European Organisation for Rare Diseases EURORDIS Rare Diseases Europe
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1 Yann LE CAM PERSONAL INFORMATION Work address: EURORDIS - 96 Rue Didot Paris - France & EURORDIS University Foundation 11 rue d Egmont Brussels - Belgium Telephone: yann.lecam@eurordis.org WORK EXPERIENCE European Organisation for Rare Diseases EURORDIS Rare Diseases Europe Main Office: Plateforme Maladies Rares - 96 rue Didot Paris - France Brussels Office: 149 Avenue Louise 1050 Brussels - Belgium Main activities: Multi-annual strategy of the organisation, annual action plan & budget, staff recruitment & team management, Board management & good governance policy, organisation of internal structures (policy action groups, task forces, steering committees, programme committees) & of external representations in expert groups or scientific assessment committees, volunteers capacity development & empowerment, resource development, project development & management, public affairs, advocacy to European Commission, Council and Parliament, research & therapeutic development strategy, public health strategy Main achievements : 1) Creation & development of a well-established and respected international non-governmental organisation gathering 779 member rare diseases patient organisations in 69 countries including 28 EU Member states, outreaching to patient organisations and covering over different diseases, with a decentralised network of 41 national rare disease alliances of patient organisations in Europe and 62 European disease specific federations, with 420 volunteers, 40 staff and a 6 M annual budget; Patient advocates information through EURORDIS website and weekly enews are available in 7 languages (EN, FR, DE, ES, IT, RU); RareConnect Platform of 148 global online multilingual rare disease communities created in partnership with 889 patient groups and managed with the support of an additional 407 volunteer moderators; European network of National Alliances, of European Federations and of Rare Diseases Help Lines; capacity building through the EURORDIS Summer School (clinical trials, drug development, regulatory & HTA) and Winter School (Translation of research, genetic, registries); elearning tools, series of national trainings and European workshops and webinars; Annual Membership Meetings; EURORDIS core funding is guaranteed by fees paid by its members, and by multi-year support from patient groups e.g. AFM-Telethon, Volunteers; Operating Grants and projects are funded by the European Commission DG Health, DG Research, IMI, by grants from corporate foundations and company donations with no strings attached; EURORDIS has a stringent Policy on Financial Support by Commercial Companies and its financial accounts are audited by Deloitte;
2 Curriculum Vitae Yann le Cam 2) Formulation of rare diseases as a public health concept and meaningful public policy instrument with contribution to the promotion of favourable environment based on public awareness, multi-stakeholder partnering, regulatory and policy environment; Specific contribution to the adoption of the EU Orphan Regulation (1999), New EU Pharmaceutical Legislation (2003), EU Regulation on Paediatric Use of Medicines (2006), EU Regulation on Advanced Therapeutic Medicinal Products (2007), Commission Communication Rare Diseases: Europe s Challenges (2008), EU Council Recommendation for actions in the field of Rare Diseases (2009), EU Directive on Patients Rights and Cross Border Health Care (2011); Specific advocacy in key areas of EU policies to promote rare diseases as a priority in the EU Research Framework Programmes (since 1998), EU Public Health Programmes (since 2004) and national plans or strategies in EU Member states and beyond (since 2005) as currently in EU programmes Horizon 2020 and Health for Growth, particularly toward the 24 European Reference Networks for rare diseases. 