Medicines for Europe Medicines for Europe

CHAIRPERSONS AND SPEAKERS

Medicines for Europe

Christoph Stoller

Senior Vice President, Teva and President Medicines for Europe

In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).

Medicines for Europe

Albert Wertheimer, PhD, MBA, Professor

College of Pharmacy, Department of Sociobehavioral and Administrative Pharmacy, Nova Southeastern University

Dr. Wertheimer is one of the leading thinkers in the health economics and outcomes research area. He has guided nearly 100 PhD students and an equal number of Masters students. He is the author or co-author of 43 books, over 400 articles in scientific and professional journals and about 30 book chapters. He has been a consultant or lecturer in more than 70 countries. Earlier he has been a pharmacy faculty professor, a dean, a researcher at Merck & Company and a vice president of a pharmacy benefit management company. He has been the recipient of numerous awards including the FIP's Henri Bedat Award, a laureate of the Swedish Academy of Pharmaceutical Sciences, a fellow of the American Association of Pharmaceutical Scientists and the Francke Medal for contributions to international pharmacy from the American Society of Health System Pharmacists. His current interests include evaluation of health policy initiatives and regulatory affairs. Since 2017, he has been a professor at the Nova Southeastern University in Ft. Lauderdale, Florida, USA.

Medicines for Europe

David Wallace

Executive Editor, Informa

As Executive Editor of Generics Bulletin, David Wallace has been writing about the global generics, biosimilars and value-added medicines industries for a decade. Bringing his background and education in law to bear on industry litigation as well as national legislative and regulatory affairs, he also keeps a close eye on corporate strategy, personnel moves, and product pipelines. A regular delegate to industry events and conferences, he has a particular interest in local market developments and maintaining close links with national industry representatives. He also organizes and judges the annual Global Generics & Biosimilars Awards.

Medicines for Europe

Ann Beliën, PhD, PMP

Founder & CEO, Rejuvenate Biomed

In October 2017, Ann Beliën established Rejuvenate Biomed, a spin-off from Johnson and Johnson where she currently functions as founder and CEO. Rejuvenate Biomed studies the biology of aging and is repurposing prescription drugs with the aim to delay the onset of multiple age-related diseases. One of the portfolio products is focussing on sarcopenia as an entry into the space of healthy aging. Ann has over 17 years of experience in drug development from bench to market, which she acquired at Johnson and Johnson throughout multiple international assignments from scientist to operational and strategic roles including external and open innovation. She joined J&J in 2000, after a postdoc at ETH, Zürich, Switzerland. She holds a PhD from the University of Irchel, Zürich, Switzerland and a Project Management Professional from PMI.

Medicines for Europe

Augusto Filipe, Dr. MD

Head of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede

  • Member of the Portuguese Medical Association.
  • Head of Medical Departmet of Farmoz/Grupo Tecnimede, Portugal.
  • European Union Qualified Person for Pharmacovigilance (EU QPPV).
  • Member of the Eudravigilance Expert Working Group (EV-EWG).
  • Member of the EGA Pharmacovigilance and Safety Working Group (EGA-PhVWG).
  • Published severals scientific papers in peer review journals (areas of interest: clinical       trials, pharmacovigilance and safety, respiratory diseases).

Medicines for Europe

Geraldine Moore

Senior Registration Manager, Mylan

Geraldine Moore is a pharmacist by training and has over 18 years’ experience in Regulatory Affairs within the generics industry and is currently a Senior Registration Manager at Mylan.

Medicines for Europe

Helen Lee

Administrator, DG Health and Food Safety - European Commission 

Helen is an administrator in the European Commission working in the Directorate General for Health and Food Safety, Unit B5 - Medicines: policy, authorisation and monitoring. She coordinates the work of the European Commission Expert Group on Safe and Timely Access to Medicines for Patients. She joined the unit dealing with the pharmaceutical legislation and the European Medicines Agency in 2012 prior to which she had worked on food and nutrition related issues in the European Commission and the UK administration.

