Medicines for Europe Medicines for Europe

CHAIRPERSONS AND SPEAKERS

Medicines for Europe

Chester “Chip” Davis, Jr.

President and Chief Executive Officer - Association for Accessible Medicines (aam)

Chester “Chip” Davis, Jr. is the President and Chief Executive Officer of the Association for Accessible Medicines, the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals and suppliers of other goods and services to the generic drug industry. Appointed to the position by the AAM Board in summer 2015, Chip is responsible for ensuring that the Association fulfills its primary mission, which is to improve the lives of patients and consumers by providing timely access to safe, effective and affordable medicines.
Prior to joining AAM, Chip most recently served as Executive Vice President for Advocacy and Member Relations at the Pharmaceutical Research and Manufacturers of America (PhRMA), where he was responsible for leading PhRMA’s federal, state and international government relations and advocacy efforts, in addition to member company recruitment and retention. Prior to joining PhRMA, he was Vice President of Corporate External Relations for AstraZeneca, where he oversaw the company’s government relations, strategic alliances, community relations and employee volunteer efforts. He was a member of AstraZeneca’s Corporate Affairs Leadership team and Vice-Chairman of the company Political Action Committee. In 2007, Chip was one of the inaugural winners of the AstraZeneca CEO Award, given to global executives who best demonstrate AstraZeneca leadership capabilities in their accomplishments.
Chip earned an undergraduate degree in Accounting from the University of Delaware, and a Juris Doctor from the University of Baltimore School of Law. He is a licensed attorney in Maryland, Virginia and the District of Columbia. He currently serves on the Board of Directors for the Washington, DC area Chapter of Autism Speaks, the University of Delaware Alumni Association, the St. Mary’s High School Royal Blue Club, and the Member Advisory Board for the National Journal.

Medicines for Europe

László György

Minister of State for Economic Strategy and Regulation - Hungary

Education:
2003 – Budapest Corvinus University, Master in Economics
2004 – CEMS, Universität St. Gallen
2008 – Budapest University of Technology and Economic Sciences (BME), MBA
Academic qualification:
2013 – PhD in Economics, Budapest University of Technology and Economic Sciences
Work experience:
2018- Ministry of Innovation and Technology, Minister of State for economic strategy and regulation
2001-2011 AGP Agency Inc. New York (manager of pianist Ádám György)
2005-2017 Budapest University of Technology and Economic Sciences, Faculty of Economics (2005-2008 PhD student; 2008-2013 university lecturer; 2013-2017 assistant professor)
2012-2018 Századvég Economic Research Institute and Századvég School of Politics (2012-2015 economic policy analyst; 2015-2018 chief economist)
2017-2018 Pallas Athéné Domus Mentis Foundation (director)
2017 – Neumann János University, Faculty of Economy (associate professor)
2017 – ELTE, Institute of Business Economics (assistant professor)
Language knowledge:
English - advanced level; German - intermediate level

Medicines for Europe

Warwick Smith

Director General - BGMA

Warwick Smith is the Director-General of the British Generic Manufacturers Association. He is a member of the Board and Executive of the European Generic medicines Association (EGA), and was one of its Vice Presidents from 1995 to 2000.
During Warwick’s period as Director-General of the BGMA, the Association has negotiated a long term market based reimbursement system for generic medicines giving the industry freedom of pricing and has agreed work sharing schemes with the national regulatory agency (MHRA) to reduce significantly the workload on members. Additionally the association has held joint seminars with the MHRA, successfully countered attacks on biosimilars, is about to agree new arrangements for secondary care contracts and the outsourcing of hospital pharmacies, and has agreed a joint study into the sustainability of the generic industry in the UK with the British Government.

Medicines for Europe

Simon Goeller

Partner - McKinsey

Simon Goeller is a Partner based in Munich and the global leader of McKinsey's Generics Practice. Since joining McKinsey in 2002, Simon has worked for clients around the world on topics related to generics, branded generics, LOE management, pharma distribution and retail. He serves pharmacos, wholesalers, retailers/pharmacy chains, and PE firms. His recent experiences include global strategy and portfolio definition for a leading player in Branded Generics, pricing and market access efforts for various off-patent pharma and branded companies, field force optimization effort for generics player in Eastern Europe, post-merger integration and brand positioning for retail pharmacy chain, global strategic purchasing strategy for major U.S. healthcare company, lead and expert on various private equity and industry due diligences in healthcare, marketing & sales excellence programs for pharma companies across Europe, Japan, and the US, including specialty players and dermatology, definition of one of the largest global healthcare provider partnerships, consumer health and branded generics growth strategies globally. Prior to joining McKinsey, Simon obtained a B.A and M.Sc in Economics and Management Research from the University of Oxford (U.K.), and a PhD in Health Care Economics from the University of Giessen (Germany).

Medicines for Europe

Knut Slatten

Vice President, Senior Analyst - Moody's Investors Service

Knut Slatten is a Vice President – Senior Analyst based in Paris. He is currently the lead analyst for European pharmaceuticals – branded and generics – at Moody’s Investors Service. Since joining Moody’s in 2007, he has covered a variety of issuers within European healthcare and has been involved in the coverage of European pharmaceuticals since then. Prior to joining Moody’s, Knut worked for a European Investment Bank. He is a graduate of NHH Bergen and HEC Paris.

Medicines for Europe

Jean-Guy Goulet

Chief Operating Officer - Pharmascience Inc.

Jean-Guy joined Pharmascience Inc.in 2017, a full-service privately owned pharmaceutical company and the largest pharmaceutical employer in Quebec with over 1,500 employees. Pharmascience ranks in Canada as the 6th largest pharmaceutical company and the 3rd largest manufacturer of over-the-counter generic drugs. Jean-Guy oversees Pharmascience’s generic portfolio, in Canada and over 60 countries in the world. Jean-Guy started his career in 1987 in the Quality Control department at Technical Pharma, later acquired by Ratiopharm. He rapidly gained increasing responsibilities to become President of the Commercial division of Ratiopharm Canada and President of North America. Jean-Guy was the President of Actavis Canada, until the sale of this division to a global pharmaceutical company. Jean-Guy graduated in Chemistry from University of Montreal. He invested time and energy in developing and representing the Canadian Generic Pharmaceutical Association (CGPA) and is currently the Vice-Chair. He recently served as a representative on the negotiating committee of the Pan Canadian Pharmaceutical Alliance (pCPA).

Medicines for Europe

Jeff Watson

President and Chief Operating Officer (COO) - Apotex

Jeff is President & Chief Operating Officer (COO) of Apotex. Appointed in 2018, Jeff oversees the day-to-day global operations of Apotex, including research and development, manufacturing, packaging, distribution and commercial activities for products across three Lines of Business to more than 115 countries.
Prior to this role, Jeff was President, Global Generics, the largest line of business at Apotex, where he provided leadership for the Commercial and Strategic Operations and was instrumental in delivering significant growth. A 25-year veteran of Apotex, Jeff has held progressively senior positions within Sales and Marketing since 1993 when he joined the company.
Before joining Apotex, Jeff spent time working in the retail pharmacy sector for Shoppers Drug Mart, Canada’s leading pharmacy chain.
Jeff has been a member of the Association for Accessible Medicines (AAM) Board of Directors since 2012 and served as Chair in 2017. He was reappointed for a second term as Chair, Board of Directors for the AAM in 2018. In 2008 he became an Executive Member of the Canadian Generic Pharmaceutical Association’s (CGPA) board. From March 2015-February 2017, he served as Chair of CGPA’s board following three years of service as Vice Chair. Jeff is a former Chair of the US Healthcare Distribution Alliance’s (HDA) knowledge partner, the HDA Research Foundation. He is also the Chair of the Board of Directors for TruLeaf Sustainable Agriculture, Nova Scotia, Canada.

Medicines for Europe

Jacek Glinka

President, European Region - Mylan

Jacek Glinka is the President of the European Region for Mylan, one of the world’s leading global pharmaceutical companies which is dedicated to providing the world’s 7 billion people access to high quality medicine. Mylan is present in 35 countries in the European region and in approximately 165 countries and territories globally. Mr. Glinka has joined Mylan from the Polpharma Group, where he served as chief executive officer from 2003 to 2006 and from 2009 to 2013. During his tenure, he led the transformation of Polpharma from a local player into a leading pharmaceutical company in Central and Eastern Europe, the Caucasus and central Asia. Prior to that, Mr. Glinka was a managing director at Spectra Services, where he oversaw a number of acquisitions and restructurings, including the acquisition and integration of Akrihin into Polpharma Group. He began his professional career as a strategic management consultant with firms including Deloitte & Touche and A.T. Kearney.

Medicines for Europe

Alexandra Moulson

Head Global Commercial Operations Strategy - Sandoz

Experienced leader and strategist with broad background in marketing, product development, business development, portfolio management and launch with a focus in oncology.
More than 16 years experience in pharmaceuticals (8 years in originators, 6 in biosimilars, 2 in generics), biotechnology, and medical devices.
Biochemist with an MBA, Associate Principal at McKinsey, various roles in biosimilars and generics at Sandoz since 2010.

Medicines for Europe

Marc-Alexander Mahl

Executive Vice President, Business Unit Generic Drugs - Fresenius Kabi and 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 improve the access to generic medicines, biosimilars and value-added medicines for patients across Europe. 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).

Medicines for Europe

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.

Medicines for Europe

Adele Paterson

CEO and Head of Corporate Partnerships - International Health Partners

As CEO of International Health Partners, Adele brings a wealth of cross sector partnership, CSR and public policy experience. An economics and politics graduate, she ran the parliamentary office of a British Government Minister, headed up CSR, fundraising and communications for a national regeneration charity and served as head of policy for financial services trade body. At IHP she has headed the work with corporate donors and as CEO, she is working to move product donations towards sustainability to ensure long term access to medicines for vulnerable and disaster hit communities. Adele sits on the Board of PQMD (Partnership for Quality Medical Donations) and Integral. She recently completed #£20kfor20k to raise funds for IHP.

Medicines for Europe

Christoph Stoller

General Manager Cluster Germany & Austria - Teva-ratiopharm and Vice President - Medicines for Europe

Christoph Stoller is General Manager Teva-ratiopharm for the cluster Germany & Austria. In that role he is responsible for all Business Units: Generics, OTC and Specialty Medicines. 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 activities. Christoph is Vice President of Medicines for Europe. Furthermore he chaired the sector group on Value Added Medicines until taking up his new role in Germany. Mr. Stoller 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).

Medicines for Europe

Lisa Günther

Head Global Business Insights - Sandoz

Lisa Günther is Head of Global Business Insights at Sandoz. In this role, which she has held since 2015, she is responsible for developing and sharing market insights across the company for maximum commercial impact. Lisa first joined Sandoz as a member of the Divisional Strategy team in 2014. She began her professional career as a management consultant with The Boston Consulting Group (BCG), where she worked in projects across the healthcare sector. A German national, Lisa graduated with a European Masters in Management with a specialization in Strategy, from LMU Munich / EMLYON Business School.

Medicines for Europe

Deborah M. Autor

Head of Strategic Global Quality & Regulatory Policy - Mylan

Deb Autor is Head of Strategic Global Quality and Regulatory Policy at Mylan, one of the largest generics and specialty pharmaceutical companies in the world. In this role, Deb represents Mylan’s diverse and complex operations to government officials globally and advises Mylan’s most senior leaders on how to navigate and influence the regulatory landscape. She also leads Mylan’s work on international trade policy, preventing antimicrobial resistance, and implementing global serialization. Previously, as Mylan’s Global Head of Quality, Deb managed thousands of personnel around the world, driving quality improvements across scores of manufacturing sites.
Prior to joining Mylan, Deb served for 12 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy, where she supervised more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs in their efforts to confront the challenges of globalization and import safety. She also served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research, where she led policymaking and enforcement for key programs for drugs, including current good manufacturing practices; human subject protection and bioresearch monitoring; marketed unapproved drugs; pharmaceutical import and export; Internet and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls. Before joining FDA, Deb served for six years as a Trial Attorney at the Office of Consumer Litigation of the U.S. Department of Justice.
Ms. Autor’s many commendations include the Meritorious Executive Presidential Rank Award and the Food and Drug Law Institute's Distinguished Service and Leadership Award. She also was a finalist for the prestigious Service to America Medal.