3) Promotion of patient representatives as active participants in decision making process (scientific opinions and policy development ) & responsible actors based on identification of processes, selection of representatives, capacity building and support to empower them; Specific active participation in EMA Scientific Committees and Working Groups (since 2000: COMP, COMP Working Group of Interested Parties, Scientific Advice / Protocol Assistance, PDCO, CAT, CHMP Scientific Advisory Groups, Patients & Consumers Working Party (Transparency, Information to Patients, Risk Management Plans, Pharmaco-vigilance), Pan-European Regulatory Framework III with new MSs), Contribution to EMA consultation e.g. EMA Road map, Adaptive Design of Clinical Trials to Small Populations, Transparency policy, Patient information, involvement of patients in Risk/Benefit Assessment, Adaptive Licencing & Medicines Adaptive Pathways to Patients, Shortages of Medicines, access to clinical data, Collaboration EMA with European Reference Networks for clinical research; Specific active participation in the Commission Expert Group on Rare Diseases (EUCERD , CEG-RD ) and in the Commission Expert Group on Cancer Control (CEG-CC ); active participation in the implementation of the EU policy on European Reference Networks for highly specialised care and in shaping the Pan-European approach to quality healthcare services for optimal patients health outcomes thanks to a Partnership Consortium on Clinical Excellence for European reference Networks (PACE-ERN) led by EURORDIS together with HOPE and Accreditation Canada International. 4) Promotion of and participation in EU policy development in research and public health, on Ethical, social, and legal implications of human gene testing ( ), Improving Access to Orphan Medicinal Products ( ), Clinical Added Value of Orphan Medicinal Products ( ), Mechanism of Coordinated Access to Orphan Medicinal Products -MOCA ( ), Centres of Expertise and European Reference Networks on Rare Diseases ( ), Rare Disease Registries and Data Collection ( ), National Plans & Strategies on Rare Diseases ( First national plans and EUROPLAN), Patients Progressive Access / Adaptive Licencing ( ), Pilots of early dialogue between product developers and payers (known as MOCA process) (2014 ongoing), Medicines Adaptive Pathways to Patients and the IMI ADAPT-SMART project ( ), Patient Engagement in Research and Development all along the life cycle of a Medicine and the IMI PARADIGM project ( ), Call to National Competent Authorities in Pricing & Reimbursement to Improve Patients Access to Medicines through early dialogue with product developers and the creation of European table for price negotiations and managed market entry. 5) Organisation of many conferences and sessions in conferences; Specific organisation of the series of European Conferences on Rare Diseases and Orphan Products (Copenhagen 2001, Paris 2003, Luxemburg 2005, Lisbon 2007, Brussels 2010, Berlin 2014, Edinburg 2016, Vienna 2018); Annual EURORDIS Membership Meetings; Specific contribution to Joint Meeting of All Interested Parties on Orphan Drug Policy with EMEA-EFPIA-EuropaBio- EURORDIS in 2002, EPPOSI Annual Workshop on Partnering on Orphan Drugs from 2000 to 2010, Annual DIA EuroMeetings Track on Orphan Product or Therapy Development (since 2006), DIA Forum on EU Regulatory Affairs, DIA Forum on Orphan Drugs, NORD-DIA US Conference on Rare Diseases and Orphan Products (since 2010), World Orphan Drug Congress (since 2011) in Washington and in Barcelona / Brussels / Geneva. European Union, europass.cedefop.europa.eu Page 2 / 8
3 6) Coordination of multistakeholder European projects. EUROBIOBANK, a 6-year EU funded infrastructure programme to coordinate a European network in 12 countries and develop best practices in DNA, Tissue and Cells Banks later transferred to TELETHON Italia and participation as Partner in the TREAT-NMD project and RD- CONNECT project ( ); Coordination of CAPOIRA, an EU funded project to build capacities of rare disease patient advocates in clinical trials and participation as a main Partner in EUPATI, an IMI funded project to build capacities of patients advocates across all diseases on clinical trials, drug development, regulatory affairs, HTA; Coordination of four Studies on the availability to patients of orphan drugs in EU Member States in 2002, 2003 and 2004; Coordination of studies on patient organisations & patient advocates involvement in research activities in EU; Study to compare access to care for 6 rare diseases in 17 European countries in 2003; Study to compare delays and conditions of access to diagnosis for 8 rare diseases in 21 European countries; Charter to promote good practices in the relations between sponsors, investigators and patient groups for clinical trials; Partner in EC funded projects on New Born Screening, Rare Best Practices Clinical Guidelines, EpiRare, and in several pilot European Reference Networks; A main partner in Joint