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

Professor James Barlow

Chair in Technology & Innovation Management (Healthcare), Imperial College Bussiness School

James is a Professor of Technology and Innovation Management at Imperial College Business School. He was educated at the London School of Economics and Political Science. James’ work focuses on innovation in healthcare from creation to adoption. He is particularly interested in the complex relationship between innovation in health technologies, services and infrastructure. He has led or been involved in many research projects and has extensive experience advising and consulting for government and industry in many countries. James has published widely and his latest book is Managing Innovation in Healthcare, published in January 2017 by World Scientific.

Medicines for Europe

Maria Rúbies Royo

Business Development Department, Oyer Pharma

8 years of experience in RA and Business Development. Bachelor of Pharmacy, Master in Marketing and Commercial Management, Master’s Degree in Drug R&D&I (University of Navarra).

Medicines for Europe

Frédéric Destrebecq

Executive Director, European Brain Council

Frédéric Destrebecq is the Executive Director of the European Brain Council since October 2014. In this capacity, he is responsible for providing strategic direction and leadership while managing the day to day operations of EBC and its ongoing relationships with its member associations and other stakeholders, as well as representing the organisation in various European and national forums.
Prior to this position, Fred served the European Union of Medical Specialists (UEMS) as Chief Executive Officer, and previously as Director for European Affairs. Fred holds a Master Degree in Political Science and International Relations from the Université Catholique de Louvain (Belgium). He also studied at the Institut d’Etudes Politiques (Paris) and University of Wales College (Cardiff), in the framework of the former EU Socrates exchange programme.

Medicines for Europe

Prof. Dr. Jean Bousquet, MD, PhD

Honorary Professor of Pulmonary Medicine, University of Montpellier

Jean Bousquet, Honorary Professor of Pulmonary Medicine at Montpellier University, France has chaired GINA (Global Initiative for Asthma: 1999-2000), ARIA and the WHO Global Alliance against Chronic Respiratory Diseases (GARD, 2006-2013). He has a research interest in the mechanisms of allergy, multimorbidity of allergic diseases, severe asthma and the digital transformation of health and care to sustain Planetary Health. He has published over 1,000 papers and is the most influential author in asthma.

Medicines for Europe

Vinciane Knappenberg

Coordinator of Procedures, National Institute for Health and Disability Insurance, INAMI-RIZIV

I’m a pharmacist since 2000. Between 2000 and 2006, I have worked in pharmacies in Brussels and in Vilvoorde. Since 2006, I’m employed by the National Institute for Health & Disability Insurance (NIHDI), first as a file manager for the Commission for Reimbursement of Medicines, and then (since 2013) as what we call ‘reimbursement procedures coordinator’ for the Directorate Pharmaceutical Policy, which means that my job is the coordination of the team of the department within the directorate that is responsible for all decision processes regarding the reimbursement of medicines, nutrition, active ingredients, managed entry agreements,...

Medicines for Europe

Klára Marton MD, MBA

Business Development Director, Egis Pharmaceuticals PLC

Klára 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 patient 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

Prof. Dr. Zoltán Kaló

Professor of Health Economics, Center for Health Technology Assessment - Semmelweis University

Zoltán Kaló is a Professor of Health Economics and Head of the Institute of Economics at Eötvös Loránd University (ELTE) in Budapest. He is the co-director of an MSc in Health Policy, Planning and Financing postgraduate course at ELTE University. 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 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

Paul Tunnah

CEO, Pharmaphorum

Dr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content communications / marketing consultancy (www.pharmaphorumconnect.com). All aspects of his work at pharmaphorum align around the company’s vision of ‘bringing healthcare together’ – ensuring all stakeholders have a voice and can collectively engage to find mutually beneficial solutions.
He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations. He is also a member of the steering committee for Frontiers Health, a leading event on digital disruption in healthcare, attended by industry, start-ups and investors.
Dr Tunnah has a scientific background, with a BA in Biochemistry and DPhil in Biological sciences, focussed on development of novel anticancer therapies, from Oxford University.
Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or email paul.tunnah@pharmaphorum.com.

