaert

Lawyer, Covington (Partner)

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Peter Bogaert is a managing partner of the Brussels Covington office and has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Court in Luxembourg and in local litigation in Belgium. Mr Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

Mr Thomas Bols

Head of Government Affairs and Public Policy, EMEA & APAC, PTC Therapeutics, Inc.

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Thomas Bols is currently Head of Government Affairs and Public Policy, EMEA & APAC for PTC Therapeutics. Mr Bols previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr Bols has held board positions for EuropaBio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations.

@thomassbols

Mr Simone Boselli

Director of Public Affairs, EURORDIS

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Simone Boselli joined EURORDIS in April 2017 as a Public Affairs Director. As member of the European and International Advocacy team, Simone contributes to European policy development and specifically represents EURORDIS in policy discussions on access to therapies, with a focus on reducing delays and inequalities, on the underlying challenges in the field of the value assessment, pricing and reimbursement of orphan medicines, and on current initiatives towards improved access. With a view to advance rare diseases as a public health priority at a global level, Simone also supports advocacy activities at Rare Diseases International and the further development of NGO Committee for Rare Diseases. He has in-depth expertise in healthcare having devised and implemented advocacy campaigns at EU and national level on a range of global health issues.

@Eubobo

Ms Maria Cavaller

Patient Engagement Junior Manager, EURORDIS

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Maria Cavaller joined EURORDIS in September 2018 as Patient Engagement Junior Manager, as part of the team based in Barcelona. She manages the process of patient engagement in medicines development procedures at the European Medicines Agency (EMA), mainly protocol assistance and coordination of  patient engagement for European initiatives namely PARADIGM, C4C and MoCA. She also supports the work of the members of the EURORDIS Therapeutic Action Group, and work on topics linked to therapeutic development. Maria holds a degree in Pharmacy. Before joining EURORDIS, Maria has worked at the European Medicines Agency, in pharmaceutical companies and in community pharmacy.

@maria_cavaller

Ms Vittoria Carraro

Senior Manager, Rare Europe & Emerging Public Affairs, Chiesi Group

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Vittoria Carraro is currently responsible for government affairs for Europe and Emerging markets at Chiesi Global Rare diseases. Previously, she led the Government Affairs of the pharmaceutical trade association European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and of an international mutlidisciplinary medical society (European Pain Federation). She worked as consultant to various pharmaceutical companies and health stakeholders whilst Account Manager on Health Policy and Market Access for Edelman, a global public affairs consultancy. Ms Carraro has been working on innovation and health policies through her accumulated professional experience including with the European Commission (DG Sante), national and regional governmental institutions. She was a Member of the Committee on Data for Healthy Societies of the European Health Parliament from 2018-2019.

@LucyintheskyLu

Mr Emmanuel Chantelot

Executive Director, Head of Policy & Government Affairs, Major Markets / Europe, Bristol Myers Squibb

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Emmanuel Chantelot serves as Executive Director, Head of Policy & Government Affairs, Major Markets / Europe for Bristol Myers Squibb (BMS). Mr Chantelot has extensive experience in the pharmaceutical industry as he has worked for various companies and associations. Before joining BMS, he had leadership roles at Celgene for three years and Shire Pharmaceuticals for 6 years. Moreover, he was the Chairman of EuropaBio’s Healthcare Biotechnology Council for two years (2013-2015). He was previously on the management team of EFPIA, where he worked as Executive Director of European Biopharmaceutical Enterprises (2006-2010).

Mr Patrick Deboyser

Professor, European College of Parma

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Mr Patrick Deboyser is currently Professor at the European College of Parma, where he is teaching on Food Law and Pharmaceutical Law.  Previously, he has lectured on EU Law at the University of Brussels and at the University of Louvain. From 1984 to 2018, he was an official of the European Commission, where he held various positions including: Head of Pharmaceuticals, Head of Cosmetics, Head of Food Law and Biotechnology, Adviser to the Director-General of DG SANTE and Minister-Counsellor at the Delegation of the European Union to Thailand. In particular, in 1998-1999, Mr Deboyser led the Unit in DG SANTE which worked on the first EU Orphan Regulation.

