Medicines for Europe Medicines for Europe

CHAIRPERSONS AND SPEAKERS

Medicines for Europe

Marc-Alexander Mahl

President, Medicines for Europe and Executive Vice President, Business Unit Generics and Complex Formulations ELAMA & Asia-Pacific Pharmaceuticals and Devices Division, Fresenius Kabi Deutschland

Marc-Alexander Mahl is heading since 2011 the global Business Unit Generics and Complex Formulations ELAMA & ASIA PACIFIC 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

Marcie McClintic Coates

Head of Global Policy, Mylan

Marcie McClintic Coates is head of global policy at Mylan where she oversees Mylan’s health and public policy efforts in the various markets Mylan serves around the world.
During her 12 years at Mylan, Marcie has held several roles of increasing responsibility including head of global regulatory affairs, vice president and chief of staff to Mylan’s CEO and global regulatory counsel in the legal department.
Among several policy efforts to expand patient access to medicine, she played a leading role in negotiating the Generic Drug User Fee Act of 2012 and 2017 as well as the FDA Safety and Innovation Act of 2012 to hold all prescription drugs to the same quality standards. Marcie serves on the Board of Directors for the U.S. generic drug and biosimilar industry association AAM.

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 #3 in the most recent “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

Per Troein

Vice President Strategic Partners, IQVIA

Per Troein has been with IQVIA for 21 years and is responsible for the relationship with suppliers and associations. The dispensing and distribution environment is very dynamic. Pricing of pharmaceutical is as complicated. He also have deep insight around generics and biosimilars and how they are handled in different markets. One of IQVIA’s priorities is to have the best understanding of those dynamics to secure the most appropriate data, to be the best partner with the different data partners, and to be able to support the industry and also when appropriate governments. He is a well know speaker in the field of distribution trends and pricing and is very active in consulting projects in the area. Prior to joining IMS, Per worked 13 years for Pharmacia in US and Europe. His last 6 years were spent in strategic development as a VP including several major mergers and acquisitions. He holds an MSc in engineering from Lund’s Institute of Technology and an MBA from INSEAD.

Medicines for Europe

Nick Haggar

Chief Executive Officer, Zentiva

Nick Haggar holds the position of the CEO for Zentiva. He joined in February this year from InsudPharma where he was CEO from 2016-2019.
Nick has been in the pharmaceutical and healthcare industry for more than 30 years. Prior to Insud he was Region Head responsible for Western Europe Middle East and Africa at Sandoz (Novartis). Whilst at Sandoz, Nick also led the Global Respiratory Franchise and co-chaired the Novartis Access to Medicines committee. He was President of Medicines for Europe (former EGA) during 2014-2015.
Nick has both a strong commercial track record with leadership positions in Ranbaxy and GlaxoSmithKline and deep technical know-how having commenced his career in technical operations at Baxter Healthcare. He holds an MBA from Cranfield Business School and a BSc in Industrial and Manufacturing Engineering.

Medicines for Europe

Karan Ambwani

Head of Commercial Strategy & Alliances, Teva

Karan is responsible for Teva’s commercial strategy & alliances for Generics, OTC & Branded medicines across more than 60 countries. Before joining Teva, Karan worked with Novartis and with various management consulting firms.
He has more than 14 years of experience in Corporate strategy, Business Performance Improvement, M&A and innovation in Healthcare and brings significant international experience having lived & worked in India, Singapore, Spain & the Netherlands.
Karan is also an author & speaker on innovation and business model disruptions in healthcare delivery. He holds an MBA with honors from IE Business School and Bachelors in Technology from University of Delhi.

Medicines for Europe

Mariângela Simão

Assistant Director General for Drug Access, Vaccines and Pharmaceuticals, WHO

Mariângela Simão joined WHO in November 2017, as part of Dr Tedros Adhanom Ghebreyesus leadership team.
She previously worked for UNAIDS since September 2010 and prior to that, she worked for the Ministry of Health in Brazil as the Director of the Sexually Transmitted Diseases, HIV/ AIDS and Viral Hepatitis department.
She worked in the Brazilian public health system since 1982, from the primary health care level to a series of managerial positions throughout the years. As a public health professional, at municipal, state and national levels, she played an active role in the decentralization of the national health system, acquiring an extensive experience in health system strengthening. She has also served on the boards of a number of organizations and government committees related to public health and HIV.
Heading the National Sexually Transmitted Diseases/HIV/AIDS Department (including Viral Hepatitis from 2009), she had the responsibility of overseeing and implementing the national Sexually Transmitted Diseases/AIDS/Viral Hepatitis policies, including universal and free of charge access to treatment, care and comprehensive prevention programs.
Dr. Simão attended medical school in Brazil, with degrees in Paediatrics and Public Health, and a MSc in Mother and Child Health in the UK.

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

Tobias Dolle

Associate, FratiniVergano - European Lawyers

Tobias Dolle is an Associate at FratiniVergano. He holds a PhD in the field of International Trade Law and dispute settlement from the University of Potsdam, Germany. He is a qualified lawyer in Germany, admitted to the Hamburg Bar, with an additional degree in French Public Law. Tobias has advised and represented governments, businesses and trade associations with respect to international trade and agro-food matters and has significant experience in the field of international trade law and policy, as well as EU regulatory affairs in highly regulated sectors (e.g., food, agriculture, pharmaceuticals, energy, tobacco, chemicals, and consumer protection law). Prior to joining FratiniVergano in 2016, Tobias held positions at the German Federal Ministry of Food, Agriculture and Consumer Protection, the German Federal Ministry of Economics and Energy, a Berlin-based law firm specialising in public law, and at the German Argentinean Chamber of Industry and Commerce in Buenos Aires, Argentina.

Medicines for Europe

Claire Hempshall

Senior Principal, IQVIA

Claire has more than a decade of experience in commercial and market access strategy gathered during her time at IMS Consulting Group, a-connect, PAREXEL Access Consulting and, most recently, IQVIA Consulting Services. Her focus is on applying strategy consulting methodologies to market access issues with the aim of addressing challenging, multi-dimensional problems in an innovative way. Her experience spans branded, generic and biosimilar medicines, across all major markets. Claire holds a BSc. (Hons) Physiology from the University of Nottingham.

