Value, Access, and Regulatory Strategy Conference
Angelika Joos, MPharm
- Executive Director, Global Regulatory Policy
- Merck Sharp & Dohme (Europe) Inc., Belgium
Angelika Joos, MPharm, is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in various Committees of the European Federation of Pharmaceutical Manufacturers and Associations, EuropaBio, and the European Confederation of Pharmaceutical Entrepreneurs; she is also involved in international policy activities as the MSD delegate in the IFPMA Regulatory Science Committee, and the BIO and the PhRMA international Committees.
Mira Pavlovic, DrMed, MS
- HTA Expert / Managing Director
- NDA Advisory Services, Medicines Development and Training (MDT) Services, France
Mira Pavlovic is the Founder and Managing Director of Medicines Development and Training Services, Associate Professor for Regulatory and HTA science at Lisbon University and consults on clinical drug development strategies as a member of the NDA Advisory Board, providing scientific peer review of NDA reports at the request of pharmaceutical companies. She previously served as Head of Scientific Advice at the French Medicines Agency and a Member of SAWP, Efficacy Working Party, and Biosimilar Medicinal Products Working Party, at the EMA. She was nominated as Deputy Director for HTA at the Haute Autorité de Santé, France, in 2010, and is a Member of the Société Française de Dermatologie and of the European Academy of Dermatovenerology.
Claudine Sapède, PharmD
- Director, Global HTA Policy
- Novartis Pharma AG, Switzerland
Claudine is Director, Global HTA Policy at Novartis global public affairs department, in Switzerland. She focuses on HTA and reimbursement decision-making frameworks and engage with internal and external parties involved in setting or influencing HTA, pricing and reimbursement decisions. Prior to this role, she has spent 16 years in a variety of pricing and market access positions in both strategic and operational roles at country and global levels at Roche. Her career in the pharma sector over 20 years spans the full spectrum of evidence generation, value demonstration, market access strategies, pricing and HTA policy. She was an active contributor in the IMI Adapt-Smart project where she co-led the workstream on managed entry agreements
- Head of Unit B5 - Medicines: Policy, Authorisation and Monitoring
- DG SANTE, European Commission, Belgium
Olga Solomon studied Chemistry at the Aristotle University of Thessaloniki, Greece and holds an MSc in Food Science from the Gothenburg University, Sweden. Before joining the European Commission she worked for 5 years for a beverage producing company in Greece. Solomon joined DG SANCO in 2000 and worked for 10 years in the field of Food Safety in particular dealing with legislation on Food Contact Materials, Food Additives and Enzymes. In 2010, she moved to the Directorate 'Health Systems and Products' where she worked in the field of substances of human origin before taking up a post in the pharmaceutical sector in 2011. She is currently the Head of the DG SANTE Unit responsible for Medicines: policy, authorisation and monitoring.
Kristin Svanqvist, MPharm
- Governmental Affairs Manager
- Amgen, Norway
Kristin Svanqvist, Governmental Affairs and Communications Sr Mgr, Amgen Norway. She is trained as a pharmacist and has been working within the field of reimbursement of pharmaceuticals and HTA since 2004. Her last position was with The Norwegian Medicines Agency as a head of the section for Reimbursement and HTA. The Agency is the decision making body for pharmaceuticals for the out care patients and for assessing the new medicines for the hospital sector. Kristin has also a position with in the Arctic University of Norway at the Department of Pharmacy.
Solange Corriol-Rohou, DrMed, MD, PhD
- Senior Director, Global Regulatory Affairs & Policy, Europe
- Astrazeneca Research & Development, France
Pulmonologist and immuno-allergologist by training, Solange joined AstraZeneca R&D in 2004. Moving from the French Medicines Agency and hospital to Industry, she has gained strategic experience in drug development. As the chair of the EFPIA Clinical Development Expert Group, she has organized workshops with the EMA. She is quite experience working in PPP, was the deputy topic lead of IMI ADAPT SMART, has developed and qualified with the IMI PROactive consortium PRO instruments to assess Physical Activity of COPD patients, and is currently involved in IMI Mobilise-D and Trials@Home projects. She has also joined ICH to complete the revision of the E11 Paediatric guideline, and is keeping the momentum with the E11A Paediatric Extrapolation.
