Value, Access and Regulatory Strategy Workshop
Solange Corriol-Rohou, DrMed, MD, PhD
- Senior Director, Global Regulatory Affairs & Policy, Europe
- AstraZeneca Global Medicines Development, France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004. Moving from the French Medicines Agency and hospital to the Pharmaceutical Industry, she has gained strategic experience in drug development. As the chair of the Clinical Development Expert Group at EFPIA (the European Federation of Pharmaceutical Industries and Associations, she has organized several workshops with the European Medicines Agency (EMA). She is currently the deputy topic leader of the IMI ADAPT SMART project. She has joined ICH (International Conference of Harmonization), where the revision of the ICH E11 paediatric guideline recently completed, and will keep the momentum with the paediatric extrapolation topic.
Angelika Joos, MPharm
- Executive Director, Global Regulatory Policy
- MSD (Europe) Inc., Belgium
Angelika Joos is working within the Global Regulatory Policy departement based in Europe and is responsible for monitoring and implementing Regulatory Policies & Procedures and advising the company on Regulatory strategies. She is delegate to several trade association working groups and her main interests are related to Paediatrics, Clinical Trials, PV and HTA.
Katarzyna Kolasa, DrSc
- Principal Senior Consultant, Market Access
- Straub Medical AG, Switzerland
Since May 2017, Katarzyna Kolasa is a Principal Senior Consultant Market Access working for the Swiss company operating in the field of endovascular systems, Straub Medical. Before that, Katarzyna was a Senior HEOR Director at GE Healthcare. In the past, she worked for pharma industry for more than ten years in both global and regional HEOR functions at AstraZeneca and BiogenIdec, Bristol Myers Squibb and Lunbeck. She is a university teacher and holds PhD in health economics. She is an author of the number of publications in the field of health technology assessment and pharmacoeconomics. Katarzyna is a reviewer for manuscripts submitted to Health Policy, Value in Health, Expert Review of Pharmacoeconomics & Out-comes Research and others.
Mira Pavlovic, DrMed, MS
- Medicines Development and Training (MDT) Services, France
Mira Pavlovic is expert in dermatology, regulatory science and health technology assessment (HTA). Mira was Head of Scientific Advice at the French Medicines Agency and a member of Scientific Advice Working Party (SAWP), Efficacy Working Party, Biosimilar Medicinal Products Working Party at the EMA. As a Vice Chair of SAWP, she reviewed more than 1000 scientific advices in 10 years. In 2010 Mira was nominated Deputy Director for HTA at the Haute Autorité de Santé, France. Mira also coordinated the Shaping European Early Dialogues project, financed by European Commission to support early dialogues as a permanent activity in Europe. Since September 2015 she consults on clinical drug development strategies as member of the NDA Advisory Board.
Claudine Sapède, PharmD, MSc
- Global HTA & Payment Policy Lead
- F. Hoffmann-La Roche, Switzerland
Claudine Sapède is Global HTA and Payment Policy Lead at Roche based in Basel. She works on the development of Roche’s external policy positions and projects on market access related subjects including HTA and pricing. She has been working in the field of reimbursement, market access and pricing for more than 20 years both at national and international levels. She is a very active participant in the IMI Adapt-Smart project where she co-leads the workstream on managed entry agreements.
- Treatment Information and Access Director, Health Policy Advisor
- EURORDIS, 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). He is involved in the IMI-Web-RADR project (data mining tool in social media, med app to report adverse drug reactions) and advisor to the SCOPE Joint Action Advisory Group (Strengthening Cooperation on Pharmacovigilance in Europe). François is also a patient.
François Meyer, MD
- Advisor to the President, International Affairs
- French National Authority for Health (HAS), France
François Meyer joined the HAS in 2005 as Director of the Health Technology Assessment (HTA) Division. He took his current position of Advisor to the President, in charge of International affairs in 2011. Dr Meyer has been involved in the European cooperation on HTA (EUnetHTA) since its launch and has been a member of the Board of Directors of HTAi, the international society for HTA from 2011 till 2017. He earned his MD from the University of Montpellier and served the teaching hospitals of Montpellier as a practicing physician qualified in Endocrinology and Internal Medicine. He worked then 5 years in the R&D department of an international pharmaceutical company. From 1997 to 2005 he held various positions at the French Medicines Agency.
