People developing PREFER recommendations
The work drafting recommendations is carried out by a large group of researchers from universities, industry, patient organisations and HTA bodies. Most of them have already been involved in the work on methodologies and case studies leading up to this.
Isabelle Huys, deputy coordinator and public lead for 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, private lead for 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, public co-lead for recommendations
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.
Mirielle Muller, private co-lead for recommendations
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.
Patient input to recommendations work
The patient input to the work on recommendations is led by the European Cancer Patients Coalition (ECPC) together with Muscular Dystrophy UK (MDUK) and the European Patients Forum (EPF).
Isabelle Manneh-Vangramberen, ECPC
Isabelle Manneh-Vangramberen leads patient input on PREFER and has worked with patients and patient empowerment for the last decade. She is ECPC's Projects Coordinator / Manager and is currently the appointed executive body for all EU funded projects participating in several European Union's Research and Innovation framework programmes in addition to working on 3 principal EU Policy files: the European Cross Border Health Directive, the General Data Protection Regulation, and Health Technology Assessment. She holds a double Bachelor of Science in Pharmacy and Pharmaceutical Sciences, a Master degree in Public Health, in addition to a post-master in European Studies specialising in EU Policy & Project Management.
Francesco De Lorenzo, ECPC
Francesco De Lorenzo (ECPC) provides input on PREFER work on methodology, clinical case studies and the recommendations coming out of the project. Professor Francesco De Lorenzo is ECPC’s President and colon cancer survivor. He is medical doctor and professor of biochemistry from the University Federico II Naples. Furthermore, Prof. De Lorenzo has a rich experience in cancer advocacy being the co-founder, former Vice-President and Board member of ECPC. He is also the founder and President of the Italian Association of Cancer Patients (AIMaC), Italy's first Cancer Information Service (CIS), and of the Italian Federation of Cancer Patients Organisations (FAVO). Prof. De Lorenzo is very active in Italy's governmental network of cancer Institutes (ACC), Italy's National Cancer Plan Committee, and the National Volunteer Observatory of the Italian Welfare Ministry. He was previously engaged in Italian politics as a Member of Parliament, holding several ministerial mandates (Ministry of Health, 1989-1993).
Jenny Sharpe, MDUK
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
Valentina Strammielloas (EPF) is part of the PREFER patient stakeholder advisory group.
Researchers who are doing the work
- Angelo Paradiso, Istituto Tumori of Bari
- Antonio Ciaglia, International Alliance of Patient Organisations
- Ardine de Wit, UMC Utrecht
- Axel Hueber, University of Erlangen
- Bennett Levitan, Janssen
- Berkeley Phillips, Pfizer
- Bruno Flamion, Actelion Pharmaceuticals
- Cathy Anne Pinto, Merck, Sharpe & Dome
- Christelle Boeynaems, Sanofi
- Dario Monzani, European Institute of Oncology
- Eline van Overbeeke, Katholieke Universiteit Leuven
- Elisabeth Wood, Newcastle University
- Emily Freeman, Abbvie
- Emma Du Four, Abbvie
- Esteban Herrero-Martinez, Abbvie
- Esther de Bekker-Grob, Erasmus University Rotterdam & Erasmus University Medical Centre
- Francesco De Lorenzo, European Cancer Patient Coalition
- Francesco Florindi, European Cancer Patient Coalition
- Georges Quartey, Roche
- Gwenda Simons, University of Birmingham
- Hanns Lochmueller, Newcastle University
- Irina Cleemput, Belgian Health Care Knowledge Centre
- Isabelle Huys, Katholieke Universiteit Leuven
- Isabelle Manneh-Vangramberen, European Cancer Patient Coalition
- Isabelle Stoeckert, Bayer
- Jenny Sharpe, Muscular Dystrophy UK
- Jorien Veldwijk, Erasmus University Rotterdam
- Jürgen Kuebler, CSL Behring
- Karim Raza, University of Birmingham
- Lydia Makaroff, European Cancer Patient Coalition
- Marie Falahee, University of Birmingham
- Marloes Van-Bruggen, Roche
- Mats Ericson, Amgen
- Matthias Englbrecht, University of Erlangen
- Matthias Gottwald, Bayer
- Mazzocco Ketti, European Institute of Oncology
- Meredith Smith, Amgen
- Mireille Collombat, Actelion Pharmaceuticals
- Mireille Muller, Novartis
- Nigel Cook, Novartis
- Reinhard Fescharek, CSL Behring
- Richard Hermann, AstraZeneca
- Rosanne Janssens, Katholieke Universiteit Leuven
- Sarah Verschueren, MindBytes
- Sheila Dickinson, Novartis
- Stephen Watt, Pfizer
- Susan Longman, Novartis
- Taisa Paluch-Kassenberg, Astellas
- Tarek Hammad, Merck KGaA
- Ulrik Kihlbom, Uppsala University
- Valentina Strammiello, European Patient Forum