Medicines for Europe

Frank Bouisset

Head Specialty Franchises West Europe – Sandoz and Chairman of the Hospital Channel WG – Medicines for Europe

Frank Bouisset is French and holds a Master degree in Marketing & Management. Frank is leading the Specialty (Oncology, Anti-infective, Neurology, Transplant, Pain, and Gynecology) franchises in West Europe for Sandoz and Chair the Hospital WG for Medicines for Europe. Frank has 25 years’ experience in European and Emerging markets of which 18 years for the healthcare industry. He gained experience in setting up, developing and managing successive new business models in primary and secondary care. Prior to this, he mainly served in commercial and general management positions in B2B industries.

Medicines for Europe

Monika Dereque-Pois

Director General - GIRP

Monika Derecque-Pois was born in Graz/Austria and holds a master’s degree in Economics from the University of Economics in Vienna, where she specialised in International Trade and Marketing. Ms. Monika Derecque-Pois is the Director General of GIRP, the European Healthcare Distribution Association, which brings together over 750 pharmaceutical full-line wholesaling companies and their national associations from 35 countries. Monika was appointed to her current position in 2001, having previously served as European affairs consultant for GIRP. She has over 20 years of experience in European public affairs. Prior to her engagement with GIRP, she served as a director in a European affairs consultancy company and she also held a six-year post as Marketing and Client Support Manager at IMS Health Austria.

Medicines for Europe

Gergely Németh

Project Manager - National Institute of Health Insurance Fund Management (NEAK)

Gergely Németh graduated as a pharmacist in 2014 in Budapest. He has been working at the department in charge of reimbursement of pharmaceuticals of the Hungarian authority for health insurance. He has been involved in the planning and implementation of the Hungarian generic pricing policy since 2007 and participated in the development of sofwares supporting pricing and reimbursement of pharmaceuticals. He has been the project manager of the EURIPID project since its establishment in 2010. The EURIPID project is a non-profit initiative of the national competent authorities of Europe for the mutual sharing of pharmaceutical price information.

Medicines for Europe

Brendan Cuddy

Head Manufacturing and Quality Compliance Service - EMA

Brendan Cuddy joined the European Medicines Agency as a Scientific Administrator in October 2002. Brendan is currently Head of Manufacturing and Quality Compliance Service and he is Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). The Manufacturing and Quality Compliance Service is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chair and secretariat of the GMDP Inspectors Working Group and the secretariat for the Quality Working Party. The Service plays a key role in collaborating and communicating with international partners on setting and recognising GMP standards, making better use of inspectional resources and exchanging information on availability of already authorised medicines. Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

Medicines for Europe

Randall Stanicky

Managing Director - RBC Capital Markets

Randall Stanicky, CFA, is a Managing Director at RBC Capital Markets. Randall has been head the RBC Specialty Pharmaceuticals team for the past three years covering global generic manufacturers and specialty therapeutic providers. He is a regular Wall Street speaker at international conferences and ranked Runner-up (RU) in the “Institutional Investor” poll this past year. Prior to RBC, he spent most of his career at Goldman Sachs, where as a Vice President in Global Investment Research, his coverage spanned specialty pharmaceuticals, drug distribution, pharmacy benefit managers, healthcare technology and the contract research organization sectors. Randall also served as a Managing Director at Canaccord Genuity and prior to joining the sell-side he was an analyst at Citigroup Global Asset Management assisting in the investment recommendations of healthcare stocks. He is also an active member and head of the audit committee of the Board of the Director of the Children’s Tumor Foundation and previous Board member of TherapeuticsMD (TXMD). Randall lives in New York City with his wife and two children.

Medicines for Europe

Martin Favié, PharmD

Chairman - Bogin (Dutch Biosimilars and Generic Medicines Association)

Bogin represents the interests of the generic and biosimilars medicines industry in the Netherlands. Bogin plays an important role in many aspects of the Dutch pharmaceutical market and related issues. Bogin is an active member of Medicines of Europe (former EGA). Martin Favié studied Pharmacy at the University of Amsterdam and was a community pharmacist for 33 years. During this period he was President of the Royal Dutch Association of Pharmacists (KNMP) from 1999-2004.

Medicines for Europe

David R. Gaugh, R.Ph.

Senior Vice President for Sciences and Regulatory Affairs - Association for Accessible Medicines (aam)

David Gaugh has over 25 years of leadership experience in the Healthcare and Pharmaceutical business. He has been employed by AAM (formerly GPhA) since February 2012 as the Senior Vice President for Sciences and Regulatory Affairs, where he is responsible for the professional liaison functions between member companies, agencies of the US Government and Legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories and a wholly owned subsidiary of Boehringer Ingelheim.Prior to Bedford Laboratories, David was Senior Director, Pharmacy Contracting and Marketing at VHA/ Novation (now Vizient). And prior to VHA/Novation, David was System Director of Pharmacy for St. Luke’s Health-System, a tertiary-care hospital in Kansas City, MO. David is a registered Pharmacist and has been engaged in several board-level pharmacy-related activities. the American Society of Health-system Pharmacists Education and Research Foundation Board of Directors, USP Council of Convention, and American Foundation for Pharmaceutical Education Board of Directors.

Medicines for Europe

Sarah Garner

Co-ordinator ‘Innovation, Access and Use’, Essential Medicines and Health Products Department - World Health Organisation (WHO)

Sarah Garner PhD, BPharm is the Co-ordinator ‘Innovation, Access and Use’ in the Essential Medicines and Health Products Department at the World Health Organisation. Sarah is a pharmacist specialising in innovation, with previous work focussing on development strategies and the interface between Health Technology Assessment (HTA) and regulation. Sarah is an honorary professor at UCL and Manchester Universities. Her previous roles have included the Associate Director for Science Policy and Research at the UK's National Institute for Health and Care Excellence (NICE) and Pharmacist Lead for the UK Government’s Special Advisory Committee on Antimicrobial Resistance. Sarah has led policy work-packages of public private research partnerships funded by the EU Innovative Medicines Initiative (GetReal, ADAPTSMART and Big Data for Better Outcomes) which are developing policy proposals for the adaptive pathways and use of real-word data in pharmaceutical development, regulatory and HTA decision making. In 2010-11 Sarah was a Harkness Fellow in Healthcare Policy and Practice in the United States. Her research examined the impact of comparative effectiveness research and Health Technology Assessment on pharmaceutical and MedTech innovation. Sarah is working with the multi-stakeholder New Drug Development Paradigms (NEWDIGS) team at Massachusetts Institute of Technology and is a Fellow at the Centre for the Advancement of Sustainable Medical Innovation which is a collaboration between Oxford University and University College London.

Medicines for Europe

Sandra L. Kweder, M.D.

Deputy Director Europe Office, Liaison to the European Medicines Agency - US FDA

Prior to assuming this post in March 2016, Dr. Kweder was Deputy Director, Office of New Drugs (OND) in FDA’s Center for Drug Evaluation & Research (CDER), since 2002. In CDER she was an active leader of a number of initiatives, including improvements in the drug review process; modernizing nonprescription drug review; building a systematic drug shortage prevention and management program; patient-focused drug development and clinical outcomes assessment, and; the growth and development of pediatrics and maternal health as standard aspects of drug development. Dr. Kweder was commissioned in the U.S. Public Health Service upon entering the Uniformed Services University of Health Sciences (USUHS), retiring in 2013 at the rank of Rear Admiral. Following internal medicine training at Walter Reed Army Medical Center she joined the U.S. Food & Drug Administration (FDA) in the Division of Antiviral Drugs to address the growing field of HIV drug development. She has since held a number of positions with FDA in premarket and postmarketing regulation. Until her move to London she was active in medical education as an adjunct faculty member of USUHS, training residents and medical students in Internal Medicine and utilizing her fellowship training from Brown University in Obstetric and Consultative Medicine.

Medicines for Europe

Riccardo Luigetti

Principal International Affairs Officer - European Medicines Agency (EMA)

Riccardo joined the EMA International Affairs Team in September 2014. He is currently leading the EMA efforts to strengthen cooperation with regulators in critical emerging economy countries, such as China and India.
He joined the European Medicines Agency in 2004 where he has covered several different roles, mainly related to GMP, implementation of the Falsified Medicine Directive and international affairs.
Before joining the EMA, he graduated in organic chemistry at the University of Perugia. After a PhD in biochemistry and some years of research work at the same University, he joined the Italian regulatory agency where he worked initially as quality assessor and as GMP inspector.

Medicines for Europe

David Jauch

Director Government Relations - Fresenius Kabi

David M. Jauch is responsible for Government Relations for Fresenius Kabi. He is the Chairman of the International Affairs Committee, Member of the Board of Medicines for Europe as well as a member of the Trade Committee of IGBA (International Generics and Biosimilar Association). Also, David is a member of the Regulatory Committee of the German Pharmaceutical Industry Association (BPI). David studied Business Administration at the University of Stuttgart in Germany, Tongji University in Shanghai, China and Seoul National University in Korea and holds an Executive Master in Business Management of Leeds University Business School in the UK.

Medicines for Europe

Nick Cappuccino

Vice-President, Quality and Scientific Affairs - Dr. Reddy's Laboratories, Inc.

Dr. Cappuccino is currently Vice-President, Quality and Scientific Affairs for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino has served in Executive Management and Scientific Leadership roles in many companies in both the innovative and generic drug industries over the past 40 years.
Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH Assembly. He has represented IGBA as an expert on several ICH Expert Working Groups in the Quality and Multidisciplinary topic areas since 1998.
Dr. Cappuccino holds a Ph.D. in Organic Chemistry along with MS and BS degrees from Stevens Institute of Technology, Hoboken, NJ, USA and an MBA from Fairleigh Dickinson University, Madison, NJ, USA.

Medicines for Europe

Jim Keon

President - Canadian Generic Pharmaceutical Association (CGPA) and President - Biosimilars Canada

Jim Keon is President of the Canadian Generic Pharmaceutical Association (CGPA), and President of Biosimilars Canada organizations representing Canada’s generic and biosimilar pharmaceutical sectors. Jim graduated with an M.A. in Economics from Queen’s University, and has more than 20 years’ experience in the pharmaceutical sector. Jim has served as President of the CGPA since 1998 and was named the founding President of Biosimilars Canada in January 2015. Prior to joining CGPA in 1994 he held senior positions in the federal government and was directly involved in international trade negotiations for NAFTA and the WTO, as well as Canada’s inter-provincial trade negotiations. Jim is Past Chair of the International Generic and Biosimilar Medicines Association (IGBA), which is committed to promoting the interests of generic and biosimilar medicines around the world. He is currently Chair of the IGBA International Trade Committee.

Medicines for Europe

Alison Cave

Principal Scientific Administrator - European Medicines Agency

Dr Cave joined the European Medicines Agency in January 2016 as a Principal Scientific Administrator in the Pharmacovigilance and Epidemiology Department where she leads on developing mechanisms to increase capacity in the use of real world data in medicines regulation. She also co-chairs the HMA-EMA Joint Big Data taskforce which is exploring the regulatory challenges presented by Big Data. She holds a BA Honours degree and PhD from the University of London and has over 20 years of academic research experience in the cardiovascular field. Prior to joining the EMA she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and, prior to this, an Expert Scientific Assessor at the UK Medicines and HealthCare products Regulatory Agency.

