Antonella Cardone is the CEO of Cancer Patients Europe, a pan-European all-cancer patient association. She's a Patient Advocacy Expert and Advisor to the Board of Pancreatic Cancer Europe (PCE), uniting physicians, patients, politicians, journalists, academia, and industry, and she is a member of Inspire2Live. Antonella led the European Cancer Patient Coalition and served as Executive Director of the Fit for Work Global Alliance. With 25 years of nonprofit experience in health, social, and employment sectors, she also directed the Global Smoke-free Partnership of the American Cancer Society. Antonella holds Master's degrees in Science and Business Administration. She has been on the Boards of All.Can and PCE, where she was vice-chair.

Jürgen joined Bayer AG in 1992 as statistician.Jürgen was appointed Head of Global Statistical Science in 2004. Effective September 1, 2005 Jürgen joint Novartis Pharma in Switzerland, where he most recently held a position as Global Head, Statistical Safety Sciences. In November 2011 Jürgen joined CSL Behring where he most recently hold the position of Global Head, Quantitative Safety Sciences. In January 2017 he started his consultancy business.Jürgen has published in statistical and scientific journals, regularly gives scientific presentations and organized various sessions at scientific conferences.

Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification to trials of all sizes. Her division covers a wide variety of therapeutic areas. She works across FDA on patient focused drug development and rare disease initiatives, master protocols, and other programs. Prior to working at the FDA, she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.

Mireille Muller Ph.D. has over 25 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, expedited regulatory pathways, and innovative clinical trials such as innovative clinical trial designs, decentralised trials and digital health systems. Involved in several public private partnerships IHI/IMI programs and pre-competitive collaboration.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Isabelle Huys has a PhD in pharmaceutical sciences from KU Leuven (Belgium) and an LLM in IPR and regulatory sciences from the Max-Planck-Institute (Munich, Germany). Since 2010, she is a full-time professor in regulatory sciences at the Faculty of Pharmaceutical Sciences and a member of the Center for IT & Intellectual Property IT law (CiTiP) of KU Leuven. Isabelle Huys has been Advisor for European Projects, Intellectual Property Officer and Regional Development officer at the KU Leuven R&D department. She did post-doctoral research at the Law Faculty of KU Leuven on patents and biomedical inventions. Isabelle Huys is deputy co-ordinator of PREFER and also academic leader for the work package on recommendations.

Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the PhRMA BRAT Framework, the MDIC Patient-Centered B-R Framework, the IMI PREFER public-private partnership and ISPOR's Quantitative B-R Task Force. He serves on committees that inform B-R policy including MDIC's Science of Patient Input Project, the Brighton Collaboration BRAVATO Team and PhRMA's Patient-Focused Drug Development Work Group. He received a B.Sc. (Electrical Eng) from Columbia Univ and an M.D.-Ph.D. (Bioengineering) from the Univ of PA.

Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.

Mathieu Boudes, PhD, joined the European Patients’ Forum (EPF) in 2018 as coordinator of the PARADIGM project, a public-private partnership financed by the Innovative Medicines Initiative and co-led by EPF and EFPIA (European Federation of Pharmaceutical Industries and Associations). Strong of 34 partners (patient organisations, pharmaceutical / biotech companies, regulators, HTA bodies and academic teams), PARADIGM (for Patients Active in Research and Dialogues for an Improved Generation of Medicines) will strengthen the understanding of stakeholders’ needs, the systems-readiness, ensure maximum synergies with other initiatives and develop an inventive and workable sustainability roadmap.

Mats G. Hansson is Professor of Biomedical Ethics and Director of the Centre for Research Ethics & Bioethics (CRB) at Uppsala University. The Centre is a multi-disciplinary unit awarded for international excellence with long experience of managing large international projects. Mats Hansson received his first degree in Biology in 1974 and then moved into Theology, Philosophy, and Bioethics. He has led several multidisciplinary projects in bioethics, has published extensively in this area, and has ongoing collaborations in several European countries, partly associated with leading ethical, legal, and social issues work packages of eight EU-projects.

He serves as a member of the scientific advisory board of the Institute for Quality Assurance and Transparency in Healthcare (IQTiG) and a board member and chair of the International Academy of Health Preference Research (IAHPR). He currently serves as associate editor of Value in Health and on the editorial advisory board of the Journal of Choice Modelling (JOCM), PharmacoEconomics, Int. Journal of Integrated Care (IJIC) and The Patient – Patient Centered Outcomes Research. Axel Mu¨hlbacher is author of several books and more than 100 peer-reviewed articles.

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In 1999 he joined the European Medicines Agency (EMA) in London, UK. Since 2009, he has held the position of Head of Oncology, Haematology and Diagnostics in the Human Medicines Evaluation Division. In 2023 he was appointed as Scientific adviser for oncology. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

As the Deputy Director of the Office of Strategic Partnerships and Technology Innovation (OST), Dr. Tarver helps provide leadership for all scientific collaborative and emerging technology-related activities at the Center for Devices and Radiological Health (CDRH). The Patient Science and Engagement Program in OST fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Under her leadership, OST is advancing efforts to include diverse and underrepresented perspectives in the evaluation of medical devices through the Health of Women program and the Pediatric and Special Populations program.

