Strategic project management

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.
 

Conny Berlin is Global Head of Quantitative Safety and Epidemiology at Novartis Pharma AG. Her responsibilities include promoting a quantitative safety and epidemiology 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. Conny Berlin holds a degree in mathematics from the University of Rostock, Germany. Since joining Novartis in 2007, she has led several initiatives to improve signal detection, safety and benefit-risk evaluation. She is a member of the company’s Medical Safety Review Board and of the Benefit-Risk Steering Committee.

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.

Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly and Company.  Since joining Lilly in 2002, 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 IMI PROTECT WP, CIRS’s Task Force on Benefit-Risk Assessment, the ICH, and via multiple other forums such as the Institute of Medicine and DIA. 

Sheila Dickinson, MSc in Medical Statistics, has led a team supporting implementation of a structured benefit-risk approach in Novartis Pharma, in particular for submissions. This has included work on templates and training for use by teams using a structured benefit-risk approach, and also development and delivery of broad training on benefit-risk for a more general audience within the company. She has also worked directly with a project team to support their use of structured benefit-risk for a submission. She has worked in the pharmaceutical industry for over 20 years.

Josepine Fernow is communications manager for PREFER. She also leads communications works packages in two H2020 projects, SIENNA (Stakeholder-Informed Ethics for New technologies with high socio-ecoNomic and human rights impAct) and STARBIOS2 (Structural Tranformation to Attain Responsible BIOSciences). She works at Uppsala University's Centre for Research Ethics & Bioethics (CRB), where she coordinates communication activities.

Dr Susan Bhatti (Merck KGaA) has worked in Regulatory Affairs in various roles for over 20 years and joined Global Regulatory Affairs at Merck in 2013. She has many years’ experience of clinical trials as well as project management and now works closely with representatives of pharmaceutical associations in her role as Director EU Global Regulatory and Scientific Policy. Susan Bhatti is resoponsible for PREFER key performance indicators.

Carl Steinbeißer (Steinbeißer Project Management) has done project management of EC funded project for 6 years and is specialised on IMI projects. He consulted and managed large life science projects such as Cancer-ID (IMI), OncoTrack (IMI),  ENS@T-Cancer (FP7) and ESGI (FP7). He holds an MA in European Ethnology and History and has also worked as a product manager for a publishing company. Carl Steinbeßer is responsible for operational project management in PREFER.

Monika Brand (Actelion Pharmaceuticals) has worked for more than 20 years in the industry and build up extensive experience in design, conduct, reporting of epidemiology/observational studies including Post Authorisation Safety Studies in response to regulatory needs. Monika Brand is leading the data management work in PREFER.

Josepine Fernow is communications manager for PREFER. She also leads communications works packages in two H2020 projects, SIENNA (Stakeholder-Informed Ethics for New technologies with high socio-ecoNomic and human rights impAct) and STARBIOS2 (Structural Tranformation to Attain Responsible BIOSciences). She works at Uppsala University's Centre for Research Ethics & Bioethics (CRB), where she coordinates communication activities.

Kristin E. Bullok, PhD, is part of the communications group within PREFER.  She has 10 years of experience in the pharmaceutical industry at Eli Lilly and Company, based in Indianapolis, Indiana in the US.  She currently is a consultant on the science of benefit and risk assessment, which has allowed participation in strategy development and benefit-risk patient preference research. Her previous roles within scientific communications, both within and outside of the pharmaceutical industry, provided in-depth experience creating communications to regulatory agencies, as well as to the public and scientific community. 

Aina Errando (ECPC) assists in the communication of partnerships and EU research projects. She liaises with partners and supports the overall organisation of events. Aina Errando also works on communication campaigns to empower cancer patients. She is a graduate of Journalism and holds a MSc in Political Science: European and International Governance as well as an Advanced Master’s degree in European Integration. 

Gudrun Briat is responsible for the communication of Belgian Health Care Knowledge Centre (KCE) reports through the organisation’s website, press contacts, social media, etc. She is also involved in making the syntheses of KCE’s scientific reports accessible for a larger public. Gudrun participated in the activities of the work package on “dissemination” of the Joint Action 2 of EunetHTA. Her activities in that work package were related to setting up a Community of Practice for dissemination of study results. Gudrun Briat is involved in the PREFER communication for the dissemination of study results to the HTA community.

Anna Holm works as a communications officer in PREFER. She joined Uppsala University's Centre for Research Ethics & Bioethics (CRB) in January 2018. She supports PREFER in everything from poster production to evaluating and reporting communication efforts. 

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.

Gudrun Briat is responsible for the communication of Belgian Health Care Knowledge Centre (KCE) reports through the organisation’s website, press contacts, social media, etc. She is also involved in making the syntheses of KCE’s scientific reports accessible for a larger public. Gudrun participated in the activities of the work package on “dissemination” of the Joint Action 2 of EunetHTA. Her activities in that work package were related to setting up a Community of Practice for dissemination of study results. Gudrun Briat is involved in the PREFER communication for the dissemination of study results to the HTA community.

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. 

Ziede Burage (IAPO) provides patient input to PREFER’s methodology and recommendations. She also contributes toward the IMI-GetReal Initiative project. Ziede is IAPO’s Policy Manager and is leading policy development and research activities to ensure patients' voice is better heard in health policy making at global and regional levels. Before joining IAPO, Ziede worked at several international health NGOs and, most recently, at Cancer Research UK on policy development and research grants management. Ziede holds a Master in Human Rights from the City University London.

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

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.