@Pdeboyser

Mr Toon Digneffe

Head of Public Affairs and Public Policy - Rare Disease Franchise Europe & Canada at Takeda

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Toon Digneffe serves as Head of Public Affairs and Public Policy – Rare Disease Franchise Europe & Canada at Takeda. Currently, he is also member of the Executive Board of EUCOPE since 2018. Mr Digneffe has extensive experience in pharmaceutical industry, as he has been working in the sector since 2002 in several companies after having spent time in the European Commission and Consultancy at the early start of his career. He worked as Head of Public Affairs for Shire since 2016, before its acquisition from Takeda. Previously, he worked for Baxter International for over 13 years, and for Baxalta, with roles of increasing responsibility at local, regional and global level. Toon holds a Master in Political Science from the University of Leuven, Belgium/ University of Leicester, England and a Post-Graduate Degree in European Studies from the College of Europe, Bruges, Belgium. He is co-author of the book by Martin Westlake, “the Council of the European Union”, John Harper publishing.

@DigneffeToon

Prof Dr Marc Dooms (Pharm D)

Senior Orphan Drug Pharmacist, University Hospital Leuven

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Mr Marc Dooms (Pharm D) is Senior Orphan Drug Pharmacist at the University Hospitals Leuven. He is compounding/dispensing pharmacist in First in Men Randomized Clinical Trials. He has been a member of the Belgian Order of Pharmaceutical Sciences and the Flemish Society of Hospital Pharmacists (VZA) since 1975 and the Belgian representative to the European Union of Experts in Rare Diseases with frequent collaboration with Orphanet, the European Society of Clinical Pharmacy, and the American Society of Health Care Pharmacists, among others, since 2000. Mr Marc Dooms is founding member of the Belgian National Board on Orphan Drugs within the King Baudouin Foundation and is a graduate-level teacher in dermatological compounding, drug adherence, and orphan drugs, since 2010. He is also teaching pharmaceutical technicians at Leuven Syntra School. He has co-authored a number of publications on orphan drugs.

@DoomsMarc

Dr Michela Gabaldo

Head of Alliance Management & Regulatory Affairs, Fondazione Telethon

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Dr Michela Gabaldo is the Head of Alliance Management & Regulatory Affairs at Fondazione Telethon in Milan supporting the two internal Scientific Institutes through the clinical development, the registration and market access of the gene therapy programmes developed internally and in partnership with pharmaceutical industry. She has more than 19 years of experience in drug development spanning from chemicals to ATMP. She joined Telethon in 2011 where she manages gene therapy projects at different stages of development ranging from preclinical, to clinical, registration and market access. Winner of 2017 edition of TopRA Award in the Future category, Dr Gabaldo offers up to date knowledge of the most recent regulations in ATMPs and Orphans. She is currently also a member of the IRDIRC Technical Scientific Committee.

Prof Dr Jean-Michel Heard

Research Director, ERN Network for Rare Hereditary Metabolic Diseases (MetabERN)

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Prof Dr Jean-Michel Heard is the Research Director of MetabERN. He has been research director at INSERM, director of the neuroscience department of the Institut Pasteur, member of the Institut Pasteur scientific board. Since 2011, he was the director of the Biology and Medicine departments of the Agence Nationale de Recherche (ANR) and of the French Ministry of Higher Education and Research. Prof Dr Heard has expertise in neurology, neuroscience and molecular virology. He is strongly interested in gene therapy, especially for the treatment of central nervous system disorders associated with lysosomal storage diseases. He published more than 130 peer-review articles and recently showed that gene therapy can improve cognitive development in children with Sanfilippo syndrome.

