Value, Access and Regulatory Strategy Workshop
Solange Corriol-Rohou, DrMed, MD, PhD
- Senior Director, Global Regulatory Affairs & Policy, Europe
- AstraZeneca Global Medicines Development, France
Chest physician and allergist by training, Solange held different positions in R&D prior to joining Regulatory Affairs following 6 years at the French Medicines Agency, Afssaps. She joined AstraZeneca R&D in March 2004 and is also involved in IMI and ICH activities. She currently chairs the EFPIA Clinical Efficacy Expert Group.
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
- Senior Project Sales Director, Health Economics & Outcomes Research, Eastern Eur
- GE Healthcare, Poland
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 & Outcomes 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.
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.
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.
Frank Bretz, PhD
- Global Head of Statistical Methodology and Consulting Group
- Novartis Pharma AG, Switzerland
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has contributed to the methodological development of clinical trials in various areas, such as adaptive designs and model-based drug development, and has recently shifted part of his focus towards bridging evidence for health decision making beyond randomized controlled trials.
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
- Founder/ CEO
- 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.
Stefan Lange, MD, PhD
- 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 PhD (second thesis) at the Ruhr University and received the venia legendi (right to teach) 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.
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.
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.