Richard Barker, PhD
- Founding Director
- Centre for the Advancement of Sustainable Medical Innovation (CASMI), United Kingdom
Richard is an internationally respected leader in healthcare and life sciences. He is the Founding Director of New Medicine Partners, a global firm assisting public and private sector organisations to accelerate the development and adoption of precision medicine. He also founded the Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), a major UK academic initiative aimed at bringing biomedical advances more rapidly and affordably to patients. He is chairman of the South London Health Innovation Network, and of Image Analysis, and is a board member of Celgene. His books ‘2030 - The Future of Medicine: Avoiding a Medical Meltdown’ and ‘Bioscience – lost in translation?’ are published by the Oxford University Press.
Antje Behring, PhD
- Team Lead, Early Benefit Assessment, Pharmaceuticals Department
- Federal Joint Committee (G-BA), Germany
Antje Behring is a pharmacist, working for the G-BA since 2011. She is team lead of the team “early benefit assessment” in the G-BA Pharmaceuticals Division. Before joining the G-BA, Antje worked as a consultant pharmacist for a health insurance company. Prior to working in the pharmaceutical area, she worked as a physical therapist in hospitals and outpatient offices.
Michael Berntgen, PhD
- Head of Product Development Scientific Support Department
- European Medicines Agency, European Union, United Kingdom
Michael Berntgen is Head of Product Development Scientific Support at the EMA. This department aims at facilitating timely availability of safe and effective medicines by promoting development, research and innovation. The activities include collaboration with other decision makers to support that relevant data for later medicine evaluation is generated. 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. In 2006 he joined the German competent authority BfArM and subsequently moved to the EMA in 2007, where he held different positions in medicine evaluation before taking over his current role in development support in September 2016.
Jacoline Bouvy, PhD
- Scientific Adviser, Science Policy and Research Programme
- National Institute for Health and Care Excellence (NICE), United Kingdom
Jacoline Bouvy is a health economist specialising in the interface between marketing authorisation and health technology assessment (HTA) of medicines. She works at the National Institute for Health and Care Excellence (NICE) in London within the Science, Policy & Research team for several research projects on topics such as adaptive pathways and big data for better outcomes in Alzheimer’s disease. Before joining NICE, Jacoline worked at the European Medicines Agency where she was involved in the EMA registries initiative. Before that, she held postdoctoral positions at Erasmus University Rotterdam and Utrecht University in the Netherlands where she worked on various drug regulatory science and health economics topics.
Olivier Chassany, MD, PhD
- Professor, Director, Patient-Reported Outcomes & Clinical Endpoints Research
- University Paris-Diderot, France
Professor of Therapeutics and specialist physician in Gastroenterology, Prof. Chassany teaches Therapeutics, Methodology, Management & Ethics of clinical research, critical reading of publications, and Patient-Reported Outcomes at the University Paris-Diderot. He has been chair of a Parisian Ethics Committee. Furthermore, he has been the medical representative of the AP-HP academic sponsor (Department of Clinical Research) for more than 10 years and acted for the recognition of several simplifications in the clinical trials regulation, such as the risk-based approach. He leads an academic research team (EA 7334) on methodology of Clinical Outcomes Assessment, and optimization of healthcare between hospital and general practice.
Elin Haf Davies, BSN, PhD
- aparito, United Kingdom
Elin Haf Davies PhD began her career as a Children’s Nurse, before going on to gain her PhD at University College London. She was part of the paediatric team at the European Medicine Agency responsible for implementing the Paediatric Regulation in Europe. After 6 years as a regulator Elin left to start aparito, a digital health company providing remote patient monitoring specifically for clinical trials. Elin is also part of the IMI consortium ADAPTSMART, focusing on adaptive pathways.