Katarzyna Kolasa, PhD
- Professor of Health Economics, Head of Dept. of Health Economics and Health Mgmt
- Kozminski University, Poland
Kolasa has more than 20 years of academic and occupational experience in the healthcare sector. Her practical skills in the field of health economics were developed during six years employment contract at the Kalmar County Council in Sweden. For the last four years she has been developing experience with the pricing & reimbursement challenges in the field of medical devices. She holds a PhD degree in health economics and is an author of scientific IF publications in the field of health technology assessment and pharmacoeconomics. Nominated by the Ministry of Science to represent Poland in the COST Action CA17117, COST Association. Since Jan 2019, she is co-chair of Global Special Interest Group for Digital Health establish at ISPOR.
- Policy Officer, Unit D4 – Health Technology and Cosmetics
- DG GROW, European Commission, Belgium
Vincent Houdry is a pharmacist by training and started his carrier in the pharmaceutical industry. Then he became pharmacist inspector for the French Ministry for health where he occupied several positions: in the Drug Agency, in the regional office in Bordeaux, in the social security directorate of the Ministry. After two years in the unit in charge of health threats in DG SANTE as a seconded national expert, he became technical advisor in the cabinet of the Minister for health, in charge of drugs, medical devices, and biology. After that, he became health attaché at the French Permanent representation in Brussels. Since July 2016, he works for the European Commission in DG GROW on the implementation of the Regulations on medical devices.
Michael Berntgen, PhD
- Head of Scientific Evidence Generation Department
- European Medicines Agency, Netherlands
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification, support to medicines for the paediatric population & for orphan diseases, provision of expertise & support in translational sciences. The department monitors the portfolio related to human medicines, manages the PRIME scheme and facilitates collaboration with downstream decision-makers, to foster timely access to medicines. Michael is a pharmacist with a PhD and a Master of Regulatory Affairs. From 1999 to 2006, he worked in the industry in Germany and the UK.
- Head of Sector, HTA, Directorate General Health and Food Safety (DG SANTE)
- European Commission, Belgium
Flora is a pharmacist by training. She is heading the team on Health Technology Assessment, at the European Commission, DG Health (SANTE), Unit "Medical products: quality, safety and innovation". The team is responsible for the recently adopted Proposal for a Regulation on HTA, for the Secretariat to the HTA Network, and it oversees the activities of the Joint Action EUnetHTA. Joined the EC in 2006 in (now) DG CNECT, she worked in the ICT for Health Unit. Before joining the EC she was Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.
Nanna Borup Johansen
- Senior Medical Officer
- Danish Medicines Agency, Denmark
Dr. Johansen has a PhD in clinical epidemiology from University of Copenhagen and has been working in the field of clinical pharmacology, diabetology and epidemiology for several years. During her career, Dr. Johansen has gotten extensive insight into the use of several data sources e.g. the Danish National Patient Register, National Prescription Register and the National Health Insurance Register in policy- and decision-making. In 2018, Dr. Johansen joined the Danish Medicines Agency, the department of medical evaluation and biostatistics as Senior Medical Officer.
William Malbecq, DrSc
- Head of Biostatistics Europe
- MSD, Belgium
William Malbecq is Executive Director, Biostatistics at MSD. He has worked for over 34 years in statistics within the pharmaceutical industry, in support of drug development mostly at MSD. He manages the global HTA-Statistics team located in Europe and is the regional head of BARDS-Europe (Biostatistics and Research Decision Sciences – Europe). In his present role, he leads a group of statisticians who develop scientifically based arguments aiming to provide fair accessibility to MSD drugs and vaccines making a real difference in patient’s lives. Malbecq holds a DSc in Mathematics/Statistics from the University of Brussels. His research interests are in survival analysis, longitudinal data and indirect treatment comparisons.
- Janssen, United Kingdom
Paul McCleverty is currently the EMEA regional lead for the oncology therapeutic area in J&J. Outside of Janssen he is a member of the EC Expert Committee on Cancer Control, has recently worked on the Efpia MAPPs working party and is leading the Efpia initative on disease interception. He has worked within the pharmaceutical industry in both discovery and development for over 20 years at Astra Zeneca, Pfizer, GSK and Janssen. After 7 years in R&D Paul transferred to regulatory. For the last 18 years he has been a regional / global team leader in multiple therapeutic areas including cardiovascular, metabolic, antifungals, antivirals, antibiotics, pain, GU, GI, ophthalmology, neuroscience and oncology.