Medicines for Europe

David Jauch

Director Government Relations, Fresenius Kabi

David M. Jauch is responsible for Government Relations globally within the Business Unit Generic Drugs of Fresenius Kabi. He is the Chair 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) and AAM (Association for Accessible Medicines). David’s 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

Warwick Smith

Director General, British Generic Manufacturers Association (BGMA) and British Biosimilars Association (BBA)

Warwick Smith is the Director-General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA). The BBA is a sector group of the BGMA. Warwick is also a member of the Board and Executive of Medicines for Europe. The BGMA is the designated industry body for consultation by the UK authorities on pricing and reimbursement. Warwick is a frequent commentator in the UK on the appropriate use of generic and biosimilar medicines and their benefits for patient access.

Medicines for Europe

Jonathan Kimball

Vice President of Trade and International Affairs, Association for Accessible Medicines (AAM)

Jonathan Kimball is the Vice President of Trade and International Affairs at the Association for Accessible Medicines (AAM). He serves as senior strategist and advocate leading the international trade strategy of AAM and represents the association and its member companies’ interests before Congress and the Administration. Jonathan has more than 20 years of trade policy and international advocacy experience, having led Burson Cohn & Wolfe’s U.S. healthcare policy offering, managed advocacy efforts in Europe, the Middle East, Africa, and the Americas for the Pharmaceutical Research and Manufactures of America, and was Director for Central and Eastern Europe at the U.S. Department of Commerce.

Medicines for Europe

Suzette Kox

Secretary General, International Generic and Biosimilar medicines Association (IGBA)

Suzette Kox has been nominated Secretary General of the International Generic and Biosimilar medicines Association, after 17 years in various functions at Medicines for Europe.
Suzette is very committed to support IGBA, which is at the forefront of preserving sustainable competition within the generic and biosimilar medicines industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality medicines.

Medicines for Europe

Nicholas Cappuccino

Chair of the IGBA Science Committee and IGBA Member of the ICH Management Committee

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 and Management Committee. 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

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, FDA

Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses.
He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering. After his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 15 years ago, he was an Assistant Professor of Chemical Engineering at the University of Michigan.

Medicines for Europe

Deus Mubangizi

Coordinator Prequalification Team (PQT) Regulation of Medicines and other Health Technologies (RHT), World Health Organization (WHO)

Mr. Mubangizi is a senior regulator with experiences in the regulation of pharmaceutical products, Vaccines, Vector Control Products and In-Vitro Diagnostics. He is currently the Coordinator of Prequalification Team (PQT) within the unit of Regulation of Medicines and other Health Technologies (RHT) in the Department of Essential Medicines and Health Products (EMP) of World Health Organization (WHO), based in Geneva, Switzerland. Prior to joining the World Health Organization (WHO) in 2008, Mr. Mubangizi had served as the Chief Inspector of Drugs (1996 - 2008) where he was one of the founder staff of Uganda’s national medicines regulatory agency, National Drug Authority (NDA), in 1994. In 1995, he worked with consultants appointed by WHO to establish a drug registration system for Uganda and subsequently coordinated a team that established the GMP inspection system for local and foreign manufacturing facilities marketing their products in Uganda. He headed the Inspectorate and Licensing Department of NDA Uganda from 1996 to March 2008. He participated in the initiation of medicine regulation harmonization in East Africa and Africa in General. In 2004 he joined a team of external dossier assessors for WHO Prequalification where he was shortly promoted to the level of senior assessor. He has, on behalf of his country Uganda and for WHO Medicines Prequalification Programme, inspected more than 200 sites in African, Europe, Asia, North America and South America for the manufacture of Finished Pharmaceutical Products, Active Pharmaceutical Ingredients, Vaccines and In-vitro diagnostics; national quality control laboratories; and Clinical Research Organizations where bio-equivalence studies are conducted. He has since 2016 been the Coordinator of the WHO Prequalification Team responsible for medicines, vaccines, in-vitro diagnostics, vector control products, male circumcision devices, immunization equipment and cold chain equipment. The team under his leadership has a launched a pilot prequalification of biotherapeutic products including biosimilars.

Medicines for Europe

Frances (Fran) M. Zipp

President & CEO, Lachman Consultant Services Inc.

Frances (Fran) M. Zipp is President & CEO of Lachman Consultant Services, Inc. Lachman Consultants provides compliance, regulatory and technical consulting services to the global pharmaceutical and related industries and Ms. Zipp delivers the strategic guidance and direction toward implementation of effective solutions to client needs. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements. Ms. Zipp has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval. She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, Due Diligence evaluations (facilities; products; technologies), and more.

Medicines for Europe

Matthew Scherer

International Policy Advisor, Europe Office, U.S. Mission to the European Union, U.S. Food and Drug Administration

Matthew Scherer is the Assistant Health Attaché and International Program and Policy Analyst for United States Food and Drug Administration’s Europe Office. In this role, he works to develop relationships and further FDA’s engagement with European regulatory counterparts and other stakeholders in the interest of advancing FDA’s public health mission. Much of his time is devoted to projects in support of the FDA-EU Mutual Recognition Agreement for pharmaceutical GMP Inspections, but his current portfolio covers all FDA regulated commodities.
He joined the FDA in 2007 in the Center for Drug Evaluation and Research's Division of Gastroenterology and Inborn Errors Products where he managed the review of new drug applications and worked with external stakeholders to facilitate new drug development.
Prior to joining the FDA, he provided market research and competitive intelligence consulting services for biotechnology, pharmaceutical and private equity clients. Matthew has a degree in Molecular Biology from the University of Wisconsin and a Master’s in Business Administration from Georgetown University.

Medicines for Europe

Aidan Fry

Executive Editor, Generics Bulletin - Informa

Aidan Fry has been the editor of Generics Bulletin, Informa’s 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. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.

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 U.S. Government and Legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, 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.

Medicines for Europe

Sudarshan Jain

Secretary General, Indian Pharmaceutical Alliance

Sudarshan has a strong passion for healthcare and the education sector. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Senior Advisor - Apax Partners and Board member of multiple organizations. He has served in several leadership positions for over 40 years in Healthcare industry (Lupin, Johnson & Johnson, Piramal, Abbott) and was formerly the Managing Director at Abbott Healthcare Solutions.
His current Board engagements include Abbott India, Healthium Limited (Apax portfolio company), Zandu Chemicals Limited, PharmEasy, Indian Institute of Health Management Research – Jaipur, Indian Education Society (IES), Advisory Board of Narsee Monjee University, Mumbai (NMIMS). He is the Visiting Faculty at Indian Institute of Management (IIM), Ahmedabad. He has contributed in shaping the healthcare policy and improving access to healthcare in India.
Sudarshan is an Alumnus of St. Stephens College, Delhi University and Indian Institute of Management (IIM), Ahmedabad.