Medicines for Europe

Michaeline Daboul

President & CEO - MediSpend

Michaeline is a veteran of the medical technology and pharmaceutical industries, with over 25 years of experience working in genomics research, pharmaceutical drug development and marketing, and medical systems innovation. She has led organizations in the development of new technologies to create products and services for their Fortune 500 clients. She has spent the past 14 years as the co-founder and president of MediSpend, leading the company in the development of the MediSpend Global Compliance Platform, the Physicians Professional Network as well as custom enterprise data management platforms and software solutions for clients around the world.
In addition to leading MediSpend, Michaeline mentors women in their tech careers and writes a blog for entrepreneurs and life science executives on topics, such as managing the growth of a SaaS company and how to improve work, life, balance.
You can follow Michaeline on Twitter: @mmispresident and connect with Michaeline via her blog at michaelinedaboul.com.

Medicines for Europe

Anna van Nieuwenhuizen

Director of Divisional Strategy - Sandoz

Anna van Nieuwenhuizen is a Director in the global strategy function at Sandoz. Prior to joining Sandoz, she was a consultant at McKinsey & Company and later served in two global public health organizations: GAVI, the Global Alliance for Vaccines and the Global Fund to Fight AIDS, TB and Malaria. She holds undergraduate degrees in International Relations from the University of Pisa and the Sant’Anna School of Advanced studies and a Masters in International Law from the Graduate Institute of International and Development Studies in Geneva.

Medicines for Europe

John Peter Mary Wubbe

Secretary General - DHE / EPPOSI II / EuDiPPA / ICPEU

John Peter Mary Wubbe is a healthcare professional, have studied MSc European Public Health, specializing in Governance. Mr. Wubbe has created EuDiPPA to improve data source quality assessment through blockchain technology as fuel to put Europe in the lead of the 2. Quantum revolution thanks to the GDPR governance. Mr Wubbe expertise lies in Genomics-Robotics-Informatics-Biometrics (GRIBs) abstraction of Phenotype and Genotype Datasets. He is deeply knowledgeable in the primary/secondary health care sectors. Mr. Wubbe sees Digital Health as a key area in health and care, prompting him to start DocSWISS organization. Mr. Wubbe had multiple organ transplants and his experience as a patient made him passionate about peer-patient involvement within multi stakeholder organizations.
Due to his expertise Mr. Wubbe chose to work at the European Patients Platform of Science and Industry / Digital Health Europe is a multi-stakeholder organization performing Rapid Health Technology Assessments and Health Impact Assessments. EPPOSI II / DHE includes consumer-patients (EuDiPPA) in its decision-making process. Mr. Wubbe sees the importance of including highly literate patient-citizens, as well as redefining disease diagnosis, which would add levels of ‘experienced frailty’, evaluating quality of life (WHODAS 2.0) of a citizen-patient as base for reimbursement. (Health records management, clinical trials reporting,. Throughout his work and educational experience he realized that the public health system would collapse unless the current paradigm changes and those changes are implemented.

Medicines for Europe

Frederik Van Remoortel

Lawyer - Crowell & Moring

Frederik Van Remoortel is a senior counsel in the Brussels office of the law firm Crowell & Moring and has been admitted at the Brussels bar since 1998. Frederik focuses on corporate, commercial, data protection, and labor & employment law. A substantial part of Frederik's work consists of the drafting and negotiation of a wide variety of complex agreements in the pharmaceutical and the telecommunications sector, such as shareholders agreements, asset transfer agreements, licensing and distribution agreements, agency agreements, co-operation agreements, software and cloud computing contracts. It is in that capacity that he also assisted in contract drafting and negotiations related to the introduction of the Falsified Medicines Directive and the related Delegated Act. Frederik also advises on Belgian and EU data protection legislation and is a Certified Information Privacy Professional/Europe (CIPP/E) and was a member of the IAPP European Advisory Board 2015-2016. Frederik is a qualified lawyer in Belgium and obtained his law degree from the Universities of Namur and Leuven. He obtained a postgraduate degree in tax law from the University of Leuven. He was a substitute judge at the Brussels Commercial Court (2010 - 2015).

Medicines for Europe

Dilip G Shah

Secretary General - IPA

Mr. Dilip G. Shah graduated from the premier business school in India, the Indian Institute of Management (IIM), Ahmedabad. He has 50 years of varied experience in the pharmaceutical industry. He has addressed several WTO workshops on TRIPS, WIPO seminars on IPRs and Public Health, WHO meetings on Access to Medicines and several other international meetings and conferences. He was a Member of the official Indian Delegation to WTO Ministerial Conference at Cancun. He also appeared before the U.S. International Trade Commission (USITC) and testified in Investigation No.332-543 Hearing in Washington DC in 2014. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Member of the Expert Review Committee of Access to Medicine (ATM) Index (www.atmindex.org); Member of the CPhI International Advisory Board; Member of the Board of Advisors of Pharmabiz.com (Weekly); and Member of Task Forces and Expert Groups constituted by the Government of India for accelerating growth of the Indian pharmaceutical industry. He was Chair of the International Generic Pharma- ceutical Alliance (IGPA) for two terms (2005-07) and (2010-11). Mr. Shah is an independent director on the Boards of Fresenius Kabi Oncology Ltd, Anuh Pharma Ltd, Shaily Engineering Plastics Ltd and CEO of Vision Consulting Group (www.vision-india.com), a firm specialized in strategic planning. Before starting Vision in 1997, he was a Member of the Board of Directors of Pfizer-India for whom he worked for 30 years.

Medicines for Europe

Ana-Eva Ampélas

Head of Unit for Medical Products: Quality, Safety, Innovation in Unit B4 - DG SANTE, European Commission

Anna-Eva Ampelas is Head of Unit for Medical Products: quality, safety, innovation in Unit B4 in DG SANTE, European Commission. In this capacity, she is managing files on medicinal products (falsified medicines, clinical trials, shortages, GMP etc); Health Technology Assessments (HTA) and substances of human origin (blood, tissues and cells, organs). She has more than ten years of experience working on health policy and legislation in the European Commission. Before joining the Unit for Medical Products, Anna-Eva was heading the unit dealing with tobacco control and global health. She was Health Counsellor at the Permanent Representation of Sweden 2002-2006 before joining the European Commission. Anna-Eva has a Master of Laws from Uppsala University.

Medicines for Europe

Ulrike Kreysa

Senior Vice President Healthcare - GS1 Healthcare

Ulrike is responsible for the Healthcare sector at the GS1 Global Office and works with her local colleagues in 112 countries to develop and implement GS1 standards in the healthcare industry. Worldwide patient safety and supply chain efficiencies will be enhanced globally through standards for AIDC (Automatic Identification and Data Capture), global data synchronisation and traceability. Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, GPO’s, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations.

Medicines for Europe

Craig Stobie

Director Global Sector Management - Domino

Craig Stobie has worked for Domino Printing Sciences for over 22 years in technical, operations, service and commercial roles. A graduate chemist and physicist with further qualifications in quality and safety assessment, Craig has a broad view of the pressures facing industry and how Domino can help companies overcome the wide range of current and emerging challenges they face. Craig leads a global team that is focused on several sectors. The team includes subject matter experts, thought leaders and technical specialists operating in sectors including Life Sciences, Tobacco, Beverage, Food and Industrial products. Prior to joining Domino, Craig worked in refining and manufacturing environments in the speciality chemicals sector.

Medicines for Europe

Andreas Walter

Director General - EMVO

After his studies of Administration Sciences at the University of Constance in Germany, Andreas M. Walter joined EFPIA, the European Federation of the researched-based pharmaceutical industry, in September 1993 as Executive for Administration and Finance. From 2011 onwards, he was responsible as Project Director to ensure that EFPIA members can comply with the safety features requirements of the Falsified Medicines Directive in the most effective way, i.e. by setting up of a stakeholder-governed pan-European verification model (EMVS). After the incorporation of the European Medicines Verification Organisation (EMVO) in February 2015, he also headed the organisation ad interim in order to manage the European hub that will connect to a series of national data repositories serving as the platform to allow the verification of authenticity of medicines anywhere in the supply chain within the EU/EEA. On 1st April 2016, he was appointed as General Manager of EMVO representing now definitely the organisation.

Medicines for Europe

Victor Lino Mendonça

Head of Policy and Market Access Europe - Mylan

Victor Lino Mendonça is the European Head of Policy & Market Access at Mylan and Board member of Medicines for Europe. Formerly he was the Head of Pharmaceutical Policy and Health Economics at the EGA – European Generic medicines Association. Before EGA he was also Advisor to the Executive Board of Infarmed - The Portuguese National Authority of Medicines and Health Products and Advisor to the Portuguese Health Secretary of State. Victor also worked as Product Manager at Boehringer Ingelheim Portugal and in the fast moving consumer goods area.

Medicines for Europe

Denis Dambois

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs - European Commission

After earning a M.Sc. in electromechanical engineering from the Brussels University (ULB) in 1987, Denis was hired as a researcher in power electronics by Philips, for which he worked both in Belgium and in Germany.
In 1991 he joined the patent department of Solvay s.a., a multinational chemical company. During that period he trained in intellectual property at CEIPI (Strasbourg) and qualified as a European Patent Attorney. He also graduated from the Executive Master in Management of the Solvay Business School (CEPAC-ULB).
In 1999 Denis was hired by the Directorate-General for Research of the European Commission, where he was responsible for R&D-related intellectual property and technology transfer issues, including the development of the IPR provisions for the 7th Framework Programme.
In 2008, Denis moved to DG Trade, and more specifically to the unit responsible for international IPR issues, where for five years he was responsible for IPR negotiations with several third countries.
From 2013 to 2016 Denis was heading the Research and Innovation Section of the Delegation of the European Union to India (Delhi), where he fostered EU-India research collaborations, and also handled IPR issues.
After reintegrating DG Research & Innovation in Brussels for about a year, in November 2017 Denis joined the IPR unit of DG GROW (‘Intellectual Property and Fight against Counterfeiting’), which is the main unit of the Commission responsible for IPR policy, where he is working on patent and other issues.

Medicines for Europe

Umberto Comberiati

Head of Marketing Europe - Teva Pharmaceuticals and Chair Value Added Medicines Sector Group

Chairman of Value Added Medicines Group. Working at Teva Pharmaceuticals Europe, head of Marketing Europe, before which he was responsible for commercial strategy and operations. Previously experience in Pricing & Reimbursement at country and at European level. Started his career as a consultant working with major pharmaceutical corporations, focusing on pricing and commercialization strategy. Background in pharmaceutical chemistry and translational medicine plus MBA.

Medicines for Europe

Aurelio Arias

Senior Consultant, European Thought Leadership - IQVIA

Aurelio is a Senior Consultant in the Thought Leadership team at IQVIA, a market leader in healthcare data, clinical trials and consulting. IQVIA is focused on supporting pharmaceutical and health organisations with real world evidence, market insights, and consultancy. Aurelio generates thought leadership insights with a view to spark high-level discourse on key pharma issues such as drug pricing, market access, and Brexit. He also advises executives on global pharma strategy where he takes a view on future market dynamics including geographical competitiveness, therapy growth areas, rare diseases, and digital technologies. Prior to Iqvia, Aurelio has advised blue chip companies on market access and M&A strategy in both Life Sciences and Financial Services while working for LEK and Accenture. He has worked in R&D for Pfizer and GlaxoSmithKline while completing a Chemistry degree at Imperial College London.

