Emer Cooke, MSc
EMA, Amsterdam, Netherlands
Emer Cooke is as of 16 November 2020 the new Executive Director of the European Medicines Agency, based in Amsterdam.
She also takes the role of Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA).
She was the Director responsible for all medical product-related regulatory activities at the World Health Organization in Geneva between November 2016 and November 2020. In this role, Ms Cooke was responsible for leading WHO's global work on regulation of health technologies (medicines, vaccines, diagnostics, vector control products and devices), coordinating the regulatory teams (Prequalification, Regulatory Systems Strengthening, and Safety), and working with member states and international partners to assure the quality, safety and efficacy of appropriate health technologies.
Ms. Cooke is a pharmacist with Masters degrees in Science and Business Administration from Trinity College Dublin. She has over 30 years’ experience in international regulatory affairs and spent 14 years (2002 to 2016) in management positions at the European Medicines Agency as Head of Inspections and Head of International Affairs respectively. From September 1998 to July 2002, she worked in the Pharmaceuticals unit of the European Commission.
Iga Lipska, MD, PhD, MPH
Medical University of Gdańsk, Clinical Trials Center, Warsaw, Poland
Iga Lipska is a Medical Doctor by education with Master of Science in public health. She graduated from the University of Utrecht in the Netherlands, where she defended her PhD thesis on health technology assessment of new medicines.
Iga has broad international and Polish experience in the healthcare sector, with a main focus on HTA at national and hospital level, drug pricing and reimbursement, health insurance, public health and evidence-based decision making process in health care.
She contributed her efforts significantly to the role of HTA in evidence based decision making processes on pharmaceutical reimbursement in Poland. She played a major role in HTA capacity building in Poland supporting the establishment of Polish national HTA Agency.
She also contributed her leadership and networking skills to the implementation of HTA in Central Eastern Europe and internationally advising in e.g. Croatia, Moldovia, Bulgaria, Turkey.
She served in variety of managerial roles in public and private sector supporting evidence based decision making in health care in Poland and abroad. She was the Director of Drug Policy and Pharmacy Department at Ministry of Health, the Director of HTA Department at Polish HTA Agency and the Director of Control Department at National Health Fund (public payer in Poland). She negotiated pharmaceutical reimbursement prices and Risk Sharing Schemes on behalf of Minister of Health while being the Economic Committee Member. She supported the establishment of global HTA benchmarking program at Center for Innovation in Regulatory Science in London, UK.
She has been co-chairing ISPOR HTA Roundtable Europe for 3 years’ term (from 2019 to the end of 2022).
Starting June 2022 she has been co-chairing HB-HTA Interest Group at Health Technology Assessment international for 3 years’ term.
Recently she has been affiliated to Medical University of Gdańsk which is also her Alma Mater.
She has just been nominated the Chairwoman of the Board at Health Policy Institute in Poland with her main role to contribute to evidence based policy in health care and build capacity in that area based on her international and national experience.
Ministry of Health, Madrid, Spain
Dr Martín Saborido is a Health Economist working on HTA economic evaluation and RWE applied to HTA. He has been working as research associate at the Spanish Health Technology Assessment Agency mainly doing HTA reports and in the Regional HTA Unit in Madrid as health economics research fellow. Internationally, Dr Martin has been working in the Liverpool Review and Implementation Group (University of Liverpool) in UK assessing economic evaluations on behalf of NICE and doing HTA reports for the NIHR Health Technology Assessment programme. He worked as Public Health Economist in the Joint Research Centre (European Commission) developing economic evaluations in the public health frame. At the private sector. also worked at several Pharma Consultancies as RTI Health Solutions and World Health Management. In the academic ground, he has lectured Statistics, Research Methods and Economic Evaluation of Health Technologies, mentoring and guiding several PhD and MSc thesis. In 2020 gained a permanent position as Scientific Officer in the Department of Health Economics at the National School of Public Health in Madrid.
In April 2021 was appointed as Advisory member at the Ministry of Health in DG of Common NHS Portfolio and Pharmacy, working on the evaluation of new drugs reimbursement applications.
Rui Santos Ivo, PharmD
INFARMED, Lisbon, Portugal
Rui Santos Ivo is currently President of INFARMED – National Authority of Medicines and Health Products, I.P. (since June 2019) and an invited Associate Professor of Medicines Regulation, at the University of Lisbon Faculty of Pharmacy since 2009.
He is member of the Management Board of the European Medicines Agency (EMA) since March 2016, Vice-chair of the Valletta Permanent Technical Committee/Valletta Declaration, since July 2017, Chair of the Heads of HTA Agencies Group (HAG), since September 2021.
Along the years, at the Ministry of Health in Portugal, he held various functions, namely: Vice-president of INFARMED (2016/2019), President (2014/2016) and Vice-President (2011/2014) of the Central Administration of the Health System (ACSS, IP) and he served as President (2002-2005) and vice-president (1994-2000) of INFARMED.
In 2000-2002 he was Administrator at the Directorate of the EMA, in London, and in 2006-2008 in the European Commission, Pharmaceuticals Unit of the Directorate General for Enterprise and Industry, in Brussels.
He was the first Chairman of the European Union Heads of Medicines Agencies Management Group (2004/2005) and, between the years 2008 and 2011, he was Executive Director of the Portuguese Association of the Pharmaceutical Industry (APIFARMA).