Action EUCERD ( ) and Joint Action RD-Action ( ), in Joint Action Rare Cancers ( ), in Joint Action EUnetHTA to Chair the Stakeholder Forum and in the IMI projects ADAPT-SMART; Leader of the Consortium PATIENT-SMART on patient engagement in research and development all along the life cycle of medicine, bringing together 25 partners including EMA, HAS, NICE, AIFA, EPF, EATG, 4 Academic teams, 10 companies; Co-Lead of the IMI project PARADIGM ( ), partner in the IMI project Care for Children C4C ( ), Co-Lead of the European Joint Programme Co-Fund for Rare Diseases Research (Pending ) which brings together EC and most EU MSs in research policy development & coordination, co-finding of research, integration of research infrastructures and their servicing for European Reference Networks, training of researchers, clinicians and patient advocates. 7) Promotion of international collaboration and promotion of rare diseases as an international priority beyond Europe; Creation in 2008 and annual coordination of Rare Disease Day expanded in 90 countries; Strategic Partnership (progressive since 2009) between EURORDIS and the National Organization for Rare Disorders (NORD), the Canadian Organisation for Rare Disorders (CORD), the Japan Patients Association (JPA), the Russian Patient Association (RPU), the Chinese Organisation for Rare Diseases (CORD), the Rare Voices Australia (RVA); Initiator (2009) & Co-founder (2015) of Rare Diseases International (RDI), the global network of rare disease national alliances and international federations to enhance the rare disease international movement and create a global voice for people living with rare diseases; Co-founder and member ( ) of the International Conference on Rare Diseases and Orphan Drugs (ICORD); Specific contribution to the initiation (2009) of the International Consortium on Research on Rare Diseases (IRDiRC), member of the Executive Committee ( ), member of the Therapeutic Scientific Committee and of Working Groups Registries, Ethics, Regulatory Affairs, Biomarkers; One of two co-founder ( ) of the United Nation NGO Committee for Rare Diseases in New York and events at UN Building One (2016, 2019); ongoing development of a Collaborative Framework for Rare Diseases at WHO. Sector Health, International Non-Governmental Organisation From October 1998 to September 2001 Special Advisor to the President (Bernard Barataud) and the Director General (Eric-Molinié) French Association for Neuro-Muscular Diseases AFM - Téléthon 1, rue de l Internationale - BP Evry Cedex France Four main achievements: First elaboration of the AFM-Téléthon policy on rare diseases (1999); Organisation of the Consensus Citizen Conference on Rare Diseases (1999) and the writing of the first public report on Rare Diseases: the Challenges of a Public Health Priority within the context of the French Government Etats Généraux de la Santé (2000); Creation of the French Alliance for Rare Diseases (2000). Sector Health and Research, National Non-Governmental Organisation. The largest and leading patient organisation for genetic diseases in Europe federating over 200 genetic neuro-muscular diseases, raising 100 million / year through the TV Telethon, employing over 500 staff, managing its own research lab Généthon
4 Curriculum Vitae Yann le Cam From May 1992 to September 1998 Executive Director (Directeur Général) (Board s Chair : Arnaud Marty-Lavauzelle) AAIDES Fédération Nationale AIDES Tour Essor, 14 Rue Scandicci, Pantin, France Four main achievements: Promotion (1992 to 1996)of HIV/AIDS as a national priority in France translated into public awareness and government policy with actions & budget; Transformation of AIDES from a volunteer based and regionally fragmented organisation into a national integrated harmonised and sustainable organisation (1994 to1998); Strategic reformulation to anticipate and adapt to multi-therapies for HIV and its resulting policy changes with a Public Policy Foresight Study Sida 2010 and an in-depth full strategic revision & reorganisation of AIDES (1996 to 1998); Promotion of patient empowerment through information tools, therapeutic education, patient advocacy and participation to policy as well as scientific committees in HIV/AIDS. Sector Health National and International Non-Governmental Organisation. The largest Aids/HIV patient organisation in Europe with 100 chapters, Volunteers, 200 staff persons and a 20 M annual budget. European Union, europass.cedefop.europa.eu Page 4 / 8