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

Michele Uda

Director General, Assogenerici and Chair of the Generic Market Access Committee, Medicines for Europe

Graduated in Political Science from the International University LUISS Guido Carli in Rome, with a specialization in International Economics, after an initial experience in one of the largest Italian trade unions, he has successfully completed a full time MBA in International Business and Economics at "Mib School of Management" of Trieste. He then continued his career in the retail consumer sector at Ferrero Italy as Assistant Brand Manager for the Italian multinational company's core business and, later, at Colgate Palmolive Italy as a market and industry sales analyst in the Household Care division. He stepped into the healthcare sector joining Johnson & Johnson Medical where he was responsible for direct management of sales and marketing for the breast care line in Italy’s central and southern regions. From march 2007 he joined Assogenerici, the Italian Generic and Biosimilar Medicines Association, as “Pharmaceutical Economics & Policy Affairs Manager”, assuming direct responsibility of the Centre for Economics and Policy Analysis of the association.
From April 2012 he has been appointed Director General of Assogenerici, keeping also the position as interim head of the Centre for Economics and Policy Analysis and the responsibility for international relations. Since 2014 is also managing IBG – Italian Biosimilars Group, the new industry body representing the biosimilar medicines industry within Assogenerici.
He is also member of the Executive Committee of Medicines for Europe (European Generic & Biosimilars Medicines Industry Association) as Chairman of the GMAC (Generici Market Access Committee of Medicines for Europe).
Updated – April 2019

Medicines for Europe

Adele Paterson

Chief Executive Officer, International Health Partners

As CEO of International Health Partners, Adele brings a wealth of cross-sector partnership, CSR and public policy experience to enable access to medicines to some of the world’s most vulnerable communities. 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 International Health Partners to a product donations-plus model using best practice, in country partners and strategic alliances to create impactful long term initiatives. Last year, International Health Partners team of 10 delivered 4.4m treatments to 33 countries. Adele sits on the Board of PQMD (Partnership for Quality Medical Donations) and Integral disaster response alliance.

Medicines for Europe

James Burt

Executive Vice President Europe & MENA, Accord Healthcare Ltd

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 nine 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

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 and preventing antimicrobial resistance. 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. Deb’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. She is the current Chair of the Board of the FDA Alumni Association.

Medicines for Europe

Jerzy Starak

President of the Supervisory Board, Polpharma

Biography soon available.

Medicines for Europe

Markus W. Sieger

CEO and President of the Management Board, Polpharma Group

Markus has been working his whole career in emerging industries such as information technology and digital media in Switzerland, the United States and Poland and in emerging markets such as Singapore, Poland and CIS countries. Since the mid-nineties he has successfully managed complex and strategic transactions in the pharmaceutical industry, the FMCG and media sector and has been a member of the board of directors of many of those private and public companies. He has been actively involved with Polpharma Group since its privatization in the year 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

Krzysztof Kopeć

President of the Board, Polish Union of Employers in Pharmaceutical Industry (PZPPF)

Krzysztof Kopeć, the President of Polish Union of Employers in Pharmaceutical Industry (PZPPF) associating the biggest domestic pharmaceutical companies that guarantee drugs’ security in Poland and economic development of the country.
He is an expert in the area of drugs’ reimbursement, pharmacy and within the scope of the law.
He also was a member of the Economic Commission at the Ministry of Health. He was appointed by the Minister of Health to the first Economic Commission, where he acted as chairman and member of its Negotiating Teams. He took part in the biggest price negotiations in the past 20 years concerning all products included on the lists of reimbursements medicines in Poland.
He acted as a Head of the Reimbursement and Prices Unit in the Drug Policy and Pharmacy Department at the Ministry of Health. He worked as an Associate at Linklaters and at the Chief Sanitary Inspectorate.
He has an experience in European Union drug-related projects, including EU working groups on drugs.
He was a polish delegate in the group of Competent Authorities on Pricing and Reimbursement.
Krzysztof is a lecturer of Postgraduate Studies Medical Law, Bioethics and Medical Sociology, Faculty of Law and Administration at Warsaw University.

Medicines for Europe

Maciej Miłkowski

Deputy Minister of Health, Poland

Biography soon available.

Medicines for Europe

Stefan Hendriks

Global Head Biopharmaceuticals, Sandoz

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

Medicines for Europe

Gustaf Befrits

Coordinator Introduction of Biosimilars, Stockholm County Council, Sweden

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

Medicines for Europe

Marnie Peterson

Chief Executive Officer, Generic and Biosimilar Medicines Association (GBMA), Australia

Marnie Peterson was appointed as Chief Executive Officer of the Australian Generic and Biosimilar Medicines Association (GBMA) in March 2018. Marnie also leads GBMA Education – the educational arm of GBMA, established to manage the Australian Government’s Educational Grant for Biosimilar Medicines, which was awarded to GBMA in April 2018. The purpose of the Grant is to increase confidence in the use of biosimilar brands of biological medicines that are listed on the Pharmaceutical Benefits Scheme (PBS). Through the increased use of biosimilar medicines, the objective is to support a competitive market for biological medicines via peer-to-peer health communication activities.
With over 15 years in business management and marketing, Marnie’s pharmaceutical experience spans key executive roles in large generic pharma, company start-ups and business ownership. Managing commercial operations in each role, Marnie’s sales channel and marketing leadership extends across retail pharmacy, business development and hospital, including the delivery of end-to-end professional services programs for community pharmacy, corporate positioning, product development and go-to-market strategies.
Marnie has predominantly spent her career in the Australian generic pharmaceutical sector, having worked for a range of key players including Apotex, Aspen generics, Actavis (Allergan) and Dr Reddy’s Laboratories.

Medicines for Europe

Professor Rob Duncombe

Director of Pharmacy, The Christie NHS Foundation Trust and Director, The Christie Pharmacy Company, UK

Professor Rob Duncombe. Director of Pharmacy at The Christie NHS Foundation Trust in Manchester. The Christie is one of the largest cancer centres in Europe treating patients from across the UK. The hospital recently opened the first NHS proton beam centres in the UK, and is one of the first hospitals to offer CAR T therapy to patients. Professor Duncombe has a particular interest in medicines optimisation in cancer drugs, identifying ways to achieve the best value from the use of these medicines. In recent years prof Duncombe has been at the forefront of delivering dose-banded chemotherapy in the UK and the introduction of biosimilar medicines in cancer.

