Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI/IHI, and passionate about paediatric drug development, rare/ultra-rare diseases and drug development optimisation.

Angelika Joos is a trained pharmacist. She 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 the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.

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.

Mira Pavlovic is the Founder of Medicines Development and Training Services (Paris, France) and Associate Professor for Regulatory and HTA science at Lisbon University (Portugal). Mira consults on clinical drug development strategies for market access purposes as a member of the NDA Advisory Board, providing scientific advice and 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 Vice-Chair of SAWP at the EMA. She was also Deputy Director for HTA and international affairs at the Haute Autorité de Santé, France, where she coordinated HTA early dialogues and work on common methodology of relative effectiveness assessment in Europe.

Claudine Sapède is Director, Global HTA Policy at Novartis. In this role, she focuses on value assessment, HTA and reimbursement decision-making approaches and their impact on patient access to innovative treatments. She engages with internal and external stakeholders involved in shaping HTA, pricing and reimbursement decisions. Claudine is currently a member of the EFPIA market access and HTA working groups, leading the workstream related to the implementation of the EU HTA Reg. Prior to this, she had different roles in the field of pricing and market access, at country and global levels. Her career of over 20 y in the pharma sector spans the full spectrum of evidence generation, value demonstration, MA strategies, pricing, and policy.

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

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 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 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, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

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.

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 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 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.

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 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.

Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around the world. She specializes in biological products in oncology and recently joined Merck as Vice President of Regulatory for Oncology, Immunology and In vitro diagnostics.

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 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 is a managing partner at Viopas, a venture capital and asset management firm investing in privately held and listed companies with a sustainable healthcare focus. As such Viopas favours investments in solutions which deliver cost-effective and improved clinical outcomes. Prior to Viopas, Michael was head of personalized reimbursement models (PRM) at Roche, responsible for implementing value-based pricing approaches globally. He was chair of the EFPIA combination pricing working group. Before that role, Michael held various senior management positions in R&D and business development at Roche, Eli Lilly and in Biotech. Michael holds a PhD in biochemistry from the University of Lausanne and an MBA from IMD.

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, 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.

Radek Wasiak, PhD is Chief Data Officer & Head of Europe at Cytel. As Chief Data Officer, he is in charge of developing and implementing Cytel’s informatics strategy for identifying and using a continuum of data assets to support the business, from clinical trial to e-health data and deploying these data via product portfolio. As Head of Europe, he provides strategic oversight and executive leadership to European business including input into communication, compensation, hiring, retention, facilities and benefits.

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.