Medicines for Europe

Rebecca Coady

Associate Principal - IQVIA Consulting Services

• Rebecca has +7 years experience in pharmaceutical consulting
• She specialises in optimising pricing and market access (PMA) in evolving payer environments using her in-depth knowledge of global PMA systems and expertise in qualitative and quantitative research methodologies
• Her work has addressed a variety of pharmaceutical industry issues including loss of exclusivity risk mitigation, launch readiness, and due diligence, and has covered a broad a range of therapy areas including inflammation, infection, diabetes, and oncology
• Rebecca holds a PhD in Biochemistry and MRes in Structural Molecular Biology from Imperial College London

Medicines for Europe

Mariano Votta

Director - Active Citizenship Network and Responsible for EU Affairs - Italian NGO Cittadinanzattiva

Public affairs professional and journalist, is the Director of Active Citizenship Network (ACN), the international branch of the Italian NGO Cittadinanzattiva, where he is responsible for European Affairs. Since 2013, he has been actively involved as ACN stepped up its advocacy activities at the European Institutions, which in 2015 led to the opening of a representative office in Brussels and - above all - to the launch of the MEP Interest Group “European Patients' Rights & Cross-Border Healthcare”, promoted with the endorsement of almost 100 organizations across Europe. Furthermore, in 2016, Mariano won the Efhre International University Excellence Awards on patients’ rights. Passionate about healthcare and consumer issues, he has more than 17 years of experience in the field of advocacy, stakeholder engagement, European projects, communication and civic information.
Mariano Votta officially represents ACN abroad, with the European Commission DG Health, DG Consumers, DG Move, DG Migration and Home Affairs and with all the other stakeholders. He is also in the Board/Executive Committee of Pain Alliance Europe, Societal Impact of Pain and Health First Europe.
Mariano Votta holds a MSc in Political Science and two post-graduate Masters in European Public Relations and in Corporate Social Responsibility.

Medicines for Europe

Kenneth V. Phelps

President and CEO - Camargo Pharmaceutical Services

In 2003, Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in Cincinnati with Dr. Ruth Stevens (chief scientific officer and executive vice president). It is no coincidence that 2003 was also the year the US FDA introduced guidelines governing the 505(b)(2) approval pathway. From the beginning, Camargo has focused solely on being the industry’s 505(b)(2) development partner of choice. In 2011, Camargo opened a second location in Durham, N.C., in the Research Triangle Park. Today, Camargo partners with companies in more than 25 countries worldwide and has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA — Camargo has led more than 1100 Agency meetings and is the industry authority in 505(b)(2). Before founding Camargo, Phelps’ diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control, and processing technology, with an assignment based in Milan, Italy. Today, as a thought leader in the shifting landscape of drug development and emergent pathways around the globe, Phelps addresses the financial challenges of pharmaceutical companies caused by the generics cliff and routinely presents on the topic at events worldwide. He has recently been invited to speak on the topic at DCAT and other international conferences on how companies can realize the opportunities of 505(b)(2) and expanded marketability. Phelps is also a founding member of the 505(b)(2) Forum, an assembly of product developers and service providers interested in improving best practices across the 505(b)(2) development process. He publishes articles frequently and is a featured interviewee in publications, videos and podcasts concerning new, repositioned, and differentiated product development around the globe. You can access these resources by following the Camargo Blog where Phelps and his team elaborate on current market trends.

Medicines for Europe

Klara Marton Klara Marton MD, MBA

Business Development Director - Egis Pharmaceuticals PLC

Klara Marton is the Business Development Director of Egis Pharmaceuticals PLC /owned by Servier/, one of the leading generic pharmaceutical companies in the CEE and CIS regions with activities extending to every field of pharmaceutical production from research and development, through active ingredient and finished production to sales and marketing. Her priorities at Egis is leading international strategic business development, defining mid- and long-term pipeline consists of value-added products, commodity generics, biosimilar products and related digital solutions. She is also responsible for licensing-in and strategic partnerships. Under her leadership the early involvement of customer insight in business development, especially patient insight has been established. Before Egis she worked as a Business Unit Director with responsibilities ranging from marketing, sales to market access covering several therapeutic fields at GSK, sanofi-aventis in Budapest. Earlier she held commercial positions at multinational innovative companies in Hungary and consulting company in the US. She is a Medical Doctor holding a Master of Business Administration degree.

Medicines for Europe

Michael Soldan

Senior Vice President Head of Biosimilars - Fresenius Kabi

Michael Soldan Ph.D. is heading the Business Unit Biosimilars for Fresenius Kabi. Before joining Fresenius Kabi he was heading the Biosimilar Business for Merck KgaA and joined the area of biosimilars first at Boehringer Ingelheim as a member of the Boehringer Ingelheim Biosimilar Executive team heading Regulatory Affairs /Drug Safety. Michael Soldan served in increasingly senior roles within the Medical and Regulatory field in the biopharmaceutical industry at Aventis Behring, Novartis Vaccines, Grünenthal and Biotest AG. Dr. Soldan holds a Ph.D. in pharmacology and has graduated in theoretical medicine and pharmacy.

Medicines for Europe

Emer Cooke

Head of Regulation of Medicines and other Health Technologies - World Health Organization (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 Safety), 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.

Medicines for Europe

Zoltán Kaló

Professor of Health Economics, Eötvös Loránd University (ELTE), Budapest, Hungary

Zoltán Kaló is a Professor of Health Economics and the co-director of an MSc in Health Policy, Planning and Financing postgraduate program at Eötvös Loránd University (ELTE) in Budapest. Dr. Kaló is also the founder and leader of Syreon Research Institute, an international research corporation specializing in health policy, health economic modeling and technology assessment. He has 20 years of international experience in academia and industry, specializing in health systems design, HTA implementation, health economics and outcomes research, economic modeling, patient access and pricing policies of healthcare technologies. Dr. Kaló serves as a policy advisor to public decision-makers and global health care corporations. He is a Scientific Committee member of the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). He was a Director of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) between 2012-2014, and the Chair of ISPOR Central and Eastern European Network Executive Committee between 2013-2015.

Medicines for Europe

Markus Sieger

CEO - Polpharma Group

He holds a degree in Economics and has been working in emerging industries, such as information technology in Switzerland and United States and in emerging markets such as Singapore, Poland and CIS countries. Since the mid-nineties he has successfully managed complex and strategic transactions in and outside of Poland in the pharmaceutical industry, FMCG and media and has been a member of the supervisory board of several of those companies. He has been associated with Polpharma Group since 2000 and was appointed President of the Management Board in June 2016. In 2018, he joined the Executive Committee of Medicines for Europe.

Medicines for Europe

Erik Bogsch

Head R&D & Manufacturing within the Biotechnology Business Unit - Gedeon Richter Plc

Dr. Erik Bogsch is Head of R&D & Manufacturing within the Biotechnology Business Unit at Gedeon Richter Plc. Erik is responsible for leading R&D efforts in the development of GR's biotechnology pipeline.
Gedeon Richter Plc. is engaged in the development and manufacture of both bacterial cell fermentation based and mammalian cell fermentation based biosimilar products. GR has R&D, analytical & manufacturing capabilities in multiple locations in Hungary & Germany.
Dr. Bogsch, has a Natural Sciences degree from the University of Cambridge and a PhD in cell biology from the University of Warwick. Following a brief postdoctoral academic research career, he worked in the food industry for many years in R&D, Quality & Manufacturing roles in the UK, Hungary & Germany. He joined Gedeon Richter Plc. in 2012, as commissioning lead for GR's biotechnology factory in Debrecen, Hungary, before moving into R&D in 2014 and into his current role in 2018.

Medicines for Europe

Christine Simmon

Senior Vice President of Policy and Strategic Alliances - aam

Christine Simmon joined the Association for Accessible Medicines (formerly GPhA) in 2012 as the Senior Vice President of Policy & Strategic Alliances, and most recently was named Executive Director of AAM’s Biosimilars Council, founded in 2015. In her current role, Christine is responsible for leading policy development and issues management for AAM, directing the Biosimilars Council, and building relationships with strategic partners in the health care sector, including patient advocacy groups.

Medicines for Europe

Aidan Fry

Editor – Generics Bulletin, Informa

Aidan Fry has been the editor of Generics bulletin, the business newsletter for the generic, biosimilar and value-added medicines industries, since August 2008. He had previously been the deputy editor of Generics bulletin since the newsletter’s inception in 2003, having also spent five years working on its sister publication, OTC bulletin, which also now forms part of the Informa group. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.

Medicines for Europe

Erin Federman

Head of Biologics (Europe) - Mylan and Chair of the Market Access Committee - Biosimilar Medicines Group for Medicines for Europe

Erin Federman is 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.

Medicines for Europe

Dr. Christiane Hanke-Harloff

Head of the Biotechnology Business Unit - Gedeon Richter

Christiane Hanke-Harloff is heading the Biotechnology Business Unit since July 2016. She has 20 years of biopharmaceutical industry experience, joining Gedeon Richter from Santen Pharmaceuticals where she was heading the European and Russian commercial departments. Previously Christiane Hanke-Harloff was as the Head of Europe and CCO responsible for the European operations of The Medicines Company. She gained significant experience in the Biotech field at VP level at Jerini AG as well as Micromet AG. Before that Christiane built the German and Russian operations for Gilead Sciences at Managing Director level. Christiane has proficiency in a broad range of therapeutic and pharmaceutical fields and in managing the entire pharmaceutical value chain. She holds a PhD degree in Molecular Biology and graduated at the Ludwigs-Maximilians University in Munich, Germany.

Medicines for Europe

Robert Andrew Johnstone

Patient Advocate - International Foundation for Integrated Care (IFIC), European Forum for Good Clinical Practice (EFGCP) & Health Quality Improvement Partnership (HQIP)

Chair: Access Matters, Midstream, Board Member: European Forum for Good Clinical Practice (EFGCP), Health Quality Improvement Partnership (HQIP), International Foundation for Integrated Care (IFIC). Having had Rheumatoid Arthritis for nearly 60 years from the age of three, I have a wealth of experience as a user of health services. Since 1990 I have voluntarily represented people with disabilities & chronic conditions locally, nationally & internationally “The people have the right & duty to participate individually & collectively in the planning & implementation of their healthcare” Alma Ata Declaration – Principle IV, 1978 World Health Organisation.

Medicines for Europe

Jamie Wilkinson

Director of Professional Affairs - PGEU

Mr Wilkinson commenced his role as Pharmaceuticals and Professional Affairs Adviser of the PGEU in January 2014 before becoming Director of Professional Affairs in April 2015. The Pharmaceutical Group of the European Union (PGEU) is the European Association representing community pharmacists in 32 European countries. A pharmacist by training, he has practice experience in the community pharmacy sector and academia in the UK, in addition to experience in health policy, professional affairs and advocacy. He was educated at the Universities of Kingston & St Georges London with an MPharm, Master of Pharmacy, an MSc in Social Research Methods from the University of Sussex and an MPH, Master of Public Health from the University of Sheffield. He is a Member of the Royal Pharmaceutical Society UK, a Fellow of the Royal Society for Public Health UK and a Practitioner Member of the Faculty of Public Health UK.

Medicines for Europe

James Burt

Executive Vice President, Europe & MENA - Accord Healthcare

James has over 20 years plus experience in the pharmaceutical industry, predominately in the generics and biosimilar sector. James’ significant pharmaceutical experience includes UK, Europe and Global management roles in commercial, business development and general management positions. Joining Accord eight years ago from Actavis, James leads Accord’s operations in the EMENA territories, with a particular focus on developing and delivering Accord’s strategy to improve access to high quality affordable medicines within the region. James holds a Bachelor's Degree of Chemical and Biochemical Engineering and a Doctor of Philosophy degree in Chemical Engineering, both from the University of Birmingham.

Medicines for Europe

Bernd Grabner

Director - Jacoby GM Pharma GmbH and Vice-President - PHAGO

Bernd Grabner was born in 1975 and started his studies of law and business economics at University of Linz in 1993. Already during his studies, he started working in the family owned wholesaling company in 1999, being in charge for an alternating range of operational tasks. Bernd Grabner became a member of the board of GM Pharma in 2003 and after the mergers with two other Austrian wholesalers now is a member of the board of Jacoby GM Pharma. He is therein responsible for the divisions supplier relation, services and new business activities.
Bernd Grabner is vice president of the Austrian Association of Full Line Wholesalers PHAGO and member of the Board of the European Healthcare Distribution Association GIRP.