Dr Denis Horgan

Executive Director, EAPM

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Dr Denis Horgan is the Executive Director of the European Alliance for Personalised Medicine (EAPM). He builds and promotes networks of collaboration between different stakeholders, involved in developing an environment for personalized medicine at the EU and national level.  He supports successful policies that foster activities for a more effective, targeted and safer therapies for patients across Europe. Prior to working with the EAPM, Denis worked with the European Cancer Patient Coalition (ECPC) and in the European Parliament on broad array of health issue relating to the pharmaceutical area and patient access.

@DHorganEU

Dr Daria Julkowska

Scientific Coordinator, European Joint Programme on Rare Diseases

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Dr Daria Julkowska has over 15 years of experience in research and management. She is the Scientific Coordinator of the European Joint Programme on Rare Diseases that brings together different type of stakeholders (researchers, funders, clinicians & patients) from 35 countries from Europe and beyond, and also is responsible for the coordination of the IRDiRC Scientific Secretariat. This position allows her to implement the strategic rare disease research and funding recommendations of IRDiRC to the development of EJP RD which includes the participation of the European Research networks. She is involved in the rare diseases field since 2010, starting from E-Rare, the ERA-Net for Research programmes on rare diseases, where for the first two years she occupied the position of the project manager to finally (April 2013-December 2018) take over the coordination of the programme. As the coordinator, she developed and put into action a set of collaborations facilitating rare diseases research, including the partnerships with European Research Infrastructures and Patients’ Organizations. She has an extensive knowledge and understanding of European funding schemes and programmes.
Dr. Julkowska obtained her international PhD in molecular biology at the University of Paris XI, France and University of Gdansk, Poland in 2005. She pursued her scientific vocation by the post-doctoral experience in cellular biology, at Institut Pasteur, Paris and extensive training in communication and European Union counselling. She also holds MSc in Management of Research from the University of Paris Dauphine.

@DariaJulkowska

Mr Alastair Kent

Independent Patient, Advocacy Consultant

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Alastair Kent has worked in the field of rare and generic diseases for over 25 years. He was the first Executive Director of Genetic Alliance UK. He was appointed to develop the vision of a group of patients and carers of a patient voice in science and health policy, working together across disease boundaries. He is passionate about improving the lives of patients and families affected by all types of genetic conditions. Mr Kent continues to advocate for patients and their families working on a consultancy basis. His interests include policy development, patient engagement and healthcare planning and delivery. He works regularly with healthcare bodies, pharmaceutical companies and medical research organisations, ensuring that the voices of patients are incorporated at all levels.

Mr Yann Le Cam

CEO, EURORDIS

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Yann Le Cam is the current CEO of EURORDIS. Mr Le Cam is a patient advocate who has dedicated over 30 years of professional and personal commitment to health and medical research NGOs in France, Europe and the United States in the fields of cancer, HIV/AIDS and rare diseases. He was one of the founders of EURORDIS-Rare Diseases Europe in 1997 and has been the organisation’s Chief Executive Officer since 2000. From 2016 – 2019, Yann Le Cam served as a member of the European Medicines Agency’s (EMA) Management Board. He was also one of the first patient representatives appointed to a committee at a medicines regulatory agency when he was appointed to the Committee for Orphan Medicinal Products (COMP) at the EMA, where he served for 9 years and was its elected vice-chair for 6 years. He also served on the Management Board and Executive Committee of the French HTA agency for 5 years. Additionally, Mr Le Cam is a member and immediate past chair (2013-2017) of the Therapies Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC).

@yann_eurordis

Dr Lucia Monaco

Former Chair, IRDiRC Consortium Assembly

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Dr Lucia Monaco has been the Chair of IRDiRC between January 2019 and December 2021. She has a long track record of working in the field of rare diseases and a longstanding involvement at the Fondazione Telethon. Previously Chief Scientific Officer, she directed the creation of the Telethon Network of Genetic Biobank. She was also the Administrative and General Coordinator of EuroBioBank, the leader of the biobanking pillar of RD-Connect, and an active member of the Horizon 2020 Advisory Group for Societal Challenge – Health, demographic change and well-being. Dr Monaco has been actively engaged in the new European Joint Programme for Rare Diseases (EJP RD).