Rui Santos Ivo initiated his professional career as a hospital pharmacist at Lisbon Egas Moniz Hospital (today part of CHLO-Hospital Centre Lisbon West) and in 1993 he joined INFARMED, where he initiated functions at the Licensing and Inspectorate Department.
Rui Santos Ivo graduated in Pharmaceutical Sciences by the University of Lisbon in 1987. Specialist in Hospital Pharmacy by the Ministry of Health (1992) and the Pharmaceutical Society (2006) and in Pharmaceutical Regulation by the Portuguese Pharmaceutical Society (1997). Post graduate education on Health Law and Pharmaceutical Legislation (by the University of Lisbon Faculty of Law and National School of Public Health), Pharmaceutical Medicine (by the University of Basel), Regulation (by the London School of Economics and Political Science) and on Health Management (by the Portuguese Catholic University, in 2000, and by AESE Business School, in 2015).
He was granted with the Almofariz Prize - Personality of the Year in the Pharmaceutical Sector (2004), recognized, in France, as European Correspondent Member of the Académie de Pharmacie (2014) and, for distinguished Services, he was awarded with Gold Medal of the Ministry of Health (2015).
With both the EMA and FDA committed to using real-world evidence (RWE) to support medical-product regulatory decision making and increasing interest by both in patient-centered endpoints, there is need to understand if and how this work can be done across countries. Several current initiatives will be discussed that can provide insights to inform future work:
The DARWIN (Data Analytics and Real-World Interrogation Network)-EU initiative aims to coordinate the gathering of evidence on the use, safety, and effectiveness of medicines across the EU. It can provide insights on how to handle the capture of patient-reported data for symptom and health-related quality of life improvements across borders.
Beginning with the landmark Patient Reported Outcomes Measurement (PROMs) programme in the English NHS, other health care funders are also embedding generic (e.g., EQ-5D) and condition-specific patient reported outcomes in routine outcomes measurement (ROM). We review key learnings from implementation of large-scale PRO data collection in the real world, including the OECD’s Patient-Reported Indicators Surveys (PaRIS) initiative, and consider scalability across the EU.
Core outcomes sets (COS) have been posited to help overcome difficulties when comparing trial results due to differing endpoints across trials. More recently, patient-centered core impact sets (PC-CIS) were proposed to overcome lack of patient centricity across a wide range of activities such as outcome and endpoint selection, protocol development, PRO measure development and selection; regulatory decision making; etc. Might PC-CIS and subsequent COS be developed internationally to improve both patient centricity and standardization across studies?
Speakers will discuss advances and lessons learned for capturing patient-centric data and whether doing so across borders is realistic to aid in effectiveness evaluation of new medicines.
Tara Symonds, PhD
Clinical Outcomes Solutions Ltd, Folkestone, Kent, KEN, United Kingdom
Tara Symonds is the Clinical Outcomes Assessment (COA) strategic lead & chief science officer at Clinical Outcomes Solutions providing advice on COA strategy from development to dissemination. Tara has more than 25 years of experience in the development and implementation of COAs for use in clinical research. Her areas of interest and expertise are in qualitative research, ePRO/BYOD (Bring Your Own Device), and application of PRO measures in comparative effectiveness research by incorporation into electronic medical records and registries. Many of the questionnaires and screening tools she has worked on, can be accessed at: www.pfizerpatientreportedoutcomes.com. She has worked across numerous therapeutic areas and has extensive expertise in sexual health, women’s health, pain, respiratory and rare diseases. She worked in industry for 16 years, her final assignment was to set-up and lead the PRO Center of Excellence at Pfizer. Tara has much experience in negotiating COA labelling at both FDA and EMA and in formulating best positioning of COA data for maximizing reimbursement with EU and US payers. Tara has also previously worked in academia teaching undergraduate and postgraduate psychology. She has published more than 80 peer reviewed articles and is co-author of the following book: “Cappelleri et al (2014) Patient Reported Outcomes: Measurement, Implementation and Interpretation, CRC Press.” Tara holds a Doctorate in Health Psychology from the University of Huddersfield, UK.
Nancy Devlin, PhD
University of Melbourne, Melbourne, VIC, Australia
Nancy is Professor of Health Economics at the University of Melbourne and Senior Fellow at the Office of Health Economics, London. She is Chair of the Board of the EuroQol Research Foundation and served as President of ISPOR (2019-2020). Her principal areas of research expertise are the measurement and valuation of patient reported health outcomes; the cost effectiveness thresholds used in making judgments about value for money in health care; and priority setting in health care. She is currently leading a large programme of research to improve measurement and valuation of quality of life in children (QUOKKA), funded by the Medical Research Future Fund (Australia). Nancy has published >150 original peer reviewed journal papers on a wide range of empirical and theoretical topics in health economics.
Juan García Burgos, MD
European Medicines Agency, Amsterdam, NH, Netherlands
Juan García Burgos is a Qualified Medical Doctor from the University of Autonoma in Madrid, specialised in urology. Juan worked as a urologist surgeon at the hospital Gregorio Maranon in Madrid. He joined the European Medicines Agency in 2002 in the scientific Units and was responsible for coordinating the preparation of EU clinical guidelines for drug development. He took up new responsibilities in 2005 where he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and HealthCare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences.
In January 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.
Eleanor M. Perfetto, PhD, RPh, MS
University of Maryland School of Pharmacy, Baltimore, MD, USA