5 From October 1985 to April 1987 Deputy to the Executive Director Association pour la Recherche sur le Cancer ARC Hôpital Paul Brousse, Villejuif, France Sector Medical Research International Non-Governmental Organisation From 1983 to 1985 Junior & Confirmed Accounting & Financial Auditor KPMG Cabinet Frinault Fiduciaire de France (became Arthur Andersen) Avenue Paul Doumer, Paris, France Sector International Financial Auditing Firm MEMBER OF COMMITTEES AND BOARD June 2016 June 2019 European Medicine Agency Position held: Member of the Management Board as Civil Society Rep Appointment by the Commission in consultation with Council and European parliament May 2016 May 2019 Rare Diseases International Position held: Elected Member to the Council March 2017 till present UN NGO Committee for Rare Diseases Position held: Founding member & Member of the Executive Committee November 2013 October 2016 Therapeutic Scientific Committee TSC International Rare Diseases Research Consortium (IRDiRC) Position held: Elected Chair (unanimity) July 2014 July 2017 July 2010 July 2013 Commission Expert Group on Rare Diseases CEG-RD European Commission Directorate of Health and Consumers, Luxembourg Position held: Member / Patient representative (European Commission Official Appointment) Type of business or sector: European Commission - EU Public Institution European Committee of Experts on Rare Diseases EUCERD European Commission Directorate of Health and Consumers, Luxembourg Position held: Elected EUCERD Vice-Chair (unanimity) / Patient representative (European Commission Official Appointment) Type of business or sector: European Commission - EU Public Institution March 2000-March 2003 (1st mandate); April 2004-March 2006 (2nd mandate) Committee for Orphan Medicinal Products COMP European Medicines Agency - EMEA, 7 Westferry Circus, London, UK Position held: Patient representative (European Commission Official Appointment) / Elected COMP Vice-Chair (elected for 1 st mandate & unanimously re-elected for 2 nd mandate ) Type of business or sector: Drug Evaluation Regulatory Authority EU Public Organisation June 2005 May 2008 High Health Authority HAS (The French HTA agency, formerly called ANAES) 2, avenue du Stade de France Saint-Denis La Plaine Cedex Position held : Commission for Quality Information and Dissemination Mandate June 2005 May 2008 Type of business or sector: National Governmental Agency From June December 2004 French National Agency for Health Evaluation and Hospital Accreditation ANAES (now called HAS), 2, avenue du Stade de France Saint-Denis La Plaine Cedex Position held: Member of the Management Board (as Patient representative) + member of the Executive Committee from 2001 to 2004 End of mandate, not renewable: December 2004 Type of business or sector: National Governmental Agency
6 Curriculum Vitae Yann le Cam EDUCATION AND TRAINING From 1999 to 2000 Executive MBA HEC Groupe HEC, Paris-Jouy-en-Josas, France National diploma of the Ministry of Education, Executive Master in Business Administration, International accreditation (AMBA, Equis, AACSB). Ranked 1 st in EU in the Financial Times for last 8 years. From 1981 to 1984 Institut Supérieur de Gestion, Paris XVI, France National diploma of the Ministry of Education, Master in Management, 1984 From 1979 to 1981 Post-High School Preparation HEC for Business School Exams ( ) Baccalaureate in Literatures and Languages (1980) Baccalaureate in Mathematics and Life Sciences (1979) ADDITIONAL INFORMATION European Union, europass.cedefop.europa.eu Page 6 / 8
7 Personal skills and competences Social Skills and Competences Organisational Skills and Competences French mother tongue, Excellent English, Good Spanish My professional and personal commitment to health NGOs and Patient Organisations for almost 25 years have deep roots in my family (cancers, Alzheimer, diabetes, hypertension, arthritis, spondilartrite) and personal history (cystic fibrosis, HIV, severe allergy) with those frequent and rare diseases directly affecting us. From my education and training, work experience, and personal commitment as a volunteer in international health organizations e.g. AIDES, IAPO, EURORDIS and public agencies at National level e.g. HAS Board, at European level e.g. COMP at the EMEA or EUCERD at the Commission, or at International level e.g. TSC at IRDiRC, I have acquired experience in working in multicultural multilingual multidisciplinary