Dr Alexander Natz

Secretary General, EUCOPE

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Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory, market access and pricing and reimbursement matters from the EU law and German law perspective.

 

Prof Michael Schlander

Professor of Health Economics, University of Heidelberg/Head of Division, DFKZ

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Prof Michael Schlander is a full professor of health economics at the University of Heidelberg and Head of Division of Health Economics at KFDZ (German Cancer Research Center). He is also the founding chairman of the not-for-profit INNOVAL (Institute for Innovation & Valuation in Health Care) in Wiesbaden (since 2005). In 2008, he was a co-founder of the German Society for Health Economics, and in 2012, he acted as scientific chair for the European ISPOR Congress in Berlin, which had more than 3,500 attendants. Prior to returning to academia in 2002, he had spent 15 years in executive roles in the international biopharmaceutical industry in Belgium, Germany, Switzerland, and the United States.

Dr Erik Tambuyzer

Co-Founder and Executive Chairperson of the Board, BioPontis Alliance for Rare Disease

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Dr Erik Tambuyzer is the co-founder and Executive Chairperson of the Board of the Foun-dation BioPontis Alliance for Rare Diseases. He co-founded and managed the biotech company Innogenetics in 1985. In 1992, he joined Genzyme Corp. as Vice-President Eu-rope, Diagnostics and Genetics. From 1996, as Genzyme’s Senior Vice-President, Corpo-rate Affairs Europe & International, Dr Tambuyzer was the industry point person in the discussions with the EC and EP on the EU OMP Regulation. He was a founding Board member and Vice-Chair of EPPOSI, the European Platform for Patients’ Organizations, Sci-ence & Industry, and a founding Board member and Chair of EuropaBio, of which he also founded the Ethics Working Group and the Rare Diseases and OMPs Task Force. From 2011- 2015, Dr Tambuyzer has been the Chair of the Centre for Medical Innovation (CMI), for translational biomedical research and biobanking in the region of Flanders, Belgium. He is a co-founder and member of the Belgian national advisory committee on rare dis-eases and orphan drugs, as well as a member of the Royal Flemish Society of Belgium for Sciences and Arts.

Dr Alexandra Tolia

Partner, Fund+

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Dr Alexandra Tolia is currently Partner at Fund+. Before joining Fund+, Dr Tolia led investments in private and public companies at PMV and Hunza Ventures, where she built strong Life sciences portfolios in Europe and the US. Alexandra is the author of high impact publications in the fields of neurodegeneration and cardiovascular disease and has served as board member in several companies active in biotech, diagnostics and medical technologies.

Dr Martine Zimmermann

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Martine Zimmermann is Senior Vice President and Head of Global Regulatory Affairs at Alexion Pharmaceuticals. She has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to her role at Alexion, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Currently, she also serves as a Director in the Board of Caelum Biosciences.

Dr Virginie Hivert

Therapeutic Development Director, EURORDIS

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Dr Virginie Hivert joined EURORDIS in 2014 as Therapeutic Development Director. Virginie is responsible for following the development of orphan medicinal products as an observer on the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency. She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the Therapeutic Action Group (TAG) and is herself the alternate member representing patients on the Pharmacovigilance and Risk Assesment Committee (PRAC). She is also Vice-Chair of the Therapies Scientific Committee of IRDiRC (International Rare Disease Research Consortium). Prior to joining EURORDIS, Virginie worked for Orphanet as coordinator of data collection of the resources related to rare diseases (such as expert centers, medical laboratories, patient organisations, research projects, clinical trials, etc.) in the 37 countries of the Orphanet Consortium. Virginie holds a PharmD and a PhD in Biological Sciences and has previously worked in basic research, particularly on pathophysiological pathways in oncology.