- Team Leader eHealth, Unit B3 - Cross Border Healthcare & eHealth, DG SANTE
- European Commission, Belgium
Katja Neubauer holds a master degree in biology. She is a senior official in the European Commission and has worked for 18 years in the Commission's Directorate-General for Health, in positions both in the food safety and health area, including deputy Head of Unit for Healthcare Systems for over 4 years. In her current position as Senior Expert for eHealth and Digital Single Market, she leads a team in charge of innovation in healthcare (eHealth). The team is developing a system for cross-border exchange of patient data and runs the eHealth Network of EU Member States' high officials promoting digital healthcare. She also implements communication on digital transformation of health and care that the commission adopted in April 2018.
- Head of the Directorate Pharmaceutical Policy
- National Institute for Health and Disability Insurance (RIZIV-INAMI), Belgium
Francis Arickx is 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. He manages administrative and scientific assessments, and appraisal of reimbursement claims for medicines, orphan drugs, and medical nutrition. Francis is former secretary general for the Commission for Reimbursement of Medicines and represents the Institute and Belgium on national and European platforms. He coordinates the BeNeLuxA Initiative. Francis graduated in pharmaceutical sciences from the University of Ghent. He teaches Health Policy in the Pharmaceutical Sciences Department at the University of Antwerp.
- Regional Director Medical Affairs Europe
- MSD, France
- Head of Medical Device Assessment Department
- French National Authority for Health (HAS), France
Hubert Galmiche is pharmacist. He holds a master's degree in clinical pharmacology and is specialised in evaluation and negotiation of health products and services. Galmiche started his career at the French Agency for the Safety of health products in the assessment of drugs before joining French National Authority for Health (HAS). He has more than 15 years of working experience in the medical device sector. Galmiche leads a team at HAS which is in charge of assessing medical devices for the French National Medical Device and Health Technology Evaluation Committee.
- Scientific Project Manager
- Haute Autorité De Santé (HAS), France
- Consultant Clinical Adviser, Observational Data Unit
- National Institute for Health and Care Excellence (NICE), United Kingdom
Dr. Hannah Patrick has worked as Consultant Clinical Adviser at NICE since 2008. She works part time as a clinical haematologist. Prior to joining NICE, she worked as a public health physician in South Africa and then in Bexley, London. Through working at NICE Dr. Patrick has gained extensive specialist experience in the commissioning and use of observational data to inform national guidance development. For the last 3 years she has been working on six ‘Commissioning through Evaluation’ projects for the NHS England. Moreover, Dr. Patrick has worked part time as a haematologist in London. The clinical work has provided her valuable insights into practical challenges to real world data collection.
Anja Schiel, PhD
- Senior Adviser/Statistician, Unit for HTA and Reimbursement
- Norwegian Medicines Agency (NoMA), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc on a range of subjects focusing on oncology, immunology and molecular biology, first at the University of Leiden and later at the University of Oslo, before starting at the Norwegian Medicines Agency (NoMA) in 2013. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of the Biostatistics Working Party for the last 3 years and currently is the Chair of the Scientific Advice Working Party at EMA.
Chris Chinn, MSc
- Head of Real World Data Strategy and Partnerships
- Sanofi, United Kingdom
In his current role within Sanofi’s Global Health Economic and Value Assessment group, Chris leads on the use of real world data to support market access over the lifecycle of medicines, including in development. He is the co-chair of the EFPIA Real World Evidence Community group. Chris graduated from Oxford University with a degree in Biochemistry; is a qualified chartered accountant and has a Masters in Health Economics from City University, London. Over the last 20 years he has also lead health outcomes groups and real world evidence projects at SmithKline Beecham, Lilly, and GlaxoSmithKline.
- Treatment Information and Access Director, Health Policy Advisor
- European Organisation for Rare Diseases (EURODIS), France
François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, Policy Advisor. He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases since 2003. He represents EURORDIS at the Patients’ and Consumers’ Working Party at the European Medicines Agency (EMA) where he is topic leader for pharmacovigilance. He is member of the Web-RADR Management Board (adverse drug reactions reporting tools). François is also a patient.