Medicines for Europe

Gerry Chillè

General Partner, Healthware Labs

Gerry’s professional work has taken him from launching a production company in NY specializing on TV advertisements for radio and TV, sound design for Broadway show productions, and producing and mixing world famous Rap music artists, to broadband digital communications and user experience research for NYNEX Science & Technology (a spin-off division of the famed Bell Labs).
While there, his work touched on early-concept designs and pilot projects in telemedicine for the sharing of high-definition diagnostic images and remote care of patients across hospitals and medical universities in the northeast of the US. (1998)
From there Gerry transitioned over to the world of digital pharma innovation when, in 2006, he helped design and launch the second ever online patient support community for the US division of a leading global pharmaceutical company. Since those early days Gerry has held various healthcare agency positions as digital strategist and planner, and in 2015 launched HealthwareLabs in NYC, whose mission is to accelerate digital health and therapeutic innovation.
Born and raised in Italy, and professionally baked in the US, Gerry is one of those unique multi-cultural individuals who are fully polymorphous in their approach to out-of-the-box thinking and problem solving, which he does by tapping into his extensive creative, technical and strategic background.
Gerry holds a BFA degree from the State University of NY and MBA coursework at the University of Phoenix.
He is currently General Partner at Healthware Labs.

Medicines for Europe

Aurelio Arias

Engagement Manager, European Thought Leadership, IQVIA

Aurelio is a global thought leader based in IQVIA’s London office. The European Thought Leadership team creates topical and forward-looking strategic content relevant to pharma executives worldwide and publishes articles, blogs and white papers on a regular basis.
Aurelio’s predominant focus is on off-patent markets where he generates evidence-led insights with a view to spark high-level discourse in established brands, biosimilars, generics and value-added medicines. He is considered a subject matter expert in these areas where he speaks at numerous conferences worldwide, presents at board-level meetings and engages in consulting projects in an advisory capacity.
Prior to IQVIA, Aurelio has worked in Discovery R&D and as a strategy consultant in Life Sciences. He holds an MSci in Chemistry from Imperial College London.

Medicines for Europe

Guilherme Safioti

Pulmonologist and Global Medical Director, Teva Pharmaceuticals

Guilherme Safioti is a pulmonologist and Global Medical Director at Teva Pharmaceuticals. For the past 4 years he's been working in Teva Pharmaceutical's Digital Respiratory program, together with a large cross-function team. This program has led to the FDA-approval of the world's first integrated electronic inhaler device measuring flow rate and providing objective information about the frequency and quality of inhalation via a mobile app. Guilherme is also designing and running clinical trials to test the effectiveness of this digital therapeutics solution to improve outcomes for asthma and COPD patients, as well as studies to develop machine-learning algorithms to predict exacerbations based on real-life usage data. His interests and the focus of his research are digital medicine, predictive analytics, airway diseases, aerosol therapy, patient adherence, behaviour and their relationships with clinical outcomes.

Medicines for Europe

Susanna Palkonen

Director, European Federation of Allergy and Airways Diseases Patients' Associations (EFA)

Susanna Palkonen is Director of European Federation of Allergy and Airways Diseases Patients’ Associations (EFA), which brings together 44 member associations from 25 countries to improve the care, environment, participation and equality of people with allergy, asthma and COPD at the European level. Among others, Susanna is the patient representative in the EC DG Research and Innovation’s Horizon 2020 Scientific Panel for Health, ERACoSysMed Advisory Board and the Clinical Advisory Board of the Human Brain Project.
Recently Susanna became the Chairperson of the PACT, Patient Access Partnership, a multi-stakeholder initiative to improve equal access to patient centered care in Europe.
In 2018 she stepped down from the Board of the European Patients’ Forum EPF, the umbrella association for 64 European level disease specific patient groups and national platforms of patient associations, of which EFA is a member, after 12 years of service and where she was vice president 8 years and represented EPF at the European Medicines Agency (EMA) Patient and Consumer Working Party. In her private life she is the Secretary of the Board of the Lehmijärvi-lake protection association, lake in Finland where her family has summer cottage, with the aim to protect and improve the quality of the water for anyone wishing to swim in or fish on the lake. Susanna has co-authored several papers with the scientific community and believes in equal participation in research by patients and their representatives. She studied social policy and as a patient with atopic eczema and allergic rhinitis she is interested in how policies and systems, but also patients themselves can support patient centered care and prevention.