Medicines for Europe

Global Generic, Biosimilar and
Value Added Medicines Conference
Joint 24th Medicines for Europe and 21st IGBA Annual Conference

Hilton Budapest Hotel, Budapest

13-15 June 2018


Medicines for Europe

Chester “Chip” Davis, Jr.

President and Chief Executive Officer - Association for Accessible Medicines (aam)

Chester “Chip” Davis, Jr. is the President and Chief Executive Officer of the Association for Accessible Medicines, the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals and suppliers of other goods and services to the generic drug industry. Appointed to the position by the AAM Board in summer 2015, Chip is responsible for ensuring that the Association fulfills its primary mission, which is to improve the lives of patients and consumers by providing timely access to safe, effective and affordable medicines.
Prior to joining AAM, Chip most recently served as Executive Vice President for Advocacy and Member Relations at the Pharmaceutical Research and Manufacturers of America (PhRMA), where he was responsible for leading PhRMA’s federal, state and international government relations and advocacy efforts, in addition to member company recruitment and retention. Prior to joining PhRMA, he was Vice President of Corporate External Relations for AstraZeneca, where he oversaw the company’s government relations, strategic alliances, community relations and employee volunteer efforts. He was a member of AstraZeneca’s Corporate Affairs Leadership team and Vice-Chairman of the company Political Action Committee. In 2007, Chip was one of the inaugural winners of the AstraZeneca CEO Award, given to global executives who best demonstrate AstraZeneca leadership capabilities in their accomplishments.
Chip earned an undergraduate degree in Accounting from the University of Delaware, and a Juris Doctor from the University of Baltimore School of Law. He is a licensed attorney in Maryland, Virginia and the District of Columbia. He currently serves on the Board of Directors for the Washington, DC area Chapter of Autism Speaks, the University of Delaware Alumni Association, the St. Mary’s High School Royal Blue Club, and the Member Advisory Board for the National Journal.


Medicines for Europe

László György

Minister of State for Economic Strategy and Regulation - Hungary

Education:
2003 – Budapest Corvinus University, Master in Economics
2004 – CEMS, Universität St. Gallen
2008 – Budapest University of Technology and Economic Sciences (BME), MBA
Academic qualification:
2013 – PhD in Economics, Budapest University of Technology and Economic Sciences
Work experience:
2018- Ministry of Innovation and Technology, Minister of State for economic strategy and regulation
2001-2011 AGP Agency Inc. New York (manager of pianist Ádám György)
2005-2017 Budapest University of Technology and Economic Sciences, Faculty of Economics (2005-2008 PhD student; 2008-2013 university lecturer; 2013-2017 assistant professor)
2012-2018 Századvég Economic Research Institute and Századvég School of Politics (2012-2015 economic policy analyst; 2015-2018 chief economist)
2017-2018 Pallas Athéné Domus Mentis Foundation (director)
2017 – Neumann János University, Faculty of Economy (associate professor)
2017 – ELTE, Institute of Business Economics (assistant professor)
Language knowledge:
English - advanced level; German - intermediate level

Medicines for Europe

Warwick Smith

Director General - BGMA

Warwick Smith is the Director-General of the British Generic Manufacturers Association. He is a member of the Board and Executive of the European Generic medicines Association (EGA), and was one of its Vice Presidents from 1995 to 2000.
During Warwick’s period as Director-General of the BGMA, the Association has negotiated a long term market based reimbursement system for generic medicines giving the industry freedom of pricing and has agreed work sharing schemes with the national regulatory agency (MHRA) to reduce significantly the workload on members. Additionally the association has held joint seminars with the MHRA, successfully countered attacks on biosimilars, is about to agree new arrangements for secondary care contracts and the outsourcing of hospital pharmacies, and has agreed a joint study into the sustainability of the generic industry in the UK with the British Government.


Medicines for Europe

Simon Goeller

Partner - McKinsey

Simon Goeller is a Partner based in Munich and the global leader of McKinsey's Generics Practice. Since joining McKinsey in 2002, Simon has worked for clients around the world on topics related to generics, branded generics, LOE management, pharma distribution and retail. He serves pharmacos, wholesalers, retailers/pharmacy chains, and PE firms. His recent experiences include global strategy and portfolio definition for a leading player in Branded Generics, pricing and market access efforts for various off-patent pharma and branded companies, field force optimization effort for generics player in Eastern Europe, post-merger integration and brand positioning for retail pharmacy chain, global strategic purchasing strategy for major U.S. healthcare company, lead and expert on various private equity and industry due diligences in healthcare, marketing & sales excellence programs for pharma companies across Europe, Japan, and the US, including specialty players and dermatology, definition of one of the largest global healthcare provider partnerships, consumer health and branded generics growth strategies globally. Prior to joining McKinsey, Simon obtained a B.A and M.Sc in Economics and Management Research from the University of Oxford (U.K.), and a PhD in Health Care Economics from the University of Giessen (Germany).


Medicines for Europe

Knut Slatten

Vice President, Senior Analyst - Moody's Investors Service

Knut Slatten is a Vice President – Senior Analyst based in Paris. He is currently the lead analyst for European pharmaceuticals – branded and generics – at Moody’s Investors Service. Since joining Moody’s in 2007, he has covered a variety of issuers within European healthcare and has been involved in the coverage of European pharmaceuticals since then. Prior to joining Moody’s, Knut worked for a European Investment Bank. He is a graduate of NHH Bergen and HEC Paris.


Medicines for Europe

Jean-Guy Goulet

Chief Operating Officer - Pharmascience Inc.

Jean-Guy joined Pharmascience Inc.in 2017, a full-service privately owned pharmaceutical company and the largest pharmaceutical employer in Quebec with over 1,500 employees. Pharmascience ranks in Canada as the 6th largest pharmaceutical company and the 3rd largest manufacturer of over-the-counter generic drugs. Jean-Guy oversees Pharmascience’s generic portfolio, in Canada and over 60 countries in the world. Jean-Guy started his career in 1987 in the Quality Control department at Technical Pharma, later acquired by Ratiopharm. He rapidly gained increasing responsibilities to become President of the Commercial division of Ratiopharm Canada and President of North America. Jean-Guy was the President of Actavis Canada, until the sale of this division to a global pharmaceutical company. Jean-Guy graduated in Chemistry from University of Montreal. He invested time and energy in developing and representing the Canadian Generic Pharmaceutical Association (CGPA) and is currently the Vice-Chair. He recently served as a representative on the negotiating committee of the Pan Canadian Pharmaceutical Alliance (pCPA).


Medicines for Europe

Jeff Watson

President and Chief Operating Officer (COO) - Apotex

Jeff is President & Chief Operating Officer (COO) of Apotex. Appointed in 2018, Jeff oversees the day-to-day global operations of Apotex, including research and development, manufacturing, packaging, distribution and commercial activities for products across three Lines of Business to more than 115 countries.
Prior to this role, Jeff was President, Global Generics, the largest line of business at Apotex, where he provided leadership for the Commercial and Strategic Operations and was instrumental in delivering significant growth. A 25-year veteran of Apotex, Jeff has held progressively senior positions within Sales and Marketing since 1993 when he joined the company.
Before joining Apotex, Jeff spent time working in the retail pharmacy sector for Shoppers Drug Mart, Canada’s leading pharmacy chain.
Jeff has been a member of the Association for Accessible Medicines (AAM) Board of Directors since 2012 and served as Chair in 2017. He was reappointed for a second term as Chair, Board of Directors for the AAM in 2018. In 2008 he became an Executive Member of the Canadian Generic Pharmaceutical Association’s (CGPA) board. From March 2015-February 2017, he served as Chair of CGPA’s board following three years of service as Vice Chair. Jeff is a former Chair of the US Healthcare Distribution Alliance’s (HDA) knowledge partner, the HDA Research Foundation. He is also the Chair of the Board of Directors for TruLeaf Sustainable Agriculture, Nova Scotia, Canada.


Medicines for Europe

Jacek Glinka

President – European Region Mylan

Jacek Glinka is the President of the European Region for Mylan, one of the world’s leading global pharmaceutical companies which is dedicated to providing the world’s 7 billion people access to high quality medicine. Mylan is present in 35 countries in the European region and in approximately 165 countries and territories globally. Mr. Glinka has joined Mylan from the Polpharma Group, where he served as chief executive officer from 2003 to 2006 and from 2009 to 2013. During his tenure, he led the transformation of Polpharma from a local player into a leading pharmaceutical company in Central and Eastern Europe, the Caucasus and central Asia. Prior to that, Mr. Glinka was a managing director at Spectra Services, where he oversaw a number of acquisitions and restructurings, including the acquisition and integration of Akrihin into Polpharma Group. He began his professional career as a strategic management consultant with firms including Deloitte & Touche and A.T. Kearney.


Medicines for Europe

Alexandra Moulson

Head Global Commercial Operations Strategy - Sandoz

Experienced leader and strategist with broad background in marketing, product development, business development, portfolio management and launch with a focus in oncology.
More than 16 years experience in pharmaceuticals (8 years in originators, 6 in biosimilars, 2 in generics), biotechnology, and medical devices.
Biochemist with an MBA, Associate Principal at McKinsey, various roles in biosimilars and generics at Sandoz since 2010.


Medicines for Europe

Marc-Alexander Mahl

Executive Vice President, Business Unit Generic Drugs - Fresenius Kabi and 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 improve the access to generic medicines, biosimilars and value-added medicines for patients across Europe. 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).


Medicines for Europe

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.


Medicines for Europe

Deborah M. Autor

Head of Strategic Global Quality & Regulatory Policy - Mylan

Deb Autor is Head of Strategic Global Quality and Regulatory Policy at Mylan, one of the largest generics and specialty pharmaceutical companies in the world. In this role, Deb represents Mylan’s diverse and complex operations to government officials globally and advises Mylan’s most senior leaders on how to navigate and influence the regulatory landscape. She also leads Mylan’s work on international trade policy, preventing antimicrobial resistance, and implementing global serialization. Previously, as Mylan’s Global Head of Quality, Deb managed thousands of personnel around the world, driving quality improvements across scores of manufacturing sites.
Prior to joining Mylan, Deb served for 12 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy, where she supervised more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs in their efforts to confront the challenges of globalization and import safety. She also served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research, where she led policymaking and enforcement for key programs for drugs, including current good manufacturing practices; human subject protection and bioresearch monitoring; marketed unapproved drugs; pharmaceutical import and export; Internet and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls. Before joining FDA, Deb served for six years as a Trial Attorney at the Office of Consumer Litigation of the U.S. Department of Justice.
Ms. Autor’s many commendations include the Meritorious Executive Presidential Rank Award and the Food and Drug Law Institute's Distinguished Service and Leadership Award. She also was a finalist for the prestigious Service to America Medal.


Medicines for Europe

Christoph Stoller

General Manager Cluster Germany & Austria - Teva-ratiopharm and Vice President - Medicines for Europe

Christoph Stoller is General Manager Teva-ratiopharm for the cluster Germany & Austria. In that role he is responsible for all Business Units: Generics, OTC and Specialty Medicines. 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 activities. Christoph is Vice President of Medicines for Europe. Furthermore he chaired the sector group on Value Added Medicines until taking up his new role in Germany. Mr. Stoller 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).


Medicines for Europe

Lisa Günther

Head Global Business Insights - Sandoz

Lisa Günther is Head of Global Business Insights at Sandoz. In this role, which she has held since 2015, she is responsible for developing and sharing market insights across the company for maximum commercial impact. Lisa first joined Sandoz as a member of the Divisional Strategy team in 2014. She began her professional career as a management consultant with The Boston Consulting Group (BCG), where she worked in projects across the healthcare sector. A German national, Lisa graduated with a European Masters in Management with a specialization in Strategy, from LMU Munich / EMLYON Business School.