@virginiehivert

Dr Elena Nicod

Associate Director, Dolon

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Elena is an Associate Director at Dolon Ltd, a strategic pricing and market access consultancy specialized in rare and severe diseases. She also recently co-led, together with Dr Karen Facey, a Work Package as part of an EU-funded H2020 project called IMPACT-HTA. They developed an appraisal framework and supporting tools suitable for rare disease treatments that supports robust and accountable decision-making across Europe. Elena previously worked as a research officer at LSE Health, clinical trial unit coordinator at the University Hospital of Lausanne, and administrator of the Swiss Vaccine Research Institute. She completed a PhD in Social Policy at the London School of Economics, MSc in Health Policy Planning and Financing at the London School of Hygiene and Tropical Medicine, and BSc in business administration at HEC Lausanne, Switzerland. She has published more than 20 peer reviewed papers mostly on topics related to rare diseases, and participated in various EU projects including Advance-HTA, Burqol or Rare-BP.

@elenanicod

Prof Michael Drummond

Professor of Health Economics, University of York

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Michael Drummond is Professor of Health Economics and former Director of the Centre for Health Economics at the University of York in the United Kingdom. His main field of interest is in the economic evaluation of health care treatments and programmes.  He has undertaken evaluations in a wide range of medical fields including care of the elderly, neonatal intensive care, immunization programmes, services for people with AIDS, eye health care and pharmaceuticals.  He is the author of two major textbooks and more than 700 scientific papers.  He has been President of the International Society of Technology Assessment in Health Care, and the International Society for Pharmacoeconomics and Outcomes Research. In October 2010 he was made a member of the National Academy of Medicine in the USA. He has advised several governments on the assessment of health technologies and chaired one of the Guideline Review Panels for the National Institute for Health and Care Excellence (NICE) in the UK. He is currently Co-Editor-in-Chief of Value in Health and has been awarded 3 honorary doctorates, from City University (London), Erasmus University (Rotterdam) and the University of Lisbon. He was a member of the Steering Group for the 2020-22 NICE Methods Review.

Mr Matias Olsen

Public Affairs and Policy Manager, EUCOPE

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Matias Olsen is the Public Affairs and Policy Manager for the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), where he covers topics such as market access and EU HTA, advanced diagnostics, Europe’s Beating Cancer Plan and the Pharmaceutical Strategy. Matias previously advocated on behalf of European cancer patients, and before moving to Brussels, worked in the claims department of the Norwegian Social Security Administration with reimbursements before he switched his role to the control department, where he coordinated social security coverage within the EU/EEA.

Mr Michael Lyng Wolden

Global HEOR Director, Rare Disease Market Access, Novo Nordisk

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Michael Lyng Wolden is currently Global HEOR Director, Rare Disease Market Access, at Novo Nordisk. Mr Wolden has been working for Novo Nordisk for over 15 years specializing within on Evidence Generation Planning, Real World study execution, Health Economic modelling and HTA interactions. He has authored +30 scientific publications mainly in the disciplines of health economic modelling, burden of illness, health-related quality of life, healthcare resource and real world outcomes. Mr Wolden holds a Master of Science in Economics from the University of Southern Denmark.

Mr Matthias Heck

Senior Director, International TA Policy Strategy, Alexion AstraZeneca

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Matthias Heck is currently Senior Director for International TA Policy Strategy at Alexion AstraZeneca rare disease. He combines market access expertise from practical experience from funding negotiations across diverse EU markets, including AMNOG, as well as from leading engagement on framework conditions from a policy perspective at national and European levels. Next to company experience, Matthias’ experience includes serving as Head of Brussels office of the German Pharmaceutical Industry Association as well as Legal Counsel of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). He has regularly written and spoken on life sciences topics. Matthias is a fully qualified lawyer by training (Cologne Bar) and holds a Masters in International Economic Relations and Diplomacy (Budapest / St. Gallen).