Medicines for Europe

Zorana Maravic

Director of Operations, Digestive Cancers Europe

Zorana Maravic is Director of Operations at Digestive Cancers Europe, previously EuropaColon, the first and only European digestive cancers patient umbrella organization. At her position, Zorana is responsible for the co-ordination and support of member groups, as well as establishing the relationship with new organisations in order to continue the network growth. As an experienced project manager, Zorana managed many of the project undertaken by The Organisation, such as the Survey on the Unmet Needs of Patients Living with Metastatic Colorectal Cancer (mCRC) which recruited more than 800 patients with the results disclosed in several publications that Zorana authored; organised several Masterclass events, educational annual meetings for partner groups; developed various awareness campaigns including a few European Colorectal Cancer Awareness Campaigns (ECCAM); participated in various projects organised by pharmaceutical industry and independent consortia; worked closely with Patient Advisory Committee (PAC) on production of various educational and materials to support patients. Zorana also acts as a public speaker.
From 2016 until 2018, Zorana served as a Board Member of EuropaColon.
Before working in the Not-For-Profit sector, Zorana worked for 10 years in the pharmaceutical industry, primarily in sales and marketing of innovative oncology drugs as well as oncology clinical trials.
Zorana holds a degree in molecular biology from the University of Belgrade, Serbia. In 2017, at the University of Sheffield, UK she gained an Executive MBA in Health Management.

Medicines for Europe

Dr Paul Cornes

Oncologist, Comparative Outcomes Group, UK

Paul Cornes is an Oncologist from Bristol, UK.
He is part of the steering group for the European School of Oncology Working Party on the Access to Innovation in Cancer Treatment. Paul was part of the team that developed and presented evidence to the Oncology Advisory drugs Committee of the FDA for the first successfully approved US biosimilar. He has been in the British Medical Journal’s “Round Table” group on Biosimilars as well as a faculty for the Drug Information Association Meeting on Biosimilars and has been on the panel for the EU Commission biosimilars meeting in Brussels and chair of the biosimilars programme for the World Cancer Congress for the UICC. In 2018 he wrote the book “Fast Facts: Biosimilars”.

Medicines for Europe

Arun Narayan

Head Global Portfolio, Mylan and Chairman of the Value Added Medicines Sector Group

Arun has a successful and diverse track record in fast growing, multinational pharmaceuticals companies, covering international expansion, portfolio strategy, M&A/licensing and operations; plus an entrepreneurial stint.

Medicines for Europe

Aurelio Arias

Senior Consultant, European Thought Leadership - IQVIA

Aurelio is a Senior Consultant in the European Thought Leadership team based in IQVIA's London office. His primary focus is on off-patent markets where he generates evidence-led insights with a view to spark high-level discourse in biosimilars, generics and value added medicines. He is considered a subject matter expert in these areas where he speaks at numerous conferences worldwide, presents to clients and engages in consulting projects in an advisory capacity. Prior to IQVIA, Aurelio has worked as a strategy consultant in both Life Sciences and Financial Services at 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

Sofia Romagosa Vilarnau

Junior Projects and Engagement Officer, European Federation of Allergy and Airways Diseases Patients' Associations (EFA)

Sofia is a Sociologist specialised in Public Health and she is currently working as a Junior Projects and Engagement Officer at the European Federation of Allergy and Airways Diseases Patients' Associations (EFA). She supports the implementation and management of EFA’s own projects and EFA’s activities and deliverables for various EU-funded research projects as well as she ensures the commitment of patients and EFA members at all levels within EFA. In 2017, she also worked at the Patients Advisory Council of the Catalan Health Department where she was involved in a research in methods for involving patients in the design, development and evaluation of health policies.

Medicines for Europe

Kenneth V. Phelps

President and Founder, 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

Francis Arickx

Head Directorate Reimbursement of Medicines and Pharmaceutical Policy, RIZIV-INAMI, Belgium

Francis Arickx is the head of the directorate Reimbursement of Medicines and Pharmaceutical Policy within the Health Care Department at the National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI) in Belgium where he manages the departments responsible for administrative and scientific assessment and appraisal of reimbursement claims for medicines, orphan drugs, medical nutrition. Francis Arickx is the former secretary general for the Commission for Reimbursement of Medicines and acts as representative/expert for the Institute and Belgium on a number of national and European platforms (NM CAPR, MEDEV, MoCA,..). He is one of the country coordinators for the BeNeLuxA Initiative (www.beneluxa.org). Francis graduated in pharmaceutical sciences from the University of Ghent, Belgium and teaches ‘Health Policy’ in the Pharmaceutical Sciences Department at the University of Antwerp.

Medicines for Europe

Carsten Brockmeyer

Chief Executive Officer, Formycon

Carsten Brockmeyer is the CEO of Formycon AG, Munich, a leading pure play developer of global quality biosimilar medicines. Formycon is currently focusing on the development of biosimilar medicines in ophthalmology and autoimmunity, and on innovative formulations and drug delivery devices. Formycon ranks number seven among the thousand fastest growing companies in Europe (Financial Times 2018) and has established a number of partnerships with leading pharmaceutical companies. Carsten has held senior management positions at Baxter, Hexal, and Sandoz/Novartis before he founded Brockmeyer Biopharma in 2010, a pharma and biotech consultancy, and helped to establish Formycon AG in 2012. His work in the field of biopharmaceutical and biosimilar medicines has been recognized with prestigious scientific awards.