Medicines for Europe

Adele Paterson

CEO and Head of Corporate Partnerships - International Health Partners

As CEO of International Health Partners, Adele brings a wealth of cross sector partnership, CSR and public policy experience. An economics and politics graduate, she ran the parliamentary office of a British Government Minister, headed up CSR, fundraising and communications for a national regeneration charity and served as head of policy for financial services trade body. At IHP she has headed the work with corporate donors and as CEO, she is working to move product donations towards sustainability to ensure long term access to medicines for vulnerable and disaster hit communities. Adele sits on the Board of PQMD (Partnership for Quality Medical Donations) and Integral. She recently completed #£20kfor20k to raise funds for IHP.


Medicines for Europe

Frank Bouisset

Head Specialty Franchises West Europe - Sandoz and Chairman of the Hospital Channel WG - Medicines for Europe

Frank Bouisset is French and holds a Master degree in Marketing & Management. Frank is leading the Specialty (Oncology, Anti-infective, Neurology, Transplant, Pain, and Gynecology) franchises in West Europe for Sandoz and Chair the Hospital WG for Medicines for Europe. Frank has 25 years’ experience in European and Emerging markets of which 18 years for the healthcare industry. He gained experience in setting up, developing and managing successive new business models in primary and secondary care. Prior to this, he mainly served in commercial and general management positions in B2B industries.


Medicines for Europe

Monika Dereque-Pois

Director General - GIRP

Monika Derecque-Pois was born in Graz/Austria and holds a master’s degree in Economics from the University of Economics in Vienna, where she specialised in International Trade and Marketing. Ms. Monika Derecque-Pois is the Director General of GIRP, the European Healthcare Distribution Association, which brings together over 750 pharmaceutical full-line wholesaling companies and their national associations from 35 countries. Monika was appointed to her current position in 2001, having previously served as European affairs consultant for GIRP. She has over 20 years of experience in European public affairs. Prior to her engagement with GIRP, she served as a director in a European affairs consultancy company and she also held a six-year post as Marketing and Client Support Manager at IMS Health Austria.


Medicines for Europe

Gergely Németh

Project Manager - National Institute of Health Insurance Fund Management (NEAK)

Gergely Németh graduated as a pharmacist in 2014 in Budapest. He has been working at the department in charge of reimbursement of pharmaceuticals of the Hungarian authority for health insurance. He has been involved in the planning and implementation of the Hungarian generic pricing policy since 2007 and participated in the development of sofwares supporting pricing and reimbursement of pharmaceuticals. He has been the project manager of the EURIPID project since its establishment in 2010. The EURIPID project is a non-profit initiative of the national competent authorities of Europe for the mutual sharing of pharmaceutical price information.


Medicines for Europe

Brendan Cuddy

Head Manufacturing and Quality Compliance Service - EMA

Brendan Cuddy joined the European Medicines Agency as a Scientific Administrator in October 2002. Brendan is currently Head of Manufacturing and Quality Compliance Service and he is Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). The Manufacturing and Quality Compliance Service is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chair and secretariat of the GMDP Inspectors Working Group and the secretariat for the Quality Working Party. The Service plays a key role in collaborating and communicating with international partners on setting and recognising GMP standards, making better use of inspectional resources and exchanging information on availability of already authorised medicines. Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.


Medicines for Europe

Randall Stanicky

Managing Director - RBC Capital Markets

Randall Stanicky, CFA, is a Managing Director at RBC Capital Markets. Randall has been head the RBC Specialty Pharmaceuticals team for the past three years covering global generic manufacturers and specialty therapeutic providers. He is a regular Wall Street speaker at international conferences and ranked Runner-up (RU) in the “Institutional Investor” poll this past year. Prior to RBC, he spent most of his career at Goldman Sachs, where as a Vice President in Global Investment Research, his coverage spanned specialty pharmaceuticals, drug distribution, pharmacy benefit managers, healthcare technology and the contract research organization sectors. Randall also served as a Managing Director at Canaccord Genuity and prior to joining the sell-side he was an analyst at Citigroup Global Asset Management assisting in the investment recommendations of healthcare stocks. He is also an active member and head of the audit committee of the Board of the Director of the Children’s Tumor Foundation and previous Board member of TherapeuticsMD (TXMD). Randall lives in New York City with his wife and two children.


Medicines for Europe

Martin Favié, PharmD

Chairman - Bogin (Dutch Biosimilars and Generic Medicines Association)

Bogin represents the interests of the generic and biosimilars medicines industry in the Netherlands. Bogin plays an important role in many aspects of the Dutch pharmaceutical market and related issues. Bogin is an active member of Medicines of Europe (former EGA). Martin Favié studied Pharmacy at the University of Amsterdam and was a community pharmacist for 33 years. During this period he was President of the Royal Dutch Association of Pharmacists (KNMP) from 1999-2004.


Medicines for Europe

David R. Gaugh, R.Ph.

Senior Vice President for Sciences and Regulatory Affairs - Association for Accessible Medicines (aam)

David Gaugh has over 25 years of leadership experience in the Healthcare and Pharmaceutical business. He has been employed by AAM (formerly GPhA) since February 2012 as the Senior Vice President for Sciences and Regulatory Affairs, where he is responsible for the professional liaison functions between member companies, agencies of the US Government and Legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories and a wholly owned subsidiary of Boehringer Ingelheim.Prior to Bedford Laboratories, David was Senior Director, Pharmacy Contracting and Marketing at VHA/ Novation (now Vizient). And prior to VHA/Novation, David was System Director of Pharmacy for St. Luke’s Health-System, a tertiary-care hospital in Kansas City, MO. David is a registered Pharmacist and has been engaged in several board-level pharmacy-related activities. the American Society of Health-system Pharmacists Education and Research Foundation Board of Directors, USP Council of Convention, and American Foundation for Pharmaceutical Education Board of Directors.


Medicines for Europe

Sarah Garner

Co-ordinator ‘Innovation, Access and Use’, Essential Medicines and Health Products Department - World Health Organisation (WHO)

Sarah Garner PhD, BPharm is the Co-ordinator ‘Innovation, Access and Use’ in the Essential Medicines and Health Products Department at the World Health Organisation. Sarah is a pharmacist specialising in innovation, with previous work focussing on development strategies and the interface between Health Technology Assessment (HTA) and regulation. Sarah is an honorary professor at UCL and Manchester Universities. Her previous roles have included the Associate Director for Science Policy and Research at the UK's National Institute for Health and Care Excellence (NICE) and Pharmacist Lead for the UK Government’s Special Advisory Committee on Antimicrobial Resistance. Sarah has led policy work-packages of public private research partnerships funded by the EU Innovative Medicines Initiative (GetReal, ADAPTSMART and Big Data for Better Outcomes) which are developing policy proposals for the adaptive pathways and use of real-word data in pharmaceutical development, regulatory and HTA decision making. In 2010-11 Sarah was a Harkness Fellow in Healthcare Policy and Practice in the United States. Her research examined the impact of comparative effectiveness research and Health Technology Assessment on pharmaceutical and MedTech innovation. Sarah is working with the multi-stakeholder New Drug Development Paradigms (NEWDIGS) team at Massachusetts Institute of Technology and is a Fellow at the Centre for the Advancement of Sustainable Medical Innovation which is a collaboration between Oxford University and University College London.


Medicines for Europe

Sandra L. Kweder, M.D.

Deputy Director Europe Office, Liaison to the European Medicines Agency - US FDA

Prior to assuming this post in March 2016, Dr. Kweder was Deputy Director, Office of New Drugs (OND) in FDA’s Center for Drug Evaluation & Research (CDER), since 2002. In CDER she was an active leader of a number of initiatives, including improvements in the drug review process; modernizing nonprescription drug review; building a systematic drug shortage prevention and management program; patient-focused drug development and clinical outcomes assessment, and; the growth and development of pediatrics and maternal health as standard aspects of drug development. Dr. Kweder was commissioned in the U.S. Public Health Service upon entering the Uniformed Services University of Health Sciences (USUHS), retiring in 2013 at the rank of Rear Admiral. Following internal medicine training at Walter Reed Army Medical Center she joined the U.S. Food & Drug Administration (FDA) in the Division of Antiviral Drugs to address the growing field of HIV drug development. She has since held a number of positions with FDA in premarket and postmarketing regulation. Until her move to London she was active in medical education as an adjunct faculty member of USUHS, training residents and medical students in Internal Medicine and utilizing her fellowship training from Brown University in Obstetric and Consultative Medicine.


Medicines for Europe

Riccardo Luigetti

Principal International Affairs Officer - European Medicines Agency (EMA)

Riccardo joined the EMA International Affairs Team in September 2014. He is currently leading the EMA efforts to strengthen cooperation with regulators in critical emerging economy countries, such as China and India.
He joined the European Medicines Agency in 2004 where he has covered several different roles, mainly related to GMP, implementation of the Falsified Medicine Directive and international affairs.
Before joining the EMA, he graduated in organic chemistry at the University of Perugia. After a PhD in biochemistry and some years of research work at the same University, he joined the Italian regulatory agency where he worked initially as quality assessor and as GMP inspector.


Medicines for Europe

David Jauch

Director Government Relations - Fresenius Kabi

David M. Jauch is responsible for Government Relations for Fresenius Kabi. He is the Chairman of the International Affairs Committee, Member of the Board of Medicines for Europe as well as a member of the Trade Committee of IGBA (International Generics and Biosimilar Association). Also, David is a member of the Regulatory Committee of the German Pharmaceutical Industry Association (BPI). David studied Business Administration at the University of Stuttgart in Germany, Tongji University in Shanghai, China and Seoul National University in Korea and holds an Executive Master in Business Management of Leeds University Business School in the UK.


Medicines for Europe

Nick Cappuccino

Vice-President, Quality and Scientific Affairs - Dr. Reddy's Laboratories, Inc.

Dr. Cappuccino is currently Vice-President, Quality and Scientific Affairs for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino has served in Executive Management and Scientific Leadership roles in many companies in both the innovative and generic drug industries over the past 40 years.
Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH Assembly. He has represented IGBA as an expert on several ICH Expert Working Groups in the Quality and Multidisciplinary topic areas since 1998.
Dr. Cappuccino holds a Ph.D. in Organic Chemistry along with MS and BS degrees from Stevens Institute of Technology, Hoboken, NJ, USA and an MBA from Fairleigh Dickinson University, Madison, NJ, USA.


Medicines for Europe

Jim Keon

President - Canadian Generic Pharmaceutical Association (CGPA) and President - Biosimilars Canada

Jim Keon is President of the Canadian Generic Pharmaceutical Association (CGPA), and President of Biosimilars Canada organizations representing Canada’s generic and biosimilar pharmaceutical sectors. Jim graduated with an M.A. in Economics from Queen’s University, and has more than 20 years’ experience in the pharmaceutical sector. Jim has served as President of the CGPA since 1998 and was named the founding President of Biosimilars Canada in January 2015. Prior to joining CGPA in 1994 he held senior positions in the federal government and was directly involved in international trade negotiations for NAFTA and the WTO, as well as Canada’s inter-provincial trade negotiations. Jim is Past Chair of the International Generic and Biosimilar Medicines Association (IGBA), which is committed to promoting the interests of generic and biosimilar medicines around the world. He is currently Chair of the IGBA International Trade Committee.


Medicines for Europe

Alison Cave

Principal Scientific Administrator - European Medicines Agency

Dr Cave joined the European Medicines Agency in January 2016 as a Principal Scientific Administrator in the Pharmacovigilance and Epidemiology Department where she leads on developing mechanisms to increase capacity in the use of real world data in medicines regulation. She also co-chairs the HMA-EMA Joint Big Data taskforce which is exploring the regulatory challenges presented by Big Data. She holds a BA Honours degree and PhD from the University of London and has over 20 years of academic research experience in the cardiovascular field. Prior to joining the EMA she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and, prior to this, an Expert Scientific Assessor at the UK Medicines and HealthCare products Regulatory Agency.