Rosa Giuliani, MD
- Consultant in Medical Oncology, S. Camillo-Forlanini Hospital, Italy
- European Society for Medical Oncology (ESMO), Switzerland
Rosa Giuliani is a consultant in medical oncology at S. Camillo-Forlanini Hospital in Rome. Her main fields of interest include metastatic breast cancer and clinical and regulatory development of innovative drugs. Dr Giuliani is a member of the ESMO EU Policy Committee, and she represents ESMO both in the EMA Healthcare Professional Working Party (HCPWP) and in the stakeholder forum of the Health Technology Assessment Network (HTAN). She serves as core member of the EMA Scientific Advisory Group on Oncology (SAG-O). Dr Giuliani firmly believes that rationale drug development and early dialogue between stakeholders are key prerequisites for timely, equitable and affordable delivery of innovative drugs and medical technologies.
- Executive Director
- Statistical Methodology and Consulting Group, Novartis Pharma AG, Switzerland
Professor Byron Jones is a Senior Biometrical Fellow and Executive Director in the Statistical Methodology and Consulting Group at Novartis Pharma AG in Basel, Switzerland. He is a Visiting Professor in the Department of Health Sciences, University of Leicester and a Visiting Professorial Fellow in the School of Mathematics at Queen Mary College, University of London. For the 25 years before joining the pharmaceutical industry, he worked in academia, ultimately holding the position of Professor of Medical Statistics at De Montfort University. He is the joint author of four statistical textbooks and over 110 peer-reviewed publications. He serves on several University Advisory Boards including Oxford University's Department of Statistics.
Stefan Lange, MD
- Deputy Director
- Institute for Quality and Efficiency in Health Care (IQWiG), Germany
Stefan Lange completed his medical studies at the Heinrich-Heine-University in Düsseldorf in 1989 and received his MD in 1994. From 1989-1993 he was initially in practical training at the Ferdinand-Sauerbruch-Clinic in Wuppertal, then assumed the position of intern/resident physician. In 1993 he joined the department of medical biometry at the Ruhr-University in Bochum and was appointed to the position of research assistant in 1995. In 2003 he received his Habilitation (qualification for a professorship) and venia legendi (title of Privatdozent) in Medical Biometry and Clinical Epidemiology. He joined the Institute for Quality and Efficiency in Health Care in 2004, and has held the position of Deputy Director of the institute since 2005.
- VP, Global Regulatory Affairs, TA Head, Oncology and InVitro Diagnostics
- Global Regulatory Affairs & Clinical Safety, Merck, United States
Julie Lepin is the VP and TA head of Oncology and IVD at Merck/MSD, leading a team of Global Regulatory Leaders responsible for progressing the oncology portfolio through all stages of development and registration. Of note, Keytruda, the first immunotherapy to be approved in the USA is the leading late stage program driving extensive regulatory activities including breakthrough therapy designations, orphan drug designations, and new indications including the pioneering pan-tumor indication recently approved in the USA. Julie has over 20 years of experience in regulatory affairs, across regions, therapeutic areas, all phases of development, with extensive leadership responsibilities of varying groups including global teams and affiliates.
Leeza Osipenko, PhD, MSc
- Head of Scientific Advice
- National Institute for Health and Care Excellence (NICE), United Kingdom
Leeza joined NICE in 2012 and has been leading the Scientific Advice (SA) service since 2014. She works closely with EMA, MHRA, and European HTA agencies. Leeza holds an Honorary Fellow post at the University of Warwick Medical School, Senior Visiting Fellow post at London School of Economics and represents NICE as a Chief Analyst at the Department of Health Appraisal Alignment Working Group. She is a reviewer at a number of academic journals. After completing a PhD in Systems Engineering, Leeza was a Senior Research Fellow at the University of Warwick, and between 2010 and 2012 she worked as Principal Economist at a public sector consultancy, Optimity Matrix.