Medicines for Europe

Prof. Elísio Costa

UCIBIO/REQUIMTE, Faculty of Pharmacy of University of Porto, Portugal. Co-coordinator of the action group on Adherence to prescription and medical plans of EIP-AHA

Professor at the Department of Biological Sciences of the Faculty of Pharmacy of the University of Porto and researcher in the Research Unit on Applied Molecular Biosciences of the same institution (UCIBIO). He is also the Director of the Competence Center on Ageing of the University of Porto, which aims to work as a convergence Centre of all the skills and knowledge of the University in the field of ageing; and co-coordinator of the activities of the University of Porto as an INNOSTARS RIS-Hub of EIT-Health. He is a member of the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA) on the Action Group A1 on Adherence to Prescription and Medical Plans, being the co-coordinator of one of the objectives of this Action Group. Moreover, he is the scientific coordinator of the EIP-AHA two-starred Reference Site: Porto4Ageing. He is author of more than 200 publications (orcid.org/0000-0003-1158-1480) and has collaborated in national and international research projects in the field of chronic diseases, namely chronic kidney disease and ageing (SACHI2; SKILLS4ADHERENCE; ICTSKILLS4ALL, FAIR4HEALTH, SHAPES, others).

Medicines for Europe

Arun Narayan

Head Global Portfolio Strategy and Head European Business Operations, Mylan and Chairman of the Value Added Medicines Sector Group, Medicines for Europe

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

3rd VALUE ADDED MEDICINES CONFERENCE
RENAISSANCE HOTEL, BRUSSELS

21 NOVEMBER 2019


Medicines for Europe

Christoph Stoller

Senior Vice President, Teva and President Medicines for Europe

In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).


Medicines for Europe

Albert Wertheimer, PhD, MBA, Professor

College of Pharmacy, Department of Sociobehavioral and Administrative Pharmacy, Nova Southeastern University

Dr. Wertheimer is one of the leading thinkers in the health economics and outcomes research area. He has guided nearly 100 PhD students and an equal number of Masters students. He is the author or co-author of 43 books, over 400 articles in scientific and professional journals and about 30 book chapters. He has been a consultant or lecturer in more than 70 countries. Earlier he has been a pharmacy faculty professor, a dean, a researcher at Merck & Company and a vice president of a pharmacy benefit management company. He has been the recipient of numerous awards including the FIP's Henri Bedat Award, a laureate of the Swedish Academy of Pharmaceutical Sciences, a fellow of the American Association of Pharmaceutical Scientists and the Francke Medal for contributions to international pharmacy from the American Society of Health System Pharmacists. His current interests include evaluation of health policy initiatives and regulatory affairs. Since 2017, he has been a professor at the Nova Southeastern University in Ft. Lauderdale, Florida, USA.


Medicines for Europe

David Wallace

Executive Editor, Informa

As Executive Editor of Generics Bulletin, David Wallace has been writing about the global generics, biosimilars and value-added medicines industries for a decade. Bringing his background and education in law to bear on industry litigation as well as national legislative and regulatory affairs, he also keeps a close eye on corporate strategy, personnel moves, and product pipelines. A regular delegate to industry events and conferences, he has a particular interest in local market developments and maintaining close links with national industry representatives. He also organizes and judges the annual Global Generics & Biosimilars Awards.