Medicines for Europe

Michaeline Daboul

President & CEO - MediSpend

Michaeline is a veteran of the medical technology and pharmaceutical industries, with over 25 years of experience working in genomics research, pharmaceutical drug development and marketing, and medical systems innovation. She has led organizations in the development of new technologies to create products and services for their Fortune 500 clients. She has spent the past 14 years as the co-founder and president of MediSpend, leading the company in the development of the MediSpend Global Compliance Platform, the Physicians Professional Network as well as custom enterprise data management platforms and software solutions for clients around the world.
In addition to leading MediSpend, Michaeline mentors women in their tech careers and writes a blog for entrepreneurs and life science executives on topics, such as managing the growth of a SaaS company and how to improve work, life, balance.
You can follow Michaeline on Twitter: @mmispresident and connect with Michaeline via her blog at michaelinedaboul.com.


Medicines for Europe

Anna van Nieuwenhuizen

Director of Divisional Strategy - Sandoz

Anna van Nieuwenhuizen is a Director in the global strategy function at Sandoz. Prior to joining Sandoz, she was a consultant at McKinsey & Company and later served in two global public health organizations: GAVI, the Global Alliance for Vaccines and the Global Fund to Fight AIDS, TB and Malaria. She holds undergraduate degrees in International Relations from the University of Pisa and the Sant’Anna School of Advanced studies and a Masters in International Law from the Graduate Institute of International and Development Studies in Geneva.


Medicines for Europe

John Peter Mary Wubbe

Secretary General - DHE / EPPOSI II / EuDiPPA / ICPEU

John Peter Mary Wubbe is a healthcare professional, have studied MSc European Public Health, specializing in Governance. Mr. Wubbe has created EuDiPPA to improve data source quality assessment through blockchain technology as fuel to put Europe in the lead of the 2. Quantum revolution thanks to the GDPR governance. Mr Wubbe expertise lies in Genomics-Robotics-Informatics-Biometrics (GRIBs) abstraction of Phenotype and Genotype Datasets. He is deeply knowledgeable in the primary/secondary health care sectors. Mr. Wubbe sees Digital Health as a key area in health and care, prompting him to start DocSWISS organization. Mr. Wubbe had multiple organ transplants and his experience as a patient made him passionate about peer-patient involvement within multi stakeholder organizations.
Due to his expertise Mr. Wubbe chose to work at the European Patients Platform of Science and Industry / Digital Health Europe is a multi-stakeholder organization performing Rapid Health Technology Assessments and Health Impact Assessments. EPPOSI II / DHE includes consumer-patients (EuDiPPA) in its decision-making process. Mr. Wubbe sees the importance of including highly literate patient-citizens, as well as redefining disease diagnosis, which would add levels of ‘experienced frailty’, evaluating quality of life (WHODAS 2.0) of a citizen-patient as base for reimbursement. (Health records management, clinical trials reporting,. Throughout his work and educational experience he realized that the public health system would collapse unless the current paradigm changes and those changes are implemented.


Medicines for Europe

Frederik Van Remoortel

Lawyer - Crowell & Moring

Frederik Van Remoortel is a senior counsel in the Brussels office of the law firm Crowell & Moring and has been admitted at the Brussels bar since 1998. Frederik focuses on corporate, commercial, data protection, and labor & employment law. A substantial part of Frederik's work consists of the drafting and negotiation of a wide variety of complex agreements in the pharmaceutical and the telecommunications sector, such as shareholders agreements, asset transfer agreements, licensing and distribution agreements, agency agreements, co-operation agreements, software and cloud computing contracts. It is in that capacity that he also assisted in contract drafting and negotiations related to the introduction of the Falsified Medicines Directive and the related Delegated Act. Frederik also advises on Belgian and EU data protection legislation and is a Certified Information Privacy Professional/Europe (CIPP/E) and was a member of the IAPP European Advisory Board 2015-2016. Frederik is a qualified lawyer in Belgium and obtained his law degree from the Universities of Namur and Leuven. He obtained a postgraduate degree in tax law from the University of Leuven. He was a substitute judge at the Brussels Commercial Court (2010 - 2015).


Medicines for Europe

Dilip G Shah

Secretary General - IPA

Mr. Dilip G. Shah graduated from the premier business school in India, the Indian Institute of Management (IIM), Ahmedabad. He has 50 years of varied experience in the pharmaceutical industry. He has addressed several WTO workshops on TRIPS, WIPO seminars on IPRs and Public Health, WHO meetings on Access to Medicines and several other international meetings and conferences. He was a Member of the official Indian Delegation to WTO Ministerial Conference at Cancun. He also appeared before the U.S. International Trade Commission (USITC) and testified in Investigation No.332-543 Hearing in Washington DC in 2014. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Member of the Expert Review Committee of Access to Medicine (ATM) Index (www.atmindex.org); Member of the CPhI International Advisory Board; Member of the Board of Advisors of Pharmabiz.com (Weekly); and Member of Task Forces and Expert Groups constituted by the Government of India for accelerating growth of the Indian pharmaceutical industry. He was Chair of the International Generic Pharma- ceutical Alliance (IGPA) for two terms (2005-07) and (2010-11). Mr. Shah is an independent director on the Boards of Fresenius Kabi Oncology Ltd, Anuh Pharma Ltd, Shaily Engineering Plastics Ltd and CEO of Vision Consulting Group (www.vision-india.com), a firm specialized in strategic planning. Before starting Vision in 1997, he was a Member of the Board of Directors of Pfizer-India for whom he worked for 30 years.


Medicines for Europe

Ana-Eva Ampélas

Head of Unit for Medical Products: Quality, Safety, Innovation in Unit B4 - DG SANTE, European Commission

Anna-Eva Ampelas is Head of Unit for Medical Products: quality, safety, innovation in Unit B4 in DG SANTE, European Commission. In this capacity, she is managing files on medicinal products (falsified medicines, clinical trials, shortages, GMP etc); Health Technology Assessments (HTA) and substances of human origin (blood, tissues and cells, organs). She has more than ten years of experience working on health policy and legislation in the European Commission. Before joining the Unit for Medical Products, Anna-Eva was heading the unit dealing with tobacco control and global health. She was Health Counsellor at the Permanent Representation of Sweden 2002-2006 before joining the European Commission. Anna-Eva has a Master of Laws from Uppsala University.


Medicines for Europe

Ulrike Kreysa

Senior Vice President Healthcare - GS1 Healthcare

Ulrike is responsible for the Healthcare sector at the GS1 Global Office and works with her local colleagues in 112 countries to develop and implement GS1 standards in the healthcare industry. Worldwide patient safety and supply chain efficiencies will be enhanced globally through standards for AIDC (Automatic Identification and Data Capture), global data synchronisation and traceability. Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, GPO’s, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations.


Medicines for Europe

Craig Stobie

Director Global Sector Management - Domino

Craig Stobie has worked for Domino Printing Sciences for over 22 years in technical, operations, service and commercial roles. A graduate chemist and physicist with further qualifications in quality and safety assessment, Craig has a broad view of the pressures facing industry and how Domino can help companies overcome the wide range of current and emerging challenges they face. Craig leads a global team that is focused on several sectors. The team includes subject matter experts, thought leaders and technical specialists operating in sectors including Life Sciences, Tobacco, Beverage, Food and Industrial products. Prior to joining Domino, Craig worked in refining and manufacturing environments in the speciality chemicals sector.


Medicines for Europe

Andreas Walter

Director General - EMVO

After his studies of Administration Sciences at the University of Constance in Germany, Andreas M. Walter joined EFPIA, the European Federation of the researched-based pharmaceutical industry, in September 1993 as Executive for Administration and Finance. From 2011 onwards, he was responsible as Project Director to ensure that EFPIA members can comply with the safety features requirements of the Falsified Medicines Directive in the most effective way, i.e. by setting up of a stakeholder-governed pan-European verification model (EMVS). After the incorporation of the European Medicines Verification Organisation (EMVO) in February 2015, he also headed the organisation ad interim in order to manage the European hub that will connect to a series of national data repositories serving as the platform to allow the verification of authenticity of medicines anywhere in the supply chain within the EU/EEA. On 1st April 2016, he was appointed as General Manager of EMVO representing now definitely the organisation.


Medicines for Europe

Victor Lino Mendonça

Head of Policy and Market Access Europe - Mylan

Victor Lino Mendonça is the European Head of Policy & Market Access at Mylan and Board member of Medicines for Europe. Formerly he was the Head of Pharmaceutical Policy and Health Economics at the EGA – European Generic medicines Association. Before EGA he was also Advisor to the Executive Board of Infarmed - The Portuguese National Authority of Medicines and Health Products and Advisor to the Portuguese Health Secretary of State. Victor also worked as Product Manager at Boehringer Ingelheim Portugal and in the fast moving consumer goods area.


Medicines for Europe

Denis Dambois

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs - European Commission

After earning a M.Sc. in electromechanical engineering from the Brussels University (ULB) in 1987, Denis was hired as a researcher in power electronics by Philips, for which he worked both in Belgium and in Germany.
In 1991 he joined the patent department of Solvay s.a., a multinational chemical company. During that period he trained in intellectual property at CEIPI (Strasbourg) and qualified as a European Patent Attorney. He also graduated from the Executive Master in Management of the Solvay Business School (CEPAC-ULB).
In 1999 Denis was hired by the Directorate-General for Research of the European Commission, where he was responsible for R&D-related intellectual property and technology transfer issues, including the development of the IPR provisions for the 7th Framework Programme.
In 2008, Denis moved to DG Trade, and more specifically to the unit responsible for international IPR issues, where for five years he was responsible for IPR negotiations with several third countries.
From 2013 to 2016 Denis was heading the Research and Innovation Section of the Delegation of the European Union to India (Delhi), where he fostered EU-India research collaborations, and also handled IPR issues.
After reintegrating DG Research & Innovation in Brussels for about a year, in November 2017 Denis joined the IPR unit of DG GROW (‘Intellectual Property and Fight against Counterfeiting’), which is the main unit of the Commission responsible for IPR policy, where he is working on patent and other issues.


Medicines for Europe

Umberto Comberiati

Head of Marketing Europe - Teva Pharmaceuticals and Chair Value Added Medicines Sector Group

Chairman of Value Added Medicines Group. Working at Teva Pharmaceuticals Europe, head of Marketing Europe, before which he was responsible for commercial strategy and operations. Previously experience in Pricing & Reimbursement at country and at European level. Started his career as a consultant working with major pharmaceutical corporations, focusing on pricing and commercialization strategy. Background in pharmaceutical chemistry and translational medicine plus MBA.


Medicines for Europe

Aurelio Arias

Senior Consultant, European Thought Leadership - IQVIA

Aurelio is a Senior Consultant in the Thought Leadership team at IQVIA, a market leader in healthcare data, clinical trials and consulting. IQVIA is focused on supporting pharmaceutical and health organisations with real world evidence, market insights, and consultancy. Aurelio generates thought leadership insights with a view to spark high-level discourse on key pharma issues such as drug pricing, market access, and Brexit. He also advises executives on global pharma strategy where he takes a view on future market dynamics including geographical competitiveness, therapy growth areas, rare diseases, and digital technologies. Prior to Iqvia, Aurelio has advised blue chip companies on market access and M&A strategy in both Life Sciences and Financial Services while working for LEK and Accenture. He has worked in R&D for Pfizer and GlaxoSmithKline while completing a Chemistry degree at Imperial College London.