Medicines for Europe

Francesco Balestrieri

Region Head Europe and Incoming ad interim CEO, Sandoz

Work history
2018 – present Region Head EUROPE
2015 – 2018 Region Head CEEMEA, Sandoz
2013 – 2015 Region Head CEE, Sandoz
2011 – 2013 Region Head APAC, Sandoz
2007 – 2011 Ciba Vision, President of Americas region (prior Alcon integration)
2003 – 2007 Novartis Consumer Health – Head of Marketing and Operations Europe and Cluster Head of Germany/Austria/Switzerland
1993 Joining Novartis – various roles in general management, marketing and finance, in the US, Germany, Switzerland and Italy
Higher education
Degree in Economics from the University of Venice

Medicines for Europe

ANNUAL MEDICINES FOR EUROPE AND IGBA CONFERENCE
SOFITEL WARSAW VICTORIA
12-14 JUNE 2019


Medicines for Europe

Marc-Alexander Mahl

President, Medicines for Europe and Executive Vice President, Business Unit Generics and Complex Formulations ELAMA & Asia-Pacific Pharmaceuticals and Devices Division, Fresenius Kabi Deutschland

Marc-Alexander Mahl is heading since 2011 the global Business Unit Generics and Complex Formulations ELAMA & ASIA PACIFIC 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

Marcie McClintic Coates

Head of Global Policy, Mylan

Marcie McClintic Coates is head of global policy at Mylan where she oversees Mylan’s health and public policy efforts in the various markets Mylan serves around the world.
During her 12 years at Mylan, Marcie has held several roles of increasing responsibility including head of global regulatory affairs, vice president and chief of staff to Mylan’s CEO and global regulatory counsel in the legal department.
Among several policy efforts to expand patient access to medicine, she played a leading role in negotiating the Generic Drug User Fee Act of 2012 and 2017 as well as the FDA Safety and Innovation Act of 2012 to hold all prescription drugs to the same quality standards. Marcie serves on the Board of Directors for the U.S. generic drug and biosimilar industry association AAM.


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 #3 in the most recent “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

Per Troein

Vice President Strategic Partners, IQVIA

Per Troein has been with IQVIA for 21 years and is responsible for the relationship with suppliers and associations. The dispensing and distribution environment is very dynamic. Pricing of pharmaceutical is as complicated. He also have deep insight around generics and biosimilars and how they are handled in different markets. One of IQVIA’s priorities is to have the best understanding of those dynamics to secure the most appropriate data, to be the best partner with the different data partners, and to be able to support the industry and also when appropriate governments. He is a well know speaker in the field of distribution trends and pricing and is very active in consulting projects in the area. Prior to joining IMS, Per worked 13 years for Pharmacia in US and Europe. His last 6 years were spent in strategic development as a VP including several major mergers and acquisitions. He holds an MSc in engineering from Lund’s Institute of Technology and an MBA from INSEAD.


Medicines for Europe

Nick Haggar

Chief Executive Officer, Zentiva

Nick Haggar holds the position of the CEO for Zentiva. He joined in February this year from InsudPharma where he was CEO from 2016-2019.
Nick has been in the pharmaceutical and healthcare industry for more than 30 years. Prior to Insud he was Region Head responsible for Western Europe Middle East and Africa at Sandoz (Novartis). Whilst at Sandoz, Nick also led the Global Respiratory Franchise and co-chaired the Novartis Access to Medicines committee. He was President of Medicines for Europe (former EGA) during 2014-2015.
Nick has both a strong commercial track record with leadership positions in Ranbaxy and GlaxoSmithKline and deep technical know-how having commenced his career in technical operations at Baxter Healthcare. He holds an MBA from Cranfield Business School and a BSc in Industrial and Manufacturing Engineering.


Medicines for Europe

Karan Ambwani

Head of Commercial Strategy & Alliances, Teva

Karan is responsible for Teva’s commercial strategy & alliances for Generics, OTC & Branded medicines across more than 60 countries. Before joining Teva, Karan worked with Novartis and with various management consulting firms.
He has more than 14 years of experience in Corporate strategy, Business Performance Improvement, M&A and innovation in Healthcare and brings significant international experience having lived & worked in India, Singapore, Spain & the Netherlands.
Karan is also an author & speaker on innovation and business model disruptions in healthcare delivery. He holds an MBA with honors from IE Business School and Bachelors in Technology from University of Delhi.


Medicines for Europe

Mariângela Simão

Assistant Director General for Drug Access, Vaccines and Pharmaceuticals, WHO

Mariângela Simão joined WHO in November 2017, as part of Dr Tedros Adhanom Ghebreyesus leadership team.
She previously worked for UNAIDS since September 2010 and prior to that, she worked for the Ministry of Health in Brazil as the Director of the Sexually Transmitted Diseases, HIV/ AIDS and Viral Hepatitis department.
She worked in the Brazilian public health system since 1982, from the primary health care level to a series of managerial positions throughout the years. As a public health professional, at municipal, state and national levels, she played an active role in the decentralization of the national health system, acquiring an extensive experience in health system strengthening. She has also served on the boards of a number of organizations and government committees related to public health and HIV.
Heading the National Sexually Transmitted Diseases/HIV/AIDS Department (including Viral Hepatitis from 2009), she had the responsibility of overseeing and implementing the national Sexually Transmitted Diseases/AIDS/Viral Hepatitis policies, including universal and free of charge access to treatment, care and comprehensive prevention programs.
Dr. Simão attended medical school in Brazil, with degrees in Paediatrics and Public Health, and a MSc in Mother and Child Health in the UK.


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

Tobias Dolle

Associate, FratiniVergano - European Lawyers

Tobias Dolle is an Associate at FratiniVergano. He holds a PhD in the field of International Trade Law and dispute settlement from the University of Potsdam, Germany. He is a qualified lawyer in Germany, admitted to the Hamburg Bar, with an additional degree in French Public Law. Tobias has advised and represented governments, businesses and trade associations with respect to international trade and agro-food matters and has significant experience in the field of international trade law and policy, as well as EU regulatory affairs in highly regulated sectors (e.g., food, agriculture, pharmaceuticals, energy, tobacco, chemicals, and consumer protection law). Prior to joining FratiniVergano in 2016, Tobias held positions at the German Federal Ministry of Food, Agriculture and Consumer Protection, the German Federal Ministry of Economics and Energy, a Berlin-based law firm specialising in public law, and at the German Argentinean Chamber of Industry and Commerce in Buenos Aires, Argentina.


Medicines for Europe

Claire Hempshall

Senior Principal, IQVIA

Claire has more than a decade of experience in commercial and market access strategy gathered during her time at IMS Consulting Group, a-connect, PAREXEL Access Consulting and, most recently, IQVIA Consulting Services. Her focus is on applying strategy consulting methodologies to market access issues with the aim of addressing challenging, multi-dimensional problems in an innovative way. Her experience spans branded, generic and biosimilar medicines, across all major markets. Claire holds a BSc. (Hons) Physiology from the University of Nottingham.