Medicines for Europe

Ann Beliën, PhD, PMP

Founder & CEO, Rejuvenate Biomed

In October 2017, Ann Beliën established Rejuvenate Biomed, a spin-off from Johnson and Johnson where she currently functions as founder and CEO. Rejuvenate Biomed studies the biology of aging and is repurposing prescription drugs with the aim to delay the onset of multiple age-related diseases. One of the portfolio products is focussing on sarcopenia as an entry into the space of healthy aging. Ann has over 17 years of experience in drug development from bench to market, which she acquired at Johnson and Johnson throughout multiple international assignments from scientist to operational and strategic roles including external and open innovation. She joined J&J in 2000, after a postdoc at ETH, Zürich, Switzerland. She holds a PhD from the University of Irchel, Zürich, Switzerland and a Project Management Professional from PMI.


Medicines for Europe

Augusto Filipe, Dr. MD

Head of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede

  • Member of the Portuguese Medical Association.
  • Head of Medical Departmet of Farmoz/Grupo Tecnimede, Portugal.
  • European Union Qualified Person for Pharmacovigilance (EU QPPV).
  • Member of the Eudravigilance Expert Working Group (EV-EWG).
  • Member of the EGA Pharmacovigilance and Safety Working Group (EGA-PhVWG).
  • Published severals scientific papers in peer review journals (areas of interest: clinical       trials, pharmacovigilance and safety, respiratory diseases).


Medicines for Europe

Geraldine Moore

Senior Registration Manager, Mylan

Geraldine Moore is a pharmacist by training and has over 18 years’ experience in Regulatory Affairs within the generics industry and is currently a Senior Registration Manager at Mylan.


Medicines for Europe

Helen Lee

Administrator, DG Health and Food Safety - European Commission

Helen is an administrator in the European Commission working in the Directorate General for Health and Food Safety, Unit B5 - Medicines: policy, authorisation and monitoring. She coordinates the work of the European Commission Expert Group on Safe and Timely Access to Medicines for Patients. She joined the unit dealing with the pharmaceutical legislation and the European Medicines Agency in 2012 prior to which she had worked on food and nutrition related issues in the European Commission and the UK administration.


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

Professor James Barlow

Chair in Technology & Innovation Management (Healthcare), Imperial College Bussiness School

James is a Professor of Technology and Innovation Management at Imperial College Business School. He was educated at the London School of Economics and Political Science. James’ work focuses on innovation in healthcare from creation to adoption. He is particularly interested in the complex relationship between innovation in health technologies, services and infrastructure. He has led or been involved in many research projects and has extensive experience advising and consulting for government and industry in many countries. James has published widely and his latest book is Managing Innovation in Healthcare, published in January 2017 by World Scientific.


Medicines for Europe

Maria Rúbies Royo

Business Development Department, Oyer Pharma

8 years of experience in RA and Business Development. Bachelor of Pharmacy, Master in Marketing and Commercial Management, Master’s Degree in Drug R&D&I (University of Navarra).


Medicines for Europe

Frédéric Destrebecq

Executive Director, European Brain Council

Frédéric Destrebecq is the Executive Director of the European Brain Council since October 2014. In this capacity, he is responsible for providing strategic direction and leadership while managing the day to day operations of EBC and its ongoing relationships with its member associations and other stakeholders, as well as representing the organisation in various European and national forums.
Prior to this position, Fred served the European Union of Medical Specialists (UEMS) as Chief Executive Officer, and previously as Director for European Affairs. Fred holds a Master Degree in Political Science and International Relations from the Université Catholique de Louvain (Belgium). He also studied at the Institut d’Etudes Politiques (Paris) and University of Wales College (Cardiff), in the framework of the former EU Socrates exchange programme.


Medicines for Europe

Prof. Dr. Jean Bousquet, MD, PhD

Honorary Professor of Pulmonary Medicine, University of Montpellier

Jean Bousquet, Honorary Professor of Pulmonary Medicine at Montpellier University, France has chaired GINA (Global Initiative for Asthma: 1999-2000), ARIA and the WHO Global Alliance against Chronic Respiratory Diseases (GARD, 2006-2013). He has a research interest in the mechanisms of allergy, multimorbidity of allergic diseases, severe asthma and the digital transformation of health and care to sustain Planetary Health. He has published over 1,000 papers and is the most influential author in asthma.