Stephane Regnier, PhD
- Head of HEOR Excellence, Global Patient Access
- Novartis Pharmaceuticals, Switzerland
Stephane is the head of HEOR Excellence. The HEOR Excellence team provides innovative HEOR solutions, methodologic support and strategic recommendations to the Global Patient Access franchises. Stephane joined Novartis in 2005 in the US. He worked in US Marketing Science, in New Product Analysis and in Pricing and Contracting. In Basel, he was Global Pricing Director for the Vaccines division and, then, HEOR Director for Lucentis. Prior to joining Novartis, Stephane worked at ZS Associates in Paris and Chicago. Stephane holds an Engineering degree from Ecole Centrale Paris (France), an M.B.A. from the Kellogg School of Management at Northwestern University (USA) and a PhD in Health Economics from the University of Neuchâtel (Switzerland).
Michael Schröter, PhD, MBA
- Head of Personalised Reimbursement Models, Global Pricing and Market Access
- F. Hoffmann-La Roche, Switzerland
Michael Schröter, Head Personalised Reimbursement Models (PRM), Global Pricing and Market Access at Roche, focuses on enabling flexible pricing solutions through use of Real World Data. Prior to his current role Michael held various positions in Europe, US and Asia with pharma and biotech companies in the area of business development and general management. Michael holds a PhD in Biochemistry from the University of Lausanne, Switzerland and an MBA from IMD, Switzerland.
Beatriz Silva Lima, PharmD, PhD
- Professor of Pharmacology; NDA Advisory Board Member
- University of Lisbon, Portugal
i) Coordinates the Group of Pharmacological Sciences of the iMed.ULisboa, ii) for 20 years acted as expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK iii) has been (end July 2012) member of CHMP, CAT and SAWP and Chair of Safety Working Party and EU Co-Deputy in ICH M3R2, S6R1 and S1 guidelines. She consults on nonclinical drug development and is member of the NDA Advisory Board. She Chairs the Scientific Committee of the Innovative Medicines Initiative. Beatriz integrates the implementation Group of EUPATI (European Patient Academy) Portugal, and is a member of the Steering Committee and the Executive Committee of EUPATI National Platform.
Kristin Svanqvist, MPharm
- Head of Unit for HTA and Reimbursement
- Norwegian Medicines Agency (NoMA), Norway
Kristin Svanqvist is head of Unit for HTA and Reimbursement at the Norwegian Medicines Agency (NoMa). She is MPharm and has a co-position at the University of Tromsø, Norway, at the department of Pharmacy in the research group of Clinical Pharmacy and Pharmacoepidemiology. The mission of The Norwegian Medicines Agency is to evolve and safeguard public and animal health by ensuring the efficacy, quality and safety of medicines. The Agency is also the decision making body for reimbursement for out-patients in Norway and the provider of HTA evaluations for pharmaceuticals to be used in hospitals. NoMa is participating in the EuNetHTA collaboration. Svanqvist has been with the Agency since 2004.
Radek Wasiak, PhD, MA
- Vice President and General Manager, Real-World Evidence and Meta Research
- Evidera, United Kingdom
Dr Wasiak has extensive applied research experience in designing and executing RWE studies. In addition to managing global RWE team at Evidera, he routinely contributes to conceptualizing advanced study designs of observational studies, with a main focus on European data sources. His past and ongoing research includes analyses aimed at evaluating burden of illness or effectiveness of health care interventions related to such therapeutic areas as oncology, pain, infectious diseases, and women’s health.
Vladimir Zah, PhD
- Chief Executive Officer, ZRx Outcomes Research Inc., Canada
- Research member, ISPOR Health Science Policy Council, Serbia
Dr Zah brings more than 20 years of Health Ecoonomics, technology and business experience. Since 2000, in various roles as Health Economist, Project Manager and Chief Investigator, Vlad has implemented more than 180 health economic models and assessments in the phase 2-4 setting across various disease areas for top 20 global pharmaceutical and medical device companies. His PhD research on early vs. late HIV detection in the UK contributed to revisions in HIV early detection policies made by the UK Parliament in 2011. He co-founded the Serbian ISPOR Chapter in 2007 and served as president until 2012. Vlad is ISPOR Central East Europe Executive Committee Chair 2015-17, Health Policy Council member and Meeting Travel Grants Committee chair.