Medicines for Europe

David Jauch

Director Government Relations, Fresenius Kabi

David M. Jauch is responsible for Government Relations globally within the Business Unit Generic Drugs of Fresenius Kabi. He is the Chair 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) and AAM (Association for Accessible Medicines). David’s 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

Warwick Smith

Director General, British Generic Manufacturers Association (BGMA) and British Biosimilars Association (BBA)

Warwick Smith is the Director-General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA). The BBA is a sector group of the BGMA. Warwick is also a member of the Board and Executive of Medicines for Europe. The BGMA is the designated industry body for consultation by the UK authorities on pricing and reimbursement. Warwick is a frequent commentator in the UK on the appropriate use of generic and biosimilar medicines and their benefits for patient access.


Medicines for Europe

Jonathan Kimball

Vice President of Trade and International Affairs, Association for Accessible Medicines (AAM)

Jonathan Kimball is the Vice President of Trade and International Affairs at the Association for Accessible Medicines (AAM). He serves as senior strategist and advocate leading the international trade strategy of AAM and represents the association and its member companies’ interests before Congress and the Administration. Jonathan has more than 20 years of trade policy and international advocacy experience, having led Burson Cohn & Wolfe’s U.S. healthcare policy offering, managed advocacy efforts in Europe, the Middle East, Africa, and the Americas for the Pharmaceutical Research and Manufactures of America, and was Director for Central and Eastern Europe at the U.S. Department of Commerce.


Medicines for Europe

Suzette Kox

Secretary General, International Generic and Biosimilar medicines Association (IGBA)

Suzette Kox has been nominated Secretary General of the International Generic and Biosimilar medicines Association, after 17 years in various functions at Medicines for Europe.
Suzette is very committed to support IGBA, which is at the forefront of preserving sustainable competition within the generic and biosimilar medicines industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality medicines.


Medicines for Europe

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, FDA

Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses.
He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering. After his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 15 years ago, he was an Assistant Professor of Chemical Engineering at the University of Michigan.


Medicines for Europe

Nicholas Cappuccino

Chair of the IGBA Science Committee and IGBA Member of the ICH Management Committee

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 and Management Committee. 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

Deus Mubangizi

Coordinator Prequalification Team (PQT) Regulation of Medicines and other Health Technologies (RHT), World Health Organization (WHO)

Mr. Mubangizi is a senior regulator with experiences in the regulation of pharmaceutical products, Vaccines, Vector Control Products and In-Vitro Diagnostics. He is currently the Coordinator of Prequalification Team (PQT) within the unit of Regulation of Medicines and other Health Technologies (RHT) in the Department of Essential Medicines and Health Products (EMP) of World Health Organization (WHO), based in Geneva, Switzerland. Prior to joining the World Health Organization (WHO) in 2008, Mr. Mubangizi had served as the Chief Inspector of Drugs (1996 - 2008) where he was one of the founder staff of Uganda’s national medicines regulatory agency, National Drug Authority (NDA), in 1994. In 1995, he worked with consultants appointed by WHO to establish a drug registration system for Uganda and subsequently coordinated a team that established the GMP inspection system for local and foreign manufacturing facilities marketing their products in Uganda. He headed the Inspectorate and Licensing Department of NDA Uganda from 1996 to March 2008. He participated in the initiation of medicine regulation harmonization in East Africa and Africa in General. In 2004 he joined a team of external dossier assessors for WHO Prequalification where he was shortly promoted to the level of senior assessor. He has, on behalf of his country Uganda and for WHO Medicines Prequalification Programme, inspected more than 200 sites in African, Europe, Asia, North America and South America for the manufacture of Finished Pharmaceutical Products, Active Pharmaceutical Ingredients, Vaccines and In-vitro diagnostics; national quality control laboratories; and Clinical Research Organizations where bio-equivalence studies are conducted. He has since 2016 been the Coordinator of the WHO Prequalification Team responsible for medicines, vaccines, in-vitro diagnostics, vector control products, male circumcision devices, immunization equipment and cold chain equipment. The team under his leadership has a launched a pilot prequalification of biotherapeutic products including biosimilars.


Medicines for Europe

Frances (Fran) M. Zipp

President & CEO, Lachman Consultant Services Inc.

Frances (Fran) M. Zipp is President & CEO of Lachman Consultant Services, Inc. Lachman Consultants provides compliance, regulatory and technical consulting services to the global pharmaceutical and related industries and Ms. Zipp delivers the strategic guidance and direction toward implementation of effective solutions to client needs. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements. Ms. Zipp has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval. She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, Due Diligence evaluations (facilities; products; technologies), and more.


Medicines for Europe

Matthew Scherer

International Policy Advisor, Europe Office, U.S. Mission to the European Union, U.S. Food and Drug Administration

Matthew Scherer is the Assistant Health Attaché and International Program and Policy Analyst for United States Food and Drug Administration’s Europe Office. In this role, he works to develop relationships and further FDA’s engagement with European regulatory counterparts and other stakeholders in the interest of advancing FDA’s public health mission. Much of his time is devoted to projects in support of the FDA-EU Mutual Recognition Agreement for pharmaceutical GMP Inspections, but his current portfolio covers all FDA regulated commodities.
He joined the FDA in 2007 in the Center for Drug Evaluation and Research's Division of Gastroenterology and Inborn Errors Products where he managed the review of new drug applications and worked with external stakeholders to facilitate new drug development.
Prior to joining the FDA, he provided market research and competitive intelligence consulting services for biotechnology, pharmaceutical and private equity clients. Matthew has a degree in Molecular Biology from the University of Wisconsin and a Master’s in Business Administration from Georgetown University.


Medicines for Europe

Aidan Fry

Executive Editor, Generics Bulletin - Informa

Aidan Fry has been the editor of Generics Bulletin, Informa’s 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. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.


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 U.S. Government and Legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, 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.


Medicines for Europe

Sudarshan Jain

Secretary General, Indian Pharmaceutical Alliance

Sudarshan has a strong passion for healthcare and the education sector. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Senior Advisor - Apax Partners and Board member of multiple organizations. He has served in several leadership positions for over 40 years in Healthcare industry (Lupin, Johnson & Johnson, Piramal, Abbott) and was formerly the Managing Director at Abbott Healthcare Solutions.
His current Board engagements include Abbott India, Healthium Limited (Apax portfolio company), Zandu Chemicals Limited, PharmEasy, Indian Institute of Health Management Research – Jaipur, Indian Education Society (IES), Advisory Board of Narsee Monjee University, Mumbai (NMIMS). He is the Visiting Faculty at Indian Institute of Management (IIM), Ahmedabad. He has contributed in shaping the healthcare policy and improving access to healthcare in India.
Sudarshan is an Alumnus of St. Stephens College, Delhi University and Indian Institute of Management (IIM), Ahmedabad.