Medicines for Europe

Rebecca Coady

Associate Principal - IQVIA Consulting Services

• Rebecca has +7 years experience in pharmaceutical consulting
• She specialises in optimising pricing and market access (PMA) in evolving payer environments using her in-depth knowledge of global PMA systems and expertise in qualitative and quantitative research methodologies
• Her work has addressed a variety of pharmaceutical industry issues including loss of exclusivity risk mitigation, launch readiness, and due diligence, and has covered a broad a range of therapy areas including inflammation, infection, diabetes, and oncology
• Rebecca holds a PhD in Biochemistry and MRes in Structural Molecular Biology from Imperial College London


Medicines for Europe

Mariano Votta

Director – Active Citizenship Network and Responsible for EU Affairs - Italian NGO Cittadinanzattiva

Public affairs professional and journalist, is the Director of Active Citizenship Network (ACN), the international branch of the Italian NGO Cittadinanzattiva, where he is responsible for European Affairs. Since 2013, he has been actively involved as ACN stepped up its advocacy activities at the European Institutions, which in 2015 led to the opening of a representative office in Brussels and - above all - to the launch of the MEP Interest Group “European Patients' Rights & Cross-Border Healthcare”, promoted with the endorsement of almost 100 organizations across Europe. Furthermore, in 2016, Mariano won the Efhre International University Excellence Awards on patients’ rights. Passionate about healthcare and consumer issues, he has more than 17 years of experience in the field of advocacy, stakeholder engagement, European projects, communication and civic information.
Mariano Votta officially represents ACN abroad, with the European Commission DG Health, DG Consumers, DG Move, DG Migration and Home Affairs and with all the other stakeholders. He is also in the Board/Executive Committee of Pain Alliance Europe, Societal Impact of Pain and Health First Europe.
Mariano Votta holds a MSc in Political Science and two post-graduate Masters in European Public Relations and in Corporate Social Responsibility.


Medicines for Europe

Kenneth V. Phelps

President and CEO - Camargo Pharmaceutical Services

In 2003, Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in Cincinnati with Dr. Ruth Stevens (chief scientific officer and executive vice president). It is no coincidence that 2003 was also the year the US FDA introduced guidelines governing the 505(b)(2) approval pathway. From the beginning, Camargo has focused solely on being the industry’s 505(b)(2) development partner of choice. In 2011, Camargo opened a second location in Durham, N.C., in the Research Triangle Park. Today, Camargo partners with companies in more than 25 countries worldwide and has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA — Camargo has led more than 1100 Agency meetings and is the industry authority in 505(b)(2). Before founding Camargo, Phelps’ diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control, and processing technology, with an assignment based in Milan, Italy. Today, as a thought leader in the shifting landscape of drug development and emergent pathways around the globe, Phelps addresses the financial challenges of pharmaceutical companies caused by the generics cliff and routinely presents on the topic at events worldwide. He has recently been invited to speak on the topic at DCAT and other international conferences on how companies can realize the opportunities of 505(b)(2) and expanded marketability. Phelps is also a founding member of the 505(b)(2) Forum, an assembly of product developers and service providers interested in improving best practices across the 505(b)(2) development process. He publishes articles frequently and is a featured interviewee in publications, videos and podcasts concerning new, repositioned, and differentiated product development around the globe. You can access these resources by following the Camargo Blog where Phelps and his team elaborate on current market trends.


Medicines for Europe

Klara Marton MD, MBA

Business Development Director - Egis Pharmaceuticals PLC

Klara Marton is the Business Development Director of Egis Pharmaceuticals PLC /owned by Servier/, one of the leading generic pharmaceutical companies in the CEE and CIS regions with activities extending to every field of pharmaceutical production from research and development, through active ingredient and finished production to sales and marketing. Her priorities at Egis is leading international strategic business development, defining mid- and long-term pipeline consists of value-added products, commodity generics, biosimilar products and related digital solutions. She is also responsible for licensing-in and strategic partnerships. Under her leadership the early involvement of customer insight in business development, especially patient insight has been established. Before Egis she worked as a Business Unit Director with responsibilities ranging from marketing, sales to market access covering several therapeutic fields at GSK, sanofi-aventis in Budapest. Earlier she held commercial positions at multinational innovative companies in Hungary and consulting company in the US. She is a Medical Doctor holding a Master of Business Administration degree.


Medicines for Europe

Michael Soldan

Senior Vice President Head of Biosimilars - Fresenius Kabi

Michael Soldan Ph.D. is heading the Business Unit Biosimilars for Fresenius Kabi. Before joining Fresenius Kabi he was heading the Biosimilar Business for Merck KgaA and joined the area of biosimilars first at Boehringer Ingelheim as a member of the Boehringer Ingelheim Biosimilar Executive team heading Regulatory Affairs /Drug Safety. Michael Soldan served in increasingly senior roles within the Medical and Regulatory field in the biopharmaceutical industry at Aventis Behring, Novartis Vaccines, Grünenthal and Biotest AG. Dr. Soldan holds a Ph.D. in pharmacology and has graduated in theoretical medicine and pharmacy.


Medicines for Europe

Emer Cooke

Head of Regulation of Medicines and other Health Technologies - World Health Organization (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 Safety), 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.


Medicines for Europe

Zoltán Kaló

Professor of Health Economics - Eötvös Loránd University (ELTE), Budapest, Hungary

Zoltán Kaló is a Professor of Health Economics and the co-director of an MSc in Health Policy, Planning and Financing postgraduate program at Eötvös Loránd University (ELTE) in Budapest. Dr. Kaló is also the founder and leader of Syreon Research Institute, an international research corporation specializing in health policy, health economic modeling and technology assessment. He has 20 years of international experience in academia and industry, specializing in health systems design, HTA implementation, health economics and outcomes research, economic modeling, patient access and pricing policies of healthcare technologies. Dr. Kaló serves as a policy advisor to public decision-makers and global health care corporations. He is a Scientific Committee member of the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). He was a Director of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) between 2012-2014, and the Chair of ISPOR Central and Eastern European Network Executive Committee between 2013-2015.


Medicines for Europe

Markus Sieger

CEO - Polpharma Group

He holds a degree in Economics and has been working in emerging industries, such as information technology in Switzerland and United States and in emerging markets such as Singapore, Poland and CIS countries. Since the mid-nineties he has successfully managed complex and strategic transactions in and outside of Poland in the pharmaceutical industry, FMCG and media and has been a member of the supervisory board of several of those companies. He has been associated with Polpharma Group since 2000 and was appointed President of the Management Board in June 2016. In 2018, he joined the Executive Committee of Medicines for Europe.


Medicines for Europe

Erik Bogsch

Head R&D & Manufacturing within the Biotechnology Business Unit - Gedeon Richter Plc

Dr. Erik Bogsch is Head of R&D & Manufacturing within the Biotechnology Business Unit at Gedeon Richter Plc. Erik is responsible for leading R&D efforts in the development of GR's biotechnology pipeline.
Gedeon Richter Plc. is engaged in the development and manufacture of both bacterial cell fermentation based and mammalian cell fermentation based biosimilar products. GR has R&D, analytical & manufacturing capabilities in multiple locations in Hungary & Germany.
Dr. Bogsch, has a Natural Sciences degree from the University of Cambridge and a PhD in cell biology from the University of Warwick. Following a brief postdoctoral academic research career, he worked in the food industry for many years in R&D, Quality & Manufacturing roles in the UK, Hungary & Germany. He joined Gedeon Richter Plc. in 2012, as commissioning lead for GR's biotechnology factory in Debrecen, Hungary, before moving into R&D in 2014 and into his current role in 2018.


Medicines for Europe

Christine Simmon

Senior Vice President of Policy and Strategic Alliances - aam

Christine Simmon joined the Association for Accessible Medicines (formerly GPhA) in 2012 as the Senior Vice President of Policy & Strategic Alliances, and most recently was named Executive Director of AAM’s Biosimilars Council, founded in 2015.
In her current role, Christine is responsible for leading policy development and issues management for AAM, directing the Biosimilars Council, and building relationships with strategic partners in the health care sector, including patient advocacy groups.


Medicines for Europe

Aidan Fry

Editor - Generics Bulletin, Informa

Aidan Fry has been the editor of Generics bulletin, the business newsletter for the generic, biosimilar and value-added medicines industries, since August 2008. He had previously been the deputy editor of Generics bulletin since the newsletter’s inception in 2003, having also spent five years working on its sister publication, OTC bulletin, which also now forms part of the Informa group. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.


Medicines for Europe

Erin Federman

Head of Biologics (Europe) - Mylan and Chair of the Market Access Committee - Biosimilar Medicines Group for Medicines for Europe

Erin Federman is 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.


Medicines for Europe

Dr. Christiane Hanke-Harloff

Head of the Biotechnology Business Unit at Gedeon Richter

Christiane Hanke-Harloff is heading the Biotechnology Business Unit since July 2016. She has 20 years of biopharmaceutical industry experience, joining Gedeon Richter from Santen Pharmaceuticals where she was heading the European and Russian commercial departments. Previously Christiane Hanke-Harloff was as the Head of Europe and CCO responsible for the European operations of The Medicines Company. She gained significant experience in the Biotech field at VP level at Jerini AG as well as Micromet AG. Before that Christiane built the German and Russian operations for Gilead Sciences at Managing Director level. Christiane has proficiency in a broad range of therapeutic and pharmaceutical fields and in managing the entire pharmaceutical value chain. She holds a PhD degree in Molecular Biology and graduated at the Ludwigs-Maximilians University in Munich, Germany.


Medicines for Europe

Robert Andrew Johnstone

Patient Advocate - International Foundation for Integrated Care (IFIC), European Forum for Good Clinical Practice (EFGCP) & Health Quality Improvement Partnership (HQIP)

Chair: Access Matters, Midstream, Board Member: European Forum for Good Clinical Practice (EFGCP), Health Quality Improvement Partnership (HQIP), International Foundation for Integrated Care (IFIC). Having had Rheumatoid Arthritis for nearly 60 years from the age of three, I have a wealth of experience as a user of health services. Since 1990 I have voluntarily represented people with disabilities & chronic conditions locally, nationally & internationally “The people have the right & duty to participate individually & collectively in the planning & implementation of their healthcare” Alma Ata Declaration – Principle IV, 1978 World Health Organisation.


Medicines for Europe

Jamie Wilkinson

Director of Professional Affairs - PGEU

Mr Wilkinson commenced his role as Pharmaceuticals and Professional Affairs Adviser of the PGEU in January 2014 before becoming Director of Professional Affairs in April 2015. The Pharmaceutical Group of the European Union (PGEU) is the European Association representing community pharmacists in 32 European countries. A pharmacist by training, he has practice experience in the community pharmacy sector and academia in the UK, in addition to experience in health policy, professional affairs and advocacy. He was educated at the Universities of Kingston & St Georges London with an MPharm, Master of Pharmacy, an MSc in Social Research Methods from the University of Sussex and an MPH, Master of Public Health from the University of Sheffield. He is a Member of the Royal Pharmaceutical Society UK, a Fellow of the Royal Society for Public Health UK and a Practitioner Member of the Faculty of Public Health UK.


Medicines for Europe

James Burt

Executive Vice President, Europe & MENA - Accord Healthcare

James has over 20 years plus experience in the pharmaceutical industry, predominately in the generics and biosimilar sector. James’ significant pharmaceutical experience includes UK, Europe and Global management roles in commercial, business development and general management positions. Joining Accord eight years ago from Actavis, James leads Accord’s operations in the EMENA territories, with a particular focus on developing and delivering Accord’s strategy to improve access to high quality affordable medicines within the region. James holds a Bachelor's Degree of Chemical and Biochemical Engineering and a Doctor of Philosophy degree in Chemical Engineering, both from the University of Birmingham.


Medicines for Europe

Bernd Grabner

Director - Jacoby GM Pharma GmbH and Vice-President - PHAGO

Bernd Grabner was born in 1975 and started his studies of law and business economics at University of Linz in 1993. Already during his studies, he started working in the family owned wholesaling company in 1999, being in charge for an alternating range of operational tasks. Bernd Grabner became a member of the board of GM Pharma in 2003 and after the mergers with two other Austrian wholesalers now is a member of the board of Jacoby GM Pharma. He is therein responsible for the divisions supplier relation, services and new business activities.
Bernd Grabner is vice president of the Austrian Association of Full Line Wholesalers PHAGO and member of the Board of the European Healthcare Distribution Association GIRP.