Medicines for Europe

Vinciane Knappenberg

Coordinator of Procedures, National Institute for Health and Disability Insurance, INAMI-RIZIV

I’m a pharmacist since 2000. Between 2000 and 2006, I have worked in pharmacies in Brussels and in Vilvoorde. Since 2006, I’m employed by the National Institute for Health & Disability Insurance (NIHDI), first as a file manager for the Commission for Reimbursement of Medicines, and then (since 2013) as what we call ‘reimbursement procedures coordinator’ for the Directorate Pharmaceutical Policy, which means that my job is the coordination of the team of the department within the directorate that is responsible for all decision processes regarding the reimbursement of medicines, nutrition, active ingredients, managed entry agreements,...


Medicines for Europe

Klára Marton MD, MBA

Business Development Director, Egis Pharmaceuticals PLC

Klára 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 patient 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

Prof. Dr. Zoltán Kaló

Professor of Health Economics, Center for Health Technology Assessment - Semmelweis University

Zoltán Kaló is a Professor of Health Economics and Head of the Institute of Economics at Eötvös Loránd University (ELTE) in Budapest. He is the co-director of an MSc in Health Policy, Planning and Financing postgraduate course at ELTE University. 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 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

Paul Tunnah

CEO, Pharmaphorum

Dr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content communications / marketing consultancy (www.pharmaphorumconnect.com). All aspects of his work at pharmaphorum align around the company’s vision of ‘bringing healthcare together’ – ensuring all stakeholders have a voice and can collectively engage to find mutually beneficial solutions.
He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations. He is also a member of the steering committee for Frontiers Health, a leading event on digital disruption in healthcare, attended by industry, start-ups and investors.
Dr Tunnah has a scientific background, with a BA in Biochemistry and DPhil in Biological sciences, focussed on development of novel anticancer therapies, from Oxford University.
Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or email paul.tunnah@pharmaphorum.com.


Medicines for Europe

Gerry Chillè

General Partner, Healthware Labs

Gerry’s professional work has taken him from launching a production company in NY specializing on TV advertisements for radio and TV, sound design for Broadway show productions, and producing and mixing world famous Rap music artists, to broadband digital communications and user experience research for NYNEX Science & Technology (a spin-off division of the famed Bell Labs).
While there, his work touched on early-concept designs and pilot projects in telemedicine for the sharing of high-definition diagnostic images and remote care of patients across hospitals and medical universities in the northeast of the US. (1998)
From there Gerry transitioned over to the world of digital pharma innovation when, in 2006, he helped design and launch the second ever online patient support community for the US division of a leading global pharmaceutical company. Since those early days Gerry has held various healthcare agency positions as digital strategist and planner, and in 2015 launched HealthwareLabs in NYC, whose mission is to accelerate digital health and therapeutic innovation.
Born and raised in Italy, and professionally baked in the US, Gerry is one of those unique multi-cultural individuals who are fully polymorphous in their approach to out-of-the-box thinking and problem solving, which he does by tapping into his extensive creative, technical and strategic background.
Gerry holds a BFA degree from the State University of NY and MBA coursework at the University of Phoenix.
He is currently General Partner at Healthware Labs.


Medicines for Europe

Aurelio Arias

Engagement Manager, European Thought Leadership, IQVIA

Aurelio is a global thought leader based in IQVIA’s London office. The European Thought Leadership team creates topical and forward-looking strategic content relevant to pharma executives worldwide and publishes articles, blogs and white papers on a regular basis.
Aurelio’s predominant focus is on off-patent markets where he generates evidence-led insights with a view to spark high-level discourse in established brands, biosimilars, generics and value-added medicines. He is considered a subject matter expert in these areas where he speaks at numerous conferences worldwide, presents at board-level meetings and engages in consulting projects in an advisory capacity.
Prior to IQVIA, Aurelio has worked in Discovery R&D and as a strategy consultant in Life Sciences. He holds an MSci in Chemistry from Imperial College London.