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

Michele Uda

Director General, Assogenerici and Chair of the Generic Market Access Committee, Medicines for Europe

Graduated in Political Science from the International University LUISS Guido Carli in Rome, with a specialization in International Economics, after an initial experience in one of the largest Italian trade unions, he has successfully completed a full time MBA in International Business and Economics at "Mib School of Management" of Trieste. He then continued his career in the retail consumer sector at Ferrero Italy as Assistant Brand Manager for the Italian multinational company's core business and, later, at Colgate Palmolive Italy as a market and industry sales analyst in the Household Care division. He stepped into the healthcare sector joining Johnson & Johnson Medical where he was responsible for direct management of sales and marketing for the breast care line in Italy’s central and southern regions. From march 2007 he joined Assogenerici, the Italian Generic and Biosimilar Medicines Association, as “Pharmaceutical Economics & Policy Affairs Manager”, assuming direct responsibility of the Centre for Economics and Policy Analysis of the association.
From April 2012 he has been appointed Director General of Assogenerici, keeping also the position as interim head of the Centre for Economics and Policy Analysis and the responsibility for international relations. Since 2014 is also managing IBG – Italian Biosimilars Group, the new industry body representing the biosimilar medicines industry within Assogenerici.
He is also member of the Executive Committee of Medicines for Europe (European Generic & Biosimilars Medicines Industry Association) as Chairman of the GMAC (Generici Market Access Committee of Medicines for Europe).
Updated – April 2019


Medicines for Europe

Adele Paterson

Chief Executive Officer, International Health Partners

As CEO of International Health Partners, Adele brings a wealth of cross-sector partnership, CSR and public policy experience to enable access to medicines to some of the world’s most vulnerable communities. 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 International Health Partners to a product donations-plus model using best practice, in country partners and strategic alliances to create impactful long term initiatives. Last year, International Health Partners team of 10 delivered 4.4m treatments to 33 countries. Adele sits on the Board of PQMD (Partnership for Quality Medical Donations) and Integral disaster response alliance.


Medicines for Europe

James Burt

Executive Vice President Europe & MENA, Accord Healthcare Ltd

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 nine 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

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 and preventing antimicrobial resistance. 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. Deb’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. She is the current Chair of the Board of the FDA Alumni Association.


Medicines for Europe

Markus W. Sieger

CEO and President of the Management Board, Polpharma Group

Markus has been working his whole career in emerging industries such as information technology and digital media in Switzerland, the United States and Poland and in emerging markets such as Singapore, Poland and CIS countries. Since the mid-nineties he has successfully managed complex and strategic transactions in the pharmaceutical industry, the FMCG and media sector and has been a member of the board of directors of many of those private and public companies. He has been actively involved with Polpharma Group since its privatization in the year 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

Krzysztof Kopeć

President of the Board, Polish Union of Employers in Pharmaceutical Industry (PZPPF)

Krzysztof Kopeć, the President of Polish Union of Employers in Pharmaceutical Industry (PZPPF) associating the biggest domestic pharmaceutical companies that guarantee drugs’ security in Poland and economic development of the country.
He is an expert in the area of drugs’ reimbursement, pharmacy and within the scope of the law.
He also was a member of the Economic Commission at the Ministry of Health. He was appointed by the Minister of Health to the first Economic Commission, where he acted as chairman and member of its Negotiating Teams. He took part in the biggest price negotiations in the past 20 years concerning all products included on the lists of reimbursements medicines in Poland.
He acted as a Head of the Reimbursement and Prices Unit in the Drug Policy and Pharmacy Department at the Ministry of Health. He worked as an Associate at Linklaters and at the Chief Sanitary Inspectorate.
He has an experience in European Union drug-related projects, including EU working groups on drugs.
He was a polish delegate in the group of Competent Authorities on Pricing and Reimbursement.
Krzysztof is a lecturer of Postgraduate Studies Medical Law, Bioethics and Medical Sociology, Faculty of Law and Administration at Warsaw University.


Medicines for Europe

Maciej Miłkowski

Deputy Minister of Health, Poland

Biography soon available.


Medicines for Europe

Stefan Hendriks

Global Head Biopharmaceuticals, Sandoz

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


Medicines for Europe

Gustaf Befrits

Coordinator Introduction of Biosimilars, Stockholm County Council, Sweden

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


Medicines for Europe

Marnie Peterson

Chief Executive Officer, Generic and Biosimilar Medicines Association (GBMA), Australia

Marnie Peterson was appointed as Chief Executive Officer of the Australian Generic and Biosimilar Medicines Association (GBMA) in March 2018. Marnie also leads GBMA Education – the educational arm of GBMA, established to manage the Australian Government’s Educational Grant for Biosimilar Medicines, which was awarded to GBMA in April 2018. The purpose of the Grant is to increase confidence in the use of biosimilar brands of biological medicines that are listed on the Pharmaceutical Benefits Scheme (PBS). Through the increased use of biosimilar medicines, the objective is to support a competitive market for biological medicines via peer-to-peer health communication activities.
With over 15 years in business management and marketing, Marnie’s pharmaceutical experience spans key executive roles in large generic pharma, company start-ups and business ownership. Managing commercial operations in each role, Marnie’s sales channel and marketing leadership extends across retail pharmacy, business development and hospital, including the delivery of end-to-end professional services programs for community pharmacy, corporate positioning, product development and go-to-market strategies.
Marnie has predominantly spent her career in the Australian generic pharmaceutical sector, having worked for a range of key players including Apotex, Aspen generics, Actavis (Allergan) and Dr Reddy’s Laboratories.


Medicines for Europe

Professor Rob Duncombe

Director of Pharmacy, The Christie NHS Foundation Trust and Director, The Christie Pharmacy Company, UK

Professor Rob Duncombe. Director of Pharmacy at The Christie NHS Foundation Trust in Manchester. The Christie is one of the largest cancer centres in Europe treating patients from across the UK. The hospital recently opened the first NHS proton beam centres in the UK, and is one of the first hospitals to offer CAR T therapy to patients. Professor Duncombe has a particular interest in medicines optimisation in cancer drugs, identifying ways to achieve the best value from the use of these medicines. In recent years prof Duncombe has been at the forefront of delivering dose-banded chemotherapy in the UK and the introduction of biosimilar medicines in cancer.