multistakeholder environments and team-working with people from different professional or personal backgrounds. As Chief Executive Officer of EURORDIS, Vice-Chair of the Committee for Orphan Medicinal products at the EMEA, Vice-Chair of the EU Committee of Experts on Rare Diseases at the European Commission, Vice-Chair of the International Alliance of Patient Organizations, Chair of Conference Programme Committees and Working Groups, Executive Director of AIDES and of ICCCR, I have learned to work in Boards, develop good practices in governance and policy making. In 25 years of executive experience, I have gained in-depth experience in strategic thinking and strategy development, planning, budget and organisation. My MBA acquired in 1984 and Executive MBA in 2000 provided me with methods and tools. From my work experience, personal commitment and contribution in many reports, public policies, laws and learning from colleagues, I have developed public health competences. The main skills are in the management of grass-roots patient organisations, networks and medical research NGOs. Secondly in communication, public policy and in representing patients in public institutions or to be the patients voice. Thirdly in having a long term vision e.g. prospective studies from my three-years work in the 90 s on the first public health prospective study in France, on Aids/Hiv in 2010, with AIDES, the Ministry of Health and 80 representatives of all interested parties, both the process and scenario outcomes were crucial to adapt France to the evolving Aids epidemic; strategic development of the cause of rare diseases as a public health priority; strategic initiative to support medicine developments and patients access to address unmet medical needs; strategic initiative to speed up the translation of research into new therapies and improve the patient access to approved therapies. Specific skills in financial information transparency from my volunteer work at the French Prime Minister advisory board Conseil National de la Vie Associative and from my contribution to the French laws in Not-for-Profit Financial Transparency. Prix Cristal to AIDES in Successful external auditing by the Inspection des Affaires Sociales, by the France Cour des Comptes, and by the European Commission. Specific skills to chair public meetings and speak at conferences. Frequent speaker at international conferences, at least once a month for the last 15 years. Includes speeches at the European Parliament, at the European Commission, at meetings of Heads of National Drugs Agencies, at meetings of industry associations, at scientific conferences, regulatory affairs conferences as well policy conferences. Publication of numerous reports, recommendations or guidelines, scientific articles, book chapters INTERNATIONAL ALLIANCE OF PATIENT ORGANISATIONS - IAPO; CO-FOUNDING MEMBER ); MEMBER OF THE GOVERNING BOARD ( ), VICE CHAIR AND ACTING CHAIR; IAPO is the global alliance representing patients of all nationalities across all disease areas and promoting patientcentred healthcare around the world. DRUG INFORMATION ASSOCIATION DIA ; Advisor for the DIA euromeeting 2003 Rome; Member of the Programme Committee for the DIA euromeeting 2006 Paris, creation of DIA Fellowship Programme for Patient Representatives; More than 20 presentations at DIA Meetings since 1998 including in Plenary sessions; chair of many sessions and track chair; Member of the DIA Europe Advisory Board ( ) FOUNDING BOARD MEMBER OF FOUNDATION GROUPAMA BOARD MEMBER 1991 TO 1997 OF VAINCRE LA MUCOVISCIDOSE FRENCH CYSTIC FIBROSIS ASSOCIATION; MEMBER SINCE CO-FOUNDER OF CHRONOS AN ASSOCIATION FOR GENETIC RESEARCH ON AGEING AT THE CENTRE DE RECHERCHE SUR LE POLYMORPHISME HUMAIN OF THE FONDATION JEAN DAUSSET.
8 Curriculum Vitae Yann le Cam Other Volunteer Work and Experience in the Not-For-Profit Sector THEATRE RIVE GAUCHE, PARIS; PRESIDENT OF THE BOARD (JUNE ONGOING) ; THE THEATRE RIVE GAUCHE IS A 400 SEATS THEATRE LOCATED IN THE ARTISTIC DISTRICT OF MONTPARNASSE, PRODUCING 4 SPECTACLES PER YEAR, PRESENTING 500 REPRESENTATIONS PER YEAR, BASED ON HIGH QUALITY LITERATURE TEXT, MOSTLY DRAMAS OR COMEDIES FROM AUTHORS OF XX AND XXI CENTURIES; THE THEATRE IS A FULLY INDEPENDENT, PRIVATE, NOT SUBSIDY ENTERPRISE, EMPLOYING 10 PERMANENT STAFF AND UP TO 30 ARTISTS, WITH A 3 M ANNUAL TURN-OVER European Union, europass.cedefop.europa.eu Page 8 / 8
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