Medicines for Europe

Guilherme Safioti

Pulmonologist and Global Medical Director, Teva Pharmaceuticals

Guilherme Safioti is a pulmonologist and Global Medical Director at Teva Pharmaceuticals. For the past 4 years he's been working in Teva Pharmaceutical's Digital Respiratory program, together with a large cross-function team. This program has led to the FDA-approval of the world's first integrated electronic inhaler device measuring flow rate and providing objective information about the frequency and quality of inhalation via a mobile app. Guilherme is also designing and running clinical trials to test the effectiveness of this digital therapeutics solution to improve outcomes for asthma and COPD patients, as well as studies to develop machine-learning algorithms to predict exacerbations based on real-life usage data. His interests and the focus of his research are digital medicine, predictive analytics, airway diseases, aerosol therapy, patient adherence, behaviour and their relationships with clinical outcomes.


Medicines for Europe

Susanna Palkonen

Director, European Federation of Allergy and Airways Diseases Patients' Associations (EFA)

Susanna Palkonen is Director of European Federation of Allergy and Airways Diseases Patients’ Associations (EFA), which brings together 44 member associations from 25 countries to improve the care, environment, participation and equality of people with allergy, asthma and COPD at the European level. Among others, Susanna is the patient representative in the EC DG Research and Innovation’s Horizon 2020 Scientific Panel for Health, ERACoSysMed Advisory Board and the Clinical Advisory Board of the Human Brain Project.
Recently Susanna became the Chairperson of the PACT, Patient Access Partnership, a multi-stakeholder initiative to improve equal access to patient centered care in Europe.
In 2018 she stepped down from the Board of the European Patients’ Forum EPF, the umbrella association for 64 European level disease specific patient groups and national platforms of patient associations, of which EFA is a member, after 12 years of service and where she was vice president 8 years and represented EPF at the European Medicines Agency (EMA) Patient and Consumer Working Party. In her private life she is the Secretary of the Board of the Lehmijärvi-lake protection association, lake in Finland where her family has summer cottage, with the aim to protect and improve the quality of the water for anyone wishing to swim in or fish on the lake. Susanna has co-authored several papers with the scientific community and believes in equal participation in research by patients and their representatives. She studied social policy and as a patient with atopic eczema and allergic rhinitis she is interested in how policies and systems, but also patients themselves can support patient centered care and prevention.


Medicines for Europe

Prof. Elísio Costa

UCIBIO/REQUIMTE, Faculty of Pharmacy of University of Porto, Portugal. Co-coordinator of the action group on Adherence to prescription and medical plans of EIP-AHA

Professor at the Department of Biological Sciences of the Faculty of Pharmacy of the University of Porto and researcher in the Research Unit on Applied Molecular Biosciences of the same institution (UCIBIO). He is also the Director of the Competence Center on Ageing of the University of Porto, which aims to work as a convergence Centre of all the skills and knowledge of the University in the field of ageing; and co-coordinator of the activities of the University of Porto as an INNOSTARS RIS-Hub of EIT-Health. He is a member of the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA) on the Action Group A1 on Adherence to Prescription and Medical Plans, being the co-coordinator of one of the objectives of this Action Group. Moreover, he is the scientific coordinator of the EIP-AHA two-starred Reference Site: Porto4Ageing. He is author of more than 200 publications (orcid.org/0000-0003-1158-1480) and has collaborated in national and international research projects in the field of chronic diseases, namely chronic kidney disease and ageing (SACHI2; SKILLS4ADHERENCE; ICTSKILLS4ALL, FAIR4HEALTH, SHAPES, others).


Medicines for Europe

Arun Narayan

Head Global Portfolio Strategy and Head European Business Operations, Mylan and Chairman of the Value Added Medicines Sector Group, Medicines for Europe

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.