Medicines for Europe

Zorana Maravic

Director of Operations, Digestive Cancers Europe

Zorana Maravic is Director of Operations at Digestive Cancers Europe, previously EuropaColon, the first and only European digestive cancers patient umbrella organization. At her position, Zorana is responsible for the co-ordination and support of member groups, as well as establishing the relationship with new organisations in order to continue the network growth. As an experienced project manager, Zorana managed many of the project undertaken by The Organisation, such as the Survey on the Unmet Needs of Patients Living with Metastatic Colorectal Cancer (mCRC) which recruited more than 800 patients with the results disclosed in several publications that Zorana authored; organised several Masterclass events, educational annual meetings for partner groups; developed various awareness campaigns including a few European Colorectal Cancer Awareness Campaigns (ECCAM); participated in various projects organised by pharmaceutical industry and independent consortia; worked closely with Patient Advisory Committee (PAC) on production of various educational and materials to support patients. Zorana also acts as a public speaker.
From 2016 until 2018, Zorana served as a Board Member of EuropaColon.
Before working in the Not-For-Profit sector, Zorana worked for 10 years in the pharmaceutical industry, primarily in sales and marketing of innovative oncology drugs as well as oncology clinical trials.
Zorana holds a degree in molecular biology from the University of Belgrade, Serbia. In 2017, at the University of Sheffield, UK she gained an Executive MBA in Health Management.


Medicines for Europe

Dr Paul Cornes

Oncologist, Comparative Outcomes Group, UK

Paul Cornes is an Oncologist from Bristol, UK.
He is part of the steering group for the European School of Oncology Working Party on the Access to Innovation in Cancer Treatment. Paul was part of the team that developed and presented evidence to the Oncology Advisory drugs Committee of the FDA for the first successfully approved US biosimilar. He has been in the British Medical Journal’s “Round Table” group on Biosimilars as well as a faculty for the Drug Information Association Meeting on Biosimilars and has been on the panel for the EU Commission biosimilars meeting in Brussels and chair of the biosimilars programme for the World Cancer Congress for the UICC. In 2018 he wrote the book “Fast Facts: Biosimilars”.


Medicines for Europe

Arun Narayan

Head Global Portfolio, Mylan and Chairman of the Value Added Medicines Sector Group

Arun has a successful and diverse track record in fast growing, multinational pharmaceuticals companies, covering international expansion, portfolio strategy, M&A/licensing and operations; plus an entrepreneurial stint.


Medicines for Europe

Aurelio Arias

Senior Consultant, European Thought Leadership - IQVIA

Aurelio is a Senior Consultant in the European Thought Leadership team based in IQVIA's London office. His primary focus is on off-patent markets where he generates evidence-led insights with a view to spark high-level discourse in biosimilars, generics and value added medicines. He is considered a subject matter expert in these areas where he speaks at numerous conferences worldwide, presents to clients and engages in consulting projects in an advisory capacity. Prior to IQVIA, Aurelio has worked as a strategy consultant in both Life Sciences and Financial Services at 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

Sofia Romagosa Vilarnau

Junior Projects and Engagement Officer, European Federation of Allergy and Airways Diseases Patients' Associations (EFA)

Sofia is a Sociologist specialised in Public Health and she is currently working as a Junior Projects and Engagement Officer at the European Federation of Allergy and Airways Diseases Patients' Associations (EFA). She supports the implementation and management of EFA’s own projects and EFA’s activities and deliverables for various EU-funded research projects as well as she ensures the commitment of patients and EFA members at all levels within EFA. In 2017, she also worked at the Patients Advisory Council of the Catalan Health Department where she was involved in a research in methods for involving patients in the design, development and evaluation of health policies.


Medicines for Europe

Kenneth V. Phelps

President and Founder, 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

Francis Arickx

Head Directorate Reimbursement of Medicines and Pharmaceutical Policy, RIZIV-INAMI, Belgium

Francis Arickx is the head of the directorate Reimbursement of Medicines and Pharmaceutical Policy within the Health Care Department at the National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI) in Belgium where he manages the departments responsible for administrative and scientific assessment and appraisal of reimbursement claims for medicines, orphan drugs, medical nutrition. Francis Arickx is the former secretary general for the Commission for Reimbursement of Medicines and acts as representative/expert for the Institute and Belgium on a number of national and European platforms (NM CAPR, MEDEV, MoCA,..). He is one of the country coordinators for the BeNeLuxA Initiative (www.beneluxa.org). Francis graduated in pharmaceutical sciences from the University of Ghent, Belgium and teaches ‘Health Policy’ in the Pharmaceutical Sciences Department at the University of Antwerp.


Medicines for Europe

Carsten Brockmeyer

Chief Executive Officer, Formycon

Carsten Brockmeyer is the CEO of Formycon AG, Munich, a leading pure play developer of global quality biosimilar medicines. Formycon is currently focusing on the development of biosimilar medicines in ophthalmology and autoimmunity, and on innovative formulations and drug delivery devices. Formycon ranks number seven among the thousand fastest growing companies in Europe (Financial Times 2018) and has established a number of partnerships with leading pharmaceutical companies. Carsten has held senior management positions at Baxter, Hexal, and Sandoz/Novartis before he founded Brockmeyer Biopharma in 2010, a pharma and biotech consultancy, and helped to establish Formycon AG in 2012. His work in the field of biopharmaceutical and biosimilar medicines has been recognized with prestigious scientific awards.


Medicines for Europe

Francesco Balestrieri

Region Head Europe and Incoming ad interim CEO, Sandoz

Work history
2018 – present Region Head EUROPE
2015 – 2018 Region Head CEEMEA, Sandoz
2013 – 2015 Region Head CEE, Sandoz
2011 – 2013 Region Head APAC, Sandoz
2007 – 2011 Ciba Vision, President of Americas region (prior Alcon integration)
2003 – 2007 Novartis Consumer Health – Head of Marketing and Operations Europe and Cluster Head of Germany/Austria/Switzerland
1993 Joining Novartis – various roles in general management, marketing and finance, in the US, Germany, Switzerland and Italy
Higher education
Degree in Economics from the University of Venice