Christoph Stoller
President, Medicines for Europe
Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe. In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).
Dirk Van Den Steen
DG Sante, European Commission
Biography soon available.
Usman Khan
Executive Director, European Patients' Forum
Dr Usman Khan was appointed Executive Director of the European Patients Forum in April 2019. In addition to managing a Secretariat team in Brussels, he represents the organisation internationally and supports the EPF Board and Membership. Prior to taking up his post at EPF, Dr Khan was Executive Director at the European Health Management Association.
A health policy and management professional with in excess of 25 years’ executive level experience within the public, private and not for profit sectors, Dr Khan spent over a decade working in academia, before moving into health and social care consulting in 2000. He has held a number of high profile non-executive positions in health and social care and currently holds academic positions at George Washington University and New York University (London).
Isabell Remus
Biosimilar Medicines Sector Group, Medicines for Europe
Biography soon available.
European Social Insurance Platform (ESIP) Representative
Biography soon available.
Dr. rer. nat. Petra Nies, LL.M.
Scientific Advisor, Federal Joint Committee (G-BA), Germany
Professional career
Following her studies of pharmacy at the Westfälische Wilhelms-Universität in Münster (1994-1999) she obtained her license as a pharmacist (2000) and as an expert pharmacist for drug information (2005) with additional stations including working in a pharmacy (1999-2001) and an occupation as a scientific employee in the field of drug approval (2001-2005).
Since 2005 Dr. Nies has been working at the Federal Joint Committee (G-BA) as a Scientific Advisor.
Philippe Van Wilder
Ecole de Santé Publique - Université Libre de Bruxelles
Actual:
Professor in Health Economics, at the Université Libre de Bruxelles, School of Public Health, Campus Erasme, 1070 Brussels
Main areas of research and teaching responsibilities are focussed on:
- Health Economics
- Health Technology Assessment
- Market Access of innovative pharmaceuticals (biological products, OMPs, ATMPs)
Educational background:
Industrial Pharmacist, Doctor in Pharmaceutical Sciences following a thesis on the market access of innovative medicinal products and the assessment of their relative therapeutic value
Previous positions in pharmaceutical companies: clinical research at Glaxo-Smith-Kline, EU market access of the 1st ATMP ChondroCelect at TiGenix
Previous position at the Belgian National Health Insurance Agency RIZIV/INAMI, responsible for the department on the reimbursement of medicinal products.
Previous position at the Belgian Independent Sickness Fund as director of the Study & Strategy Department, responsible for the department on the reimbursement of medicinal products.
Both positions allowed me to be member of the Permanent Network of Competent Authorities (EU Joint Action).
First author of the report: Towards a harmonised EU Assessment of the Added Therapeutic Value of Medicines. Study for the ENVI Committee. Directorate-General for Internal Policies. June 2015
Floriane Pelon
Direction de la Sécurité Sociale, Ministère des solidarités et de la santé (inv)
Biography soon available.
Maciej Miłkowski
Ministry of Health Poland: Access to biological treatment (inv)
Biography soon available.
Dr. Thierry Schaeverbeke
Hospital Bordeaux, France (inv)
Biography soon available.
Dr. Holger Neye
Association of panel doctors, Nordrhein, Germany
Dr. Holger Neye is a pharmacist and has been head of the pharmacotherapy consulting department at the Association of Statutory Health Insurance Physicians in the region North Rhine (KVNO) since 2008. With 19.000 physicians the KVNO provides outpatient medical care for 8.3 million patients. Dr. Neye is responsible for prescription consulting, regional treatment guidelines and contracting with the Statutory Sickness Funds. He specializes in regional prescription management and in the assessment and implementation of innovative drugs.
Vera Pataki
Biosimilar Medicines Group, Medicines for Europe
Biography soon available.
Ana Hidalgo
Specialised Scientific Disciplines, European Medicines Agency
Biography soon available.
Elena Wolff–Holz
Biosimilar Medicinal Products Working Party (BMWP) of CHMP, European Medicines Agency
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.
Emer Cooke
WHO
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.
Eva Temkin
Acting Director Policy in the Office of Therapeutics and Biologics, FDA’s Center for Drug Evaluation and Research, US
Eva Temkin is the Acting Director for Policy in the Office of Therapeutics and Biologics within FDA’s Center for Drug Evaluation and Research. In this role, she oversees the development and implementation of regulatory policy related to biosimilar, interchangeable, or other therapeutic biologic products. In addition, Ms. Temkin is the agency lead for FDA’s Biosimilar Action Plan, which outlines the Administration’s plans for encouraging innovation and competition among biologics and the development of biosimilars. Prior to joining the Office of Therapeutic Biologics and Biosimilars, Ms. Temkin was Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, where she served as counsel to CDER on complex issues relevant to drug development and approval. Previously, Ms. Temkin was a litigator at the law firms of Cravath, Swaine & Moore LLP and Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP and a law clerk in the United States District Court for the Eastern District of New York. She earned her J.D. from New York University School of Law, where she was the NYU Law and Economics Fellow, and her B.A. in economics, cum laude, from the University of Michigan.
Kelly Robinson
Biologics and Genetic Therapies Directorate, HPFB, Health Canada
Kelly Robinson joined Health Canada in 2001 and has extensive experience in both the pre-market and post-market review and regulation of drugs. Kelly is the Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics at the Biologic and Radiopharmaceutical Drugs Directorate of Health Canada where she leads a team of multi-disciplinary clinicians and scientists who are responsible for reviewing biologic drug submissions. In addition to her regulatory role in the review and approval of new drugs, Kelly also plays a role in large initiatives influencing the business of the directorate and the branch including international work sharing, health technology alignment and policy related to advanced therapeutic products.
Dr. Stacey Ricci
Acting Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs, CDER
Dr. Stacey Ricci is the Acting Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs, CDER. In this role, she leads a multidisciplinary team that provides oversight of biosimilar and interchangeable products at all stages of their development, identifies novel scientific issues associated with biosimilars and other biological products, and facilitates intra-agency collaboration necessary to achieve resolution. During her 14 years at FDA, her work has focused primarily on the scientific and regulatory review of biotechnology-derived therapeutic proteins, including making major contributions to FDA guidance and standards development for biosimilars and other protein therapeutics.
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 18-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.
Niklas Ekman
Biosimilar Medicinal Products Working Party (BMWP) of CHMP, European Medicines Agency
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).
EURORDIS Representative (inv)
Biography soon available.
Government/Payer Representative
Biography soon available.
Anna Rose Welch
Chief Editor, Biosimilar Development
Since the launch of Biosimilar Development in 2015, Chief Editor Anna Rose Welch has conducted interviews and written thought-leadership columns on the biosimilar development, regulatory, policy, and commercialization advances in the global biosimilar industry. She has built an editorial board and interviewed experts from a wide variety of biosimilar stakeholder organizations. In addition to speaking or moderating panels at several U.S. & EU 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 establishing 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.