- Senior Health Economist/Health Services Researcher
- Department of Health Sciences, University of York, United Kingdom
Cynthia Iglesias is senior health economist at the Department of Health Sciences, University of York; and Professor at the Department of Business and Management, Aalborg University. She has a first degree in Actuary, National Autonomous University of Mexico; and both a MSc in Health Economics and a PhD in Health Sciences from the University of York. Her main areas of interest are health technology assessment, economic evaluation of medical devices, uncertainty characterisation and Bayesian statistical methods for economic evaluation. She is particularly interested in the contribution of these methods to healthcare policy decision making. Cynthia is one of the two health economists at the Medical Technologies Advisory Committee at NICE.
Thomas Metcalfe, MBA
- Data Policy Leader, Personalised Healthcare
- F. Hoffmann-La Roche, Switzerland
Tom Metcalfe graduated in Biochem from King's in London and has an MBA from the Open University. He currently works as a Data Policy Leader in Roche Pharma's Personalised Healthcare Centre of Excellence. Prior to that he worked for Roche as a Strategic Innovation Leader in Global Development from 2015 to 2018. He served as CEO of Oncotest GmbH, a CRO providing preclinical profiling services in Oncology from 2011 to 2104 and worked for Roche Pharma and Diagnostics in a variety of roles from 1993 to 2011 including as Head of the Personalised Healthcare Portfolio and the Roche Biomarker Program.
- Scientific Assessor
- G-BA, Germany
Dr. Marco Petschulies studied pharmacy at the universities of Tuebingen, Germany, and Hamburg, Germany. During his dissertation between 2009 and 2013 he had worked as a research fellow at the Institute of Pharmacy of the University of Hamburg, Germany. Since 2013 he is working at the Pharmaceutical Department of the Federal Joint Committee in Berlin, where he gives advice to pharmaceutical companies and is involved in the early benefit assessment of new drugs. Marco also had a coordinating role in several European advice procedures.
- GB-A (Gemeinsamer Bundesausschuss), Germany
Meriem Bouslouk-Marx (PhD in dentistry, MSc International Health) joined the Pharmaceuticals Department of Germany’s top health policy body, the Federal Joint Committee (G-BA), in 2011 and has worked on the implementation of AMNOG, the Act on the Reform of the Market for Medicinal Products, from the start. Her main responsibilities included conducting consultations with industry on clinical study design and appropriate comparators, assessing reports by the Institute for Quality and Efficiency in Health Care (IQWiG), and drafting G-BA resolutions under AMNOG which became binding amendments to the German Pharmaceutical Directive. During this time, she conceptualised and co-ordinated the health policy procedure for orphan drugs at the G-BA.
Sini Eskola, MPharm, MSc
- Director Regulatory Affairs
- European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.
- Patient Advocate
- EURORDIS, France
Inés Hernando joined EURORDIS as ERN and Healthcare Director in February 2018. She monitors the European landscape on rare disease healthcare from a policy and advocacy perspective. Inés supports the establishment of European Reference Networks (ERNs) leading the EURORDIS team that manages the 24 European Patient Advocacy Groups (ePAGs). Previously she worked for two years at COCIR as eHealth Senior Manager where she led the organisation's work on digital health. She also worked for eight years in the Spanish Electronic Health Record initiative as eHealth Coordinator where she provided overall programme management. Inés holds a Master’s in Health Economics, Policy and Management from the London School of Economics.
Edith Frenoy, MA, MSc
- Director Market Access, HTA policy lead
- EFPIA, Belgium
Edith Frénoy is Director Market Access, HTA policy lead at the European Federation of Pharmaceutical Industries and Associations, the representative voice of R&D-based pharmaceutical industry in Europe. She is in charge of driving the industry strategy on HTA at European level, as well as several key EFPIA priorities in the field of pricing and reimbursement and market access of pharmaceuticals and orphan medicines. She joined EFPIA in 2007. She holds a Master of Science in Health Economics from the London School of Economics, as well as a Master of Arts in European Studies from the College of Europe.
Ansgar Hebborn, PhD, MBA
- Head European Access Policy Affairs
- F. Hoffmann-La Roche AG, Switzerland
Ansgar Hebborn is Roche Pharma's Head of European Access Policy Affairs. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.