People developing PREFER recommendations

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.

Jürgen Kübler holds a PhD in Statistics from the University of Dortmund, Germany. He is a consultant for quantitative sciences and represents CSL Behring GmbH in Marburg, Germany. He has almost 25 years of experience in the pharmaceutical industry in both expert and managerial roles at Bayer Pharmaceuticals, Novartis Pharmaceuticals and CSL Behring. Throughout his career, Jürgen Kübler has continued to be active in the scientific community, e.g., the International Biometric Society and the Drug Information Association. His research is focused in statistical approaches in safety analyses.

Irina Cleemput is senior health economist at the Belgian Health Care Knowledge Centre (KCE) since 2004.   Through KCE, she has been involved in EUnetHTA from the very beginning of the network. Currently, KCE is co-leading the work package on “Quality management, methodological guidance and tools”. In PREFER, Irina is coordinating the HTA and Payers Stakeholder Advisory Group and co-leading work package 4 on recommendations. Irina will also participate in the other work packages of PREFER.

Mireille Muller currently holds the position of Regulatory Policy Director at Novartis and has over 18 years of experience in regulatory affairs working with regulatory agencies at the global level, including policy, benefit-risk research, drug development and general knowledge of HTA requirements. Benefit-risk assessments throughout the development life cycle, closely connected to clinical teams, integrating assessment and use of patient reported outcomes. Specific interest in early development clinical trials, scientific advice, and technology-enabled clinical trials. She was a lecturer at the University of Montréal for Master of DRA. Member of EFPIA’s CDEG and of DIA and TOPRA. Mireille Muller holds a PhD in organic chemistry, MSc in supramolecular chemistry, MSc in molecular pharmacology.

Antonella Cardone (ECPC) is the Director of the European Cancer Patient Coalition, the largest cancer patient umbrella organization in Europe with over 450 members from 48 countries. She has 25 years of experience working for non-profits in health, social and employment sectors. Prior to ECPC, Antonella Cardone was the Executive Director of the Fit for Work Global Alliance, a multi-stakeholder coalition championing change in health and work policy. She has previously served as the Director of the Global Smoke-free Partnership of the American Cancer Society, leading a movement of over 100 members to coordinate the development of smoke-free laws in 40 countries. She holds a Master’s in Science and one in Business Administration. She currently represents ECPC on the Board of Pancreatic Cancer Europe, in which she is vice-chair, and she is also Board Member of All.Can, an international multi-stakeholder not-for-profit organisation working to improve the efficiency of cancer care. 

Jenny Sharpe (MDUK) leads the patient input in the clinical case studies. She also gives input to PREFER communications, methodology and recommendations. Jenny is MDUK’s Research Communications Officer and is primarily responsible for translating research findings into a language that patients can understand. This involves engaging with a range of people, including scientists, industry representatives, clinicians, and individuals and families affected by neuromuscular conditions. Prior to joining MDUK, she completed a PhD in mitochondrial biology at University College London.

Valentina Strammielloas (EPF) is part of the PREFER patient stakeholder advisory group.