Conny Berlin leads the department Quantitative Safety and Epidemiology at Novartis Pharma AG. Her responsibilities include supervising a team of statisticians and epidemiologists, providing epidemiology support for all clinical programs and promoting a quantitative safety culture which enables evaluation, understanding and communication of safety data and benefit-risk to support decision-making at all stages of the drug life-cycle.

Kevin Marsh is Vice President of Patient Centered Research (PCR) at Evidera. PCR has over 130 scientists dedicated to the integration of the patient's experience into product development. Kevin's specialism is in the use of patient preference data to inform health decisions, including pipeline optimisation, trial design, authorisation, reimbursement, and prescription decisions. He is a though leader in the use of patient preference data. He is currently co-chairing the ISPOR Health Preference SIG, and has co-chaired taskforces and working groups for ISPOR. He has recently led the development of StudyGage, a preference-data based tool to allow sponsors to simulate participation rates in clinical studies.

Ilene L. Hollin, PhD is currently an Assistant Professor in the Department of Health Services Administration and Policy within the College of Public Health at Temple University. Dr. Hollin earned her PhD in Health Economics and Policy from the Johns Hopkins Bloomberg School of Public Health and her MPH in Effectiveness and Outcomes Research from the Columbia University Mailman School of Public Health. Dr. Hollin’s research interests include patient-centered decision-making and the value of health technologies. She is passionate about incorporating the patient perspective in all aspects of healthcare, research, and policy. Dr. Hollin’s research interests include patient-centered decision-making including patient and care-g

Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA Benefit-Risk Action Team (BRAT), the Innovative Medicines Initiative PROTECT project, the International Conference on Harmonization, and via multiple other forums.

Irina Cleemput is Scientific Programme director at the Belgian Health Care Knowledge Centre (KCE). She graduated as PhD in Health Economics at the KULeuven in 2003. On behalf of KCE, Irina co-led the work package on recommendations and chairs the stakeholder advisory group for HTA bodies and payers in PREFER, an international study about incorporating patient preferences in the medical product development life cycle. Currently she leads the NEED project (Needs Examination, Evaluation and Dissemination), an initiative of KCE and Sciensano to identify and assess unmet patient and societal needs in healthcare, in order to move from supply-driven to more needs-driven innovation and policy in healthcare.

Sheila has an in-depth understanding of the topic of patient preferences through several leadership roles and key contributions to the 5.5-year IMI PREFER project which addressed the question of why, when and how to assess and use patient preferences in medical product decision-making. She has been instrumental in developing the PREFER framework for patient preference studies as industry lead. In addition, Sheila has deep expertise in structured benefit-risk and was recognized with a Novartis Leading Scientist Award for her work in this area. She spearheaded the implementation of structured benefit-risk at Novartis to address regulatory expectations and to ensure alignment with the ICHM4E(R2) guidance.

Dr Falahee is an academic psychologist and Lecturer in Behavioural Rheumatology at the University of Birmingham. Her research focuses on patient perceptions and preferences, patient reported outcomes, and the development of strategies to improve clinical outcomes for individuals with or at risk of inflammatory conditions. Dr Falahee is passionate about patient and public involvement in research, and leads the Rheumatology Research Patient Partnership at the University of Birmingham.

Rosanne Janssens is a post-doctoral researcher at the KU Leuven in Belgium, in the Regulatory Sciences & Pharmaco-Economics research unit. Her research interests and activities are focused on investigating policy and multi-stakeholder challenges and solutions towards optimizing drug development, regulatory, and Health Technology Assessment (HTA) decision-making frameworks spanning across the medicinal product life cycle. During her PhD, she derived methodological and policy-related recommendations regarding the design, conduct and use of patient preference studies for informing drug development, regulatory and HTA decisions. Rosanne holds a Master's degree in Biomedical Sciences (KU Leuven, 2016, summa cum laude).

Valentina Strammiello is currently the Director of Programmes at the European Patients Forum where she has been working for the past ten years. She oversees the EPF project portfolio and represents EPF in HTA and health data related activities.Before joining EPF, Valentina worked as freelance OSINT analyst on Security and Energy issues. Self-trained in website management and web 2.0 applications, she is among the founders of ecpa2.0 (European Centre for Public Affairs 2.0), a forum of young professionals in Public Affairs. She holds a BA in International Relations and a Master’s Degree in European Studies.

Mother of two, co-founder of a non-profit organization KARKINAKI, dedicated to support pediatric cancer research, account manager of The ad case, a content & advertising provider. Strong planner and problem solver who readily adapts to change, works in groups, team player and exceeds expectations. Able to juggle multiple priorities and meet tight deadlines without compromising quality. A book-lover. A volunteer. Member of Board of PANCARE PanEuropean Network for Care of Survivors after Childhood and Adolescent Cancer (www.pancare.eu) Member of Childhood Cancer International Europe and member of the Research & Innovation Group of CCI Europe Member Visit my profile at https://www.linkedin.com/in/menia-koukougianni.